united states court of appeals for the fourth circuit 36-1 intervenor... · 2019-12-20 · united...

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 19-2130 (L) (8:18-cv-00883-PWG)

In re: CIGAR ASSOCIATION OF AMERICA; CIGAR RIGHTS OF AMERICA; PREMIUM CIGAR ASSOCIATION, f/k/a International Premium Cigar and Pipe Retailers Association

Appellants ___________________________________________________

AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTER-AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; CAMPAIGN FOR TOBACCO-FREE KIDS; TRUTH INITIATIVE; DR. LEAH BRASCH, MD; DR. CYNTHIA FISHMAN, MD; DR. LINDA GOLDSTEIN, MD; DR. STEVEN HIRSCH, MD; DR. DAVID MYLES, MD

Plaintiffs – Appellees

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E. SHARPLESS, in his official capacity as Acting Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services

Defendants

USCA4 Appeal: 19-2130 Doc: 36-1 Filed: 12/13/2019 Pg: 1 of 30 Total Pages:(1 of 215)

No. 19-2132 (8:18-cv-00883-PWG)

AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTER-AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; CAMPAIGN FOR TOBACCO-FREE KIDS; TRUTH INITIATIVE; DR. LEAH BRASCH, MD; DR. CYNTHIA FISHMAN, MD; DR. LINDA GOLDSTEIN, MD; DR. STEVEN HIRSCH, MD; DR. DAVID MYLES, MD


v.

AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION; AMERICAN VAPING ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- CALIFORNIA; ARIZONA SMOKE FREE BUSINESS ALLIANCE; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- CONNECTICUT; INDIANA SMOKE FREE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- HAWAII; IOWANS FOR ALTERNATIVE TO SMOKING AND TOBACCO; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- LOUISIANA; KENTUCKY SMOKE FREE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- RHODE ISLAND; MARYLAND VAPOR ALLIANCE; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- TEXAS; NEW YORK STATE VAPOR ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- WISCONSIN; OHIO VAPOR TRADE ASSOCIATION; RIGHT TO BE SMOKE-FREE COALITION; SMOKE FREE ALTERNATIVES TRADE ASSOCIATION; TENNESSEE SMOKE FREE ASSOCIATION; TEXAS VAPOR COALITION

Intervenors – Appellants

and


UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E. SHARPLESS, in his official capacity as Acting Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services

Defendants

No. 19-2198 (8:18-cv-00883-PWG)

AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; LEAH BRASCH, MD; CAMPAIGN FOR TOBACCO-FREE KIDS; CYNTHIA FISHMAN, MD; LINDA GOLDSTEIN, MD; STEVEN HIRSCH, MD; DAVID MYLES, MD; TRUTH INITIATIVE; MARYLAND CHAPTER- AMERICAN ACADEMY OF PEDIATRICS


v.

UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E. SHARPLESS, in his official capacity as Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services

Defendants – Appellants

No. 19-2242 (8:18-cv-00883-PWG)

In re: AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION; AMERICAN VAPING ASSOCIATION; ARIZONA SMOKE FREE BUSINESS ALLIANCE; INDIANA SMOKE FREE ASSOCIATION; IOWANS FOR ALTERNATIVE TO SMOKING AND TOBACCO;


KENTUCKY SMOKE FREE ASSOCIATION; MARYLAND VAPOR ALLIANCE; NEW YORK STATE VAPOR ASSOCIATION; OHIO VAPOR TRADE ASSOCIATION; RIGHT TO BE SMOKE-FREE COALITION; SMOKE FREE ALTERNATIVES TRADE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- CALIFORNIA; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- CONNECTICUT; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- HAWAII; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- LOUISIANA; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- RHODE ISLAND; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- TEXAS; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- WISCONSIN; TENNESSEE SMOKE FREE ASSOCIATION; TEXAS VAPOR COALITION

Appellants

___________________________________________________

AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; LEAH BRASCH; CAMPAIGN FOR TOBACCO-FREE KIDS; CYNTHIA FISHMAN; LINDA GOLDSTEIN; STEVEN HIRSCH; DAVID MYLES; MARYLAND CHAPTER- AMERICAN ACADEMY OF PEDIATRICS; TRUTH INITIATIVE


v.

UNITED STATES FOOD AND DRUG ADMINISTRATION; SCOTT GOTTLIEB, in his Official capacity as Commissioner of Food and Drugs; NORMAN E. SHARPLESS, in his Official capacity as Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services; AMERICAN ASSOCIATION FOR RESPIRATORY CARE

Defendants


On Appeal from the United States District Court for the District of Maryland

INTERVENORS-APPELLANTS’ MOTION TO STAY PENDING APPEAL AND TO EXPEDITE CONSIDERATION ON THE MERITS

Respectfully submitted,

/s Eric P. GottingKELLER AND HECKMAN LLP 1001 G Street, N.W. Suite 500 West Washington, D.C. 20001(202) 434-4269 (phone) (202) 434-4646 (fax) [email protected]

Counsel for Intervenors-Appellants


1

Pursuant to Fed. R. App. P. 8 and Local Rule 12(c), Intervenors-Appellants,

trade associations representing small businesses that manufacture e-cigarette

(“vapor”) products, respectfully request a stay of several district court decisions on

appeal and expedited consideration on the merits as discussed below.1

The district court held in a Merits Decision (Ex. A) that Defendant Food and

Drug Administration (“FDA”) violated stakeholders’ procedural rights to notice

and comment rulemaking under the Administrative Procedure Act (“APA”), 5

U.S.C. §553, when it issued guidance setting an August 2022 deadline for

manufacturers to file Premarket Tobacco Product Applications (“PMTAs”)

pursuant to the Family Smoking Prevention and Tobacco Control Act, Pub. L. No.

11-31, 123 Stat. 1776 (2009) (“TCA”). The court vacated the guidance and

required FDA to comply with notice and comment procedures when exercising its

discretion to set a new deadline. However, only weeks later in a Remedies Order

(Ex. B), the court stripped manufacturers of these procedural rights and imposed a

May 12, 2020 deadline without remand, giving manufacturers only 10 months to

complete PMTAs that will take years to finish. This is not permitted under settled

law. A stay and expedition are thus necessary to prevent thousands of businesses

1 Intervenors-Appellants notified the other parties of this motion under Local Rule 27(a). Appellants cigar associations consent. Plaintiffs-Appellees will oppose. Defendants take no position pending review of the motion. Intervenors-Appellants intend to file a reply.


2

from shutting down in May 2020 and clearing the market of products that countless

adult smokers rely on to move away from more dangerous cigarettes.

The trade associations’ members are small U.S. businesses, many of them

“Mom and Pop” shops. Ex. C at ⁋18. They make and sell e-liquids used in

refillable open-systems that adult smokers use in lieu of cigarettes. FDA, the

National Academies of Sciences, the British Government, and many other experts

have found vapor products, which do not burn tobacco leaf, to be significantly less

risky than inhaling smoke and tar from combustible cigarettes. ECF #37-1 at 1-2.

These manufacturers do not produce pre-filled pod systems like JUUL that have

driven underage use.2 Ex. D at ⁋9; Ex. E at 2.

Manufacturers must file PMTAs with FDA and obtain approval to remain on

the market. 21 U.S.C. §387j(a). PMTAs are time-consuming, costly, and

complex. They require substantial amounts of information for each product to

assess human health and population-level impacts—e.g., extensive testing on

constituents, toxicological and pharmacological properties, and storage/stability

performance, as well as consumer perception studies, environmental assessments,

and literature reviews. ECF #37-1 at 18-19. PMTAs must also include long-term

2 FDA and Centers for Disease Control (“CDC”) have determined that the recent outbreak of “vaping” related lung illnesses is being driven by illicit tetrahydrocannabinol (“THC”) products containing vitamin E acetate. See FDA at https://tinyurl.com/y3bgtdtx; CDC at https://tinyurl.com/sxx48th. Commercial nicotine products do not contain THC or vitamin E acetate.


3

data from clinical and epidemiological studies showing the product is “appropriate

for the protection of the public health.” 21 U.S.C. §387j(c). This “population

effects” standard assesses the product’s impact on the population as whole,

including the likelihood people will stop using tobacco products (i.e., cessation) or

start using them (i.e., initiation). Id. The PMTA process is so onerous that FDA

has rejected 98% of the applications filed to date as incomplete. Ex. F at ⁋5.

Beginning with the 2016 Deeming Rule—the regulations implementing the

TCA (81 Fed. Reg. 28,973)—and through later guidance, FDA set and extended

the PMTA deadline. Manufacturers have reasonably relied on FDA’s many public

statements that, in the interim, it would develop further guidance and regulations

detailing the types of information required for PMTAs, and importantly, how to

conduct the extensive testing. Critically, that process is ongoing. Nevertheless,

Plaintiffs challenged the most recent deadline as violating APA’s notice and

comment procedures. The district court agreed, but then imposed its own deadline

without remand. While the court allowed the trade associations to intervene for

purposes of appeal, it denied their motion to stay. Exs. E, G.

BACKGROUND

The Deeming Rule initially established an August 8, 2018 deadline for vapor

products on the market as of August 8, 2016. If a timely PMTA was filed, the

product could remain on the market for up to an additional year pending FDA


4

review. 81 Fed. Reg. at 28,978. FDA concluded this approach balanced concerns

regarding underage use, manufacturers’ need for adequate time to comply and file

high-quality PMTAs, and, significantly, the recognition that vapor products may

help adults move away from more dangerous cigarettes. Id. at 28,977-78.

In July 2017, FDA extended the deadline to August 8, 2022 in guidance

finalized without APA notice and comment.3 Again, FDA highlighted the

importance of balancing competing interests. In addition to public health

considerations, FDA repeatedly stressed that it needed sufficient time to develop

additional “foundational” rules and guidance for manufacturers to follow when

navigating the complex PMTA process. FDA further noted that an extension was

necessary to avoid forcing vapor products off the market and depriving addicted

smokers of a potentially less risky alternative. And it reiterated the importance of

providing manufacturers adequate time to submit complete PMTAs. Products

meeting the deadline could remain on the market pending FDA review.

3 Gottlieb, S., FDA Commissioner, Protecting American Families: Comprehensive Approach to Nicotine and Tobacco (June 28, 2017) (speech transcript), available at https://tinyurl.com/v73kwdc; FDA, Extension of Certain Tobacco Product Compliance Deadlines Related to Final Deeming Rule (Guidance for Industry), at 4 (October 2017), available at https://tinyurl.com/qmurhsx.


5

Then, in March 2019, FDA issued draft guidance that proposed changing the

PMTA cutoff yet again, to August 8, 2021.4 This was done in response to recent

data showing increased underage use of certain types of vapor products. In doing

so, FDA again balanced concerns regarding minors with the potential benefit of

giving adult smokers non-combustible options to completely switch from

cigarettes. The draft guidance was never finalized.

Several months later, the district court issued its Merits Decision, vacating

the August 2017 guidance. Ex. A. Plaintiffs had argued that the August 2022

deadline constituted a legislative rule that was required to go through APA notice

and comment rulemaking. Id. at 41. The lower court agreed. Id. at 6. However, it

recognized that FDA has some discretion to set a PMTA filing deadline beyond the

Deeming Rule’s effective date. Id. at 8, 29-30. The court noted Plaintiffs have

long conceded this point. Id.

While the court determined that FDA’s discretion is “circumscribed by the

language of the TCA itself,” and therefore the August 2022 cutoff was set too far

into the future, id. at 45, the agency still has authority to establish a new deadline

provided it complies with APA notice and comment procedures. As the court

noted, “[a]ny Guidance providing for a compliance period will, of course, have to

4 FDA, Modifications to Compliance Policy for Certain Deemed Tobacco Products (Draft Guidance), at 12, 14 (March 2019), available at https://tinyurl.com/yyywgoat.


6

adhere to the notice and comment requirements of the APA.” Id. at 53; id. at 42

n.10 (“Because . . . [the guidance] . . . needed to follow the APA’s notice and

comment requirements, but failed to do so, I will grant Plaintiffs’ motion”); Ex. B

at 1 (FDA “violated the . . . APA . . . by issuing the [guidance] . . . without

following the APA’s notice and comment requirements”).

The district court then asked for briefing on a remedy. Ex. A at 53. At this

point, the Appellant trade associations moved to intervene in the remedies phase.

ECF #80. In support, they asserted the same interests identified by FDA when

establishing the prior compliance periods—namely, that a deadline should give

FDA time to clarify uncertainties in the PMTA process, provide manufacturers

with sufficient time to complete the costly and time-consuming applications, and

ensure there would be no mass exit of reduced harm products that adult smokers

rely on to move away from cigarettes. Id. at 2-3. However, the court denied the

motion, finding inter alia that FDA adequately represented the trade associations’

interests and, significantly, they would be protected going forward through

additional notice and comment. The court stated:

Indeed, any remedy will involve further action by the FDA, which may well have to comply with the APA notice and comment process. At such time, [the trade associations] would have ample opportunity to be heard regarding the deadlines the FDA proposes to implement and the opportunity to protect their interests.

ECF #84 at 2. The associations were, instead, granted amicus status. Id. at 3.


7

In its remedies brief, FDA initially urged the court to reject calls from

Plaintiffs to set a 4-month PMTA deadline with a one-year grace period for

products subject to timely filed applications and, instead, remand the issue for

further proceedings. Ex. B at 3, 6. An accompanying sworn affidavit from Mitch

Zeller, Director of FDA’s Center for Tobacco Products, expressed concerns with

such a short cutoff date. Ex. F. These included the risk of a “mass market exit” of

vapor products, which offer “a potentially less harmful alternative for adult

smokers seeking to transition or stay away from combustible tobacco products.”

Id. at ⁋15. FDA also reasserted that more time was required on several fronts, so

that it could finalize PMTA rules and guidance, manufacturers could complete the

complex PMTA process and file high-quality applications, and FDA could review

PMTAs within a statutorily-mandated 180-day period. Id. at ⁋⁋16-22.

Despite having pushed for a remand, FDA then did an about-face and

proposed a 10-month deadline, essentially making a settlement offer, arguing this

would better reflect stakeholder interests. Id. at ⁋13. But this deadline was based

on nothing more than Director Zeller’s own subjective belief and made without

any analysis or explanation of how a May 2020 cutoff would sufficiently address

or balance competing concerns. Id. at ⁋⁋13, 22. In fact, Director Zeller’s affidavit

was filed one day before the associations’ joint amicus brief, in which they

presented numerous reasons why a longer time-period would be required (ECF


8

#121-1 at 3-8). Needless to say, Director Zeller did not consider these comments

as FDA would have if the proposed compliance period had gone through notice

and comment rulemaking.

In response, the court ignored its prior decision and imposed the 10-month

deadline. Ex. B. It acknowledged that “[u]nder settled principles of administrative

law, when a court reviewing agency action determines that an agency made an

error of law, the court’s inquiry is at an end: the case must be remanded to the

agency for further action consistent with the corrected legal standards.” Id. at 5-6

(quoting PPG Indus. v. United States, 52 F.3d 363, 365 (D.C. Cir. 1995)).

However, the court stated that it may “issue detailed remedial orders” under

“extraordinary circumstances.” Id. at 6 (quoting N.C. Fisheries Ass’n v. Gutierrez,

550 F.3d 16, 20 (D.C. Cir. 2008)). It cited a recent rise in underage vaping as

constituting “extraordinary circumstances” and justifying a court-imposed

deadline. Ex. A at 10. Finally, the court found additional authority in the APA,

Sections 706(1) and (2). 5 U.S.C. §§ 706(1), (2).

Because the 10-month cutoff decidedly works against the interests of

manufacturers and adult smokers, the trade associations filed a motion to intervene

for purposes of appeal and to stay the decision. ECF #130. The court granted

intervention, finding that FDA’s views “have diverged” from those of the trade

associations, but denied the stay. Ex. G at 2, 5. This appeal followed.


9

STANDARD OF REVIEW

The trade associations must demonstrate: (i) they will likely prevail on the

merits; (ii) they will suffer irreparable injury without a stay; (iii) the other parties

will not be substantially harmed; and (iv) the public interest will be served by a

stay. Nken v. Holder, 556 U.S. 418, 426 (2009). These factors are satisfied here.

ARGUMENT

I. The District Court Improperly Imposed Injunctive Relief Without Remand For Notice And Comment

The trade associations are likely to succeed on the merits. The district court

made three relevant findings in the Merits Decision: (i) FDA committed a

procedural error under the APA when it adopted a PMTA compliance period

without notice and comment rulemaking (Ex. B at 6); (ii) FDA nevertheless

retained some discretion to set a shorter compliance period (id. at 8, 29); and (iii)

any future PMTA deadline must go through notice and comment proceedings (id.

at 53; ECF #84 at 2). The upshot of these holdings, however, is that the court did

not have authority to unilaterally adopt a 10-month deadline without remanding

back to FDA for further consideration.

Where a district court determines that an agency has acted unlawfully—i.e.,

committed a substantive legal error—the typical remedy is not for the court to

issue injunctive relief, but rather to remand to the agency. PPG Indus., 52 F.3d at

365 (stating as settled law that a court must remand when an agency has committed


10

legal error); Ex. B at 5-6 (district court conceding same). This is because a district

court is acting not as a trial court, but rather as an appellate tribunal. Bennett v.

Donovan, 703 F.3d 582, 589 (D.C. Cir. 2013); Hill Dermaceuticals, Inc. v. FDA,

709 F.3d 44, 46 n.1 (D.C. Cir. 2013).

This holds more true in cases involving procedural error, like the failure to

comply with the APA’s notice and comment requirements. Gurrola v. United

States, 751 F.3d 629, 634 (D.C. Cir. 2014); Am. Medical Ass’n v. Reno, 57 F.3d

1129, 1130-31 (D.C. Cir. 1995). And where the agency retains discretion to

consider an issue on remand, ordering injunctive relief is not permitted. Indeed,

APA Section 706(1) is the only provision that allows a court to “compel agency

action” unlawfully withheld. But as the Supreme Court made clear in Norton v. S.

Utah Wilderness Alliance, 542 U.S. 55, 65 (2004), this only applies where the

agency has no discretion to act. City of New York v. U.S. DoD, 913 F.3d 423, 432

(4th Cir. 2019) (same). Given the district court below concluded (and Plaintiffs

agreed) that FDA has discretion to set a new PMTA deadline, the court lacked

authority to impose the 10-month compliance period on its own.

Further, APA Section 706(2) does not save the district court. That provision

only allows a court to “set aside” unlawful agency action. The district court said it

did that here when vacating the August 2022 deadline as inconsistent with the

TCA. But to interpret Section 706(2) as further permitting injunctive relief,


11

particularly where the agency retains discretion in the matter, would be to read

Section 706(1) out of the statute and render Norton a dead letter. Hibbs v. Winn,

542 U.S. 88, 101 (2004) (courts must avoid rendering statutory terms inoperative

or superfluous). Indeed, as the D.C. Circuit held in Gurrola, when those two

provisions are read together, agency “discretion forecloses a detailed order” when

the “statutory failure was of notice and comment.” 751 F.3d at 634.

And courts take this approach for good reason. Notice and comment

“serve[s] important purposes of agency accountability and reasoned

decisionmaking.” Am. Medical Ass’n, 57 F.3d at 1132.

[It] allow[s] the agency to benefit from the experience and input of the parties who file comments . . . and to see to it that the agency maintains a flexible and open-minded attitude towards its own rules. The notice-and-comment procedure encourages public participation in the administrative process and educates the agency, thereby helping to ensure informed agency decisionmaking.

Chocolate Mfrs. Ass’n v. Block, 755 F.2d 1098, 1103 (4th Cir. 1985) (citations and

internal quotations omitted). In fact, the court initially ruled that manufacturers

would be able to avail themselves of these procedural rights on remand. But where

a court, as the district court eventually did here, steps into the shoes of the agency

and strips it of all discretion, any legitimacy accompanying notice and comment

rulemaking is completely lost.

It is more worrisome when a court adopts an agency’s litigation position in

lieu of notice and comment rulemaking. Conservation Northwest v. Sherman, 715


12

F.3d 1181, 1187 (9th Cir. 2013) (“a district court abuses its discretion when it

enters a consent decree that permanently and substantially amends an agency rule

that would have otherwise been subject to statutory rulemaking procedures”).

Here, the court absolved FDA of any accountability for setting a reasonable PMTA

deadline. The court, after finding that the August 2022 date failed to comply with

the APA, immediately reversed course and allowed FDA to circumvent the

rulemaking process through a litigation concession, thereby avoiding any

obligation to adequately justify the new deadline. Motor Vehicle Mfrs Ass’n v.

State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43-44, 52-53 (1983) (agencies must

consider all relevant factors and explain decisions).

Finally, the district court took the unprecedented step of relying on an

“extraordinary circumstances” exception that was briefly mentioned by the D.C.

Circuit in N.C. Fisheries Ass’n. Ex. B at 6. The district court cited no cases

affirmatively applying the exception or any Fourth Circuit decision that even

references the doctrine. In the few cases that have cited to it, the courts focused on

the authority of the agency and refused to order injunctive relief where the agency

retained some discretion on remand. See Gurrola, 751 F.3d at 634-35 (refusing to

impose on remand a specific tax refund procedure where the IRS retained

discretion to “design the [procedure’s] details”); Baptist Med. Ctr. v. Sebelius, 855

F. Supp. 2d 1, 3 (D.D.C. 2012) (refusing to dictate specific standards for


13

recalculating Medicare payments where agency was entitled to have an

“opportunity to reconsider the issues on remand”). Those courts took a narrow

approach and did not interpret the exception as encompassing public policy

considerations, a virtually limitless expansion adopted by the court here, that are

better addressed through agency decision-making.5

II. A Stay Is Required To Avoid A Mass Exit Of Products And The Filing Of Incomplete PMTAs

The manufacturers will suffer irreparable harm absent a stay. Under Fourth

Circuit law, the movant must make a “clear showing” that any harm is “neither

remote nor speculative, but actual and imminent.” Direx Israel, Ltd. v.

Breakthrough Med. Corp., 952 F.2d 802, 812 (4th Cir. 1991) (internal citations and

quotations omitted). Moreover, an alleged injury is considered irreparable if it

cannot be fully redressed with money damages after trial. Hughes Network Sys. v.

Interdigital Commc’ns Corp., 17 F.3d 691, 694 (4th Cir. 1994). Here, if the Court

remands the compliance period for notice and comment after the May 2020 PMTA

5 The Remedies Order also cited cases discussing a court’s equity powers, including the authority to extend statutory deadlines. Those cases are inapposite. None involved denying procedural rights to notice and comment rulemaking or depriving an agency of its discretionary authority. Ex. B at 5. Another case cited by the court—Coal. for Gov’t Procurement v. Fed. Prison Indus., Inc., 365 F.3d 435, 459-60, 474-75 (6th Cir. 2004)—is also off-point. Id. at 4-5. While the Sixth Circuit considered imposing injunctive relief (but ultimately did not), it also considered at the same time preserving some discretion for the agency to exercise on remand, unlike the district court here. Id.


14

deadline has passed, but without having issued a stay, the associations’ members

will have suffered one of two injuries: (i) thousands of small manufacturers will

have been forced out of business; and (ii) any remaining manufacturers meeting

the filing deadline will likely have submitted incomplete PMTAs.

Before the district court, the associations presented evidence as amici

showing that a 10-month deadline would not provide sufficient time to file

compliant PMTAs. First, even if manufacturers began conducting long-term

clinical and epidemiological studies in August 2016, when the Deeming Rule was

adopted, many would still not be done. 21 U.S.C. §387j(c). Based on a PMTA

expert’s review of federally-funded tobacco research, the average time to complete

clinical and epidemiological studies was 6.67 and 5.11 years, respectively. Ex. H

at ⁋10. Indeed, FDA’s own epidemiological (“PATH”) study of tobacco and e-

cigarette use has taken eight years and is still ongoing. Id. at ⁋⁋14-16. Clearly,

manufacturers will not be able include this data in PMTAs filed in May 2020.

Second, equally troubling is that there remain significant uncertainties

regarding how manufacturers should test their products and gather information.

For years, FDA repeatedly promised industry it would set forth “rules of the road”

and promulgate “foundational regulations” to make the PMTA process

“transparent, predictable, and sustainable.”6 However, only recently did FDA

6 See supra note 4.


15

finalize guidance regarding the types of information to be included in the

applications.7 An additional regulation, also designed to specify PMTA contents,

was only proposed at the end of September 2019, with a public comment deadline

of December 16, 2019.8 And while these documents provide recommendations for

“what” manufacturers may include in a PMTA, they leave substantial unanswered

questions regarding “how” to test products and develop information.

For example, the final guidance does not provide testing protocols for

devices or e-liquids. Ex. I at ⁋10. Variables like power settings, airflow settings,

humectant composition, nicotine concentrations, and flavors can greatly influence

the cost and time to perform these studies. FDA vaguely asserts that

manufacturers should conduct tests that reflect a “reasonable range” of conditions.

But relying on such ambiguous instructions runs a serious risk of falling short of

FDA’s expectations. Id. Similarly, FDA has not provided any standardized testing

methods for Harmful and Potentially Harmful Constituents (“HPHCs”). Ex. D at

⁋7; Ex. C at ⁋11. To complicate matters, FDA recently added new HPHCs to the

list that manufacturers must test for and include in PMTAs. Now labs must

7 Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (Guidance for Industry) (June 2019), available at https://tinyurl.com/y3s62jno. 8 Premarket Tobacco Product Application and Recordkeeping Requirements (Proposed Rule) (September 2019), available at https://tinyurl.com/tezsy8k.


16

develop more testing methodologies that will need to be validated and go through

third-party accrediting processes. Ex. D at ⁋7. All of this takes time.9

Third, to fill-in these critical gaps, FDA essentially requires manufacturers

to attend pre-application meetings with FDA. Ex. C at ⁋14; Ex. I at ⁋14. But this

back-and-forth takes months, even years, to play out for even a single

manufacturer. Id. For instance, there were nearly two years of such

communications with Philip Morris for a heat-not-burn product called IQOS after

the company submitted its initial application, with FDA requesting additional

information and/or corrections at least 12 times. Ex. I at ⁋16. And that period does

not include pre-application meetings leading up to the submission. And there are

growing concerns regarding the significant inefficiency of this process. Many

association members have tried, without success, to schedule meetings for late

2019. Ex. D at ⁋5. Given FDA anticipates hundreds of PMTAs, at a minimum, it

will be simply impossible for FDA to confer with all manufacturers and provide

adequate guidance well before May 2020. Id.; Ex. C at ⁋14.

Fourth, even if FDA provided guidance on testing protocols in the near

future, the 10-month deadline would still be insufficient due to a severe shortage of

third-party lab capacity. Ex. I at ⁋24; Ex. C at ⁋12. Small manufacturers do not

9 FDA has also failed to establish Good Manufacturing Practices, which must be verified in each PMTA as having been implemented. Ex. I at ⁋9; Ex. C at ⁋10.


17

have resources to conduct testing in-house. Ex. C at ⁋12. Yet the associations are

only aware of five qualified labs in the US, UK, and Canada. Ex. D at 2. As small

manufacturers produce millions of vapor products, space at these labs would run

out quickly, thus making it impossible for them to generate testing data by early

2020. Ex. I at ⁋24.

Clearly, the 10-month deadline will have devastating impacts. According to

Director Zeller, Plaintiffs’ slightly shorter 4-month deadline would “likely” result

in a “mass market exit” of products as manufacturers would not have time to file

applications. Ex. F at ⁋15. Indeed, the associations presented evidence that

thousands of small companies will likely be forced to close their doors given time

constraints and PMTA uncertainties. Ex. D at ⁋⁋4, 8 (e.g., enclosing letter to FDA

from 1,464 small businesses indicating they will likely go out of business); Ex. C

at ⁋19 (same). Fed. Leasing, Inc. v. Underwriters at Lloyd’s, 650 F.2d 495, 500

(4th Cir. 1981) (loss of entire business or good will constitutes irreparable harm).

Moreover, Director Zeller observed these PMTAs will involve “first-ever

applications for a previously novel” product and “newly regulated entities lacking

experience with FDA.” Ex. F at ⁋18. He concluded that manufacturers, under

Plaintiffs’ proposal, were “unlikely to submit quality PMTA applications (e.g.,

applications that are sufficiently complete and organized to enable [FDA] to

efficiently conduct the required scientific review).” Id. at ⁋16. As one PMTA


18

expert stated, given the complexity of these applications and the need to resolve

complicated issues, like protocols for testing and research, manufacturers will

require longer than 10 months to file high-quality PMTAs. Ex. I at ⁋⁋25-26; see

Ex. F at ⁋22 (Director Zeller acknowledging the “complexity of [these]

applications and the scientific review process”). Thus, there is a substantial risk

that PMTAs filed in May 2020 will be quickly rejected by FDA as incomplete.

Yet FDA and Director Zeller did not address any of these bottlenecks or

sources of delay when proposing the 10-month deadline. There was no

explanation for how a 4-month cutoff could have such disastrous consequences,

but a slightly longer 10-month deadline would not. There was no discussion of

how FDA accounted for the extensive time it takes for pre-application meetings or

how manufacturers will be able to conduct all required testing. This much is

undoubtedly required by the APA. Motor Vehicle Mfrs Ass’n, 463 U.S. at 43-44,

51-52. Instead, Director Zeller merely said “I believe” that 10 months is sufficient.

Ex. F at ⁋13. But “belief” tells us nothing about FDA’s rationale.

If the district court had remanded for notice and comment, as it previously

held was required, these procedural shortcomings would have been addressed. A


19

stay should therefore be issued to preserve the manufacturers’ rights to an

informed decision-making process.10

III. The Parties Will Not Be Substantially Harmed

Neither FDA nor the Plaintiffs would be substantially harmed by a stay.

FDA has no interest in acting contrary to the law by failing to conduct required

notice and comment rulemaking on any new compliance policy. The district court

held the August 2022 deadline constituted a legislative rule and that any further

compliance policy would need to comply with the APA. Ex. A at 52-53. If the

Court rules in the associations’ favor after the May 2020 cutoff, FDA will have

avoided its procedural obligations to the detriment of other stakeholders’ rights. In

fact, by virtue of FDA’s own conduct, we know that it will not suffer substantial

injury pending appeal. Just three months before it suggested the 10-month

deadline, it had proposed an August 2021 deadline, thus indicating that a

temporary stay ending in 2020 will not impact FDA’s interests.

The same holds true for Plaintiffs. Their only alleged injury is a lack of

information from PMTAs that they would purportedly use to educate patients and

the public. But they would not have access to that information until at least

November 2020 or later, if ever. FDA does not disclose PMTAs before a product

10 In denying the stay request, the district court said the associations would suffer no harm until May 2022. Ex. G at 5. But as the foregoing demonstrates, such harm is imminent.


20

receives pre-market approval. That means Plaintiffs do not have access when a

PMTA is filed and being reviewed. Moreover, FDA has 180 days to process any

PMTAs filed in May 2020. 21 U.S.C. §387j(c). However, given it took almost

two years to review and approve the IQOS PMTA (Ex. I at ⁋16), it is readily

apparent that few, if any, PMTAs will be granted for several years.

Moreover, Plaintiffs already have access to thousands of publicly-available,

peer-reviewed papers on vaping products, with over 100 articles being published

each month. Ex. I at ⁋21. Indeed, the recent National Academies of Sciences

report evaluated over 4,000 such publications. Id. The FDA’s ongoing PATH

study, which is investigating the same issues as PMTAs, has released three waves

of extensive population data on vaping. Ex. H at ⁋⁋14-16. And significantly,

information regarding each vaping product now on the market, including product-

specific ingredients (substances, compounds, and additives) has been disclosed to

FDA and is accessible by Plaintiffs. 21 U.S.C. §387d(a)(1). A short delay of a

few months will not result in substantial harm.

IV. Adult Smokers’ Interests Favor A Stay

The public interest will be served by a temporary stay. The associations’

members agree that underage use must be confronted head-on. It is imperative,

however, that this Court acknowledge the other half of the public health

equation—i.e., ensuring adult smokers have access to products to help them move


21

away from more dangerous cigarettes. And to avoid confusion, this Court must

also understand the difference between the PMTA’s “population effects standard”

and what is nevertheless actually happening on the ground with individual

smokers. While research continues on the former, there is no doubt that countless

individual adults have used vaping to transition away from their smoking habits.

Director Zeller states that a mass exit of vapor products will create a

“genuine risk of migration from potentially less harmful [vapor] products back to

combustible tobacco products within the population of addicted adult smokers who

have completely switched to [vaping]. This is a public health outcome that should

be avoided if at all possible.” Ex. F at ⁋12. He continues:

[T]hese products may be less harmful at an individual level than [cigarettes]. . . [I]t is likely that some [vapor] products may reduce harm at the individual level and that some addicted adult smokers use these products with a goal to end use of [cigarettes]. . . . [M]ass market exit . . . would limit the availability of a potentially less harmful alternative for adult smokers seeking to transition or stay away from [cigarettes]. Dramatically and precipitously reducing availability of these products could present a serious risk that adults, especially former smokers, who currently use [vapor] products and are addicted to nicotine would migrate to [cigarettes].

Id. at ⁋15.

FDA stated in the Deeming Rule that vapor products “are likely less

hazardous for an individual user than continued smoking” (81 Fed. Reg. at 29,035)

and “may potentially provide cessation benefits” (Id. at 29,039). The National

Academies of Sciences recently concluded there is “conclusive evidence that


22

completely substituting e-cigarettes for combustible tobacco cigarettes reduces

users’ exposure to numerous toxicants and carcinogens” in cigarettes. ECF #37-1

at 2. These potential health benefits are enormous and cannot be ignored.

Clearly, a short stay is warranted if it prevents the wide-spread return to

cigarettes by adult vapers across the country.

V. Expedition Is Warranted

For the reasons above, the associations ask this Court to expedite

consideration by scheduling argument for the March 2020 session. Absent a stay,

they also request a decision prior to the pending May 12, 2020 PMTA deadline.

CONCLUSION

Based on the foregoing, this Court should grant the motion to stay and to

expedite consideration.


23

December 13, 2019


/s Eric P. GottingKELLER AND HECKMAN LLP 1001 G Street, N.W. Suite 500 West Washington, D.C. 20001(202) 434-4269 (phone) (202) 434-4646 (fax) [email protected]

Counsel for Intervenors-Appellants


24

CERTIFICATE OF SERVICE

I certify that on December 13, 2019, I caused to be electronically filed the

foregoing motion with the Clerk of the Court for the U.S. Court of Appeals for the

Fourth Circuit using the appellate CM/ECF system. All participants in the case are

registered CM/ECF users and will be served by the CM/ECF system.

/s Eric P. Gotting Eric P. Gotting


25

CERTIFICATE OF COMPLIANCE

1. This motion complies with the type-volume limitation of Fed. R. App. P.

27(d)(2)(A) because this motion contains 5,186 words, excluding the parts

of the motion exempted by Fed. R. App. P. 27(d)(2) and Fed. R. App. P.

27(a)(2)(B).

2. This motion complies with the type-face requirements of Fed. R. App. P.

32(a)(5) and the type-style requirements of Fed. R. App. P. 32(a)(6) because

this motion has been prepared in a proportionally spaced typeface using

Microsoft Word in Times New Roman 14-point font.

December 13, 2019 /s Eric P. Gotting Eric P. Gotting


EXHIBIT A


IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

Southern Division

* AMERICAN ACADEMY OF

PEDIATRICS, et al., *

Plaintiffs, * v. * Case No.: PWG-18-883 FOOD AND DRUG *

ADMINISTRATION, et al. *

Defendants. *

* * * * * * * * * * * * * *

MEMORANDUM OPINION

It was bound to happen. Just as email and text messages replaced “snail mail,” social media

made face-to-face communications passé, and the internet rendered libraries all but obsolete, it

was only a matter of time before “electronic cigarettes”1 replaced combustible tobacco products

as a desirable means of nicotine delivery. As it turns out, even addiction has become electronic.

And not only among adults, but particularly for teenagers (and younger kids). Especially, as

manufactures of e-cigarette products have learned, if they are fruit or dessert flavored, and

marketed as cool and alluring. Stmt. of FBA Commissioner, ECF No. 43-2.

Since 2014, [e-cigarettes] have been the most popular nicotine product among American teenagers.

And e-cigarettes’ popularity is accelerating: From 2017 to 2018, … the number of high-school-age children reporting use of e-cigarettes rose by more than 75 percent. Use among middle-schoolers also increased nearly 50 percent. That is an epidemic.

1 These electronic nicotine products are more accurately—and ironically—called “ENDS”—“electronic nicotine delivery systems.” See Stmt. of FBA Commissioner, ECF No. 43-2.

Case 8:18-cv-00883-PWG Document 73 Filed 05/15/19 Page 1 of 54USCA4 Appeal: 19-2130 Doc: 36-2 Filed: 12/13/2019 Pg: 2 of 55 Total Pages:(32 of 215)

2

The surge in e-cigarette use by teenagers is alarming because nicotine is highly addictive and can harm brain development, which continues into young adulthood. Worse, kids who start on e-cigarettes are actually more likely than non-user peers to migrate to smoking tobacco ….

It is crucial that e-cigarettes do not become an on-ramp for children to become addicted to nicotine.

… [N]early 90 percent of adult smokers started when they were teens.

Alex M. Azar & Scott Gottlieb, We cannot let e-cigarettes become an on-ramp for teenage

addiction, Wash. Post (Oct. 11, 2018) (“Azar & Gottlieb Op. Ed.”).2

To address public health concerns associated with tobacco use, and use by minors in

particular, Congress enacted the Family Smoking Prevention and Tobacco Control Act (“Tobacco

Control Act”), Pub. L. No. 111-31, 123 Stat. 1776 (2009) (enacting 21 U.S.C. §§ 387 – 387u and

amending and redesignating other statutes), which requires manufacturers of various nicotine

products, now including e-cigarettes,3 to apply for and obtain premarket authorization before

introducing new products into interstate commerce for commercial distribution. 21 U.S.C.

§ 387j(a)(1)-(2), (b)(1); see also Defs.’ Mem. 1, ECF No. 36-1; Pls.’ Mem. 3; Guidance 2, ECF

No. 48-1, at 715, GAR 423.4 Yet, although it might come as a surprise to a reader of the Tobacco

2 Alex M. Azar is the Secretary of the U.S. Department of Health and Human Services. Until April 2019, Scott Gottlieb was the Commissioner of the Food and Drug Administration (“FDA”). E-cigarettes are devices that use “a small battery to heat a liquid that contains nicotine” and then “turn the liquid into an inhalable vapor.” Azar & Gottlieb Op. Ed. 3 On May 10, 2016, the FDA adopted the “Deeming Rule” to deem electronic nicotine device systems (“e-cigarettes”), cigars, and pipe tobacco subject to regulatory controls under the Tobacco Control Act. See Deeming Rule, 81 Fed. Reg. 28,974-01 (May 10, 2016), AR 11,882, ECF No. 48-1, at 69. The parties and the Court use “e-cigarette” to refer to “any sort of electronic nicotine delivery system (ENDS), including so-called ‘vaping’ devices.” Defs.’ Mem. 10 n.7 (citing 81 Fed. Reg. at 28,976 (“ENDS” includes “e-cigarettes, ehookah, e-cigars, vape pens, advanced refillable personal vaporizers, and electronic pipes”); Pls.’ Mem. 6 n.2, ECF No. 31-2. 4 “Citations to ‘AR’ in the parties’ briefs are to the Deeming Rule’s administrative record, which has ‘FDA’ Bates-stamped page numbers. Citations to ‘GAR’ are to the separate administrative record for the Guidance, which is separately paginated with ‘FDA GUID’ Bates-stamped pages.” Notice 2 n.1, ECF No. 48.


3

Control Act, currently, “certain e-cigarettes—particularly the products with flavors that might

appeal to children[5]—can remain on the market without submitting a premarket application to the

FDA until 2022,” id., and some can remain on the market while their application is pending, Aug.

2017 Guidance 3, ECF No. 48-1, at 716, GAR 424 (emphasis added). This is because the

Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule:

Guidance for Industry (Revised) (“August 2017 Guidance”), which the FDA issued in August

2017 regarding the statutory requirements for “newly deemed tobacco products” like e-cigarettes,

provides that manufacturers of those products can continue to market and distribute these products

while they seek FDA approval; they do not have to seek FDA approval until 2021 or 2022; and

for some of the products, once the manufacturers have submitted their applications, they can

continue to market and distribute the products until the FDA “renders a decision.” Aug. 2017

Guidance 3, 8, ECF No. 48-1, at 716, 721, GAR 424, 429; see Compl. ¶¶ 1–3, ECF No. 1.

5 E-cigarettes come in flavors including maple, vanilla, and coconut. See Popcorn Lung: A Dangerous Risk of Flavored E-Cigarettes (ALA July 7, 2016), https://www.lung.org/about-us/blog/2016/07/popcorn-lung-risk-ecigs.html (last updated Sept. 18, 2018). As an example of a tobacco product “targeted at children and teenagers,” Plaintiffs note that there is “an ‘Apple Juice’ e-cigarette product”:

Compl. ¶ 41.


4

Alarmed by this exemption, the American Academy of Pediatrics; the Maryland Chapter –

American Academy of Pediatrics; the American Cancer Society Cancer Action Network; the

American Heart Association; the American Lung Association; the Campaign for Tobacco-Free

Kids; the Truth Initiative; Dr. Leah Brash, MD; Dr. Cynthia Fishman, MD; Dr. Linda Goldstein,

MD; Dr. Steven Hirsch, MD; and Dr. David Myles, MD filed a Complaint for Declaratory and

Injunctive Relief against the FDA, then-Commissioner of Food and Drugs Scott Gottlieb, the U.S.

Department of Health and Human Services, and Secretary of Health and Human Services Alex M.

Azar II. Compl. 1. In Plaintiffs’ view, the exemption violates the Tobacco Control Act’s

requirement of premarket review of newly deemed products before they are marketed or

distributed to consumers. Id. They brought three claims for the same relief pursuant to the

Administrative Procedure Act (“APA”), 5 U.S.C. § 701 et seq. Specifically, Plaintiffs ask the

Court to vacate the August 2017 Guidance, claiming that it is unlawful in that it “exceeds the

agency’s statutory authority” and “is an express and deliberate abdication of FDA’s

responsibilities under the Tobacco Control Act” (Count I); “was not promulgated in accordance

with the APA’s notice and comment requirements,” despite being a substantive rule (Count II);

and “is arbitrary and capricious and not the product of reasoned decisionmaking” (Count III).

Compl. ¶¶ 4–7, 92–118.

Plaintiffs filed a Motion for Summary Judgment, ECF No. 31, and Defendants filed a

Motion to Dismiss or, in the Alternative, for Summary Judgment, ECF No. 36.6 Defendants argue

that the Court lacks subject matter jurisdiction because (1) the August 2017 Guidance does not

6 The parties fully briefed the motions. ECF Nos. 31-2, 36-1, 39, 43, 44-1. Plaintiffs also filed a Notice of Errata, ECF No. 47, and Notices of Supplemental Authority, ECF Nos. 54, 58, and the parties informally addressed steps that the FDA has taken since the parties filed their motions. ECF Nos. 51, 53, 59, 61. Right to be Smoke-Free Coalition filed an amicus curiae brief. ECF No. 37-1. A hearing is not necessary. See Loc. R. 105.6.


5

cause any cognizable harm to Plaintiffs and therefore they do not have standing to bring this

lawsuit; (2) the FDA has unreviewable discretion in deciding how to enforce the Tobacco Control

Act and its rules; and (3) the August 2017 Guidance is not final agency action, rendering it beyond

the reach of judicial review. Defs.’ Mem. 3–4. Alternatively, they contend that Plaintiffs’ claims

fail on the merits because the August 2017 Guidance does not conflict with the Tobacco Control

Act; it is a policy statement, not a rule, and therefore is exempt from the notice and comment

requirements; and the FDA provided a rational explanation for the policy. Id. at 4–5.

On March 13, 2019, while the motion remained pending, the FDA published draft guidance

that, “if finalized, would modify the August 2017 Guidance challenged in this case.” Mar. 26,

2019 Ltr. Order, ECF No. 62; see Defs.’ Second Notice, ECF No. 59. Noting that the agency was

“accepting public comments on the draft guidance for a 30-day period that closes on April 15,

2019,” with the revisions intended to “take effect 30 days after the publication of a final guidance

document,” I denied the parties’ motions without prejudice to renewal following the FDA’s

finalization or rejection of the draft guidance. Mar. 26, 2019 Ltr. Order; Defs.’ Second Notice;

see also FDA, Modifications to Compliance Policy for Certain Deemed Tobacco Products:

Guidance for Industry: Draft (March 2019), ECF No. 59-1; Statement from FDA Commissioner

Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal

of, flavored tobacco products, including e-cigarettes and cigars 2 (Mar. 13, 2019), ECF No. 59-2.

Plaintiffs promptly moved for reconsideration, arguing that “[t]here is . . . no reason to

expect that a final Guidance is imminent, and substantial reason to doubt that it will issue this

year,” and that having “the benefit of a ruling on [the August 2017] Guidance” would increase the

FDA’s “ability to issue a legally sustainable replacement” and “thus obviat[e] or at least simplify[]

challenges to that replacement.” Pls.’ Ltr. Mot. 1, ECF No. 63. Defendants responded in favor of


6

“postpon[ing] resolution of this case while the draft guidance is finalized, lest the Court

unnecessarily expend resources—and potentially issues what could, in practical terms, largely

amount to an advisory opinion—on a policy that is under revision and soon stands to change in

material ways.” Defs.’ Ltr. Opp’n 1, ECF No. 71. They contend that, “[i]f finalized, the draft

guidance would modify the deferred-enforcement policy set forth in the August 2017 Guidance

challenged in this case with respect to . . . the[] same products [that] are the apparent focus of

Plaintiffs’ public-health concerns,” that is, “e-cigarettes targeted to youth and flavored cigars.” Id.

at 1, 2. But, as Plaintiffs note in their reply, ECF No. 72, Defendants do not state, even generally,

when the draft guidance will be finalized; they simply state that “the FDA has given every

indication that it plans to finalize the draft guidance as quickly as possible,” after it finishes

reviewing the approximately 15,467 comments it received electronically and the additional

comments it received via U.S. mail. Defs.’ Ltr. Opp’n 5. Given the pace at which the FDA has

implemented the premarket review provisions of the Tobacco Control Act, its notion of “as quickly

as possible” must be taken with a grain of salt.

Upon further review of their briefing of Plaintiffs’ letter motion for reconsideration, as well

as their briefing of their cross-motions for summary judgment, I am persuaded that Plaintiffs have

standing and that this Court has jurisdiction to review the August 2017 Guidance, which was not

a nonreviewable discretionary decision and which qualifies as final agency action for purposes of

the APA. Moreover, the undisputed evidence establishes that Defendants were required to, but

did not, follow the APA’s notice and comment requirements issuing the August 2017 Guidance,

and therefore Defendants violated the APA by issuing it. Accordingly, I will grant Plaintiffs’

motion for reconsideration and reopen the parties’ cross-motions. Having done so, I deny


7

Defendants’ motion, which I treat as a motion for summary judgment; grant Plaintiffs’ motion for

summary judgment; and order supplemental briefing on an appropriate remedy.

Background

Congress enacted the Tobacco Control Act in 2009 to “protect the public health and to

reduce tobacco use by minors.” Guidance 2, ECF No. 48-1, at 715, GAR 423. The Act “granted

FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette

tobacco, roll-your-own tobacco (RYO), and smokeless tobacco products . . . .” Id. Additionally,

pursuant to the Act the FDA can “deem[] other products that meet the statutory definition of a

tobacco product” to be subject to the Act. Id. These products are referred to as “new tobacco

products.” 21 U.S.C. § 387j(a)(1). On May 10, 2016, the FDA issued the “Deeming Rule,”

bringing approximately 25,000 new tobacco products, including various cigars, e-cigarettes, pipe

tobacco products, and hookah within the purview of the Act. Defs.’ Mem. 1; Pls.’ Mem. 6;

Guidance 2, ECF No. 48-1, at 715, GAR 423. The Deeming Rule went into effect 90 days after its

publication. Deeming Rule, 81 Fed. Reg. 28,974-01, 28,976 (May 10, 2016).

The Act requires “[m]anufacturers of products subject to the Act [to] generally register

with the FDA, submit lists of their products and ingredients, obtain premarket authorization before

marketing new products, and include health warnings on packaging and advertisements.” Defs.’

Mem. 1. To obtain premarket authorization, a manufacturer must submit to the FDA either

(1) a “premarket tobacco application” demonstrating that the product would be appropriate for the protection of the public health, [21 U.S.C.] § 387j(b)–(c); (2) a “report” establishing that the product is “substantially equivalent” to a predicate product, id. §§ 387j(a)(2)(A)(i), 387e(j)(1); or (3) a request for an “exemption” from the substantial equivalence requirement, id §§ 387j(a)(2)(A)(ii), 387e(j)(3).

Id. at 5.


8

If products are marketed without adhering to these requirements, they may be considered

“adulterated” and seized, and the manufacturers, distributors and retailers may be subject to civil

injunctions and/or criminal prosecutions. 21 U.S.C. §§ 331(a)–(c) (prohibited acts), 332 (court

jurisdiction to issue injunction), 333(a) (criminal penalties), 334 (seizure), 387b(6) (“A tobacco

product shall be deemed to be adulterated if . . . it is required by section 387j(a) . . . to have

premarket review and does not have an order in effect under section 387j(c)(1)(A)(i); or . . . it is

in violation of an order under section 387j(c)(1)(A).”).

Initially, the Act required the FDA to permit the four products then subject to the Act to remain on the market during premarket review so long as their manufacturers submitted premarket applications by March 2011. But there is no statutory grace period for products later deemed subject to the Act. Thus, when the deeming rule took effect in August 2016, all newly deemed products then on the market were suddenly noncompliant with the statute.

Defs.’ Mem. 1.

It is undisputed that the FDA has some “discretion to adapt those provisions to the special

circumstances of products that become subject to the TCA [Tobacco Control Act] by virtue of

deeming” and, to that end, to “[p]ermit[] a compliance period for newly deemed products.” Id. at

2 (quoting Organizational Plaintiffs’ comments on the proposed deeming rule, AR 145,551,

145,607, ECF No. 48-1, at 566, 622). And, when it published the Deeming Rule, the FDA, in what

it called an “exercise of enforcement discretion,” stated that “newly deemed, new tobacco

products” would not “be subject to enforcement” during “compliance period[s]” that the Deeming

Rule established. Deeming Rule, 81 Fed. Reg. at 28,978. Specifically, the Deeming Rule

“establish[ed] staggered initial compliance periods based on the expected complexity of the

applications to be submitted, followed by continued compliance periods for FDA review,” with

the FDA’s “exercise of enforcement discretion [set to] end twelve months after each initial

compliance period.” Id. Thus, the Deeming Rule provided that


9

manufacturers of all newly deemed, new tobacco products [would] have a 12-, 18- or 24-month initial compliance period in which to prepare applications for marketing authorization, as well as a 12-month continued compliance period after those dates in which to obtain authorization from FDA (resulting in total compliance periods of 24, 30, or 36 months).

Id.

The FDA established these specific compliance periods because it “determined that

exercising enforcement discretion indefinitely could put youth and young adults at risk for

tobacco-related death and disease.” Id. at 28,977; see also Aug. 2017 Guidance 3, ECF No. 48-1,

at 716, GAR 424 (“Unless FDA has issued an order denying or refusing to accept the submission,

products for which timely premarket submissions have been submitted will be subject to a

continued compliance period for 12 months after the initial compliance period described

previously. For such products, FDA does not intend to initiate enforcement for failure to have

premarket authorization during this continued compliance period.” (quoting 81 Fed. Reg. at

29,011)). The “compliance policy did not apply to any new tobacco product that was not on the

market on August 8, 2016.” Aug. 2017 Guidance 3, ECF No. 48-1, at 716, GAR 424.

In May 2017, the FDA extended the compliance deadline by three months. Three-Month

Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule:

Guidance for Industry (May 2017), GAR 206, ECF No. 48-1, at 687. Specifically, it provided that

the “compliance period for manufacturers to submit a substantial equivalence exemption request” was November 8, 2017;

the “compliance period for manufacturers that have submitted substantial equivalence exemption requests by November 8, 2017 (unless they have received an order denying, or FDA has refused to accept their submission)” was one year later, November 8, 2018;

the “compliance period for manufacturers to submit a substantial equivalence report” was May 8, 2018;

the “compliance period for manufacturers that have submitted substantial equivalence reports by May 8, 2018 (unless they have received an order denying, or FDA has refused to accept their submission)” was one year later, May 8, 2019;


10

the “compliance period for manufacturers to submit a premarket tobacco product application (PMTA)” was November 8, 2018;

the “compliance period for manufacturers that have submitted PMTAs by November 8, 2018 (unless they have received an order denying, or FDA has refused to accept their submission)” was one year later, November 8, 2019.

May 2017 Guidance 7–8, GAR 214–15, ECF No. 48-1, at 695–96.

Then, in August 2017, without allowing for a notice and comment period, Pls.’ Mem. 7,

the FDA issued the August 2017 Guidance (which revised its May 2017 Guidance), “announc[ing]

that it would further defer enforcement of the premarket review provision with respect to

combustible products (like cigars) until 2021, and noncombustible products (like most e-

cigarettes) until 2022—but only for products that were on the market when the deeming rule took

effect in August 2016.” Defs.’ Mem. 2; see Aug. 2017 Guidance 8, GAR 429, ECF No. 48-1, at

721. The August 2017 Guidance explained that the FDA had set “compliance date[s] . . . as a

matter of enforcement discretion, stating that it does not intend to enforce [] particular

requirement[s] that [were] already in effect for a period of time in order to give industry more time

to comply.” Aug. 2017 Guidance 4, ECF No. 48-1, at 717, GAR 425. Notably, pursuant to the

August 2017 Guidance, “there will be a continued compliance period pending review of [certain]

applications,” and “[t]his compliance period will continue until the agency renders a decision on

an application (i.e., issuance of: a Marketing Order; a No Marketing Order; a Refuse to File; or

Refuse to Accept) or the application is withdrawn.” Id. at 3, GAR 424, ECF No. 48-1, at 716

(emphasis added). The chart of compliance deadlines only identified the end of the compliance

periods for manufacturers to make their submissions; it no longer included a deadline for the

compliance period for manufacturers that had made their submissions. Id. at 8, GAR 429, ECF

No. 48-1, at 721.


11

During the compliance period, “the agency plans to issue regulations governing the

information to be included in premarket applications, to develop standards that certain products

must meet, and to publish additional guidance explaining what applications should contain and

how they will be reviewed.” Defs.’ Mem. 2.

The effect of this deferred enforcement is that the products subject to the Act pursuant to

the Deeming Rule may remain on the market until 2021 or 2022 without submitting an application

or having it reviewed and approved. These products include e-cigarettes. As noted, youth use of

e-cigarettes has reached epidemic proportions. Azar & Gottlieb Op. Ed. The FDA recognizes this

and professes to be “deeply concerned about the risks that e-cigarettes pose for children, given

how quickly teenage use of these products has accelerated.” Id. It also “believe[s] e-cigarettes

can be an important off-ramp for adults who are addicted to combustible cigarettes,” but asserts

that “[t]he technology that might help adults end one addiction cannot [be permitted to] pull a

generation of kids into a new one.” Id. In fact, the FDA has stated that it is “actively reconsidering

our policy under which certain e-cigarettes — particularly the products with flavors that might

appeal to children — can remain on the market without submitting a premarket application to the

FDA until 2022,” noting that “products such as e-cigarettes need to be put through an appropriate

regulatory process. Under the most likely path for marketing authorization, they must show that

their marketing is appropriate for protecting the public health, taking into account their risks and

benefits to the population as a whole,” and that “[r]ising e-cigarette use by children makes the

marketing of this product especially deserving of close attention.” Id.

Standard of Review

Defendants challenge this Court’s subject matter jurisdiction based on Plaintiffs’ purported

lack of standing and their view that the August 2017 Guidance is not subject to judicial review


12

because it was an action within agency discretion and not a final agency action.7 They also move

to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim. When a defendant moves to

dismiss pursuant to Fed. R. Civ. P. 12(b)(1) for lack of subject matter jurisdiction, asserting a facial

challenge that “a complaint simply fails to allege facts upon which subject matter jurisdiction can

be based,” as Defendants do here, “the facts alleged in the complaint are assumed to be true and

the plaintiff, in effect, is afforded the same procedural protection as he would receive under a

12(b)(6) consideration.” Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 1982); see Lujan v. Defs.

of Wildlife, 504 U.S. 555, 561 (1992) (noting that, on a motion to dismiss, a plaintiff’s pleading of

the elements of standing are “presum[ed] [to] embrace those specific facts that are necessary to

support the claim” (quoting Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 889 (1990))). But when,

as here, a motion is styled in the alternative as one for summary judgment, both parties file their

briefs along with evidence that is not integral to the pleadings, and the Court considers that

evidence in reaching a decision, the Court must treat the motion as one for summary judgment.

See Fed. R. Civ. P. 12(d); Laughlin v. Metro. Wash. Airports Auth., 149 F.3d 253, 261 (4th Cir.

1998) (observing that, while the parties must have notice that a motion will be treated as one for

summary judgment, the styling of a motion in the alternative, as well as the filing of evidence in

support of the parties’ arguments, provides sufficient notice).

Summary judgment is proper when the moving party demonstrates, through “particular

parts of materials in the record, including depositions, documents, electronically stored

7 When a plaintiff does not have standing, its claim is not justiciable. Flast v. Cohen, 392 U.S. 83, 95 (1968); Lansdowne on the Potomac Homeowners Ass’n, Inc. v. OpenBand at Lansdowne, LLC, 713 F.3d 187, 198 (4th Cir. 2013). “Justiciability is an issue of subject-matter jurisdiction.” Hamilton v. Pallozzi, 848 F.3d 614, 619 (4th Cir.), cert. denied, 138 S. Ct. 500 (2017). Likewise, whether an agency’s action “constituted final agency action under the APA so as to be reviewable in court” is “a question of subject matter jurisdiction.” Invention Submission Corp. v. Rogan, 357 F.3d 452, 458 (4th Cir. 2004).


13

information, affidavits or declarations, stipulations . . . admissions, interrogatory answers, or other

materials,” that “there is no genuine dispute as to any material fact and the movant is entitled to

judgment as a matter of law.” Fed. R. Civ. P. 56(a), (c)(1)(A); see Baldwin v. City of Greensboro,

714 F.3d 828, 833 (4th Cir. 2013). If the party seeking summary judgment demonstrates that there

is no evidence to support the nonmoving party’s case, the burden shifts to the nonmoving party to

identify evidence that shows that a genuine dispute exists as to material facts. See Matsushita Elec.

Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 585–87 & n.10 (1986). When considering cross-

motions for summary judgment, “the court must view each motion in a light most favorable to the

non-movant.” Linzer v. Sebelius, No. AW-07-597, 2009 WL 2778269, at *4 (D. Md. Aug. 28,

2009); see Mellen v. Bunting, 327 F.3d 355, 363 (4th Cir. 2003).

Standing

This Court may “adjudicate only actual cases and controversies.” Zaycer v. Sturm Foods,

Inc., 896 F. Supp. 2d 399, 407 (D. Md. 2012) (citing U.S. Const. art. III, § 2; O’Shea v. Littleton,

414 U.S. 488, 493 (1974); Bishop v. Bartlett, 575 F.3d 419, 423 (4th Cir. 2009)). This “constraint

of Article III” has two distinct but overlapping facets that must be satisfied for a federal district

court to have subject matter jurisdiction: standing (which addresses who may sue and which is at

issue here) and ripeness (which addresses when a party may bring a suit). See South Carolina v.

United States, 912 F.3d 720, 730 (4th Cir. 2019) (quoting Scoggins v. Lee’s Crossing Homeowners

Ass’n, 718 F.3d 262, 269 (4th Cir. 2013)).

A plaintiff has standing if

(1) [the plaintiff] has suffered an “injury in fact” that is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical; (2) the injury is fairly traceable to the challenged action of the defendant; and (3) it is likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.


14

Zaycer, 896 F. Supp. 2d at 408 (quoting Bishop, 575 F.3d at 423)); see also Lujan, 504 U.S. at

560–61 (same). Notably, while a plaintiff must plead these elements to allege standing, these

elements are more than “mere pleading requirements”; they are “an indispensable part of the

plaintiff’s case,” and “each element must be supported in the same way as any other matter on

which the plaintiff bears the burden of proof, i.e., with the manner and degree of evidence required

at the successive stages of the litigation.” Lujan, 504 U.S. at 561. In response to Defendants’

Motion for Summary Judgment, Plaintiffs cannot “rest on . . . ‘mere allegations’” of injury

resulting from Defendants’ conduct. Id. Rather, they have to “‘set forth’ by affidavit or other

evidence ‘specific facts.’” Id. (citing Fed. R. Civ. P. 56). If one of multiple plaintiffs has standing

for a claim, then the claim can proceed. Kenny v. Wilson, 885 F.3d 280, 287 (4th Cir. 2018). Here,

the three claims are each brought by all Plaintiffs. Compl. ¶¶ 92–118.

Injury in Fact

The Fourth Circuit has held that, where an organization’s “efforts to carry out its mission”

are impeded, that impediment is a concrete and particularized injury. Lane v. Holder, 703 F.3d

668, 674 (4th Cir. 2012). Likewise, “an organization suffers an injury in fact when it is deprived

of information integral to its core activities.” Pub. Citizen Health Research Grp. v. Acosta, 363 F.

Supp. 3d 1, 12 (D.D.C. 2018) (finding that plaintiffs alleged injury in fact sufficiently by

“alleg[ing] that [their] ‘activities [are] impeded’ when [they] cannot rely on the information OSHA

would ordinarily collect under the Electronic Reporting Rule”). The Supreme Court refers to this

as an “informational injury.” Dreher v. Experian Info. Sols., Inc., 856 F.3d 337, 345 (4th Cir.

2017) (quoting Fed. Election Comm’n v. Akins, 524 U.S. 11, 24 (1998)).

For a plaintiff to have standing based on an informational injury, the plaintiff must “lack

access to information to which he is legally entitled and . . . the denial of that information [must]


15

create[] a ‘real’ harm with an adverse effect.” Id. (quoting Spokeo, Inc. v. Robins, --- U.S. ----,

136 S. Ct. 1540, 1549 (2016) (internal quotation marks omitted)). Thus, “a plaintiff suffers a

concrete informational injury where he is denied access to information required to be disclosed by

statute, and he ‘suffers, by being denied access to that information, the type of harm Congress

sought to prevent by requiring disclosure.’” Id. (quoting Friends of Animals v. Jewell, 828 F.3d

989, 992 (D.C. Cir. 2016) (emphasis supplied)). In Spokeo, the respondents’ injury in fact

“‘consist[ed] of their inability to obtain information . . . that . . . [a] statute require[d] [to be] ma[d]e

public’ where that information ‘would help them . . . evaluate candidates for public office.’” Id.

(quoting Spokeo, 136 S. Ct. at 1548).

The injury also must be “imminent,” that is “not too speculative”; in other words, it must

be “certainly impending.” Lujan v. Defs. of Wildlife, 504 U.S. 555, 564 (1992) (quoting Whitmore

v. Arkansas, 495 U.S. 149, 158 (1990)). Injury cannot be predicted “at some indefinite future

time” or expected to result from acts “partly within the plaintiff’s own control.” Id.

Six Plaintiffs are “Organizational Plaintiffs”: American Academy of Pediatrics (“AAP”),

the American Cancer Society Cancer Action Network (“ACS CAN”), the American Heart

Association (“AHA”), the American Lung Association (“ALA”), the Campaign for Tobacco-Free

Kids (“CTFK”), and the Truth Initiative. Pls.’ Rely & Opp’n 3. Plaintiffs assert that the

Organizational Plaintiffs’ “missions center on educating the public about the dangers of [new

tobacco products]” and “advancing the public health.” Id. at 6, 7. To this end, the Organizational

Plaintiffs “work daily on the front lines of a multi-faceted effort to eradicate tobacco addiction and

to avert the creation of new generations of addicted children and adults.” Id. at 2.

Plaintiffs offer evidence that,


16

[a]s implemented by the Deeming Rule, the Act would have enabled sustained progress toward that goal by subjecting hazardous and addictive products such as cigars and e-cigarettes to premarket review—requiring manufacturers to supply data and other information to FDA showing that the products they seek to market advance the public health, directing FDA to issue public orders determining whether the statutory public health standard has been met, and prohibiting the marketing of those products for which premarket orders have not been issued. . . . . . . Were FDA performing its statutorily required premarket review responsibilities, FDA would be disclosing to the public significant information about new tobacco products that Organizational Plaintiffs would use to further their missions.

Id. at 2–3 (citing Myers (CTFK) Decl. ¶¶ 10-17, ECF No. 39-1); see also, e.g., Myers (CTFK)

Decl. ¶ 11 (noting that one FDA “premarket review order disclosed a wealth of information that

aid[ed] Tobacco-Free Kids in understanding and educating about the risks of tobacco products and

the relative risk among products,” such as “how standards in [one producer]’s manufacturing

process help ensure lower levels of certain carcinogens; the relative disease risk of [its product]

vs. cigarettes and other forms of smokeless tobacco; and the contribution of various harmful and

potentially harmful constituents to disease risk”). Plaintiffs assert that they suffered informational

injury because

FDA’s suspension of premarket review requirements for approximately 25,000 new tobacco products deprives Organizational Plaintiffs of access to vital scientific and health information necessarily generated as a part of that process—information Plaintiffs need to carry out their missions.

Pls.’ Reply & Opp’n 3.

Additionally, Plaintiffs argue, “the Guidance interferes with Organization Plaintiffs’

missions of advancing the public health by allowing nearly 25,000 unreviewed products to remain

on the market—requiring Plaintiffs to expend more resources to monitor the marketplace and to

counsel and educate the public about e-cigarettes, cigars, or both.” Id. at 7. Specifically,

Plaintiff AAP, for instance, has expended “approximately 2000 hours on e-cigarette work” since FDA issued the Guidance, AAP Decl. ¶ 15—hours spent updating and offering educational programs focused on e-cigarettes, id. ¶¶ 16-25;


17

developing and issuing educational curricula and clinical materials, id. ¶¶ 30-34; and researching and publishing a policy statement on e-cigarettes, id. ¶¶ 35-44. The “massive increase in time that [AAP has] had to spend on e-cigarette work in light of the proliferation of products without premarket review” has required the organization to reduce staffing on other projects, postpone new initiatives, spend funds that it would not have otherwise had to, and forgo grant funding—all as a direct result of the Guidance. Id. ¶¶ 45-51. Other Organizational Plaintiffs attest to similar resource expenditures. See, e.g., ALA Decl. ¶¶ 11-14; ACS CAN Decl. ¶ 15; AHA Decl. ¶¶ 15, 17.

Id.; see also, e.g., Phillips (ACS CAN) Decl. ¶ 15, ECF No. 39-3 (“Without a prohibition on

marketing newly deemed products until review is complete, hundreds of products in thousands of

flavors are currently being sold without a decision from FDA on those products’ effect on public

health. This situation forces ACS CAN to invest considerably more resources in monitoring the

market and the products in the market so that we can determine where the greatest risks to public

health are arising. This work hinders ACS CAN from working on other priorities in our evidence-

based tobacco prevention and control efforts.”).

Notably, the Tobacco Control Act is quite clear that its purpose is, in part, “to ensure that

consumers are better informed,” and, to that end, it “require[s] tobacco product manufacturers to

disclose research which has not previously been made available . . . relating to the health and

dependency effects or safety of tobacco products.” Pub. Law. 111-31, at § 3(6), 123 Stat 1776,

1782. It recognizes that “the use of tobacco by young people and dependence on tobacco” are “of

particular concern to public health officials.” Id. § 3(2), 123 Stat. 1776, 1781. And, the Act

unambiguously established the public’s right to the information by requiring the FDA to disclose

products’ “detailed information regarding data concerning adverse health effects . . . within 30

days” of any substantial equivalence determination. 21 U.S.C. § 387j(a)(4)(B).

The August 2017 Guidance’s provisions, which do not require manufacturers to submit

their applications (accompanied by research in support) for five or more years and announce that

the FDA will defer enforcement during that period, deny the Organizational Plaintiffs “access to


18

information required to be disclosed by statute.” Dreher, 856 F.3d at 345; Friends of Animals,

828 F.3d at 992; see, e.g., Phillips (ACS CAN) Decl. ¶¶ 12–13 (“When FDA does not conduct

premarket review, it is far more difficult for ACS CAN to advocate effectively for its members.

Scientific data on the contents of novel tobacco products and their physiological consequences are

crucial to ACS CAN’s ability to identify effective and feasible product standards. Without such

data, designing and proposing a product standard is akin to building a highway without knowing

how to make asphalt. And such data largely comes from FDA, because tobacco manufacturers

typically release as little information about their products’ specific contents and interactions as

possible. For example, JUUL, currently one of the most popular e-cigarettes among school-aged

youth, has not gone through the premarket review process. If it did, it would have to provide

information to FDA about its contents and their effects, and FDA would make that information

public if it approved JUUL. Having that information would allow ACS CAN to determine whether

there were specific aspects of JUUL that were troublingly carcinogenic and determine whether

there are product standards that would minimize the carcinogenic effects of all e-cigarettes.

Without premarket review, however, that information is simply unavailable.”). Further, Congress

intended for the research provided pursuant to the Tobacco Control Act to be publicly available

promptly after product approval. 21 U.S.C. § 387j(a)(4)(B); Pub. Law. 111-31, at § 3(2), (6), 123

Stat 1776, 1781, 1782. Therefore, through this deprivation of information, Plaintiffs are suffering

“the type of harm Congress sought to prevent by requiring disclosure.” Dreher, 856 F.3d at 345;

Friends of Animals, 828 F.3d at 992.

Moreover, this injury to the organizations’ daily operations due to agency action limiting

their access to the information is the type of injury that courts have recognized as both concrete

and particularized. E.g., Acosta, 363 F. Supp. 3d at 12; People for the Ethical Treatment of


19

Animals v. U.S. Dep’t of Agric. (PETA), 797 F.3d 1087, 1095 (D.C. Cir. 2015) (“Because PETA’s

alleged injuries—denial of access to bird-related AWA information including, in particular,

investigatory information, and a means by which to seek redress for bird abuse—are ‘concrete and

specific to the work in which they are engaged,’ we find that PETA has alleged a cognizable injury

sufficient to support standing.” (citation omitted)); see id. at 1094 (noting that, when “the

challenged regulations den[ied] the [organization plaintiffs] access to information and avenues of

redress they wish to use in their routine information-dispensing, counseling, and referral

activities,” that “inhibition of [plaintiff organizations’] daily operations” is “an injury both

concrete and specific to the work in which they are engaged”); Lane, 703 F.3d at 674 (“An

organization may suffer an injury in fact when a defendant’s actions impede its efforts to carry out

its mission.”).

Further, the injury is not speculative, as the FDA currently is not requiring applications for

new products and therefore is not making available the information it otherwise would make

available. Additionally, Plaintiffs already have spent time and resources researching and educating

the public on e-cigarettes due to the dearth of such information from the FDA. See Phillips (ACS

CAN) Decl. ¶ 15 (“Without a prohibition on marketing newly deemed products until review is

complete, hundreds of products in thousands of flavors are currently being sold without a decision

from FDA on those products’ effect on public health. This situation forces ACS CAN to invest

considerably more resources in monitoring the market and the products in the market so that we

can determine where the greatest risks to public health are arising.”); Schoeberl (AHA) Decl.

¶¶ 15–16, ECF No. 39-4 (“In lieu of premarket review, AHA must do its own research and review

published research on e-cigarettes and cigars. But due to the paucity of published information, the

variable contents of the unregulated products, and the sheer number of products on the market, this


20

endeavor is not only a completely inadequate substitute for premarket review, but also expensive.

Similarly, AHA develops resources for individuals, including its 40 million volunteers and

supporters. It is currently developing or updating materials on topics such as resources to help quit

smoking, whether vaping is safer than smoking, common products such as JUUL, and the public

health implications of e-cigarettes. All of this material is more costly to develop—and less

complete—due to the absence of premarket review and the information it would provide, as well

as the immense diversity of products in the absence of premarket review.”).

This Court has held that an organization has standing where, as here, “the defendants’

actions ‘have caused the organization to divert resources to identify and counteract the defendants’

unlawful practices,’ and thereby impede[d] and frustrate[d] its core mission.” Equal Rights Ctr.

v. Equity Residential, 483 F. Supp. 2d 482, 487 (D. Md. 2007) (plaintiff’s mission was “through

‘education, counseling, advocacy, enforcement, and referral services to aid protected

individuals’”); see also Equal Rights Ctr. v. Abercrombie & Fitch Co., 767 F. Supp. 2d 510, 519–

20 (D. Md. 2010) (“[D]iversion of funds and frustration of an organization’s missions are injuries

sufficient to establish standing under Article III . . . .”); Shield Our Constitutional Rights & Justice

v. Hicks, No. DKC-09-940, 2009 WL 3747199, at *5 (D. Md. Nov. 4, 2009) (noting that

“Plaintiffs’ complaint [wa]s devoid of any facts . . . similar to those in Equity Residential,” and

concluding that plaintiffs failed to establish organizational standing). Therefore, Plaintiffs have

demonstrated a concrete, non-speculative injury. See PETA, 797 F.3d 1087, 1094–95; Lane, 703

F.3d at 674; Acosta, 363 F. Supp. 3d at 12; Abercrombie & Fitch Co., 767 F. Supp. 2d at 519–20;

Equity Residential, 483 F. Supp. 2d at 487.


21

Traceable Injury

If “the alleged injury is solely ‘th[e] result [of] the independent action of some third party

not before the court,’” then the “plaintiff may not have standing.” Kravitz v. U.S. Dep’t of

Commerce, 336 F. Supp. 3d 545, 559 (D. Md. 2018) (quoting Lujan v. Defs. of Wildlife, 504 U.S.

555, 560 (1992)). But, “[f]or an injury to be ‘fairly traceable’ to the defendant, the defendant’s

actions need not be ‘the very last step in the chain of causation.’” Id. (quoting Bennett v. Spear,

520 U.S. 154, 168–69 (1997)). Rather, “the causation element of standing is satisfied . . . where

the plaintiff suffers an injury that is ‘produced by [the] determinative or coercive effect’ of the

defendants’ conduct ‘upon the action of someone else.’” Id. (quoting Lansdowne on the Potomac

Homeowners Ass’n, Inc. v. OpenBand at Lansdowne, LLC, 713 F.3d 187, 197 (4th Cir. 2013)

(quoting Bennett, 520 U.S. at 169)).

Here, Plaintiffs’ injuries result from the FDA’s actions to exempt certain products from

premarket review for years. Certainly, the FDA’s actions arguably are not “the very last step in

the chain of causation,” as the manufacturers theoretically could have chosen to submit

applications promptly or to remove their products from the market in response to the August 2017

Guidance stating that they were exempt from premarket review and enforcement for five or six

years or more. But theory and reality are not always in harmony, and the record before me contains

no facts to suggest that manufacturers actually have done so, nor would it be the slightest bit

surprising to learn that they have not. And, it is telling that the FDA has not issued any orders on

premarket tobacco product applications since 2015 or taken any final action on any premarket

tobacco product applications since June 2017. See FDA, Summary of Premarket Tobacco Product

Application Final Actions, https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-

product/tobacco-product-marketing-orders; see also Fed. R. Evid. 201(b)(2). Under these


22

circumstances, the injury is undeniably traceable to Defendants’ August 2017 Guidance. See Pub.

Citizen Health Research Grp. v. Acosta, 363 F. Supp. 3d 1, 12 (D.D.C. 2018) (“Here, the causal

relationship is quite clear. Plaintiffs allege that OSHA, in violation of the APA, indefinitely

suspended the Electronic Reporting Rule without following proscribed statutory procedures and

without adequate justification. As a result of that suspension, employers are not required to submit

Forms 300 and 301, nor will OSHA even accept those forms if submitted, and thus OSHA no

longer collects the occupational health and injury data on which Plaintiffs profess to rely.”).

Redressability

A plaintiff’s allegations satisfy the redressability prong if it is “likely, and not merely

speculative, that a favorable decision will remedy the injury.” Friends of the Earth, Inc. v. Gaston

Cooper Recycling Corp., 204 F.3d 149, 154 (4th Cir. 2000). Here, if the Court vacated the August

2017 Guidance as Plaintiffs request, then the manufacturers would be required to submit their

applications immediately (as the deadlines in the Deeming Rule and the May 2017 Guidance have

passed) or by a reasonable date proposed by FDA, if the Court orders supplemental briefing on a

remedy, and then imposes one. See Pls.’ Reply & Opp’n 40 n.14. Either way, the deadline would

be sooner than under the August 2017 Guidance. Once applications are submitted, the FDA would

have to respond in 180 days. 21 U.S.C. § 387j(c)(1)(A). This would generate the information

Plaintiffs seek and eliminate the need for them to expend time and resources obtaining the

information and educating the public. Thus, it is likely that a decision in Plaintiffs’ favor would

redress their injury. See Friends of the Earth, 204 F.3d at 154.

Therefore, the Organizational Plaintiffs have standing. See Lujan, 504 U.S. at 560–61;

Bishop, 575 F.3d at 423. Because these Plaintiffs have standing, I need not consider whether the

other Plaintiffs have standing. See Kenny v. Wilson, 885 F.3d 280, 287 (4th Cir. 2018); see also


23

Pub. Citizen Health Research Grp. v. Acosta, 363 F. Supp. 3d 1, 11 (D.D.C. 2018) (“Since

Plaintiffs’ organizational standing alone would suffice to satisfy Article III’s requirements,

however, the Court will focus its analysis there.” (citing Bowsher v. Synar, 478 U.S. 714, 721

(1986))).

Judicial Review of Nonenforcement Decision

The actions of an agency such as the FDA “are presumptively subject to judicial review.”

Elecs. of N.C., Inc. v. Se. Power Admin., 774 F.2d 1262, 1266 (4th Cir. 1985) (citing Abbott Labs.

v. Gardner, 387 U.S. 136, 140–41 (1967)). Two exceptions exist. First, “where Congress

manifests its intent to preclude such review,” the action is nonreviewable. Id.; see 5 U.S.C.

§ 701(a)(1). Second, if the agency’s action “is ‘committed to agency discretion by law,’” then it

is nonreviewable. Id. (quoting 5 U.S.C. § 701(a)(2)). For this second “very narrow exception” to

apply, the statute must be “drawn in such broad terms that in a given case there is no law to apply.”

Id. (quoting Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971) (quoting

legislative history of the APA, S. Rep. No. 752, 79th Cong., 1st Sess., 26 (1945))). That is, under

§ 701(a)(2), “review is not to be had if the statute is drawn so that a court would have no meaningful

standard against which to judge the agency’s exercise of discretion.” Heckler v. Chaney, 470 U.S.

821, 830 (1985).

Further, because an agency’s “[r]efusal to take enforcement steps” is “generally . . .

precisely the opposite” of an agency’s actions in accordance with “a statute that set[s] clear

guidelines for [such actions],” the “presumption of reviewability” does not apply to that refusal.

Chaney, 470 U.S. at 831. Indeed, “in that situation . . . the presumption is that judicial review is

not available.” Id.; see also Elecs. of N.C., 774 F.2d at 1266.


24

Relying on the U.S. District Court for the District of Columbia’s decision in National

Association for the Advancement of Colored People v. Trump, 298 F. Supp. 3d 209 (D.D.C. 2018),

Defendants insist that “a ‘general enforcement policy,’” such as an agency’s decision not to

enforce a statute, “is reviewable only where it announces an agency’s ‘legal interpretation’ of a

statute.” Defs.’ Reply 7 (quoting Nat’l Ass’n for the Advancement of Colored People v. Trump,

298 F. Supp. 3d 209, 231 (D.D.C. 2018), adhered to on denial of reconsideration, 315 F. Supp. 3d

457 (D.D.C. 2018)) (emphasis added). Indeed, Trump held that “legal interpretations couched as

broad enforcement policies . . . are reviewable, . . . individual enforcement decisions . . . are

presumptively unreviewable, . . . and discretionary enforcement policies . . . are presumptively

unreviewable. . . .” Trump, 298 F. Supp. 3d at 231 (emphasis added). Significantly, however, this

holding defines the applicable presumption; the Trump Court also noted that the presumption of

unreviewability of agency discretionary enforcement policies is rebuttable under two

circumstances. Trump, 298 F. Supp. 3d at 234; see also Chaney, 470 U.S. at 832–33 (discussing

when presumption of unreviewability of broad refusal to take enforcement action can be rebutted).

First, while “an agency’s decision whether to take an enforcement action is presumptively

unreviewable, . . . that presumption can normally be rebutted . . . by pointing to statutory language

that constrains the agency’s exercise of its enforcement discretion.” Trump, 298 F. Supp. 3d at

234 (citing Chaney, 470 U.S. at 832–33). In other words, the presumption that “an agency’s

decision not to take enforcement action [is] immune from judicial review under § 701(a)(2) . . .

may be rebutted where the substantive statute has provided guidelines for the agency to follow in

exercising its enforcement powers.” Chaney, 470 U.S. at 832–33. To determine whether this

exception to the presumption of unreviewability applies, the court considers whether Congress

“has indicated an intent to circumscribe agency enforcement discretion, and has provided


25

meaningful standards for defining the limits of that discretion.” Chaney, 470 at 834–35. If so,

“there is ‘law to apply’ under § 701(a)(2), and courts may require that the agency follow that law.”

Id. If Congress has not demonstrated such an “intent to circumscribe agency enforcement

discretion, . . . then an agency refusal to institute proceedings is a decision ‘committed to agency

discretion by law’” and is not reviewable in court. Id. Second, the Chaney “presumption of

unreviewability does not apply to ‘an agency’s announcement of its interpretation of a statute even

when that interpretation is advanced in the context of a decision not to take enforcement action.’”

Trump, 298 F. Supp. 3d at 228 (quoting Edison Elec. Inst. v. EPA, 996 F.2d 326, 333 (D.C. Cir.

1993) (citations and internal quotation marks omitted)).

Additionally, if the agency’s decision is “‘tantamount to amending or revoking a rule,’”

then it “amounts to substantive rulemaking subject to the APA’s constraints and generally

reviewable by courts.” Public Citizen Health Research Group v. Acosta, 363 F. Supp. 3d 1, 18

(D.D.C. 2018) (quoting Clean Air Council v. Pruitt, 862 F.3d 1, 6 (D.C. Cir. 2017) (per curiam)).

Thus, an agency enforcement decision, including a refusal to take enforcement action, may be

reviewed in court (1) if the agency’s decision is a statement of statutory interpretation, albeit

couched as an exercise of enforcement discretion; (2) if Congress indicated, such as through the

language of the statute itself, that it intended to circumscribe the agency’s enforcement discretion,

see Trump, 298 F. Supp. 3d at 228, 234; Chaney, 470 U.S. at 832–35, or (3) if it amounts to a rule

amendment or revocation, see Acosta, 363 F. Supp. 3d at 18.

In Chaney (on which the FDA heavily relies), prison inmates who had been sentenced to

death by lethal injection asked the FDA to “take various enforcement actions” regarding the use

of drugs for lethal injection; the inmates asserted that the use violated the Federal Food, Drug, and


26

Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”),8 but the FDA refused to take action. 470 U.S.

at 823. The inmates filed suit, and the Supreme Court considered “the extent to which a decision

of an administrative agency to exercise its ‘discretion’ not to undertake certain enforcement actions

is subject to judicial review under the Administrative Procedure Act, 5 U.S.C. § 501 et seq.

(APA).” 470 U.S. at 823.

Specifically, the Chaney Court considered the language of the FDCA, noting that one part

“provide[d] only that [t]he Secretary is authorized to conduct examinations and investigations”

and did not give any “indication of when an injunction should be sought,” and another was “framed

in the permissive.” Id. at 835.9 Also, while “[t]he section on criminal sanctions state[d] baldly that

any person who violates the Act’s substantive provisions ‘shall be imprisoned . . . or fined,’” the

Court was “unwilling” to construe that language to “mandate[] criminal prosecution of every

violator of the Act . . . particularly since the Act charges the Secretary only with recommending

prosecution; any criminal prosecutions must be instituted by the Attorney General.” Id. (emphasis

added). It concluded that “[t]he Act’s enforcement provisions thus commit complete discretion to

the Secretary to decide how and when they should be exercised.” Id. The Court also stated that

“the Act’s substantive prohibitions of ‘misbranding’ and the introduction of ‘new drugs’ absent

agency approval” were “simply irrelevant to the agency’s discretion to refuse to initiate

8 The Tobacco Control Act has been codified, in part, as part of the FDCA. See 21 U.S.C. §§ 387 – 387(u). 9 On most occasions, the Act refers to the authority of the Secretary of the

Department Health and Human Services (HHS) to take certain actions. However, the Secretary acts through the Commissioner of Food and Drugs. 21 U.S.C. § 393(d)(2). For simplicity, [the court] will refer to any legislative delegation as if made directly to the FDA.

Brown & Williamson Tobacco Corp. v. Food & Drug Admin., 153 F.3d 155, 161 (4th Cir. 1998), aff’d, 529 U.S. 120 (2000).


27

proceedings.” Id. at 836. And, it rejected the argument that another provision of the act, stating

that nothing in the act would “be construed as requiring the Secretary to report for prosecution . . .

minor violations of this chapter” gave “rise to the negative implication” that “the Secretary is

required to report for prosecution all ‘major’ violations of the Act.” Id. at 837 (some emphases

added).

In sum, the Court “conclude[d] that the presumption that agency decisions not to institute

proceedings are unreviewable under 5 U.S.C. § 701(a)(2) is not overcome by the enforcement

provisions of the FDCA,” such that “[t]he FDA’s decision not to take the enforcement actions

requested by [the inmates] is therefore not subject to judicial review under the APA.” Id. at 837-

38. But, as Plaintiffs are quick to point out, Chaney is not the last word on how to interpret an

agency’s professed reliance on the presumption of judicial unreviewability of its exercise of

enforcement discretion, because the Circuit and District Courts have examined this subject

extensively. Pls.’ Reply & Opp’n 28–29.

For example, Public Citizen Health Research Group v. Acosta, 363 F. Supp. 3d 1 (D.D.C.

2018), has a fact pattern that is quite similar to the facts in this case. There, the District Court for

the District of Columbia considered the justiciability of an action that the Occupational Safety and

Health Administration (“OSHA”) took that set the requirements for “qualifying employers to

record work-related injuries and illnesses on a set of standardized forms.” 363 F. Supp. 3d at 6.

Initially, OSHA only occasionally collected these forms from employers, either during on-site inspections or as part of broader industry surveys. But in May 2016, OSHA issued a new rule requiring employers to submit them—three in total—electronically each year. In May 2018, however, and after the first filing deadline had passed, OSHA announced employers were only required to submit one of the three forms while it considered revising or rescinding the existing rule, citing privacy and waste concerns. In fact, OSHA stated that, until it completed its review, it would not accept two of the three forms from employers at all.


28

Id. Three public-health advocacy groups that “view[ed] these forms as valuable sources of

workplace health data, and . . . allege[d] that they intended to use that data in their research and

advocacy efforts once OSHA collected it,” filed suit pursuant to the APA, claiming that OSHA’s

conduct “unlawfully deprived them of access to an important source of workplace health data.”

Id. at 6–7. They asked the court to “require[] OSHA to lift its suspension of the filing deadlines

and to accept all three forms.” Id. at 7.

The court concluded that the plaintiffs sufficiently alleged that “OSHA did not simply

exercise its discretion not to enforce the Rule, but suspended its reporting requirement entirely

such that covered employers are not legally obligated to submit the forms, regardless of whether

OSHA decides to take action against them for not doing so.” Id. at 18 (“Plaintiffs’ complaint

plausibly alleges that the May 2018 OSHA action they challenge was a wholesale suspension of

the Electronic Reporting Rule, not merely a policy statement regarding OSHA’s enforcement

discretion.”). It noted that, in the District of Columbia Circuit, “[s]uch decisions . . . ‘are

tantamount to amending or revoking a rule,’” which “amounts to substantive rulemaking subject

to the APA’s constraints and generally reviewable by courts.” Id. (quoting Clean Air Council v.

Pruitt, 862 F.3d 1, 6 (D.C. Cir. 2017) (per curiam)). Therefore “OSHA’s action d[id] not warrant

a presumption against reviewability.” Id.

The court also considered the mandatory requirements within the statutory language of the

Occupational Safety and Health Act (“OSH Act”). Specifically,

Section 673(a) of the OSH Act mandates that OSHA “shall develop and maintain an effective program of collection, compilation, and analysis of occupation safety and health statistics.” 29 U.S.C. § 673(a). Similarly, § 657(c)(2) mandates that OSHA “shall prescribe regulations requiring employers to maintain accurate records of, and to make periodic reports on, work-related deaths, injuries and illnesses.” Id. § 657(c)(2). And § 673(e) further provides that “[o]n the basis of the records made and kept pursuant to section 657(c) . . . , employers shall file such


29

reports with [OSHA] as [it] shall prescribe by regulation, as necessary to carry out [its] functions under this chapter.” Id. § 673(e).

Id. at 19 (emphases added). The court concluded that these provisions “do not rest unfettered

discretion with OSHA to promulgate—or not promulgate—regulations concerning reporting

requirements and data compilation. OSHA must issue regulations necessary to fulfilling the

purposes of the OSH Act and its administrative functions.” Id.

Here, the parties agree that, pursuant to the August 2017 Guidance, the FDA currently does

not have to undertake premarket review for e-cigarettes, cigars, and other newly deemed tobacco

products, and manufacturers currently do not have to file applications with the FDA for those

products to remain on the market. Pls.’ Mem. 1; Defs.’ Mem. & Opp’n 2. Defendants

acknowledge that Congress did not establish a statutory grace period for new tobacco products as

it did “for originally regulated products,” but they argue that the inclusion of such a provision in

another section of the Act “in no way curtails the agency’s inherent discretion to extend a similar

grace period to newly deemed products—if anything, it shows that deferring enforcement of this

provision for newly regulated products is entirely sensible.” Defs.’ Mem. 4. But, “[w]here

Congress includes particular language in one section of a statute but omits it in another section of

the same Act, it is generally presumed that Congress acts intentionally and purposely in the

disparate inclusion or exclusion.” Nat’l Ass’n of Mfrs. v. Dep’t of Def., ––– U.S. ––––, 138 S. Ct.

617, 631 (2018) (quoting Russello v. United States, 464 U.S. 16, 23 (1983) (internal quotation

marks and brackets omitted)).

In Defendants’ view, the August 2017 Guidance is a nonenforcement decision that is

“committed to agency discretion, and thus presumptively immune from judicial review,” as

explained in Chaney. Defs.’ Mem. 21. Certainly, the parties agree that the FDA has some discretion

to allow for a compliance period for new tobacco products, and the FDA did just that in the


30

Deeming Rule. But, Plaintiffs insist that “Congress cabined any FDA discretion under the

[Tobacco Control] Act,” and therefore the Court may review the August 2017 Guidance. Pls.’

Reply & Opp’n 23 (quoting Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 410

(1971)). As Plaintiffs see it, “[t]he Tobacco Control Act plainly makes premarket review

mandatory, not discretionary, for both regulated entities and FDA.” Pls.’ Mem. 9.

The extent of the FDA’s discretion under the Tobacco Control Act is a matter of statutory

interpretation.

“The ‘first step’ of statutory interpretation ‘is to determine whether the language at issue has a plain and unambiguous meaning’ by looking to ‘the language itself, the specific context in which that language is used, and the broader context of the statute as a whole.’ ” Orquera v. Ashcroft, 357 F.3d 413, 418 (4th Cir. 2003) (quoting Robinson v. Shell Oil Co., 519 U.S. 337, 340–41, 117 S.Ct. 843, 136 L.Ed.2d 808 (1997)). When the words of the statute are “sufficient in and of themselves to determine the purpose of the legislation” and do not produce unreasonable results “plainly at variance with the policy of the legislation as a whole,” courts must follow their plain meaning. United States v. Am. Trucking Ass’ns, 310 U.S. 534, 60 S.Ct. 1059, 84 L.Ed. 1345 (1940) (quoting Ozawa v. United States, 260 U.S. 178, 194, 43 S.Ct. 65, 67 L.Ed. 199 (1922)). Indeed, “[t]here is ... no more persuasive evidence of the purpose of a statute than the words by which the legislature undertook to give expression to its wishes.” Am. Trucking Ass’ns, 310 U.S. at 543, 60 S.Ct. 1059.

Nat’l Ass’n for the Advancement of Colored People v. U.S. Dep’t of Homeland Sec., 364 F. Supp.

3d 568, 574–75 (D. Md. 2019).

Plaintiffs rely on 21 U.S.C. § 387j(a)(2) and (c)(1)(A)(i), which provide:

(a) In general

. . .

(2) Premarket review required

(A) New products

An order under subsection (c)(1)(A)(i) for a new tobacco product is required unless--

(i) the manufacturer has submitted a report under section 387e(j) of this title; and the Secretary has issued an order that the tobacco product--


31

(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and

(II) is in compliance with the requirements of this chapter; or

(ii) the tobacco product is exempt from the requirements of section 387e(j) of this title pursuant to a regulation issued under section 387e(j)(3) of this title.

(B) Application to certain post-February 15, 2007, products

Subparagraph (A) shall not apply to a tobacco product--

(i) that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009; and

(ii) for which a report was submitted under section 387e(j) of this title within such 21-month period,

except that subparagraph (A) shall apply to the tobacco product if the Secretary issues an order that the tobacco product is not substantially equivalent.

. . .

(c) Action on application

(1) Deadline

(A) In general

As promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall--

(i) issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or

(ii) issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.

(B) Restrictions on sale and distribution

An order under subparagraph (A)(i) may require that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title.

(2) Denial of application

The Secretary shall deny an application submitted under subsection (b) if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that--


32

(A) there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health;

(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 387f(e) of this title;

(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or

(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 387g of this title, and there is a lack of adequate information to justify the deviation from such standard.

21 U.S.C. § 387j(a)(2), (c)(1)(A)(i), (2) (emphases added).

These statutes include mandatory language like that in Acosta, not the permissive language

at issue in Chaney. The term “shall,” which appears repeatedly in these statutory provisions,

“normally creates an obligation impervious to . . . discretion.” Lexecon Inc. v. Milberg Weiss

Bershad Hynes & Lynch, 523 U.S. 26, 35 (1998); see also Cook v. Food & Drug Admin., 733 F.3d

1, 7 (D.C. Cir. 2013) (applying Lexecon holding with regard to judicial discretion to conclude that

agency did not have absolute discretion where mandatory language appeared in the statute).

Giving the statute’s language its ordinary meaning, these provisions require premarket review

(involving applications and decisions on those applications) within a specific timeframe, and the

August 2017 Guidance suspends the deadlines for both until 2021 or 2022 or later. Moreover, the

plain language of the statute prohibits products from entering the market without the FDA’s

approval. Therefore, the FDA’s “wholesale suspension” of the application filing and approval

requirements constitutes a rule amendment or revocation that is subject to review by this Court.

Acosta, 363 F. Supp. 3d at 18; see also Elecs. of N.C., 774 F.2d at 1266.

And, even if the agency’s deferral of the premarket approval process constituted an

enforcement decision, which would be presumptively unreviewable by the Court, see Chaney, 470

U.S. at 831, I note that, as the Acosta Court concluded regarding the OSH Act and OSHA’s actions,


33

these provisions of the Tobacco Control Act “do not rest unfettered discretion” with the FDA to

modify or suspend the product approval process. Acosta, 363 F. Supp. 3d at 19. Rather, the FDA

“must” require filings from manufacturers and approve or deny those filings, that is, it must take

actions that are “necessary to fulfilling the purposes of the [Tobacco Control] Act.” See id.; see

also Cook, 733 F.3d at 7 (concluding that any presumption of immunity from judicial review was

“rebutted by the specific ‘legislative direction in the statutory scheme’” that “set[] forth precisely

when the [FDA] must determine whether a drug offered for import appears to violate the FDCA,

and what the agency must do with such a drug”). Thus, the Tobacco Control Act was not “drawn

in such broad terms that . . . there is no law to apply” in this case, see Citizens to Preserve Overton

Park, 401 U.S. at 410; Elecs. of N.C., 774 F.2d at 1266, and therefore the FDA’s actions were not

“committed to agency discretion by law,” see 5 U.S.C. § 701(a)(2). Neither has Congress

“manifest[ed] its intent to preclude [judicial] review” of the FDA’s action under the Tobacco

Control Act. See Elecs. of N.C., 774 F.2d at 1266; 5 U.S.C. § 701(a)(1).

I further note that the Tobacco Control Act “has provided guidelines for the agency to

follow in exercising its enforcement powers,” Chaney, 470 U.S. at 832–33, and the Act’s language

shows Congressional “intent to circumscribe agency enforcement discretion”; also, it “has

provided meaningful standards for defining the limits of that discretion,” id. at 834–35.

Specifically, the statute provides that, “[a]s promptly as possible, but in no event later than 180

days after the receipt of an application . . . the Secretary . . . shall” consider the report and

recommendation submitted with the application and issue an order, either allowing the product

into interstate commerce, if the Secretary makes certain findings that the statute identifies, or issue

an order prohibiting the product from interstate commerce, if the Secretary makes certain other

findings, which also are identified. 21 U.S.C. §§ 387j(c)(1)(A). One of these orders “is required


34

unless” the Secretary issues an order that the product “is substantially equivalent to a tobacco

product commercially marketed (other than for test marketing) in the United States as of February

15, 2007” and meets certain statutory requirements, or is exempt from the requirements. 21 U.S.C.

§§ 387j(a)(2). Also, “[t]he Secretary shall deny an application” if it makes certain findings

identified in the statute. 21 U.S.C. §§ 387j(c)(2). This is “statutory language that constrains the

agency’s exercise of its enforcement discretion.” Trump, 298 F. Supp. 3d at 234 (citing Chaney,

470 U.S. at 832–33).

Defendants disagree, arguing that these provisions “do not circumscribe the agency’s

enforcement discretion.” Defs.’ Reply 6. They reason that “[w]ords like ‘required’ and ‘shall’ are

common throughout the U.S. Code, yet they have never been thought to ‘mandate . . . prosecution

of every violator.’” Id. (quoting Chaney, 470 U.S. at 835). But, as noted, when the Chaney Court

refused to construe the phrase “shall be imprisoned . . . or fined” to “mandate[] criminal

prosecution of every violator of the Act” and concluded that the Secretary had “complete discretion

. . . to decide how and when [the enforcement provisions] should be exercised,” it was not because

the term “shall” is not mandatory. Chaney, 470 U.S. at 835. Rather, the Court reasoned that the

statute at issue “charge[d] the Secretary only with recommending prosecution” and provided that

“any criminal prosecutions must be instituted by the Attorney General.” Id. (emphases added).

This language differs from the language of § 387j(a)(2) and (c), which expressly directs the

Secretary to approve or deny applications.

Insofar as mandatory language may not “mandate[] criminal prosecution of every violator”

of a given statute, to hold that such language does not mandate that the agency enforce the statute

against any violator would render the language surplusage. The Court “cannot adopt a reading of

[the statute] that renders part of the statute superfluous over one that gives effect to its ‘every


35

clause and word,’” as doing so would violate the “well-established rule against surplusage.” United

States v. Simms, 914 F.3d 229, 241 (4th Cir. 2019) (quoting United States v. Menasche, 348 U.S.

528, 538–39 (1955)) (quoting Inhabitants of Montclair Twp. v. Ramsdell, 107 U.S. 147, 152

(1883)). Thus, to hold that the FDA’s discretion was not circumscribed by the Tobacco Control

Act’s mandatory language would “violat[e] a cardinal rule of statutory construction.” Id.

Accordingly, any presumption that the August 2017 Guidance is unreviewable under § 701(a)(2)

is overcome by these provisions, and therefore, the FDA’s decision in the August 2017 Guidance

not to undertake premarket review is subject to judicial review under the APA. See Chaney, 470

U.S. at 837–38; Trump, 298 F. Supp. 3d at 234; Acosta, 363 F. Supp. 3d at 18.

Final Agency Action

“Judicial review under the APA . . . is limited to ‘final agency actions.’” City of New York

v. U.S. Dep’t of Def., 913 F.3d 423, 430 (4th Cir. 2019) (quoting 5 U.S.C. § 704). Generally, “two

conditions must be satisfied for agency action to be ‘final.’” Vill. of Bald Head Island v. U.S. Army

Corps of Eng’rs, 714 F.3d 186, 194–95 (4th Cir. 2013) (quoting Bennett v. Spear, 520 U.S. 154

(1997)). The first requirement is that “the action must mark the consummation of the agency’s

decisionmaking process—it must not be of a merely tentative or interlocutory nature.” Id. (quoting

Bennett, 520 U.S. at 177–78 (citation and quotation marks omitted)). The second is that “the action

must be one by which rights or obligations have been determined or from which legal

consequences will flow.” Id. (quoting Bennett, 520 U.S. at 178 (citation and quotation marks

omitted)). Stated differently, “[t]he core question is whether the agency has completed its

decisionmaking process, and whether the result of that process is one that will directly affect the

parties.” Franklin v. Massachusetts, 505 U.S. 788, 797 (1992). “[T]he measure of finality is also

‘pragmatic’; an agency action is ‘immediately reviewable’ when it gives notice of how a certain


36

statute will be applied even if no action has yet been brought.” Int’l Refugee Assistance Project v.

Trump, 883 F.3d 233, 285 (4th Cir.), as amended (Feb. 28, 2018) (quoting U.S. Army Corps of

Eng’rs v. Hawkes Co., ––– U.S. ––––, 136 S. Ct. 1807, 1815 (2016)), cert. granted, judgment

vacated on other grounds, 138 S. Ct. 2710 (2018).

Defendants argue that, “[e]ven if the Guidance were more than the FDA’s ‘current

thinking’ on enforcement of the premarket authorization requirement, Guidance at 1 (GAR 422),

it does not satisfy the second criterion because it does not determine any rights or obligations, nor

will any legal consequences flow from it.” Defs.’ Mem. 31 (citation omitted). Defendants cite

BBK Tobacco & Foods, LLP v. FDA, 672 F. Supp. 2d 969, 975–76 (D. Ariz. 2009), in which the

U.S. District Court for the District of Arizona held that the FDA’s guidance documents at issue in

that case, which included the same boilerplate disclaimer about “not creat[ing] or confer[ring] any

rights” that appears in the August 2017 Guidance, “d[id] not constitute final agency action within

the meaning of the ripeness inquiry” because the guidance documents at issue in that case “d[id]

not provide any legal basis from which the FDA [could] institute civil or criminal legal

proceedings” and therefore ‘legal consequences’ [could not] flow” from the documents. But, that

case is not on point because here the issue does not concern the FDA instituting legal proceedings

based on a provision in the August 2017 Guidance but rather failing to take any action, and

justifying its decision with the language of the August 2017 Guidance. If the August 2017

Guidance is not a final action, then the FDA’s rationale for its inaction is that much less plausible.

In any event, case law from the District of Arizona is not binding on this Court, and the

only Fourth Circuit case Defendants cite is Flue-Cured Tobacco Coop. Stabilization Corp. v.

U.S.E.P.A., 313 F.3d 852 (4th Cir. 2002). There, the Fourth Circuit concluded that the EPA’s

report was not a final agency action. Id. at 858–59. That case is readily distinguished from this


37

one because when the Fourth Circuit “first look[ed] for direction to the Radon Act,” it noted that

“section 404 of the Radon Act prohibits the EPA (and the courts) from giving the Report ‘any

regulatory’ effect.” See id. at 858. Defendants have not identified any equivalent provision of the

Tobacco Control Act.

The Fourth Circuit’s recent decision in Sanitary Board of City of Charleston v. Wheeler,

918 F.3d 324 (4th Cir. 2019), likewise is not on point. There, the court reasoned that “‘advisory,’

‘pre-decisional,’ or ‘staff’” letters that “clearly state[] that the comments contained therein ‘do not

constitute approval or disapproval decisions[]’ . . . do not, in fact, reflect the agency’s final

position” because “[a]gencies need the ability to designate the import of the information they

disseminate, and this includes the ability to clearly communicate when a decision is final.” 918

F.3d at 337–38. Here, in contrast, the Guidance is not a letter, and it is not labeled “advisory” or

“pre-decisional.” Compare Aug. 2017 Guidance, GAR 420, ECF No. 48-1, at 712 (“Extension of

Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule: Guidance for

Industry (Revised) (Aug. 2017)”), with Premarket Tobacco Product Applications for Electronic

Nicotine Delivery Systems (ENDS): Guidance for Industry: Draft Guidance (May 1, 2016), AR

28350, ECF No. 48-1, at 358.

Certainly, the Guidance includes boilerplate language that it “does not establish any rights

for any person and is not binding on FDA or the public” and that it “do[es] not establish legally

enforceable responsibilities . . . and should be viewed only as [a] recommendation[ ].” Aug. 2017

Guidance 1, GAR 422, ECF No. 48-1, at 714. But it also states: “You can use an alternative

approach if it satisfies the requirements of the applicable statutes and regulations.” Id. (emphasis

added). Given that the applicable statutes and regulations imposed a deadline and the August 2017

Guidance suspended it, the only acceptable alternative approach would be to adhere to a more


38

stringent schedule. See id. Thus, if a manufacturer sought additional time to submit an application,

the only approach was to follow the Guidance. See id. Contra Mallinckrodt Inc. v. U.S. Food &

Drug Admin., No. DKC-14-3607, 2015 WL 13091366, at *13–14 (D. Md. July 29, 2015)

(concluding that FDA’s draft guidance that reclassified the plaintiff’s drug was not binding

because “the language used by FDA in the documents itself [including the same boilerplate

language in the August 2017 Guidance, quoted above] d[id] not purport to ‘impose legally binding

obligations’ . . . or to ‘set forth legally binding requirements” and “[m]oreover, . . . the document

itself is devoid of commands, orders, or binding requirements” and “alternative approaches may

satisfy the [relevant] statutes and regulations”; also reasoning that the draft guidance “did not

effectively amend a prior legistative rule because it ‘neither repudiate[d] nor [wa]s inconsistent

with any pre-existing FDA regulations”).

Moreover, with regard to the language purporting to limit the effects of the Guidance,

Philip Morris USA Inc. v. United States Food & Drug Administration, 202 F. Supp. 3d 31 (D.D.C.

2016), provides helpful guidance, even if it is not controlling authority. There, the District Court

for the District of Columbia considered the finality of “Demonstrating the Substantial Equivalence

of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 2)” (“Second SE

Guidance”), a document that the FDA had released regarding the term “new tobacco product” and

“how label and quantity changes could result in a ‘new tobacco product.’” 202 F. Supp. 3d at 43,

46. Specifically, the court addressed whether the Second SE Guidance “determine[d] rights or

obligations or establish[ed] legal consequences” so as to “fulfill the second requirement of

finality.” Id. at 46.

It noted that “boilerplate language” in the Second SE Guidance stating that it “‘do[es] not

establish legally enforceable responsibilities . . . and should be viewed only as [a]


39

recommendation[ ]’” and that it “‘does not establish any rights for any person and is not binding

on FDA or the public’”—language that is identical to language Defendants cite in the August 2017

Guidance, see Defs.’ Mem. 31 (quoting Aug. 2017 Guidance, ECF No. 48-1, at 714)—could not

“dictate whether the Second SE Guidance is a final agency action fit for review.” Philip Morris,

202 F. Supp. 3d at 46 (citing Appalachian Power Co. v. EPA, 208 F.3d 1015, 1022–23 (D.C. Cir.

2000) (concluding that “boilerplate” language in guidance released by an agency does not

determine whether an agency action has legal consequences)).

Rather, the court determines whether the guidance has legal consequences based on “the

context and form in which the agency action arises.” Id. at 46. The Philip Morris Court observed

that, while “[n]on-legislative agency statements of the type at issue . . . generally do not qualify as

a final agency action[,] . . . [t]hat does not mean, however, that such statements can never constitute

final agency action.” Id. (citing Appalachian Power, 208 F.3d at 1023). Indeed, agency statements

“‘can, as a practical matter, having a binding effect’ which contributes to a finding that the action

is ‘final.’” Id. (quoting Pharm. Research, 138 F. Supp. 3d at 41).

To determine if an agency’s interpretive rule or guidance is sufficiently final to warrant pre-enforcement review, the court may consider a host of factors. The three most important factors are: (1) whether the agency has taken a “definitive legal position” regarding its statutory authority; (2) whether the case presents a “purely legal question of statutory interpretation;” and (3) whether the action “imposes an immediate and significant practical burden on the regulated entity.”

Id. (quoting Pharm. Research, 138 F. Supp. 3d at 41–43).

In Philip Morris, the court concluded that “the first two factors [we]re easily met,” and it

focused on “whether the action imposes a significant burden on tobacco companies.” Id. As for

that factor, it concluded that the action did impose a significant burden because “[t]he fact that the

FDA is purporting merely to interpret a statute that vests it with regulatory authority does not mean

. . . that its action is not final,” and “the ‘distinction’ between whether the statute or the guidance


40

is the actual source of binding authority is ‘a hollow one without any meaningful difference.’” Id.

at 47 (quoting Pharm. Research, 138 F. Supp. 3d at 44).

Here, the statute requires premarket review for all tobacco products, 21 U.S.C. § 387j(a)(2),

(c)(1)(A), and the FDA announced in the August 2017 Guidance that certain products that had

been deemed to be tobacco products could remain on the market for five years or more without

premarket review. Aug. 2017 Guidance 8, GAR 429, ECF No. 48-1, at 721. Thus, the FDA has

“taken a ‘definitive legal position’ regarding its statutory authority,” asserting that it has the

authority under the Tobacco Control Act to delay the premarket review requirement. See Philip,

202 F. Supp. 3d at 46. Indeed, the August 2017 Guidance gave “notice of how [the Tobacco

Control Act] will be applied . . . .” See Int’l Refugee Assistance Project, 883 F.3d at 285. And,

this case concerns a legal question of statutory interpretation: can premarket review be postponed,

permitting a product to be on the market prior to approval, and if so, for how long? The FDA’s

action did not “impose[] an immediate and significant practical burden on the regulated entity.”

Id. (quoting Pharm. Research, 138 F. Supp. 3d at 41–43). In fact, it did the exact opposite—it

removed the burden of premarket review, allowing products to be on the market for five years or

longer prior to approval. Aug. 2017 Guidance 8, GAR 429, ECF No. 48-1, at 721. But, this factor

still weighs in favor of finality under the circumstances, as the effects (welcomed by the

manufacturers) on the regulated entities were “immediate and significant.” And, the agency action

does impose a burden; it simply is on Plaintiffs, rather than the regulated agencies. Further, the

August 2017 Guidance marked the culmination of the FDA’s decision-making process, as it served

as a definitive statement that immediately brought a number of new tobacco products into

compliance. Thus, the answer is “yes” to the “core question” of “whether the agency has

completed its decisionmaking process, and whether the result of that process is one that will


41

directly affect the parties.” See Franklin v. Massachusetts, 505 U.S. 788, 797 (1992). Therefore,

the August 2017 Guidance constitutes final agency action subject to this Court’s review. See id.;

Int’l Refugee Assistance Project, 883 F.3d at 285; Philip Morris, 202 F. Supp. 3d at 46–47.

APA Claims

Plaintiffs claim that the August 2017 Guidance “is ultra vires and unconstitutional,” in

violation of the APA, in that it “conflicts with the Tobacco Control Act; exceeds FDA’s statutory

authority; and violates the Constitution’s Take Care clause, U.S. Const. art. II, § 3.” Compl. ¶ 94;

see also id. ¶¶ 92–102 (Count I). They also claim that, because the August 2017 Guidance “is a

‘rule’ within the meaning of the APA,” the FDA violated the APA by issuing it without complying

with the notice and comment requirements for rule-making. Id. ¶¶ 105–07; see also id. ¶¶ 103–10

(Count II). Additionally, Plaintiffs claim that the August 2017 Guidance “is arbitrary and

capricious” because

FDA offered no contemporaneous explanation whatsoever in the Guidance to justify [its] decisions [regarding deadlines] or to explain how those decisions are remotely consistent with FDA’s statutory obligations to protect the public health from the dangers of tobacco products, the purposes of the Tobacco Control Act, the administrative record before the agency in the Deeming Rule, or FDA’s own prior findings.

Id. ¶ 113; see id. ¶¶ 111–18 (Count III); see also id. ¶¶ 115–17 (August 2017 Guidance is

inconsistent with compliance policy adopted in Deeming Rule and the findings in the Deeming

Rule and other FDA statements, and the inconsistencies are unexplained). Specifically, they claim

that “FDA failed to address—much less explain—how an indefinite review period comports with

the 180-day review period prescribed by Congress in the Tobacco Control Act. 21 U.S.C.

§ 387j(c)(1)(A),” and did not “identif[y] any basis on which it determined the length of the newly

announced compliance periods, nor has it provided any reasoned basis for establishing different


42

compliance periods for different product types—an approach it had previously rejected.” Id. ¶ 114.

On these bases, Plaintiffs ask the Court to vacate the August 2017 Guidance.

Defendants counter that the August 2017 Guidance “is fully consistent with the statutory

text, is a policy statement exempt from notice and comment, and reflects an entirely reasonable

enforcement strategy.” Defs.’ Mem. 33. As they see it, the Guidance “does not purport to modify

or interpret any provision of the TCA [Tobacco Control Act]. Rather, it simply states that the FDA

‘does not intend to enforce a particular requirement’ of the statute for a limited period,” which they

insist is “an entirely unexceptional exercise of enforcement discretion that conflicts with no

legislative directive.” Id. (citing Aug. 2017 Guidance 4, ECF No. 48-1, at 717, GAR 425). And,

Defendants insist that its publication of the August 2017 Guidance was neither arbitrary nor

capricious because it “rationally explained its updated enforcement policy,” and its “explanation

was more than sufficient.” Id. at 43, 45.10

Tobacco Control Act’s Provisions and Extent of FDA’s Statutory Authority

The power of an agency like the FDA “is ‘not the power to make law. Rather, it is “the

power to adopt regulations to carry into effect the will of Congress as expressed by the statute.”’”

Brown & Williamson Tobacco Corp. v. Food & Drug Admin., 153 F.3d 155, 161 (4th Cir. 1998),

aff’d, 529 U.S. 120 (2000) (quoting Ernst & Ernst v. Hochfelder, 425 U.S. 185, 213–14 (1976)

(citation omitted)). Moreover, “neither federal agencies [like the FDA] nor the courts can substitute

their policy judgments for those of Congress.” Id. at 176. Stated differently, the court’s

“estimations, and the [agency’s] estimations, of desirable policy cannot alter the meaning of [a

10 Because the undisputed evidence establishes that the August 2017 Guidance conflicts with the Tobacco Control Act and needed to follow the APA’s notice and comment requirements, but failed to do so, I will grant Plaintiffs’ motion on those grounds. Therefore, I need not consider their argument regarding whether Defendants’ actions were arbitrary and capricious.


43

federal statute].” Id. (quoting MCI Telecomm’cns Corp. v. Am. Tel. & Tel. Co., 512 U.S. 218, 234

(1994)). Thus, when the FDA takes action contrary to the FDCA, through that ultra vires action

the FDA “exceed[s] the authority granted to it by Congress, and its . . . action cannot stand.” Id.

In Brown, decided more than a decade before the Tobacco Control Act went into effect and

authorized the FDA to regulate tobacco products’ manufacture and distribution, the Fourth Circuit

considered a final rule that the FDA published that “set out regulations restricting the sale and

distribution of cigarettes and smokeless tobacco (collectively referred to as tobacco products) to

minors and limiting the advertising and promotion of tobacco products.” Id. The court concluded

that publishing the rule was ultra vires action, reasoning that, even though “Congress . . . charged

the FDA with protecting the public health and . . . tobacco products present serious health risks for

the public,” Congress did not intend for the FDA to regulate tobacco products. Id. at 167. The

court noted that “neither the [FDCA] nor its legislative history mention[s] tobacco products,” and

“[f]rom 1914 until the present rulemaking attempt, the FDA had consistently stated that tobacco

products were outside the scope of its jurisdiction.” Id. at 168. The court observed:

This is not a case about whether additional or different regulations are needed to address legitimate concerns about the serious health problems related to tobacco use, and particularly youth tobacco use, in this country. At its core, this case is about who has the power to make this type of major policy decision.

Id. at 176.

Here, as noted, FDA’s across-the-board suspension of the Tobacco Control Act’s

premarket approval process, with regard to applications, substantial equivalence reports,

exemption requests, approval and enforcement of these requirements, amounts to a rule

amendment or revocation, as it is inconsistent with the statute. See Acosta, 363 F. Supp. 3d at 18.

Through the August 2017 Guidance, the FDA is abdicating its statutory duty to review new tobacco

products in the prompt fashion dictated by Congress in its premarket review requirements; as


44

Plaintiffs asserted, the FDA “will conduct a form of postmarket review, analyzing whether

products should be introduced after they have been on the market for years.” Pls.’ Mem. 11. This

is not simply a policy statement about how the FDA will act, within the confines of the Tobacco

Control Act. I agree with Plaintiffs that “[t]hat is not the scheme envisioned by Congress and

created by the Act,” as “premarket review no longer operates as the gateway to the market that

Congress intended.” Id.

Moreover, the August 2017 Guidance defeats, rather than furthers, the purpose of the

Tobacco Control Act by allowing unapproved tobacco products to be manufactured, advertised,

and sold for five years or longer, and informing the manufacturers that the Tobacco Control Act

requirements for premarket review will not be enforced. Instead of addressing public health

concerns associated with tobacco use by minors and others, the August 2017 Guidance exacerbates

the situation by stating, in essence, that manufacturers can continue to advertise and sell products

that are addictive and that target a youth market, like the “Apple Juice” e-cigarette discussed in

Plaintiffs’ Complaint, at a time when minors’ use of tobacco products like e-cigarettes is at an

epidemic level and rising. Arguably, the five-year compliance safe-harbor has allowed the

manufacturers enough time to attract new, young users and get them addicted to nicotine before

any of their products, labels, or flavors are pulled from the market, at which time the youth are

likely to switch to one of the other thousands of tobacco products that already are approved—

results entirely contrary to the express purpose of the Tobacco Control Act. The publication of

the August 2017 Guidance clearly was contrary to the Tobacco Control Act’s purpose and

therefore an ultra vires action through which the FDA “exceeded the authority granted to it by

Congress, and its . . . action cannot stand.” See Brown & Williamson, 153 F.3d at 176.


45

Defendants argue—and indeed the August 2017 Guidance itself states—that it is an

exercise of “enforcement discretion.” See Defs.’ Mem. 33; Aug. 2017 Guidance 4, ECF No. 48-

1, at 717, GAR 425. Certainly, Plaintiffs themselves refer to Defendants’ enforcement discretion,

but Plaintiffs’ use of the term does not mean that it is applicable under the facts of this case.

It is true that the Supreme Court “has recognized on several occasions over many years

that an agency’s decision not to prosecute or enforce, whether through civil or criminal process, is

a decision generally committed to an agency’s absolute discretion.” Chaney, 470 U.S. at 831

(collecting cases). Therefore, as a matter of its “enforcement discretion,” the FDA may decide not

to enforce the provisions of the Tobacco Control Act with regard to specific products. See id. But,

“if the court could find that “the agency ha[d] ‘consciously and expressly adopted a general policy’

that is so extreme as to amount to an abdication of its statutory responsibilities[,] . . . the statute

conferring authority on the agency might indicate that such decisions were not ‘committed to

agency discretion.’” Chaney, 470 U.S. at 833 n.4. Such is the case here. Defendants are not

deciding, on a case-by-case basis, to enforce or not enforce provisions of the Tobacco Control Act.

Rather, they decided not to enforce the premarket review provisions at all for five years or longer.

Moreover, the Tobacco Control Act makes clear that, insofar as the FDA has enforcement

discretion, that discretion is circumscribed by the language of the Act itself, requiring applications,

requests, and reports to be filed before products enter commerce and requiring an agency ruling

within 180 days of the filing.

Further, the “enforcement discretion” argument is a red herring, because the August 2017

Guidance does not fulfill the purpose for which an agency is granted enforcement discretion. As

for why an agency has enforcement discretion, the Supreme Court explained:

[A]n agency decision not to enforce often involves a complicated balancing of a number of factors which are peculiarly within its expertise. Thus, the agency must


46

not only assess whether a violation has occurred, but whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency’s overall policies, and, indeed, whether the agency has enough resources to undertake the action at all. An agency generally cannot act against each technical violation of the statute it is charged with enforcing. The agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities. . . .

Chaney, 470 U.S. at 831–32. Simply put, an agency may decide whether to exercise its

enforcement discretion as to one or more discrete violations, in light of the circumstances

surrounding a particular violation and considering other responsibilities and resources that the

agency has at that time. But this bears no relation to a decision to hold in abeyance enforcement

of mandatory provisions of a statute that Congress viewed as integral to address public health

dangers that the agency itself acknowledges are alarming for five or more years while it tries to

figure out how it will implement the statute, all the while affording those manufacturers

responsible for the public harm a holiday from meeting the obligations of the law.

The Chaney Court also observed that

an agency’s refusal to institute proceedings shares to some extent the characteristics of the decision of a prosecutor in the Executive Branch not to indict—a decision which has long been regarded as the special province of the Executive Branch, inasmuch as it is the Executive who is charged by the Constitution to “take Care that the Laws be faithfully executed.” U.S. Const., Art. II, § 3.

Chaney, 470 U.S. at 832. But, the decision here, not to enforce the premarket review requirements

against any manufacturers, does not “share . . . the characteristics of the decision of a prosecutor

. . . not to indict” to any extent; it is more akin to an across-the-board statement that no one will be

indicted for a certain crime for a period of time. In sum, the FDA’s action cannot fall within its

enforcement discretion. Its action is inconsistent with the Tobacco Control Act and in excess of

its statutory authority, and it cannot stand.


47

Notice and Comment

Plaintiffs contend that the August 2017 Guidance must be vacated because the FDA did

not follow the APA’s notice and comment requirements in issuing it. Pls.’ Mem. 16. Defendants

counter that the August 2017 Guidance “is a policy statement exempt from notice and comment.”

Defs.’ Mem. 33.

“[W]hen an agency issues new ‘legislative’ or ‘substantive’ rules that establish binding

norms having the force of law,” it must follow the APA’s notice and comment requirements.

Mallinckrodt Inc. v. United States Food & Drug Admin., No. DKC-14-3607, 2015 WL 13091366,

at *11 (D. Md. July 29, 2015) (quoting Berlex Labs., Inc. v. Food & Drug Admin., 942 F. Supp.

19, 26 (D.D.C. 1996) (quoting 5 U.S.C. § 553)); see also Perez v. Mortg. Bankers Ass’n, 135 S.

Ct. 1199, 1206 (2015). In contrast, “‘[i]nterpretive’ rules . . . are expressly excused from the

notice-and-comment requirements.” Mallinckrodt, 2015 WL 13091366, at *11 (quoting Berlex

Labs., 942 F. Supp. at 26 (quoting 5 U.S.C. § 553(b)(3)(A))). Thus, the issue is whether the August

2017 Guidance qualifies as a legislative rule or an interpretive rule.

A rule is “the whole or a part of an agency statement of general or particular applicability

and future effect designed to implement, interpret, or prescribe law or policy.” 5 U.S.C. § 551(4).

A rule is interpretive if it is “issued by an agency to advise the public of the agency’s construction

of the statutes and rules which it administers.” Mallinckrodt, 2015 WL 13091366, at *11 (quoting

Berlex, 942 F. Supp. at 26 (quoting Shalala v. Guernsey Memorial Hosp., 514 U.S. 87, ––––

(1995))). A rule is legislative

if any one of the following four questions is answered in the affirmative:

(1) whether in the absence of the rule there would not be an adequate legislative basis for ... agency action to confer benefits or ensure the performance of duties,


48

(2) whether the agency has published the rule in the Code of Federal Regulations,

(3) whether the agency has explicitly invoked its general legislative authority, or

(4) whether the rule effectively amends a prior legislative rule.

Id. at *11–12 (quoting Berlex, 942 F. Supp. at 26 (quoting American Mining Congress v. Mine

Safety & Health Admin., 995 F.2d 1106, 1112 (D.C. Cir. 1993))). The answer to the fourth

question is “yes” if, through the rule, the “agency adopts a new position inconsistent with an

existing regulation, or effects a substantive change in the regulation.” Nat’l Mining Ass’n v.

Jackson, 768 F. Supp. 2d 34, 48 (D.D.C. 2011) (observing that, under these circumstances, “notice

and comment are required”) (quoting U.S. Telecom Ass’n v. FCC, 400 F.3d 29, 35 (D.C. Cir.

2005)). “Such a rule ‘grant[s] rights, impose[s] obligations, or produce[s] other significant effects

on private interests;’ ‘narrowly constrict [s] the discretion of agency officials by largely

determining the issue addressed’; and ‘[has] substantive legal effect.’” Id. (quoting Batterton v.

Marshall, 648 F.2d 694, 701–02 (D.C. Cir. 1980)) (emphasis added). Notably, “the standard for

determining whether an agency pronouncement is a legislative rule is very similar to the second

element of the Bennett finality analysis.”11 Id.

In Mallinckrodt, 2015 WL 13091366, this Court turned to Berlex, 942 F. Supp. 19, and

National Mining Ass’n v. McCarthy, 758 F.3d 243 (D.C. Cir. 2014), for guidance. The Berlex

Court had considered whether an FDA guidance document was an interpretive or legislative rule

and had determined that it was an interpretive rule “because all four of the criteria articulated in

American Mining Congress were answered in the negative.” Mallinckrodt, 2015 WL 13091366,

11 As noted above, the second requirement for finality is that “the action must be one by which rights or obligations have been determined or from which legal consequences will flow.” Bennett v. Spear, 520 U.S. 154, 178 (1997).


49

at *12. In concluding that the rule did not “effectively amend[] a prior legislative rule,” the court

reasoned:

The existing FDA regulation requires the submission of “data derived from nonclinical laboratory and clinical studies.” 21 C.F.R. § 601.2(a). In the guidance document, FDA interpreted that language to include data from clinical studies completed on “comparable” biological products. Comparability Guidance Document, 3. That interpretation extended the boundaries of previous FDA actions and policies, to be sure, but it did not “run[ ] 180 degrees counter to the plain meaning of the regulation,” as did the agency directive at issue in National Family Planning and Reproductive Health Ass’n, Inc. v. Sullivan, 979 F.2d 227, 235 (D.C. Cir. 1992).

Id. (quoting Berlex, 942 F. Supp. at 26). Thus, the guidance document “neither repudiate[d] nor

[wa]s inconsistent with any pre-existing FDA regulations.” Berlex, 942 F. Supp. at 26.

In McCarthy, the appellate court similarly had considered whether an Environmental

Protection Agency (“EPA”) guidance document “was a general policy statement or a legislative

rule subject to judicial review,” concluding that it was a policy statement. Mallinckrodt, 2015 WL

13091366, at *12.

The court emphasized that in determining whether something is a legislative rule “[t]he most important factor concerns the actual legal effect (or lack thereof) of the agency action in question on regulated entities.” The court noted that the guidance document in question . . . did “not tell regulated parties what they must do or may not do in order to avoid liability[,]” did not impose “obligations or prohibitions on regulated entities[,]” could not serve as “the basis for an enforcement action against a regulated entity[,]” and did “not impose[] any requirements in order to obtain a permit or license.” In addition, the court assessed the agency’s characterization of the guidance, and noted that the document itself “disclaims any intent to require anyone to do anything” and the language used throughout the document was devoid of commands, requirements, or orders.

Id. (quoting McCarthy, 758 F.3d at 252–53).

The Mallinckrodt Court likewise concluded that the FDA draft guidance document before

it, which reclassified a drug of Mallinckrodt’s, “was an interpretive rule rather than a legislative

rule.” Id. at *13. It reasoned that the FDA had a pre-existing duty to determine whether


50

bioequivalence had been established and therefore had “the authority to require Mallinckrodt to

establish the bioequivalence of its drug using the criteria and measurements FDA f[ound]

necessary for the given product”; the “FDA did not invoke its general authority” to publish the

draft guidance document; the language of the draft guidance document stated that it did “not create

or confer any right”; and “the document itself [wa]s devoid of commands, orders, or binding

requirements.” Id. Additionally, it found that the draft guidance document “did not effectively

amend a prior legislative rule because it ‘neither repudiate[d] nor [wa]s inconsistent with any pre-

existing FDA regulations”; rather, it “merely fine-tuned the measurements and metrics it believe[d]

[we]re most useful in measuring bioequivalence” in the drug at issue. Id. at *14. The court

explained:

It has done so by altering its 2012 Guidance Document to tweak its recommendations on what measures are most helpful in determining this particular product’s bioequivalence. The recommended studies and metrics in the 2014 Guidance Document are consistent with the agency’s regulations on bioequivalence and with the recommendations made in the 2012 Guidance Document. The revised 2014 Guidance Document merely requests some additional metrics to ensure the drug’s bioequivalence, as the prior metrics may not adequately capture the bioequivalence and efficacy of the drug in the later phases of the twelve-hour dose. The additional metrics requested by FDA fall within the normal range of evidence and measures that FDA may request as part of its process of assessing bioequivalence. Accordingly, FDA’s 2014 Guidance Document is not irreconcilable with nor does it repudiate FDA’s regulations on bioequivalence or FDA’s prior 2012 Guidance Document. The Guidance Document merely clarifies the metrics FDA believes are helpful in showing bioequivalence.

Id. (citations to record and C.F.R. omitted).

National Mining Association v. Jackson, 768 F. Supp. 2d 34 (D.D.C. 2011), is on point

with circumstances of the case before me. There, the plaintiff filed suit because the EPA had

issued “a series of memoranda and a detailed guidance,” which the plaintiff believed “unlawfully

obstructed the Clean Water Act permitting process for coal mining.” 768 F. Supp. 2d at 38. The

court observed that, through the documents, “the EPA seem[ed] to be imposing an additional step


51

to the permitting process that [wa]s not contemplated or set forth in the [Clean Water Act Section]

404(b)(1) guidelines,” and “these changes to the statutorily established process g[a]ve rise to the

legal consequences necessary to satisfy the second prong of the Bennett finality analysis.” Id. at

44, 45. It noted that the EPA was applying the guidance memorandum “in a binding manner” and

implementing it “in its current version even though the EPA continue[d] to receive comments

about it,” such that it “qualifie[d] as final agency action . . . despite the [EPA’s] representation that

it [wa]s an interim document.” Id. at 45. The court concluded that, on the same basis, the

documents constituted “legislative rules that were adopted in violation of the APA’s notice and

comment requirements.” Id. at 49. It reasoned:

As explained above in regard to the Court’s finality analysis, based on the record currently before the Court the MCIR Assessment, the EC Process Memoranda, and the Guidance Memorandum all appear to qualify as legislative rules because they seemingly have altered the permitting procedures under the Clean Water Act by changing the codified administrative review process. Thus, the MCIR Assessment, the EC Process, and the Guidance Memorandum all seem to “effectively amend” the Clean Water Act’s permitting process, Am. Mining Cong., 995 F.2d at 1112, and represent the EPA’s adoption of a new position inconsistent with an existing regulation. U.S. Telecom Ass’n, 400 F.3d at 34–35.

Id.

Finally, in National Family Planning and Reproductive Health Ass’n, Inc. v. Sullivan, 979

F.2d 227 (D.C. Cir. 1992), the plaintiff challenged a Department of Health and Human Services

(“HHS”) directive that, in its view, amended a 1998 HHS regulation. The regulation provided that

a “Title X project may not provide counseling concerning the use of abortion as a method of family

planning or provide referral for abortion as a method of family planning.” 979 F.2d at 234 (quoting

42 C.F.R. § 59(a)(1)). The Department of Health and Human Services previously “interpreted

[that] 1988 regulation . . . not to permit physicians to counsel patients on abortion.” Id. The

Supreme Court agreed. Id. at 236. Then, HHS issued a directive, without adhering to the APA


52

notice and comment requirements, “announcing that [the] 1988 regulation . . . would thereafter be

interpreted to permit doctors to counsel on abortion within the context of the doctor–patient

relationship.” Id. at 228–29; see id. at 234–35 (“The Directives say that Title X physicians may,

pursuant to the same regulations, provide counseling and referrals for abortions when their medical

judgment so dictates.”).

Observing that “[i]t is a maxim of administrative law that: ‘If a second rule repudiates or

is irreconcilable with [a prior legislative rule], the second rule must be an amendment of the first;

and, of course, an amendment to a legislative rule must itself be legislative,’” the court concluded

that the directive was a legislative rule because its “interpretation of the [regulation ran] 180

degrees counter to the plain meaning of the regulation” and its earlier interpretation of the

regulation. Id. at 235 (quoting Michael Asimow, Nonlegislative Rulemaking and Regulatory

Reform, 1985 Duke L.J. 381, 396). The appellate court held that HHS could not “proceed[] with

the enforcement of the new Directives without first adhering to the requirements of § 553 of the

APA.” Id. at 229.

Here, as discussed with regard to finality, the August 2017 Guidance is not a policy

statement; it is tantamount to an amendment to the Tobacco Control Act. As with the guidance

and other documents at issue in Jackson, the August 2017 Guidance implements “changes to the

statutorily established process.” 768 F. Supp. 2d at 45. Those changes have “legal consequences,”

and the agency has put the process established in the August 2017 Guidance into effect. See id. at

44–45. Certainly, its requirements are more favorable to manufacturers than the Tobacco Control

Act, essentially lifting statutory prohibitions for five or more years and imposing obligations across

a longer timeframe. Nevertheless, the language used in the August 2017 Guidance includes

commands, requirements, and order: It tells manufacturers when they must submit their


53

applications, reports, and requests for new tobacco products. More fundamentally, these

requirements cannot be reconciled with the Tobacco Control Act, as they “run[ ] 180 degrees

counter to the plain meaning of the [statute],” which set much more stringent deadlines. See Nat’l

Family Planning, 979 F.2d at 235; see also Mallinckrodt, 2015 WL 13091366, at *12; Berlex, 942

F. Supp. at 26. Thus, applying the factors identified in Mallinckrodt confirms that the August 2017

Guidance is a rule amendment and therefore a legislative, rather than interpretive, rule. See

Mallinckrodt, 2015 WL 13091366, at *12. Even if the half-decade or longer extension were a

rational decision within the FDA’s discretion, the FDA could not have made that decision without

adhering to the APA. Accordingly, the August 2017 Guidance must be vacated.

Conclusion

In sum, Plaintiffs’ Motion for Reconsideration, ECF No. 63, IS GRANTED and the parties’

cross-motions, ECF Nos. 31 and 36, ARE REOPENED; Defendants’ Motion to Dismiss or, in the

Alternative, for Summary Judgment, treated as a motion for summary judgment, IS DENIED; and

Plaintiffs’ Motion for Summary Judgment, ECF No. 31, IS GRANTED. This Memorandum

Opinion and the accompanying Order vacate the FDA’s August 2017 Guidance.

Given that the application deadlines set in the Deeming Rule and the May 2017 Guidance

have passed, Plaintiffs will submit additional briefing regarding a remedy (which should be

specific, rather than generalized), in fifteen pages or less, within fourteen days of the date of this

Memorandum Opinion. Defendants will have fourteen days to respond, in fifteen pages or less,

and Plaintiffs will have five business days to reply, in ten pages or less. Any Guidance providing

for a compliance period will, of course, have to adhere to the notice and comment requirements of

the APA. Even so, manufacturers long have been on notice that they will have to file premarket

approval applications, substantial equivalence reports, and exemption requests, and if they have


54

chosen to delay their preparations to do so, then any hardship occasioned by their now having to

comply is of their own making. And, in adopting new Guidance, the APA can propose that the

deadlines can be set sufficiently soon beyond the end of the notice and comment period to afford

relief to Plaintiffs and to attempt to combat the epidemic-level use of new tobacco products like e-

cigarettes, especially by teenagers.

A separate order will issue.

Date: May 15, 2019 /S/ Paul W. Grimm United States District Judge

lyb


EXHIBIT B



Southern Division

* AMERICAN ACADEMY OF

PEDIATRICS, et al., *

Plaintiffs, * v. * Case No.: PWG-18-883 FOOD AND DRUG *

ADMINISTRATION, et al. *

Defendants. *

* * * * * * * * * * * * * *

MEMORANDUM OPINION AND ORDER

In a Memorandum Opinion and Order issued on May 15, 2019, I concluded that Defendants

the Food and Drug Administration (“FDA”), then-Commissioner of Food and Drugs Scott

Gottlieb, the U.S. Department of Health and Human Services, and Secretary of Health and Human

Services Alex M. Azar II violated the Administrative Procedure Act (“APA”), 5 U.S.C. § 701 et

seq. by issuing the Extension of Certain Tobacco Product Compliance Deadlines Related to the

Final Deeming Rule: Guidance for Industry (Revised) (“August 2017 Guidance”) without

following the APA’s notice and comment requirements. ECF Nos. 73, 74. Accordingly, I granted

Plaintiffs’1 motion for summary judgment and vacated the FDA’s August 2017 Guidance.

1 Plaintiffs are the American Academy of Pediatrics; the Maryland Chapter – American Academy of Pediatrics; the American Cancer Society Cancer Action Network; the American Heart Association; the American Lung Association; the Campaign for Tobacco-Free Kids; the Truth Initiative; Dr. Leah Brash, MD; Dr. Cynthia Fishman, MD; Dr. Linda Goldstein, MD; Dr. Steven Hirsch, MD; and Dr. David Myles, MD.


2

Because the application deadlines set in the Deeming Rule2 and the May 2017 Guidance3

(which otherwise would have applied following the vacatur) had passed, I ordered the parties to

submit additional briefing regarding a remedy, while noting that “[a]ny Guidance providing for a

compliance period will, of course, have to adhere to the notice and comment requirements of the

APA.” May 15, 2019 Mem. Op. 53.4 The parties have completed their briefing and responded to

amicus curiae briefs that the State of Maryland and various organizations5 filed on behalf of the

e-cigarette industry (“Industry”). Pls.’ Remedy Br., ECF No. 78; Maryland Br., ECF No. 97;

Defs.’ Remedy Br., ECF No. 120; Indus. Br., ECF No. 121-1; Pls.’ Reply, ECF No. 123; Pls.’

Resp. to Indus. Br., ECF No. 124; Defs.’ Resp. to Indus. Br., ECF No. 125. A hearing is not

necessary. See Loc. R. 105.6. Balancing the need to address the existing public health crisis

among today’s youth, which both parties acknowledge, and the need to avoid creating an additional

2 On May 10, 2016, the FDA issued the “Deeming Rule,” bringing approximately 25,000 new tobacco products, including various cigars, e-cigarettes, pipe tobacco products, and hookah within the purview of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), Pub. L. No. 111-31, 123 Stat. 1776 (2009) (enacting 21 U.S.C. §§ 387 – 387u and amending and redesignating other statutes). May 15, 2019 Mem. Op. 7; Guidance 2, ECF No. 48-1, at 715, GAR 423. The Deeming Rule went into effect 90 days after its publication. Deeming Rule, 81 Fed. Reg. 28,974-01, 28,976 (May 10, 2016). 3 In May 2017, the FDA extended the compliance deadline by three months in the “May 2017 Guidance.” Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule: Guidance for Industry (May 2017), GAR 206, ECF No. 48-1, at 687. 4 As Defendants note, I did not suggest that the FDA needed to issue a formal regulation in lieu of guidance as it has done previously. See May 15, 2019 Mem. Op. 53; Defs.’ Resp. to Indus. Br. 6, ECF No. 125. Contra Indus. Br. 10 (referring to a need to “go through notice-and-comment rulemaking”). 5 The Industry includes American E-Liquid Manufacturing Standards Association, American Vaping Association, Arizona Smoke Free Business Alliance, Consumer Advocates for Smoke-Free Alternatives Association (“CASAA”), ITG Brands LLC, Indiana Smoke Free Association, Iowans for Alternative to Smoking and Tobacco, JUUL Labs, Inc., John Middleton Co., Kentucky Smoke Free Association, Maryland Vapor Alliance, NJOY LLC, New York State Vapor Association, Ohio Vapor Trade Association, RIGHT TO BE SMOKE-FREE COALITION, Smoke Free Alternatives Trade Association, Tennessee Smoke Free Association, and Texas Vapor Coalition.


3

public health crisis if e-cigarette availability dropped so precipitously as to push users to

combusted tobacco products, and considering both the FDA’s laudable efforts to guide the

premarket approval process and the Industry’s lack of effort to obtain approval without an

imminent deadline, I will impose a ten-month deadline for submissions and a one-year deadline

for approval, as the FDA suggested.

Plaintiffs’ Requests

Plaintiffs propose that the Court first order the FDA to

take whatever actions are necessary and in accord with the APA, to allow new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule to remain on the market without being subject to FDA enforcement actions, only under the following conditions:

1. Applications for marketing orders must be filed within 120 days of issuance of this Court’s order and products for which applications have not been filed within this period shall be subject to FDA enforcement actions;

2. Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application.

Pls.’ Remedy Br. 8, ECF No. 78. In their view, the four-month deadline for manufacturers is both

reasonable and feasible because the manufacturers have been on notice that the deadline was

looming and could be accelerated, and the FDA has encouraged them to move forward with their

submissions before the deadline. Id. at 10–11. Second, Plaintiffs propose that the Court require

the FDA to file quarterly reports with the Court “on the measures it is taking to carry out its

premarket review responsibilities under the TCA [Tobacco Control Act], including reporting the

number and nature of the enforcement actions it has undertaken against companies for marketing

their products without a marketing order.” Id. at 9. And third, Plaintiffs ask the Court to retain

jurisdiction over this case. Id. The State of Maryland filed an amicus curiae brief in support of

Plaintiffs’ position, noting the health risks e-cigarettes pose to Maryland’s youth and the


4

consequential medical expenses the State will incur “[a]s these young Marylanders age and sicken”

and seek treatment through Medicaid. Maryland Br. 1–2, ECF No. 97.

Plaintiffs argue that this relief is within the Court’s “broad remedial authority,” insisting

that “the ‘Court may tailor its remedy to the unlawful agency behavior’” and “‘adjust its relief to

the exigencies of the case in accordance with the equitable principles governing judicial action.’”

Pls.’ Remedy Br. 7 (quoting Thompson v. U.S. Dep’t of Hous. & Urban Dev., 348 F. Supp. 2d 398,

464–65 (D. Md. 2005)). Plaintiffs also acknowledge that “the court must act within the bounds of

the statute and without intruding into the administrative province.” See id. (quoting Thompson,

348 F. Supp. 2d at 465). Still, in Plaintiffs’ view, “[t]here is ample authority for a Court to structure

its remedy to account for the realities of immediate vacatur or reinstate the status quo.” Pls.’ Reply

2, ECF No. 123 (citing Andrulis Res. Corp. v. U.S. Small Bus. Admin., No. 9-2569, 1990 WL

169318, at *2 (D.D.C. Oct. 19, 1990)). They insist that the Court “may craft declaratory and

injunctive relief designed to preclude a federal agency from acting in contravention of its statutory

and regulatory authority.” Id. at 6 (quoting Coal. For Gov’t Procurement v. Fed. Prison Indus.,

365 F.3d 435, 460 (6th Cir. 2004)).

Legal Precedent

The Sixth Circuit has noted the courts’ authority to order injunctive relief to address agency

action or inaction:

It is well-established that federal courts possess broad discretion to fashion equitable remedies. See United States v. R.W. Meyer, Inc., 932 F.2d 568, 572–73 (6th Cir.1991) (observing the “principle of equity that the chancellor has broad discretion to frame a decree”). It also is established that we may craft declaratory and injunctive relief designed to preclude a federal agency from acting in contravention of its statutory and regulatory authority. See Howard v. Pierce, 738 F.2d 722, 730 (6th Cir.1984) (holding that the court may award declaratory and injunctive relief in order to ensure that the Department of Housing and Urban Development adopted regulations consistent with its enabling statute).


5

Furthermore, the court may require an agency to modify its current or future practices in order to account for past violations of its statutes or regulations. See Charter Township of Huron, Michigan v. Richards, 997 F.2d 1168, 1175 (acknowledging the court’s authority to issue an injunction requiring the agency to conduct an environmental assessment notwithstanding the implementation of the completed action); Northwest Envtl. Def. Ctr. v. Gordon, 849 F.2d 1241, 1245 (9th Cir. 1988) (determining that claims asserted against federal agencies alleging that the agencies unlawfully authorized the overfishing of coho salmon during the 1986 season were not moot because the court could award injunctive relief in the form of “higher escapement provisions and lower quotas in 1989”).

Coal. for Gov’t Procurement v. Fed. Prison Indus., Inc., 365 F.3d 435, 460 (6th Cir. 2004). And,

in 1990, the District of the District of Columbia noted that “various appellate court decisions [have]

affirm[ed] a district court’s power to extend statutory deadlines to remedy improper agency delay.”

Andrulis Research Corp. v. U.S. Small Bus. Admin., No. 90-2569(CRR), 1990 WL 169318, at *2

(D.D.C. Oct. 19, 1990) (citing Connecticut v. Schweiker, 684 F.2d 979, 997–99 (D.C. Cir. 1982);

Burr v. Ambach, 863 F.2d 1071, 1077–78 (2d Cir. 1988), vacated, 109 S. Ct. 3209 (1989), aff’d

on remand sub nom., Burr v. Sobel, 888 F.2d 258 (2d Cir. 1989); Smith v. Miller, 665 F.2d 172,

180 (7th Cir. 1981); Carey v. Klutznick, 637 F.2d 834, 837 (2d Cir. 1980) (per curiam)).

More recently the D.C. Circuit has held that “[w]hen a district court reverses agency action

and determines that the agency acted unlawfully, ordinarily the appropriate course is simply to

identify a legal error and then remand to the agency, because the role of the district court in such

situations is to act as an appellate tribunal.” N. Air Cargo v. U.S. Postal Serv., 674 F.3d 852, 861

(D.C. Cir. 2012) (citing PPG Indus., Inc. v. United States, 52 F.3d 363, 365 (D.C. Cir. 1995)); see

N.C. Fisheries Ass’n v. Gutierrez, 550 F.3d 16, 20 (D.C. Cir. 2008) (“To be sure, the district court,

sitting as a court in review of agency action under the Act and APA, should have done what a court

of appeals normally does when it identifies an agency error: remand to the agency for further

proceedings. As we have said, ‘[u]nder settled principles of administrative law, when a court

reviewing agency action determines that an agency made an error of law, the court’s inquiry is at


6

an end: the case must be remanded to the agency for further action consistent with the corrected

legal standards.’” (quoting PPG Indus., 52 F.3d at 365)); see also Maine Med. Ctr. v. Burwell, 841

F.3d 10, 16 (1st Cir. 2016) (quoting PPG Indus., 52 F.3d at 365). But, the D.C. Circuit also

acknowledged that, “in extraordinary circumstances,” district courts reviewing agency action will

“issue detailed remedial orders.” N.C. Fisheries, 550 F.3d at 20.

Discussion

The issue is whether this case presents those “extraordinary circumstances” that call for

more than a simple remand or vacatur. Defendants agree with Plaintiffs (and the Court) that “the

recent ‘epidemic-level rise in youth e-cigarette use’ is a ‘mounting public health crisis’” that

“demands a robust regulatory response, including through enforcement of the Tobacco Control

Act’s premarket review provision.” Defs.’ Remedy Br. 1 (quoting FDA, Statement from FDA

Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access

to, and appeal of, flavored tobacco products, including e-cigarettes and cigars (Mar. 13, 2019), at

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-

gottlieb-md-advancing-new-policies-aimed-preventing-youth-access). But, they argue that,

nonetheless, “bedrock principles of administrative law constrain the Court’s authority to enter the

specific relief the Plaintiffs request.” Id. In their view, “the Court should simply remand to the

FDA to permit it to choose a course of action consistent with the Court’s opinion.” Id.

Additionally, Defendants insist that the timeframe Plaintiffs propose “would create

massive administrative burdens at the agency that would ultimately be counterproductive.” Defs.’

Remedy Br. 1. Defendants have made a commendable record detailing their own resources and

ability, as well as the negative impact of rushed, unguided applications that would exacerbate their

difficulties in timely approving—or denying—applications.


7

Also, Defendants, along with the amici that filed a joint brief in support of Defendants’

position, Indus. Br.,6 contend that the four-month timeframe for applications “would threaten to

abruptly clear the market of e-cigarette products, creating a ‘genuine risk’ that adult former

smokers addicted to nicotine would ‘migrat[e] from potentially less harmful ENDS products [i.e.,

e-cigarettes] back to combustible tobacco products.’” Defs.’ Remedy Br. 1 (quoting Zeller Decl.

¶ 12, ECF No. 120-1) (emendation in Defs.’ Remedy Br.). Aware of these potential public health

implications in not only the presence of e-cigarettes, but also in what could be a precipitous

absence, Defendants have carefully calibrated a plan to deal with nicotine addiction throughout

the public health sector. Their goal of not driving e-cigarette products out of the market appears

to be part of a broader attack on tobacco by encouraging the availability of potentially less

addictive products. And, it appears that, in the new guidance that the FDA expects to approve

within 120 days, the FDA plans to accelerate the premarket review requirements for the products

that are most attractive to youth, such as flavored products, consistent with the Tobacco Control

Act. The factual record here is unlike in Cobell v. Norton, 240 F.3d 1081, 1095, 1096 (D.C. Cir.

6 The Industry goes so far as to propose that the Court should remand the August 2017 Guidance to “FDA without vacatur [to] avoid upending FDA’s massive existing regulatory efforts and caus-ing unwarranted harm to consumers and manufacturers.” Indus. Br. 2. Plaintiffs oppose this ap-proach at length in their Response to Industry Brief, and Defendants note in their Response that they “have not asked the Court to revisit its vacatur of the August 2017 guidance.” Defs.’ Resp. to Indus. Br. 1. As Defendants note, I already have vacated the August 2017 Guidance, see May 15, 2019 Mem. Op. 53, and I will not accept an amicus brief as a motion for reconsideration of an existing order. In any event, remand without vacatur is not appropriate under the circumstances of this case. See Sierra Club v. U.S. Army Corps of Eng’rs, 909 F.3d 635, 655 (4th Cir. 2018) (noting that remand without vacatur is only appropriate (if at all) when “a serious possibility” exists that an agency “will be able to substantiate its decision on remand,” that is, under circum-stances in which the agency has rules that are “inadequately supported,” rather than rules that are “legally deficient” because “they exceed[] [the agency’s] statutory authority” (quoting Allied-Sig-nal, Inc. v. U.S. Nuclear Reg. Comm’n, 988 F.2d 146, 151 (D.C. Cir. 1993))). Nor is it necessary, since the Court can (and in this Memorandum Opinion and Order does) order a remedy that, in the Industry’s words, see Indus. Br. 2, will allow the FDA to continue with its “existing regulatory efforts” and will not “caus[e] unwarranted harm to consumers and manufacturers.”


8

2001), where the agency completely failed to act, or in Nat. Res. Def. Council v. EPA, 489 F.3d

1364, 1374 (D.C. Cir. 2007), where the agency actively undermined a statute. The record does

not show contumacious behavior by the FDA, which is not actively thwarting the law. Nor does

the record support a conclusion that the FDA is a puppet to the tobacco industry.

Indeed, the FDA’s position is strongly at odds with the Industry’s in two significant

respects. First, the Industry contends disingenuously that it cannot complete its applications

without further formal guidance. See Indus. Br. 3–6, Yet, according to Defendants, it is

commonplace for companies and individuals to call the FDA for guidance, and the FDA has made

clear that it is willing to work with manufacturers in the interim to provide informal guidance.

Defs.’ Resp. to Indus. Br. 2–3. Specifically,

the FDA disagrees with amici’s suggestion that the premarket review provision could not be enforced before the completion of planned rulemakings concerning the premarket tobacco application (PMTA) and substantial equivalence (SE) path-ways. Industry Br. at 3–4. The statute itself sets forth the baseline requirements for PMTAs and SE reports, see Defs.’ Remedy Br. at 9; 21 U.S.C. §§ 387d(j), 387j(b)(1), and the agency has issued a number of lengthy guidance documents discussing these statutory requirements: it issued final guidance concerning the SE process in January 2011, long before the deeming rule was finalized; three versions of a frequently asked questions document concerning the SE process, most recently in December 2016; and draft guidance concerning PMTAs for electronic nicotine delivery systems (ENDS, or e-cigarettes) in May 2016, which it finalized in sub-stantially similar form in June 2019. The FDA has authorized the marketing of more than a thousand tobacco products under the statute alone, without the rulemakings that amici suggest are essential: since 2013, it has issued 1,070 SE marketing orders and 12 PMTA marketing orders, Zeller Decl. ¶ 5(b), (d)—including for some of amici’s own products. And it has in fact issued warning letters for the unauthorized marketing of deemed new tobacco products that were not on the market as of Au-gust 8, 2016—among them, such kid-friendly e-liquid flavors as “Cherri Bombz,” “Cereal Treats Loopz,” and “Heavy Custard Unicorn Cake.”

Id. (some citations omitted); see also id. at 4–5 (discussing extent of guidance FDA has provided

to date and the number of PMTAs and SEs it has resolved).


9

Second, Defendants acknowledge that, contrary to the Industry’s claim that “‘millions of

American adults . . . use ENDS products to help them quit smoking cigarettes[,]’ . . . there is

currently insufficient data to draw a conclusion about the efficacy of e-cigarettes as a cessation

device,” as there is evidence for and against the proposition that e-cigarettes “help some individual

users to quit using combusted tobacco products or to reduce their use of such products.” Defs.’

Resp. to Indus. Br. 5 n.11 (quoting Indus. Br. 6). Further, Defendants note the Industry’s

“responsibility for fueling the present problem of youth e-cigarette use by allowing dangerous and

addictive products to fall into the hands of youth, whether by neglect or design” and assert that

“there is substantial evidence that manufacturers have specifically targeted youth, both with kid-

friendly fruit and candy flavors and youth-directed advertising.” Defs.’ Resp. to Indus. Br. 7–8

(citation omitted).

Indeed, however laudable the FDA’s intended regulatory response is, the record before me

shows a purposeful avoidance by the industry of complying with the premarket requirements

despite entreaties from the FDA that it can do so, and it establishes a shockingly low rate of filings.

And, it is far from clear how an impending deadline would force some of the more successful

companies to withdraw from the market entirely, when they have large purses and the resources

to complete promptly the applications that they have had before them for years. See generally

Indus. Br. 6 (“ENDS manufacturers have not just sat around. They have done what they can to

prepare for the PMTA process. But . . . ENDS manufacturers come in in different shapes and

sizes, with vastly different levels of resources to devote to trying to anticipate what FDA would

require. For example, there are not enough accredited third-party laboratories qualified to conduct

various types of testing, and small manufacturers lack the resources to do those tests themselves.”

(citations to declarations omitted)). Thus, the record offers little assurance that, in the absence of


10

a deadline for filing, the Industry will do anything other than raise every roadblock it can and take

every available dilatory measure to keep its products on the market without approval. See Pls.’

Remedy Br. 10–11.

Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the

overstated effects that a shorter deadline may have on manufacturers, the Industry’s recalcitrance,

the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear

public health emergency, I find that a deadline is necessary. The Industry insists that “FDA, not

the courts, must set that timetable in the first instance.” Indus. Br. 9. In fact, it has. Defendants

wisely have proposed an alternative to Plaintiffs’ suggested four-month application deadline that

Defendants view as too short. Defs.’ Remedy Br. 2; see also id. at 6–7 (“These dates, while still

significantly accelerated, would at least reduce the expected abrupt and massive market exit of e-

cigarette products, and give the FDA an opportunity to administratively prepare for and review a

massive influx of applications sooner than anticipated. Critically, they would also allow the

agency to finalize the March 2019 draft guidance setting forth its enforcement priorities in the

interim—particularly with respect to e-cigarettes targeted to minors or sold in ways that heighten

the risk of youth access.”). I agree with Defendants that the ten-month deadline for applications

would be more reasonable than the four-month deadline, allowing sufficient time for application

submissions that present the information that the FDA needs to assess the e-cigarette products,

while not delaying longer than necessary.

Moreover, I conclude that this Court has the authority to impose such a deadline under the

extraordinary circumstances of this case in which prompt action is necessary to combat the

“epidemic-level rise in youth e-cigarette use,” which undisputedly is a “mounting public health

crisis.” Defs.’ Remedy Br. 1 (quoting FDA, Stmt. from FDA Comm’r Gottlieb). Pursuant to the


11

APA, a federal district court may “compel agency action unlawfully withheld or unreasonably

delayed,” 5 U.S.C. § 706(1), or, as Plaintiffs ask this Court to do, “hold unlawful and set aside

agency action, findings, and conclusions found to be [unlawful].” 5 U.S.C. § 706(2). “‘[A]gency

action’ . . . include[s] a ‘failure to act.” Thompson v. U.S. Dep’t of Hous. & Urban Dev., No. MJG-

95-309, 2006 WL 581260, at *4 (D. Md. Jan. 10, 2006) (quoting 5 U.S.C. § 551(13)). As Plaintiffs

assert, this Court has observed that “the words ‘set aside’ need not be interpreted narrowly” when

“devising an appropriate remedy.” Thompson v. U.S. Dep’t of Hous. & Urban Dev., 348 F. Supp.

2d 398, 464 (D. Md. 2005) (citing NAACP v. HUD, 817 F.2d 149, 161 (1st Cir. 1987)); see also

Thompson, 2006 WL 581260, at *4 (citing NAACP, 817 F.2d at 161).

In Thompson, the Court noted that, “once a court concludes that an agency failed to remedy

past wrongs, the court is required to fashion a remedy that ensures future compliance with the

Constitution,” and that “[f]ederal agencies are not immune from the federal court’s traditional

equitable powers,” id. at *9, *10. After finding that HUD was “unlikely to [comply with its

statutory obligations] in the foreseeable future absent judicial compulsion,” the Court concluded

that “it ha[d] discretion to exercise its equitable powers to tailor a remedy” for HUD’s “long-

standing failure to meet [its statutory] obligations,” id. at *5, *6. This is consistent with the Sixth

Circuit’s stance in Coalition for Government Procurement, 365 F.3d at 460, and the District of the

District of Columbia’s earlier collection of appellate cases “affirming a district court’s power to

extend statutory deadlines to remedy improper agency delay,” Andrulis, 1990 WL 169318, at *2.

And, it is not inconsistent with the D.C. Circuit’s more recent observation that “ordinarily the

appropriate course is simply to identify a legal error and then remand to the agency, because the

role of the district court in such situations is to act as an appellate tribunal,” N. Air Cargo, 674

F.3d at 861 (emphasis added), because these are the “extraordinary circumstances” in which


12

district courts reviewing agency action should “issue detailed remedial orders,” see N.C. Fisheries,

550 F.3d at 20. Given the steps that the FDA has outlined with respect to its coordinated approach

to deal with this public health crisis, and the timetable that they have proposed (and I have

approved), I do not find that there is any present need to require court monitoring through quarterly

reports. However, I will retain jurisdiction to ensure that, if the need arises, further action could be

taken by the Court.

Order

Accordingly, it is this 11th day of July, 2019, hereby ORDERED that

1. the FDA shall require that, for new tobacco products on the market as of the August 8,

2016 effective date of the Deeming Rule (“New Products”), applications for marketing

orders must be filed within 10 months of the date of this Memorandum Opinion and

Order;

2. New Products for which applications have not been filed within this period shall be

subject to FDA enforcement actions, in the FDA’s discretion;

3. New Products for which applications have been timely filed may remain on the market

without being subject to FDA enforcement actions for a period not to exceed one year

from the date of application while FDA considers the application;

4. The FDA shall have the ability to exempt New Products from filing requirements for

good cause on a case-by-case basis.

/S/ Paul W. Grimm United States District Judge

lyb


EXHIBIT C


1

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MARYLAND

AMERICAN ACADEMY OF PEDIATRICS, et al.,

Plaintiffs,

v.

FOOD AND DRUG ADMINSTRATION, et al.,

Defendants.

Civil Action No. 8:18-cv-883-PWG

DECLARATION OF MARK ANTON, PRESIDENT, WHAT A SMOKE, LLC, AND

EXECUTIVE DIRECTOR, SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION

1. I am the President of What a Smoke, LLC, a small Electronic Nicotine Delivery

Systems (ENDS) manufacturer, distributor and retailer based in Flanders, New Jersey. What a

Smoke was established in 2008 as one of the country’s first ENDS businesses. In my capacity, I

manage the day-to-day operations of the company, but also engineer ENDS devices and e-liquid

formulations. We market 138 unique ENDS products, all of which will have to go through FDA

premarket review.

2. Since 2017, I have also served as the Executive Director of the Smoke-Free

Alternatives Trade Association (SFATA), one of the largest national trade associations of U.S.

ENDS businesses. Our membership includes hundreds of manufacturers, retailers and

distributors, both large and small, located in all 50 States. Our members employ thousands of

individuals across the country.

Case 8:18-cv-00883-PWG Document 113-7 Filed 06/12/19 Page 2 of 8USCA4 Appeal: 19-2130 Doc: 36-4 Filed: 12/13/2019 Pg: 2 of 8 Total Pages:(100 of 215)

2

3. Based on my experiences with What a Smoke and SFATA, I have an extensive

knowledge of the industry and the related actions taken by the Food and Drug Administration

(FDA) under the Tobacco Control Act (TCA).

4. In May 2016, when the final Deeming Rule was published, FDA extended the

TCA’s requirements to all deemed products, including ENDS that contain tobacco-derived

nicotine. Now, ENDS manufacturers are subject to a host of regulatory requirements, including

registration, product listing, ingredient reporting, harmful constituent testing, warning labels and,

most critically, premarket authorization for any new tobacco products.

5. Since the Deeming Rule went into effect, FDA has consistently moved regulatory

deadlines to give the ENDS industry a reasonable amount of time to comply, as well as

accommodate FDA’s own needs, technical issues and capacity. For example, the initial

registration and product listing deadline for U.S. manufacturing establishments was moved

several times from December 31, 2016 to October 12, 2017. The ingredient reporting deadline

was moved from February 8, 2017 for large manufacturers, and August 8, 2017 for small-scale

manufacturers, to May 8, 2018 and November 8, 2018, respectively. The harmful and potential

harmful constituent (HPHC) reporting deadline, which was originally set for August 8, 2019, has

been moved indefinitely to either six or nine months after FDA’s final guidance on HPHC

testing is published (depending on whether the reporting company is large or small). As a

practical matter, it would not have made sense to require PMTAs even before much less-

involved ingredient reports were due.

6. The most critical requirement for ENDS companies is premarket authorization for

new products. A “new” tobacco product is one that was either introduced to the U.S. market

after the February 15, 2007 “grandfather date” or, if it was already on the market as of that date,


3

had any modifications made to the product other than to its label. Although my company has

been in business for 11 years, none of my products – nor any ENDS on the market – are

grandfathered, and all will have to go through “premarket” review.

7. More specifically, while the TCA offers several pathways for premarket approval

to combustible tobacco products (i.e., substantial equivalence), the only approval route available

to lower risk products such as ENDS is through the most onerous of these pathways, the PMTA.

8. The PMTA is the most extensive pre-market review pathway and, according to

the statute, requires tobacco product manufacturers to submit information for each product

showing that marketing the product is “appropriate for the protection of the public health” with

respect to both users and nonusers of tobacco products. This has become known as the

“population effects” standard, which requires FDA, when deciding whether a product may be

commercialized, to consider the product’s impact on the population as a whole, including the

likelihood that people will stop using tobacco products (i.e., cessation), as well as start using

them (i.e., initiation).

9. Since the Deeming Rule was published in May 2016 and until yesterday (June 11,

2019), only a draft guidance has been published by FDA on the PMTA process for ENDS. The

fact that the guidance was not finalized for over three years has made it very difficult for

companies like mine, and hundreds of SFATA members, to understand what information would

satisfy this population effects standard. Such understanding, of course, is necessary for

companies to plan and invest in the appropriate level of resources. Unlike well-established

regulations for drugs and medical devices, which require demonstration of safety and

effectiveness, the more burdensome public health or population effects standard is brand new for


4

both industry and FDA – making the need for clear guidance so critical, especially for small

ENDS businesses.

10. Beyond the PMTA guidance itself, FDA has also so far failed to provide any

guidance or initiate rulemaking in other critical areas necessary to complete PMTAs. For

example, FDA has not yet established Tobacco Product Manufacturing Practices (TPMP),

although a proposed TPMP rulemaking has been on FDA’s regulatory agenda for several years.

Section 910(b)(1)(C) of the TCA requires that PMTAs include “a full description of the methods

used in, and the facilities and controls used for, the manufacture, processing, and, where relevant,

packing and installation of the new tobacco product.” The recently finalized PMTA guidance

summarizes information about manufacturing processes that will need to be included in an

application, but does not itself provide any guidance on what practices or procedures are

appropriate for the protection of the public health when, for example, manufacturing e-liquids.

11. Another example is the lack of guidance on how to assess the levels of HPHCs in

ENDS products. This is a particular concern for “open-tank” (i.e., refillable) products. There are

no standardized test methods for aerosol produced from open-tank ENDS, unlike for cigarettes

which have established smoke testing regimes. In the recently finalized PMTA guidance, FDA

indicates that, in lieu of testing, “it might be acceptable to provide the quantity [of an ingredient]

added to an e-liquid,” but still does not provide any guidance on testing procedures, sample sizes,

validation methods, limits of detection, or how to conduct exposure assessments.

12. Another major concern for smaller companies that market open-tank products, of

which FDA records indicate there are millions, is the lack of available third-party laboratory

space to conduct HPHC and other analytical testing necessary for PMTAs. Small companies like

mine do not have their own laboratory capabilities and so must rely on third-party labs and


5

consultants. Based on our research and outreach, there are only handful of establishments in the

country that would be able to conduct this research.

13. Another challenging aspect of the PMTA process for ENDS companies is

developing an Environmental Assessment (EA), which applicants must submit so that the agency

can assess the environmental impact of issuing a marketing order for a new product, as required

by the National Environmental Policy Act (NEPA). Significant clarity on what an EA requires

for an ENDS manufacturer is needed. For example, it is not clear if and how companies need to

assess the potential greenhouse gas emissions that result from the manufacture, use and disposal

of ENDS products. This is particularly concerning for ENDS companies whose devices and

other components are produced by contract manufacturers in China. The time and expense to

prepare EAs for PMTAs that meet FDA standards is expected to be significant.

14. In addition, as the final PMTA guidance makes clear (page 51), pre-PMTA

meetings are essentially required with FDA. FDA specifically recommends applicants meet with

them “well in advance of the planned premarket applications so that the applicant has the

opportunity to consider CTP feedback prior to preparing the application and to help ensure the

application will be complete at the time of submission and likely to provide the data and

information required for the Agency to make a final authorization decision.” Moreover, FDA

states that to ensure a successful pre-submission meeting, applicants are “expected to have a

fully developed approach to meet the regulatory requirements for its planned application(s)”

before the meeting with FDA. Thus, given the large number of PMTAs that are expected to be

filed, it is likely that even scheduling a meeting with FDA could take months or more. In the

end, FDA still needs time, even with the final guidance, to flesh out parameters and solve hard

technical questions for individual applications.


6

15. While we are encouraged that FDA has finally published a final PMTA guidance,

significant time and expense will be needed to complete this process.

16. Based on the recently finalized PMTA guidance, the expected cost to complete a

PMTA is exorbitant – potentially millions of dollars per application. Literature reviews alone,

the backbone of any PMTA, are estimated to cost over $500,000 to generate according to

consultants. This far exceeds the $300,000 per application FDA estimated in the Deeming Rule.

17. My business has over 138 ENDS products. Even if I can realize some economies

of scale in filing multiple applications, it is easy to see that my costs would sky-rocket, at a

minimum, into the tens of millions of dollars.

18. There are thousands of small businesses like mine, many of them “Mom and Pop”

type businesses. In fact, we understand FDA has over 3 million different products registered.

This means an industry that is estimated at $6 billion annually in sales would have to spend far in

excess of that figure to just keep the products we currently have on the market.

19. There will be many unintended economic consequences of the PMTA process as

outlined by FDA. Small businesses investing in a PMTA will struggle to pay their bills and

overhead, to invest in new inventory and equipment and extend their leases. Beyond

manufacturers, many of whom will go out of business because of the PMTA process, there are

over 15,000 small “vape shops” that focus on selling open-tank devices and e-liquids whose

businesses will be severely impacted by a shortage of approved products, and will likely have to

shut down, putting thousands of employees out of jobs.

20. This will cause economic hardship on multiple levels for small business owners.

Many have invested their life savings into their vapor business, mortgaged their homes, and

personally guaranteed leases and SBA loans. If we are forced out of business, we will also lose


7

the significant resources we spent on outfitting our labs to incorporate clean rooms and advanced

production equipment.

21. In short, the FDA needs sufficient time to work with the industry to develop a fair

and streamlined PMTA process that takes into account the lower risk profile of ENDS products

and provide additional, and much needed, guidance on manufacturing standards and other PMTA

requirements.

22. As a business owner I believe I am doing a public good by helping adult smokers

transition to products that studies show are at least 95% less harmful than combustible cigarettes.

We would like to continue to help millions of addicted smokers reduce or eliminate their harm

from tobacco smoke.

23. The youth issue is of paramount importance and our industry members strive to

operate under the laws to prevent youth access. However, it is important to consider the

devastation the PMTA process will have on the thousands of U.S. businesses and workers, as

well as the millions of smokers who have made the switch and have seen their health

dramatically improve, if the compliance period effectively results in millions of products being

arbitrarily removed from the market.

It is with great honor and thanks to the court in taking into consideration the points and

concerns of a citizen, industry member and leader. I thank you.

I declare under penalty of perjury that the foregoing is true and correct. Executed on

June 12, 2019.

Mark Anton


EXHIBIT D


1




Plaintiffs,

v.


Defendants.


SUPPLEMENTAL DECLARATION OF MARK ANTON,

PRESIDENT, WHAT A SMOKE, LLC, AND EXECUTIVE DIRECTOR,

SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION

I, Mark W. Anton, do hereby declare as follows:

1. I am submitting a supplemental declaration in response to statements made by the

plaintiffs and the government (FDA) in this case.

2. I am the President of What a Smoke, LLC, a small Electronic Nicotine Delivery

Systems (ENDS) manufacturer, distributor and retailer based in Flanders, New Jersey. What a

Smoke was established in 2008 as one of the country’s first ENDS businesses. In my capacity, I

manage the day-to-day operations of the company, but also engineer ENDS devices and e-liquid

formulations. We market 138 unique ENDS products, all of which will have to go through FDA

premarket review (PMTA).

3. Since 2017, I have also served as the Executive Director of the Smoke-Free

Alternatives Trade Association (SFATA), one of the largest national trade associations of U.S.

ENDS businesses. Our membership includes hundreds of manufacturers, retailers and


2

distributors, both large and small, located in all 50 States. Our members employ thousands of

individuals across the country.

4. As part of my responsibilities with SFATA, I have had many discussions with

members regarding the PMTA and the obstacles to completing that process. In my last

declaration, I outlined those barriers based on feedback from SFATA members. In short, it is

self-evident from my previous declaration, as well as my updated observations presented below,

that the May 2020 deadline, or any similar date, will not allow for quality submissions. As a

result, our members will not be in compliance and, as I stated earlier, will have to close.

5. One issue that is becoming increasingly a problem is scheduling time to meet with

FDA to discuss individual company PMTA requirements. The recently issued final PMTA

guidance essentially requires these meetings and it is now our understanding that they will not be

scheduled before late October, 2019. To date, many of our members have sought pre-submission

meetings and have not been provided a time or date to meet with FDA. We are now only eight

months away from the May 2020 deadline. Considering the large number of anticipated

applications for newly regulated tobacco products, it is likely that even scheduling a meeting

with FDA could take months or years.

6. Since filing my previous declaration, we also have not seen any improvement in

the other areas of concern that I discussed. We still do not have enough qualified third-party labs

to do the necessary analytical work (we are only aware of 5 in the US, UK, and Canada), which

is extensive for the open tank products that make up the backbone of the entire small vapor

industry. We still do not have from FDA the required Tobacco Product Manufacturing Practices,

testing protocols, and instructions on how to conduct environmental assessments under NEPA.


3

7. Manufacturers must also test for Harmful and Potentially Harmful Constituents

(HPHCs), but we still do not have any standardized testing methods (e.g., sample sizes,

validation methods, etc.) similar to the ones used by cigarette companies. FDA also recently

added new HPHCs to the list of those substances that must be tested for, but then removed old

ones, which means that whatever testing we did in the past is now partially useless and must be

done over. Additionally, testing laboratories must now establish independently validated testing

methodologies for new HPHCs. All the work and resources dedicated to prior validations by

companies like mine have now been spent in vain. It is also my understanding from recent

discussions with these labs that, after the testing methodologies have been developed, they will

need to go through accrediting processes with organizations like the American Association for

Laboratory Accreditation, which will take weeks or even months.

8. It is critical for SFATA’s members to have clear guidance on these and other

areas I previously identified. Without this direction, countless small companies will likely go out

business. Just a few weeks ago, I signed a letter along with over 1,400 other individual, small

vapor companies that went to FDA Commissioner Sharpless outlining concerns regarding the

accelerated deadline and stating that, as a result, “[t]housands of small vape shop owners and

vapor product manufacturers are on the precipice of extinction.” Attachment A.

9. I was also alarmed that plaintiffs recently implied that increased vaping by minors

is attributable to the open-system products made by SFATA’s member companies. Last

February, SFATA submitted a letter to FDA presenting data that shows instead that underage use

is likely due to pod-systems, like JUUL, sold in convenience stores. Former FDA Commissioner

Gottlieb agreed that open-systems, which are typically sold in vape shops and online, are not

behind the recent youth survey results. Attachment B.


4


September 23, 2019.


Attachment A


September 10, 2019 Norman E. Sharpless, M.D. Acting Commissioner Food and Drug Administration 1903 New Hampshire Avenue Silver Spring, MD 20993 Mitchell Zeller Director Center for Tobacco Products Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 Dear Acting Commissioner Sharpless and Mr. Zeller,

We are writing to you today to express our concern for small businesses in the open vapor product industry in regard to the current PMTA guidance. Thousands of small vape shop owners and vapor product manufacturers are on the precipice of extinction. We are facing vague, unattainable regulatory gates and the terrifying threat of regulatory termination of the most impactful tobacco harm reduction products to date. We are being forced to prepare for a future where we will not be able to afford costly and unclear premarket approval, casting small businesses out of the lifesaving industry that we once created. It is our hope that the FDA can convene with our industry representatives to develop a pathway to clear and concise industry regulation that is mutually agreeable.

Current PMTA guidance recommends extensive research into each product, which includes bottle size and nicotine variations, as well as environmental assessments. We are not large corporations that can afford to fund departments devoted to regulatory affairs, science, toxicology, and legal matters, nor do we have millions of dollars to secure these services. We are mostly “mom and pop” small businesses. Many of us started with nothing but a few thousand dollars and a desire to help smokers quit, using the same method we used ourselves. Through hard work, and a firm belief in our mission, we have been able to develop successful small businesses that have not only created job opportunities for thousands of people, but helped countless people quit smoking cigarettes, and even quit using nicotine entirely, for good. This industry was created by thousands of small business owners who exemplify the American Dream—that through dedication and hard work, everyone has the opportunity to be successful. The current PMTA structure may well turn out to be impossible to navigate or comply with, at least to any distinction of consistency and dependability for advancing products and incentivizing improvements.

Thus far, efforts to engage consultants, laboratory services, and legal counsel all seem to

produce professional regulatory experts that are just as unclear on how to advance through FDA’s current regulatory structure successfully. This leaves the industry even further confused, and effectively paralyzed, as we consider the risk of potentially spending ourselves out of business – because none of these entities can provide definitive answers to a process that remains completely subjective. The estimated costs given to us by the very services we would need to utilize to achieve adequate PMTA submission, amounting to millions of dollars per SKU, are


Small Business Letter to Commissioner Sharpless September 10, 2019 Page 2 of 36

significantly higher than the FDA’s “average application cost” of $131,643 for initial e-liquid submissions. PMTA guidance, by its very nature, gives the vapor industry a loose understanding of what will and won’t result in approval. These recommendations, combined with high costs for only a potential chance of approval, create an unrealistic paywall to industry compliance.

We are already beginning to see vape shops and vapor product manufacturers shut their

doors—the smallest partnerships and family-owned businesses in the industry are steadily beginning to disappear. Some vapor product manufacturers are moving their American-based businesses to more vapor-friendly countries that have clear, attainable regulatory structures. Those manufacturers who do not have the ability to uproot their lives to make such a business move are instead selling their livelihood for pennies on the dollar, rather than risking a total loss when FDA exercises their enforcement discretion. Many members of the open vapor industry are making the difficult decision not to renew leases on the buildings they occupy because the pathway to remain on the market is completely subjective, undefined, and makes compliance extremely difficult, if not impossible. We will continue to see this industry slowly collapse under the heavy burden of the current regulatory framework that is unlike any other and offers no consistent baseline for the industry to follow.

It is clear that the outcome of the current regulatory structure will hand the entire vapor

product industry to massive tobacco companies who have a long, sordid, and extremely profitable history of damaging the health and wellbeing of this country. The open vapor industry has and hopefully always will be able to be committed to helping combustible tobacco users transition to a nicotine delivery system that has been proven less harmful by orders of magnitude. We represent a group of businesses prepared to work with the FDA towards reasonable, realistic and sustainable regulations that are attainable for industry participants and more consistent with established and commonplace regulations for other consumable products.

Perhaps our most important concern is that combustible tobacco products, which are

clearly and demonstrably harmful to public health, will be allowed to remain on the market in every smoke shop, gas station, grocery store, and convenience store in the country with little more than an age restriction and modest tax as a use deterrent. The only remaining choices Americans will have are combustible tobacco products, big tobacco company owned vapor products, or potentially hazardous, unsafe, and illegal black market products. Not only will these vague and unattainable PMTA guidelines reward tobacco companies for their current and past behavior, but they will also surely undo much of the hard work open vapor product manufacturers, distributors, and resellers have done to help millions of combustible tobacco users transition to safer nicotine delivery systems and even quit nicotine altogether.

Tobacco companies created the distrust that now exists. They also followed our lead into these less harmful alternatives while vilifying our products without factual basis. They have exponentially more resources, lobbyists, and influence, but current realities will give them the harm reduction market that we established and advanced. The current regulatory structure will take this from us and hand deliver it to those companies who created and advanced the harms of combustible cigarettes with no concern for the consequences. Furthermore, the FDA’s own age-of-sale enforcement stings show that youths are not obtaining these products from our industry participants, they obtain them from the tobacco distribution pathways.1

1https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-forceful-new-actions-focused-retailers-manufacturers?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=statement&utm_campaign=CTP+News%3A+March4Announcement+-+3419&fbclid=IwAR3o1gS1Gx8R2QPExHlB_X3GUAoDp3u8rK_PGb2lD6CHTnwBGXBALeXyYVQ



So why allow tobacco companies to commandeer this industry when we are the ones who have introduced these products, created this new harm reduction strategy, and are verifiably (by the FDA’s own enforcement evaluations) maintaining youth sales prevention and discouragement?

Our concerns go beyond the loss of our businesses or the added power those losses would hand tobacco companies. We are equally concerned about vapor product manufacturing being handled by irresponsible, potentially dangerous black-market entities. These black-market entities will have no incentive to ensure that their illegal products follow standardized, unadulterated manufacturing practices. Consumers will unwittingly be put at risk by potentially hazardous and unsafe vapor products.

We understand and respect the FDA’s mandate to ensure reasonable consumer protections. We, the undersigned, are prepared to meet with FDA to cooperate and work together to find mutually satisfactory structures to regulate these products that will provide the requisite consumer protections, and also create a regulatory approach that is defined, clear, and attainable by those industry participants, like us, who are fully prepared to preserve and solidify the harm reduction public health benefits these products are capable of providing.

We hope the FDA will recognize and consider that this industry is different than any other. Most consumable products get introduced by big conglomerates or multinational manufacturers with correlative budgets and regulatory experts. Meanwhile, vapor products are facing regulatory approaches advanced many years after the products were already on store shelves. We acknowledge and respect the difficulties this adds for both the FDA and the industry. We are prepared to work with the FDA to find regulatory frameworks that meet our mutual goals. If we cannot find some realistic, consistent, and compliable common ground, businesses will close, thousands of jobs will be lost, many leases broken, investments lost (some even at life-changing levels) – many may lose their homes, savings, and much more.

On behalf of the undersigned 1,464 small vapor businesses, I respectfully request that you engage with us in a timely manner to navigate an attainable solution for small business owners so that we can reach our common goal: to save the lives of more than 480,000 American adult smokers a year without subjecting a new generation to nicotine addiction.

With warm regards,

Amanda Wheeler, Co-Owner Jvapes E-Liquid 1201 Iron Springs Rd., Suite 3 Prescott, AZ 86305 (928) [email protected]



Dustin & Cassy Pitts, Owners Cloud Addiction, LLC Anniston, AL

Curt Reynolds, Owner Leet Vaping, LLC, dba Leet Vape Athens & Toney, AL

Heidi Malone, Owner Leet Vaping, LLC, dba Leet Vape Athens & Toney, AL

Sylvia Reynolds Stanford, Partner Leet Vaping, LLC, dba Leet Vape Athens & Toney, AL

Joe Ferrell, Owner Attalla Vapor, Centre Vapes, Gadsden Vapes & Southside Vapes Attalla, AL Jay & Meghan Hardesty, Owners VapenJays, LLC & The Amish Collection Eliquid Auburn, AL "Melissa Anderson , Owner Vapor Craft of Auburn Auburn, AL"

Landon Barton, Owner 205 Vape Shop Bessemer, AL

Amy Albers, Co-Owner Vaper Forge Birmingham, AL

Michael Ibe, Owner Cahaba Vapes, LLC Birmingham, AL

Rhonda Osment Lambert, Co-Founder The Vapor Apothecary Birmingham, AL

Gordon Tinsley, Owner Earths Bounty & The Vape Place Boaz, AL

Keith aldijaili, Owner Vapors of Alabama, Inc. Cullman, AL

Rod Cochran, CEO/Founder Vape Radio Daphne, AL

Zack Carpenter, Owner Cyclops Vapor, LLC Daphne, AL

Eric Slaick, CEO Save A Smoker Dothan, AL

Keith R Lewis, Owner North Alabama Vape Florence, AL

Tina Roberts, Owner TJ’s Juices Florence, AL

Debra Gruwell, Owner Nu Way Vape Florence, AL

Karen Gean, Vice President Southern Vape Florence, AL

Tina Roberts, Owner Nu Way Vape & TJs Juices Florence, AL

Daniel Duncan, Owner Vapor Craft Fort Payne, AL

Gordon Tinsley, Owner Sweet Home Vapor Co. Gadsden, Guntersville & Hampton Cove, AL Phil Ferguson, Owner Fergy’s Vape Gardendale, AL

John Hurd, Owner Mystik Vape, LLC Hartselle, AL

Randy Toffel, Owner Vapeology, LLC Hoover, AL

Stokes Tod Yarbrough, Owner Vape On!, LLC Madison, AL

Stardust Martin, Owner Vapor Magic McCalla, AL

Buzzy Owen, Owner Vapor Dreamz Mobile, AL

William H. Robertson, Owner Vapor Craft of Montgomery Montgomery & Tuscaloosa, AL

Cornelius Hampton, Owner Hit it N Quit it Vape Lounge Muscle Shoals, AL

Lisa Murray, Owner S & L Vapes Opelika, AL

Robert Ware, Owner Tiger Vapor Opelika, AL

Wayne Murray, Owner S & L Vapes Opelika, Auburn & Montgomery, AL

Cindy West, Owner Downtown Vape, LLC Pell City, AL

Jon Roundy, Owner Tasty Haze, LLC Rainbow City, AL

Ryan Austin, Owner Cold Vapes 907 Anchorage, AK

Shaun D'Sylva, Founder Fatboy Vapors Anchorage, Wasilla & Fairbanks, AK

Ryan & Tanya Kitka, Owners Kodiak Steam Trunk, LLC Kodiak, AK

Steven Mapes, Owner Mapes Vapes Soldotna, AK

Elia Najm, Owner V.World Avondale, AZ

Parviz Barati, Owner Vapor Solutions Bisbee, AZ

Tim Tibbles, Owner Bullhead Vape, LLC Bullhead City, AZ

Richard Blodgett, Owner White Mountains Vape Concho, AZ

Elizabeth Browning, Owner Vixen Vapes Cottonwood, AZ



Alex & Jessica Griffith, Owners The Ohm Factory Gilbert, AZ

Dan Short, Owner Short Designs, LLC Glendale, AZ

Debbie Pearson, Owner Red Vapor, LLC Glendale, AZ

Jessi Bell, Owner Red Vapor, LLC Glendale, AZ

Amanda Rice, Owner Vape Escapes Glendale Glendale, AZ

Frank Zeiter, Owner Frank N Juice, LLC Glendale, AZ

Ali A Odeh, Owner V. World, LLC Goodyear, AZ

Carlos Olea, CEO Exotica Vapor Shop Hermosillo, AZ

Patrick Legenzoff, Owner Designer Vape, LLC Laveen, AZ

Randy Miller, Owner The Vapor Pimp, LLC Laveen, AZ

Anthony & Sonia Perkins, Owner Oracle Vapory Mesa, AZ

Craig Larsen, Owner Kidney Puncher, LLC Mesa, AZ

David Riddle, Owner Vape Era Mesa, AZ

Declan Clarke, General Managing Partner Gourmet Vapor Mesa, AZ

James Thompson, Owner Mt Baker Vapor Mesa, AZ

Karim Salem, President Lite it Up, Inc. Mesa, AZ

Kris O'Connor, Owner Irican Mods Mesa, AZ

Melissa Shedd, Owner Southern Beginnings, LLC Mesa, AZ

Tony Valenzuela, Owner The Habit Smoke Shop Mesa, AZ

Igor Vojvodic, Owner BroScience Vapes, LLC Peoria, AZ

Carlos Coe, Director Mr. Vape USA Phoenix, AZ

Dave Morris, Owner Vape Gravy Brands, LLC Phoenix, AZ

Edward Townes, Owner Synergy Mixing Labs, LLC Phoenix, AZ

Eli Kaczka New Method, Owner This Old Vape Shop, Co-owner Phoenix, AZ Geoff Habicht, President SV3, LLC Phoenix, AZ

James Willett, Owner American Vapor Group Phoenix, AZ

John-Paul Willett, CEO Red Star Vapor Phoenix, AZ

Keith Higgins, Director of Operations Kure Phoenix, AZ

Kyle Adolph, Co-owner Cream Vapor, Adult Geared Eliquid & Loverly Phoenix, AZ Layal Aoufe, Owner Liquid Vape Phoenix, AZ

Minh Tran, Owner/CEO Vape Central Phoenix, AZ

Rick Avila, Owner Spartan Distribution Phoenix, AZ

Ronald Beneduce, Owner Nimbus House Phoenix, AZ

Ronn Beneduce, Owner Nimbus House, LLC, TrapT Eliquid & Juice Fiend Phoenix, AZ

Steve Johnson, Co-owner Glenn Johnson Ventures, LLC Phoenix, AZ

William Sagert, Owner Phoenix Vape Supply, LLC Phoenix, AZ

Amanda & Jourdan Wheeler, Owners Jvapes E-Liquid Prescott, AZ

John Fisher, Owner Jvapes Prescott, AZ

Michael Brown, Owner Valor Vapor Prescott Prescott, AZ

Joel Rivera, Owner Steam Heaven Rio Rico, AZ

Sofia Coert, Owner The Vaporium/A Vape Escape, LLC Sedona, AZ

Benjamin Cruz, Owner Monstro, LLC Surprise, AZ

Gunnar & Katie Birtel, Owner GK Vapor Surprise, AZ

Josh Aguiar, Owner Redline Vapor Surprise, AZ

Conor Rauen, Owner Mums Fantasy Factory Tempe, AZ



Beecher Howard, Owner Coilturd, LLC Tucson, AZ

Brett Flagg, Owner Southwest Smokeless Tucson, AZ

Eddie & Maggie Jayko, Owners Southwest Smokeless Tucson, AZ

Kyle Barnett, Owner The Vape Zone Smokeless Tucson, AZ

Luke Carnathan, CEO Double Tap Vapor, LLC Tucson, AZ

Rod Criger, Owner/Operator Vape or Dye, LLC, dba Southwest Smokeless Tucson, AZ Allen Epley, Owner Vapor Pros Tucson, AZ

Joshua Stewart, Owner Vapor Pros Tucson, AZ

Nicholas LaBanca, Owner/CEO Vapor-Riffic, Inc. Conway, AR

Michael Glisson, Owner New Era Vapours Corning, AR

Jamie Weaver, Owner Drippers Vape Shop El Dorado, AR

Alicia Fanning, Owner Vapor Springs Eureka Springs, AR

David Lawson, Owner Buffalo River Elixirs & 2 Pimps Juice Lab Flippin, AR

Scout Stubbs, Owner Drippers Vape Shop Greenbrier, AR

Supreet Momi, Owner Vapor House Little Rock, AR

Troy & Melissa Meuret, Owner Rogue Vapers Little Rock & Russellville, AR

William & Brenda McCullough, Owners My Home Town Vapor Little Rock, AR

Shawn Bresnahan, Owner Brooklyns Vape Shop Morrilton, AR

Topher Kent, Owner Rogue Vapers 2 North Little Rock, AR

Sharon Goodson, Owner/Operator JRILY Enterprises, LLC Rogers, AR

Rhonda Yi, Owner The Velvet Vapor & Hillbilly Hooch E-Juice Co. Rogers, AR Bobby White, Owner Rogue Vapers Searcy Searcy, AR

Donna Miller-Stacy, Owner Payless Tobacco & Vape Sherwood, AR

James H Stacy, Owner Alishas 3 Cs, dba Payless Tobacco and Vape Sherwood, AR Mark Fabela, Owner Cool Whic Cotton Alhambra, CA

Garrett Mann, Owner E-Cig Vault, LLC Aliso Viejo, CA

Anthony Garcia, Owner Cyber Liquids, LLC Anaheim, CA

Kiyo Sato, Owner Sugarlicious E Liquids Anaheim, CA

David Vanburen, Owner Big City Vapor Anderson, CA

Hani Tannous, Owner Tannous Enterprises Belmont, CA

Brian Buenaventura, Owner BJC Cerritos, CA

DJay Salas, VP The Finest Eliquid Chatsworth, CA

Jimmy Fung, Owner VPR Collection City of Industry, CA

Peter Koch, Chief Operating Officer Cosmic Fog Vapors Costa Mesa, CA

Shane Simpson, Owner C3 Vapors and Coffee, The Company MFG, LLC & Crumbz Vapor Costa Mesa, CA Suzanne Gearhart, Owner High Tide Vapes Crescent City, CA

Inho Choi, Owner VAPE Couture Cypress, CA

Mac Chu, Owner Sensual Cloud Vapors Daly City, CA

Molly Sylvester, Owner Vapin the 619 El Cajon, CA

James Raymond, CEO South Coast Vapor Co. Encinitas, CA

Marlow Younan, Owner TVL and PlanB Mods Escondido, CA

Anthony Jaramillo, Owner Flawless Vapes and Supplies, LLC Fountian Valley, CA

Jason Davis, Owner Midas Vape Garden Grove, CA

Patrick Mulcahy, CEO Streamline Vape Co., LLC Garden Grove, CA

Huy Nguyen, Owner USA Vape Lab Huntington Beach, CA



Bert SY, CEO Ism Vape, Inc. Huntington Beach, CA

Daniel Coleman, Owner Desce, Inc. Huntington Beach, CA

Chris Wheeler, CEO Savage Enterprises Irvine, CA

Jay Oku, Partner Five Pawns, LLC Irvine, CA

Mark Mathis, Owner Voltrove Kelseyville, CA

Chris Messick, Owner Vapor Meister Lakeside, CA

Kristen & Dwane Morrison, Owners Liquid EFX, Inc. Long Beach, CA

Travis Anthony, Owner Vapor Land Long Beach, CA

Samer Kauzman, Owner Smoking Box Long Beach, CA

Arsen Stepanyan, Owner Aspire Vape Co Los Angeles, CA

Ash Mazarei, CMO Liquid Barn Los Angeles, CA

Brett Goldenberg, Managing Member All Day Vapes Los Angeles, CA

Jennifer Cacavas, Owner J2 Productions Los Angeles, CA

John JJ Jenkins, Owner The Vapor Spot Los Angeles, CA

Kai Chen, Managing Member All Day Vapes Los Angeles, CA

Ryan Thomas, Owner Lost Art Liquids Los Angeles, CA

Scott Friedman, CEO Tasty Cloud Vape Co., LLC Los Angeles, CA

James Whiting, Co-Owner E-Cig City Mission Viejo, LLC Mission Viejo, CA

Brian Weber, Owner Mohawk Vapors Moreno Valley, CA

Ryan Stump, Owner Charlies Chalk Dust Newport Beach, CA

Brandon Acosta, President The Neighborhood E-Liquid Norco, CA

Ryan Chalme, Owner Vapor Delux North Hollywood, CA

Daoud Muwahed, Co-owner The Right Investment Oceanside, CA

Fabiola Elias Ramsey Feels Good Vapor, Inc. Oceanside, CA

Fig Ramsey FGV, Inc. Oceanside, CA

Yazan Muowahid, Owner Aroma Avenue Vape Oceanside, CA

Monica Schick, CEO North Guide Solutions, Inc. Ontario, CA

Russ Smelser, Owner Desert Vapors Palm Desert, CA

Susan Decell, Co-Owner Vapor Capers, LLC dba LunaVapes Palm Desert, CA

Victoria Drower, Owner Desert Vapors Palm Desert, CA

Steve Shazad, Owner Premier Smokes Palmdale, CA

Eddie Yin, Owner Asmodus Distribution Paramount, CA

Raffy Tasmajian, Owner The Clean Vape Pasadena, CA

Lacey Miller, Owner The Vapour Lounge Rancho Cucamonga, CA

Jeff and Kari Hess, Owner Nor Cal Vape Redding, CA

Rami Issa, Owner Royal Smoke Shop Rialto, CA

Brian Bereber, Owner/CEO Drip More Riverside, CA

Brian Heacox, President Doomsday Gourmet, LLC Sacramento, CA

Khaled, Owner Cig Zone San Bernardino, CA

Jake Rubenstein, President Nude Nicotine San Diego, CA

James Mitchell, Founder Vapor Invasion, LLC San Diego, CA

Mike Ebrahimi, Owner Vapor Authority San Diego, CA

Todd Skezas, Owner Vapor Authority San Diego, CA

Elia Baida, Owner Tobacco Spot San Fernando, CA

Nam Nguyen, Owner Stay Vaped San Jose, CA



Tony Doan, CEO Shijin Vapor San Jose, CA

Mike Guitron, Owner Cloud 9 San Marcos, CA

Austin Hopper, President Tailored Vapors MFG Santa Ana, CA

Patrick Taylor, CEO Nicky Drops Santa Ana, CA

Travis Hostutler, President Arc Distribution Santa Ana, CA

Nathan Kinghorn, Owner Simple, Inc. Santa Ana, CA

Patrick Visconti, Co-founder Tailored Vapors, LLC Santa Ana, CA

Dr. Andrew Dyson, Owner Mothers Milk WTA (MMWTA) Santa Clara, CA

Tarik Dugum, CEO DripNvape, Inc. Santa Clarita, CA

Randolph B Freer, CEO/Owner P.O.E.T. Ind. Inc. Seal Beach, CA

Steve Green, Owner Mountain Vapors Sonora, CA

Raymond Yang, Owner BLVK Unicorn South El Monte, CA

Jimmy Wilson, Owner Vapor Mo's Stockton, CA

Lonnie J. Bozeman, President & CEO Saveurvape Torrance, CA

Luis Martinez, Owner VAME Vapory, LLC Torrance, CA

Jacob Nesheiwat, Owner Vaperack, Inc. Whittier, CA

Louis Peick, Owner Unique Vapors Wildomar, CA

Joe Vondruska, Owner Cignot Colorado Arvada, CO

Justin Ganoe, Owner Inno-Vapor Arvada, CO

James Corey, Owner Woodshark Trading Company Aurora, CO

Patrick Vandiver, Owner High-Voltage Vapes Aurora, CO

Timothy Roberts, Owner Perfect Alternatives Aurora, CO

Caleb Vannice, Owner Merkury, LLC Bailey, CO

Ginger & Sean Tanner, Owners Boulder Vapor House Boulder, CO

Nathan T Keller, President The Game Trader, Inc., dba Steampunk E-lixers Brighton, CO Peggy Hegler, Owner VAPEz, LLC Castle Rock, CO

Mark Branson, Owner Centennial Vapor Centennia, CO

Michael & Jennifer Mahaney, Owners Headed West Centennial, CO

Sarah Walter, Owner Vapewize Centennial, LLC Centennial, CO

Christofer Parker, CEO A Perfect Vape, Inc. Colorado Springs, CO

Joshua L Sprague, Owner Absolute Vapor Lounge Colorado Springs, CO

Margaret Shable, COO Flavor Monster Colorado Springs, CO

Tanner Adams, Owner Chief Vapor Colorado Springs, CO

Laura Riggs, President Artisan Vaper, Inc., DBA Flavor Monster Colorado Springs, CO

Clayton Kelley, Owner/Managing Partner Vape Loft - Denver Denver, CO

Cory Vigil, President Boosted Ejuice Denver, CO

Ian Firth, Owner Cloud Provisions, LLC Denver, CO

Robert Lindsey, Owner Vapor HQ Englewood, CO

Chris burgess, CEO E cig, LLC Federal heights & Denver, CO

Dan Rzonca, Owner The Magic Dragon Vape Shop Glenwood Springs, CO

Raquel Morton, Owner 970 Vapor Cigs / 971 Vapor Cigs Glenwood Springs, CO

Shylo Harlan, Owner 970 Vapor Cigs / 971 Vapor Cigs Glenwood Springs, CO

Monica Vondruska, Owner Free Range Vapor Golden, CO

Monica Vondruska, Owner Uska Designs Golden, CO

Bill Lash, Owner Lost iN Time, L.i.T iN GJC LLC Grand Jct, CO



Dominette Celli, President Lizard Lounge Vapor Grand Junction, CO

Dominette Celli, President Indy Vapes Grand Junction, CO

Andrew Salsbury, Owner Cloudy Peak Vapes, LLC Greenwood Village, CO

James Beutler, Owner Vapergate Lakewood, CO

Keith Pettersen, Owner Rocky Mountain Ecigs, LLC Lakewood, CO

Robert South, Owner Budz House of Vape Lakewood, CO

Shaune Walter, Owner VapeWize, LLC Lakewood, CO

James & Kelly Cline, Owners FogTown, Ltd. Lamar, CO

Anthony Acosta, Owner Skys The Limit Industries Littleton, CO

James Evans, Owner Skys The Limit Industries Littleton, CO

Michael Huff, Owner Moutain View Vapes Littleton, CO

Daniel Garcia, Owner Legacy Vapors Loveland, CO

Francesca Gettler, CEO Vapor Source, Inc. Pueblo, Colorado Springs, Fountain, Trinidad & Canon City, CO Jason Casados, Owner Vapor Source, Inc. Pueblo, Colorado Springs, Fountain, Trinidad & Canon City, CO Beverly Strength, Owner Crazy B’s Smoke Shop Ridgway, CO

Corbin Elliott, Owner/Operator HTO, LLC, dba Up in Vape Thornton, CO

Ann Fulgham, Owner Elite Vapes Thornton, CO

Kateri & Shawn Hillis, Owner Mountain Pass Premium Elixirs Westminster, CO

Shawn and Kateri Hillis, Owners The Vapor Shop Westminster, CO

Lori Johnson, Owner Steep Slope Vape Supply Wheat Ridge, CO

Betti & Dave Anderliter, Owners Mountain Vapor Lounge Woodland Park, CO

Ben Harrison, Owner E-Six, LLC Branford, CT

Joseph Menna, Owner E-Six, LLC Branford, CT

Ted Szabo, Owner E-Six, LLC Branford, CT

Albert Hamon, Owner UVAPE ,LLC Colchester, CT

Mark Nowak, Owner Pure Cigs, LLC Hartford, CT

Chris Leary, Partner HLMS, LLC Milford, CT

Chandler Kopacz, Owner Fog Factory New London, CT

Adam Webster, Owner The Steam Co. Orange, CT

Cassidy Greathouse, Owner Quite Corner Vapor Shop, LLC Putnam, CT

John Papaspyrou, Owner DeadMenzHandz Seymour, CT

Christine Solazzo, Founder Very Vocal Vapers South Windsor, CT

Albert Barone, Owner Ab3 LLC, DBA Puffin Vapor & Leaf Vernon, CT

Don Thompson, CEO The Zen Vaper E-Liquids, LLC Claymont, DE

David R Eisenhour, CEO Delmar Vapor Lounge, LLC Delmar, DE

Don Wills, Owner Maxed Out Vape Dover, DE

Macchavelli Spielberg, Owner The Modfather, Inc. Middle Island, DE

Andrew Wolford, Owner Delaware Vapor Newark, DE

Harrison Kay, Owner Evocation Elixirs Odessa, DE

Michael Crilley, Owner Evocation Elixirs Odessa, DE

Barbara Hogan, COO LanMark Alternatives, LLC Bradenton, FL

Brandy Shriver, Owner Big John’s Vapes Brandon, FL

Shannon Whitesell, Owner Elysium Vapor Co. Brandon, FL

Steven Kollias, Owner Red Shield Reserve, Inc. Brooksville, FL

Monique Levesque, Owner Cloud 352, LLC Bushnell, FL



Robert Hargrove, Managing Partner Naples Vapor, LLC Cape Coral, FL

Nick Orlando, CEO The Vapers Depot Clearwater, FL

Terrance & Bonnie Shaw, Owners Vapin Crazy E-cigs & Juice, LLC Clermont, FL

Ryan Silva, President Ryan Flavors Coral Springs, FL

Horacio Moreno, Owner Offensive Clouds Distro Davie, FL

Nick Bold, CEO Just Eliquids Distro, Inc. & The Vapor Club Deerfield Beach, FL Jonathan Risteen, Owner Gentleman’s Draw E-Liquid Edgewater, FL

Keilei Ann MacInness, Owner TNA Vapes Eustis, FL

Nikole Maloy, Owner Vape Out Fernandina Beach, FL

Brian Lavin, Owner Pro Vapor & Sinful E-Liquids Fort Lauderdale, FL

Dan Marlin, Owner Johnny Copper Vapor Co. Green Cove Springs, FL

Sarah Fairman & Keith Fairman, Owners Diamond Vapor, LLC & Diamond Distro, LLC Hollywood, FL Victoria Parr, Owner Vapor This Florida, LLC Inverness, FL

Drew Chase, Owner Axis Vapor Jacksonville, FL

Ernesto Fragoso, Owner New Start Vapor Company Jacksonville, FL

Logan Lampert, Owner Mamas Kitchen Jacksonville, FL

Will Arnold, Owner Mamas Kitchen Jacksonville, FL

Glen Newman, Owner Blackhat Vapor Company Jacksonville, FL

Lance Culver, Managing Partner Blackhat Vapor Company Jacksonville, FL

Scott & Lorrie Covington, President Vapin in the Cape, LLC Kissimmee, FL

Kevin Cinar, Owner Mountain Oak Vapors Lake Mary, FL

Craig & Kristin Heflin, Owner Doghouse Vapes, LLC Largo, FL

Paul Vairo, Owner Viper Vape & Smoke Company Largo, FL

Timothy Gee, Owner Mr. Gee Liquids Largo, FL

Sean Kenny, Owner Rock Bottom Vapes, LLC Longwood, FL

Eric Gilbert, Owner/President Vapor Technologies, Inc. Marianna, FL

Joy & Patrick Vota, Owners Simply Vapor Mary Esther, FL

Rob Blankenship, Co-owner Secret City Vapor Ft Walton Beach, Mary Esther & Navarre, FL Martha Rodriguez, Owner Happy Vapor Shops Miami, FL

James Jackson, Owner Jacks Vapor Milton, FL

Bjorn B Johansen, President Broward Vapor Stores, Inc. Miramar, FL

Sam Markopulos, Partner/Owner Sweet Southern Vapes Niceville, FL

Miles Corson, Owner Take a Break Vapes North Palm Beach, FL

Stacey Pescosta, Owner Breathe Free E Cig, Inc., & NPB Vapes North Palm Beach, FL Jeff Wood, CEO Let the Smoke Out! Ocala, FL

Stephen Perry, Owner Maxx Vape Co. Ocala, FL

Christopher Kennedy, Owner Psiquid E-Liquid Orlando, FL

David Jones, Owner Orlando Vape & E-Cig Orlando, FL

Sonny Westmoreland, Owner Monster Vape Labs Orlando, FL

David Speung, Owner O Town Vapes Orlando, FL

Shasta Lievers, Owner Lifted Spirits Vape & More Palatka, FL

John Avey, Owner Palm Beach Vapors Palm Beach, FL

Paul Strand, Owner Shop Vapes, Inc. Palm Beach Gardens, FL

Robert Watson, Owner Smokin Vapor Panama City, FL

Michael Angell, Owner Angel Vapors Panama City Beach, FL



Harvey Brodzki, Owner Parkland Vapors Parkland, FL

Daniel Canceleno, Owner The Salty Vapor Pensacola, FL

Eugenia L Crump, Owner Vaping Genie, LLC Pensacola, FL

Patricia Stokes, Owner The Vape Shop of Pensacola Pensacola, FL

Joe Carco, Owner Jim’s Vape Escape, Inc. Pensacola, FL

Anthony Nieblas, Owner Coil Butter Pinellas Park, FL

Paul Foote, Owner PDF Media Designs Pinellas Park, FL

Brad Kugler, Owners Steam Train Vapor Company Pinellas Park & Clearwater, FL

Jordan Dalessio, Owner Steam Train Vapor Company Pinellas Park & Clearwater, FL

Richard Webb, Owner Molten Arts, LLC Port Richey, FL

Jaime Price, Owner ATL Vaping Port Saint Joe, FL

Steve Scales, Owner VLS Brands, LLC Port St. Lucie, FL

Peter Bertorello, Owner Puffs Tobacco Riverview, FL

Shane Johnson, Owner Fuzion Vapor Saint Augustine, FL

Justin Sampson, Owner Downsouth Vapors Saint Cloud, FL

Alycia Singleton, Owner Karma Vapors Saint Petersburg, FL

Judi Hall, Owner Vapor Vault Sait Petersburg, FL

Joe Capozzi, Owner Clean Blends Sarasota, FL

Michael Boling, CEO American Bottle and Packaging Sarasota, FL

Matt & Shannon Conner, Owners CNR Vapors LLC & Vapor Trails, Inc. Spring Hill, FL

Chris Conte, Partner Dixie Vapor St. Augustine, FL

Ericka Nelson, Owner Blind Squirrel Blends Starke, FL

Aaron Cartwright, Owner C Solution Services Stuart, FL

J.D. McCormick, Owner Vape Haven, Chrome Liquid & Rogue Liquid Tallahassee, FL Angel Collazo, Owner Wolfpaq E-liquid & The Vape Discount Tampa, FL

John & Mike Synychak, Owners Tampa Vapor, Inc. Tampa, FL

Michael Cherup, Owner LBC Vapor, LLC dba South Tampa Vape Tampa, FL

Thomas Mueller, Owner Affluent Wellness and Vapor Lounge & Affluent Eliquid Tampa, FL TD Bowen, CEO Moon Mountain, LLC Tampa, FL

Cindy Kinch, Owner Lady Boss Vapor Tarpon Springs, FL

Jorge Rios, Owner Premier Vapor Lounge Tavares, FL

Laura Dupuis, Owner Vero Vapor, LLC Vero beach, FL

Trevor Campbell, Owner/CEA Vapor Unlimited, LLC Wesley Chapel, FL

Bogdan Gradinariu, Owner Myvapor-Lounge, LLC Winter Garden, FL

Kathi Murtagh, Co-Owner VapeRings Acworth, GA

Evan M. Cochran, Owner Odysseus Vapor, LLC Alpharetta, GA

Melissa Anderson, Owner Vapor Craft of Auburn Columbus, GA Auburn, AL Craig Perryman, Owner Crazy Vapors, LLC Augusta, GA

Kristy Valdes, Owner Empire of E Cigs Blairsville, GA

Robin C Carter, Owner Art of Vaping Bremen, GA

Sheryl Whitaker, Owner Smokers Wanted Vapor Company, LLC Brunswick, GA

Karen Norris, Owner VapeWares Buford, GA

London Osborn, Owner Working Class Vapors Cairo, GA

Jacob Menard, President Maximum Vapor Canton, GA

Eric Albright, Owner Cool Vapors Carrollton Carrollton, GA



Michael & Donya Davis, Owners Cedartown Vapor Lounge, LLC & Tasty Wicks, LLC Cedartown, BA Michael & Donya Davis, Owners Cedartown Vapor Lounge Cedartown, GA

Michael & Donya Davis, Owners Tasty Wicks E-liquid Cedartown, GA

Eric Turner, Co-Owner Vapourizen Clayton, GA

Fredrick Setelin II, Co-owner Rivertown Vapor, LLC Columbus, GA

Keith & Sherry Gossett, Owners Buckys, LLC, dba Buckys Vape Shop Columbus, GA

Michael Reynolds, Co-owner Rivertown Vapor, LLC Columbus, GA

Joseph Cacciatore, COO JC Vape Shop, LLC Columbus, GA

Melissa Anderson, Owner Vapor Craft of North Columbus Columbus, GA

Jason Carroll, Owner Peace Pipe Vapors Cornelia, GA

Noah Richardson, CEO Colonial Vapor, LLC Cumming, GA

Scott Tripp, Owner Vapors Emporium GA LLC Cumming, GA

Eric & Susan Stutzman, Owners Ciggys2 Dallas, GA

Carrie Heffner & John O'Connor, Owners Vapers Alley Dalton & Chatsworth, GA

John Ashley Fields, Owner MidKnight Mods, LLC Danielsville, GA

Bobby Lewis, Owner My Vape Shack Dawsonville, GA

Alan & Vicki Futch, Owners Vaping Easy Douglas, GA

Donald &Tracy Shelnutt, Owners Atl Vaping Douglasville, GA

Justin Flores, Owner Venture E-Liquid Lab Elberton, GA

Scott M Wolkow, COO Victorious Vapors, LLC Evans, GA

Angela Funderburk, Owner Emote Vapes Fort Oglethorpe, GA

Joe King, Owner The Shoppe Fort Oglethorpe, GA

Billy Lowery, Owner In the Cloudz, LLC GA

Donna Turner, Owner Electric Smoke, LLC Griffin, GA

Michael Lee Bailor, Owner Olde Towne Vape Shoppe Griffin, GA

Deidra Casey, Owner Sundance Southern Vapors Grovetown & Harlem, GA

Anthony Cecchetto, Owner Crazycanadiangrass Hiram, GA

Cathy Stonemark, Owner Ciggys Hiram, GA

Keith England, Owner FogItUp! Vape Shop Hiram, GA

Justin Kicklighter, CEO My Vape Bar MFG Kennesaw, GA

Amy Washington, Owner Smoke Stop Vape Shop Lagrange, GA

Bob Lewis, Owner Hard Rock Vapor, LLC Lawrenceville, GA

Tobey Cox, CEO Juanavape Leesburg, GA

David & Jennifer Higginbotham, Owner HiggyCigs, LLC Lilburn, GA

Wesley Swanson, CEO Bulldog Vapor, LLC Loganville, GA

Tara & Phillip Alexander, Owner Opt2mist Vapor Shop, LLC Lula & Cornelia, GA

Joe Exum, Owner Macon Vape and More Macon, GA

Lisa Gano, Owner VapeRite.com Marietta, GA

Jason Wells, Owner Vaporious, LLC Marietta & Dallas, GA

Geraldo Saldanha, Owner L&G Alibaba Smoke and Vapor Moultrie, GA

Lester Rodrigues, Owner Alibaba Vapor and Tobacco Moultrie, GA

Trent Struck, Jr., Owner Vapes Gone Wild Newnan, GA

Douglas Rudler, Owner D and D Concessions, LLC Perry, GA

Gayle Kraft, Owner/Partner Vapor Trails, LLC Pooler, GA

Joseph M Yarger, Owner The Wolfy Vape Ray City, GA



Jon & Dana Alfred, Owners Signature Vapors Ringgold, GA

Shea Dale, Owner Star Promos, LLC, dba The Cloud Shack Rome, GA

Jack & Morgan Nathan, Owners VapeZone, Inc. Roswell, GA

Devin Flagor, Owner Patriot Vapors Saint Marys, GA

Dillon Gilbert, Owner The Vape Loft Savannah, GA

Nancy Truong, Owner Southeast Vapes Savannah, GA

Rick D Conner, Owner City Vape, LLC Savannah, GA

Vimesh Patel, Owner The Vape Loft, Foghouse Vapors & Skye Vapes Savannah, GA Farris Tompkins, Owner Foghouse Vapors & Basic Eliquids Statesboro, GA

Marcus Bannister, Owner Foghouse Vapors & Basic Eliquids Statesboro, GA

Stephanie Hayes, Owner Absolem Vapes Stockbridge, GA

Brian McReynolds, Owner Angry Dragon Vapors, LLC Villa Rica, GA

Paula Perkins, Owner West Georgia Vape Villa Rics, GA

Apryl & Stewart Pickering, Owners Epic Vapes, LLC Winder, GA

Keith Uyeno, Owner Pacific Express, Inc. Honolulu, HI

Garett Uyesugi, Owner Island ecig and Vape Co. Kahului, HI

Derek Dame Known Distro, LLC Vape Storm Labs, LLC & KL Labs, LLC Boise, ID Erica Spivey, Owner Primal Elixir & Vapun Magazine Boise, ID

Ryan Muckenthaler, Owner Vape Boise, ID

Erica Louise Emory, CEO Vapun Magazine Boise, ID

Evan Drake Fischer, Owner Durity Vape and Smoke Boise, ID

Michael Larsen, Partner/Director of Sales Lotus Vaping Technologies Boise, ID

Nathan Maggard, Owner Atomic Vapor Supply Boise, ID

Duston Wurtz, Owner Ejuice BLVD, LLP Caldwell, ID

Jeremy & Stacy Foresee, CFO/Co-owner Ejuice BLVD, LLC Caldwell, ID

Heidi & Trent Carrell, Owner The Vaping Outlet Idaho Falls, ID

Nicholas Richards, Co-owner Wick N Vape, LLC Meridian, ID

Tessa Lancaster, Owner Vapor Loft Chinden Meridian, ID

Shelley Epstein, Owner Bear Lake Vape Montpelier, ID

Bob miller, Owner Canyon Vapors Nampa, ID

James Sumner, Owner Cloudhut Vaping Company Nampa, ID

Jose Quintero, Owner Vape Kastle Nampa, ID

Ben Bosworth, Owner Outlaw Vapor Pocatello, ID

Michael Thorn, Owner Vaporland Post Falls & Marysville, ID

Travis Gledhill, Owner Gtc, LLC dba Outlaw Vapor Preston & Malad, ID

Samantha Pruitt, Co-owner Mountain River Vapor Company Rigby, ID

Shelly Papke, Owner Cjs Vapehouse, LLC Twin Falls, ID

Brandin Olsen, Co-Owner Metro East Vapor Supply Alton, IL

Charles M. Rose, Co-Owner Metro East Vapor Supply Alton, IL

Demondre Cotton, Owner The Vapory Belleville, IL

Kiel Carl, Owner Liquid Temptations Bloomington, IL

Scott Walk, Owner Smokers Choice Bloomington, IL

Wanda K. Janssen, Owner Veteran's Vape, Inc. Bradley, IL

Shukri Yanni, Owner Transistor, LLC Buffalo Grove, IL

Heather Hosick, Owner Up in Vape Carmi, IL



Tiffany Looman, Owner Flavor Vapor, Inc. Centralia, IL

Melissa Freeman, Owner Vapors E-cigs Champaign, IL

Michael Ballerini, Owner Stardust Vapes, LLC Champaign, IL

Scott Shull, Owner Vape Vault, Inc. Champaign, IL

Chris Mann, Owner Legendary Vapor Chicago, IL

Richard Victorio, Owner Isovape Corporation Chicago, IL

Larry Eng, Owner/Operator Level Vape, LLC Chicago, IL

Jodee Barks, Owner Mystic Vapes Collinsville, IL

Jill Yates, Owner Mystic Vapes Collinsville, IL

William Peska, Owner Bulk Clouds Vapor, LLC Dixon, IL

Tisha D'Ambrosio St Vape 111, Inc, Downers Grove, IL Strictly, Inc., Woodridge, IL

Michele Frans, Co-owner Breathe Vapor, LLC East Peoria, IL

Tom Connor, Owner Basic Liquid Elmhurst, IL

Victoria Vasconcellos, Owner Cignot, Inc. Elmhurst, IL

Bridget Carey, Owner Cool Clouds, LLC Evergreen Park, IL

Reid Nuttall, Owner Cool Clouds, LLC Evergreen Park, IL

Patrick Browning, Owner E-Liquidz Fairfield, IL

David & Marie Workman, Owners D&M Vape and Nutrition Flora, IL

Dirk Critser, Owners 309 Vapors Macomb & Galesburg, IL

Stacey Crister, Owner 311 Vapors Macomb & Galesburg, IL

Jeff & Tammy Thurow, Owners Vapor Effect, LLC Harvard, IL

Roger Walker, Owner Vapors 4 U Herrin, IL

Jerrie M Belcher, Owner Jerries Si Vapors, LLC Herrin, IL

Tony Persico, Owner Haze Vapor, Inc. Island Lake, IL

Craig Kitson, CEO 911 Vapor, Inc. Jacksonville, IL

Shelli Tribble, Owner Tribble Vapors Jacksonville, IL

Tim Teml, CE0 That 1 Vape Joliet, IL

Jaime Havenar & Wesley Martinez, Owners Boss Vapes, LLC Lasalle, Ottawa & Mendota, IL

Tisha D'Ambrosio Dank E-Juice LLC, Lockport, IL St Vape 11, Inc., Lockport, IL

Diana Crister, Owner 309 Vapors Macomb & Galesburg, IL

Kevin D Brazell, Owner Mixing-It-Up Vape Shop Metropolis, IL

Tiffany Smith, Owner I80 Vapors Morris, IL

Kathy Linker, Owner Vapor Haus Mt. Prospect Mt. Prospect, IL

Paul Hansel, Owner Vapor Haus Mt. Prospect Mt. Prospect, IL

Bryn Hubbard, Owner Tri Moon Vapes Mt. Vernon, IL

Steve Symmonds, Owner Market Street Vaping Paxton, IL

Donna Tello, Owner E-Cigs Depot, LLC Peoria, IL

Joshua Malone, Owner Cloud Express & Lost City Creations Peoria, IL

Gail Smolinski, Owner TGI Vapor Robinson, IL

Thad Headley, Owner Quad City Vapers Club, LLC Rock Island, IL

Marco Altamore, Owner Marcos Vapor Rockford, IL

Adam Fitzgerald, Owner Vape-N-Juice & VPN Liquids Rockford, IL

Jeremy Petrocelli, Owner Vape-N-Juice & VPN Liquids Rockford, IL

Kandy I Overton, Owner Gogos Variety and Vapor Sivlis, IL

Tracy Larsen, Owner Elixrz South Elgin, IL



Paul & Vicki Schmidt, Owner Chuckin Clouds Vape Shop Troy, IL

Richard Ussery, President Meowphomet, Inc. dba RPM Vape Vernon Hills, IL

Rick Ussery, Co-Owner RPM Vape Vernon Hills, IL

Charlene Craft, Owner Hayze Vape, LLC Waukegan, IL

Danne & Heathe Reinke, Owner 3D Vapor Wood River, IL

Charlotte Stowers, Owner Hoosier Vapes Anderson, IN

Jessica Dreesen, Owner Vapor This, LLC Beech Grove, IN

Michael Griffith, Owner Duneland Eliquid, LLC Chesterton, IN

Ryan Hickman, Owner Warthog Wire Colfax, IN

Tracy Jones, Co-Owner SturgillJones, LLC Columbus, IN

Tracy Lea Jobes, Owner Hilltop Vape Shop Columbus, IN

Christopher Lee, Owner Shifters Vapors Corydon, IN

Wendy Meriwether, Owner D&W Vapors Corydon, IN

Cassandra & Chris Brown, Owner Cool Breeze Vapor Evansville, IN

Brian Hockenberry, Owner Hock n Vape Smoke Shop Fort Wayne, IN

Lisa Tift, Owner Indy’s Vape Escape, LLC Greenfield, IN

Brent A. McCullough, President Hoosier E-Cig Inc., Exiled Vapes & Exiled E-Liquid Greensburg, IN James Colip, Owner 317 Vapers Greenwood, IN

David Schuetter, Owner / Partner Db Vapes, LLC Indianapolis, IN

Melissa & Willie Zollicoffer, Owners Big Willie’s Liquids Indianapolis, IN

Tim & Patricia Birdwell, Co-owner The Vapor Vice, LLC Indianapolis, IN

Josh Snead, Owner Vaper Kings Indy Indianapolis, IN

Charity Hlavsa, Owner HSC, dba VVJuice La Porte, IN

Randy George, Owner NKY, LLC Lawrenceburg, IN

Brian Smith, Owner Naptown Vapors Martinsville & Indianapolis, IN

Douglas Scott, Owner Naptown Vapors Martinsville & Indianapolis, IN

Jeff Webb, Owner Vapin Tonight, LLC & Vapin Tonight Distribution Scottsburg, IN Cara Caprino, Owner Purely Vapor, Inc. Vincennes, IN

Seth Peters, Owner The Vaped Ape Carroll, IA

Don Gier, Owner Smokin Hot, LLC Centerville, Ottumwa & Oskaloosa, IA

Jeremy Vallet, Owner Smokin Hot, LLC Centerville, Ottumwa & Oskaloosa, IA

Thomas Hudson, Owner 515 Vape and Disc, LLC Clive, IA

Todd Smith, Founder The Vaporosity Shops, Inc. Davenport, IA

Jason Glenn, Owner Taste the Vape, LLC Des Moines, IA

Travis Puls, Owner Atmosphere Vapors Grinell, IA

Heather Glenn, Owner Route 69 Vapor Indianola, IA

Andrew & Darcie Kiwacz, Owners River City Vape Company Mason City, Ft. Dodge & Algona, IA

Johna Kraft, Owner E Cigarette Impressions Mediapolis, IA

Midge Haller, Owner No More Butts Vapor Lounge, LLC Muscatine, IA

James Deheer, Owner Solardrops Juice Co Pleasantville, IA

Corey Halfhill, Owner Central Iowa Vapors Urbandale, IA

Justin Petty, Owner/Partner JD Vapour, LLC Andover, KS

Marc D Melton, Owner Marcs Place Vape Shop, LLC Chanute, KS

Byron McNary, Owner McVape, LLC Derby, KS

Robyn Slate, Owner Vaporwave Garden City, KS



Theresa Herlocker, Owner Grasshopper Vapes Hays, KS

Ronald Nickle, Owner Indy Vapes Independence, KS

Walter L Gibson, Owner/CEO One Stop VAPE Shop Independence, KS

Britt Klotz, Owner Viscosity Vapor Lola, KS

Korey Owen, Co-owner Juice-e Vapes Lawrence, KS

Joe Kopatich, Owner Ritchy US, LLC Lenexa, KS

Antonio Saverino, Owner The Vapebar Manhattan, KS

Colby White, Owner Level Up Vapor Olathe, KS

Maria Harris, Owner Vape Attic Olathe, KS

Nathan Wells, Owner Vaper Generation Pittsburgh, KS

Eric & Lori McPherson, Owners Flatland Vapes Shawnee, KS

Dave Scott, Owner Puffs Magic Vapes, LLC Wichita, KS

Elizabeth Webb, Owner Puffs Magic Vapes, LLC Wichita, KS

Kirk Schminke, Owner Element Vapes Wichita, KS

Scott Mchargue, Owner Mcvapour Wichita, KS

Tom Rogers, Owner Lucky's Convenience &Tobacco, LLC Wichita, KS

Melissa Goodwin, Owner District 4 Vapor Ashland, KY

Stephen Hosfeld, Owner Hosfeld's Vapor Berea, KY

Matt Stringer, Owner Iconic Vape & 270 Wirez Bowling Green, KY

Randy George, Owner Club Vape Florence, KY

Chad Johns, Operating Partner Dripwell Vapors, LLC Fort Wright, KY

Rob Bowen, Owner Nice Guy Vapors, LLC Henderson, KY

Angelique N Sulfsted, Owner Vape Shop Mafia Independence, KY

Blayne Hogue, Owner Vapor Vision Junction City, KY

Russ Scarbrough, Owner Vigilante Juice Co Lexington, KY

Tony Florence, President 723 Vapor & Vapor Stockroom Lexington, KY

Jerry Scrivner, CEO Magic Vapor Shop, LLC London, KY

Jerry Wayne, Owner Magic Vapor Shop, LLC London, KY

Andrew Watkins, Owner Magic Vapes E-Cigs Louisville, KY

Edward LeBlanc, Owner OPMH Project Louisville, KY

Brian Chrystal, Owner Mr. Salt-E Midway, KY

Bill S, Owner Elevated Vaporz Newport, KY

Bobbi Ironmonger, Owner Vapor Gear, LLC Nicholasville, KY

Robin Trego, Owner eCig Source Owensboro, KY

Richard Keith Hall, Owner Mountain Vapors Pikeville, KY

Kristi Kendall & Johna Lawson, Owners Kickin’ Ash Prestonsburg, KY

Michael P Regan, Owner Kick Ash Vape, LLC Providence, KY

Christopher Grayson & Wade Grayson, Owner Twisted Vapors Russellville, KY

Joshua LaVigne, Owner Allen County Vapes Scottsville, KY

Robert Crume, Owner Main Street Vape Taylorsville, KY

Jason Sutton, Owner Cloudville Vapor Tompkinsville, KY

Tabitha Sutton, Owner Michael Sutton, Owner The Flappy Flower Tompkinsville, KY Jamie Harris, Owner 3 LaBordes, LLC, dba The Hotbox Juice Bar and Vaporium Bossier City, LA Robert owens, Managing Member Great American Ventures Bossier City, LA

Brittany Guidry, Owner Vapor Springs Denham Springs, LA



Adam Rivet, Owner Overcast Vapor Lounge Gonzales, LA

Peter Massoud, Owner Vapor Viper Vapes Lafeyette, LA

Kym Condon, Owner Cajun Vapes Lake Charles, LA

Brian Uzun, Owner Legacy Vapor Co. Mandeville, LA

Linda Bordelon, Owner Red Dog Vape Shop and Collectibles Marksville, LA

Jeff Weber, Owner The Vaping Tiger & Crescent City Clouds Metairie, LA

Victoria Wood, Owner The Vaping Tiger & Crescent City Clouds Metairie, LA

Suzanne Thibodeaux, Owner City Vapes, LLC New Iberia, LA

Anthony Kolesa, Owner Smokecignals, LLC New Orleans, LA

Chad Rogers, Owner Calhoun Vapor New Orleans, LA

Heather Hutton, Owner Big Chief Vapor Products New Orleans, LA

Tim & Carmen Champagne, Owner Troposphere Vapors, LLC Scott & Lafayette, LA

Daniel Borel, Owner BukuVapor Shreveport, LA

Raymond Odom, President Great American Vapes Shreveport, LA

Crystal Hambrick-Burdick, Owner The Vapor Stop Sulphur, LA

Dale Stevens, VP Empire Vape Shop Augusta, ME

Steven Roy, Owner Vapor City, LLC Biddeford, ME

Minh Q Nguyen, Owner Vapor Room Lewiston & Gardiner, ME

Max Sobol, Co-owner Lunar Rover Baltimore, MD

Antoinette Shaffer, Owner NettMix Custom Vapes Inc. Baltimore, MD

Steven Walman, Co-owner Lunar Rover Baltimore, MD

Vic & Kyle Vega, Owner Vapor Villa Baltimore, MD

Amanda McArdle, Owner Class 5 Vapors Bel Air, MD

Penny Walker, Owner Walker Enterprises, LLC, dba MaddCatt Vapors Cumberland, MD Joshua Hargett, Owner Jamz Vaporium, LLC Curtis Bay & Pasadena, MD

Melissa Hendrix, Owner Vape Loft Edgewater, MD

Collin McIlvired, Business Partner Wesleys Vape, LLC Elkton, MD

Rich Wesley, Owner Wesleys Vape, LLC Elkton, MD

Dylan Vogtman, Owner DVO, LLC & Straight Up Eliquid Finksburg, MD

Taylor Cage, Owner Straight Up Eliquid & North American Nicotine Finksburg, MD

Eric Frit, Owner Vapor Worldwide Gaithersburg, MD

Aaron McCracken, Owner Mean Street Vapor Glen Burnie, MD

Thomas & Amber Perdue, Owners HavoK Vape Co. Glen Burnie, MD

Clinton Legg, Owner Liquid Art, Inc. Glen Burnie, MD

William Jameson, Owner Vapors Lounge Mechanicsville, MD

E.P. Bailey lll, Owner The Vapor Emporium New Market, MD

Andrew Raftery, Owner 4Ten Vapors, LLC North East, MD

Larry Abass, Owner Abass Vapors, LLC Owings Mills, MD

Lisa Barkhorn, Owner B&B's Vape Café Parkville, MD

William Roberts, Owner BS Vapes, LLC Pasadena, MD

Barry Vuong, President DC Vapor, Inc. Rockville, MD

Patrick Carpenter, Owner Vape Chalet & Chalet MFG Severn, MD

Gerald Reed, Owner Smoke Free Nation Sykesville, MD

Matt Milby, CEO Smoke Free Nation Sykesville, MD

Nitanel arieh, Owner Towson Vaporium Towson, MD



Charles & Candice Gott, Owners Vape Jungle, LLC Waldorf, MD

Joe Rondoletto, Owner My Ecigs, Inc. Agawam, MA

Jonathan Lau, Owner Dragon Vapors, dba The Vape Shop Brighton, MA

Jamey Petruzzelli, Owner North Shore Vapor Everett & Malden, MA

Anthony Caldalda, Owner Vapers Edge Holyoke, MA

John Nathan, Co-Owner SN Holdings, Inc. Kingston, MA

Brian Philips, Owner Sixty-2 Distribution, Inc. Mansfield, MA

Sean Conway, Owner Branded Vapors Mansfield, MA

Ian Devine, Owner Wicked Vaped Mansfield & Walpole, MA

Jaymin Patel, CEO Royal Smoke & Vape Natick, MA

David Bershad, Owner Vape Daddys, Inc. Newton, MA

Chad Perry, Owner The Vape Way Plymouth, MA

Thomas Coniaris, Owner Vape Cod, LLC Sandwich, MA

Patrick Smith, Owner Safehouse Vapors, LLC Waltham, MA

Christian Henriquez, Owner Uplifted Vapor and Smoke Supplies, LLC West Springfield & Agawam, MA

Michael Portelle, Owner Front Line Vapor, LLC Woburn, MA

Josh Flavin, Owner Expressive E-liquid, Inc. Worcester, MA

Marc O’Connor, Owner Dawn of Hope Vapor, LLC Worcester, MA

Navi Sengaloune, Owner House of Vapors Worcester, MA

Anne Switala, Owner Smokin Vapor Bay City, LLC Bay City, MI

Richard LaFramboise, Owner Smokin Vapor Bay City, LLC Bay City, MI

Kaleb Spicer, Owner Encounters of Big Rapids Vape Shop Big Rapids, MI

Christopher & Angela Davey, Owners Eliquid Master Byron Center, MI

Joe & Nicole Barhoumi, Owners Ritual Vape, Ritual Craft Vapor Eliquid & Ritual Distribution Canton, MI Ramon Garcia, Owner Ritual Vape, Ritual Craft Vapor Eliquid & Ritual Distribution Canton, MI Tommy Huynh, Owner Vape N Chase Canton, MI

Jennifer Marsack, Owner Mad Buck Vapes Laboratories Clinton Township, MI

John & Christy Miller, Owners Johnnys Juice, LLC Clinton Twp., MI

Chris Bacho, President TVS Distributors Detroit, MI

Duane L Peterson, Owner TatJu, LLC Edmore, MI

Earl Fisher, Owner Great Lakes Vapor Farmington, MI

Marion Ayar, Owner Vaporia, Inc. Fenton, MI

Todd Melancon, Owner The Vapor Shop, LLC Flushing, MI

Sammy Garip, Partner Smoke & Vape Depot Grand Rapids, MI

Rhiannon Oleson, Owner Steaming Bull Vapors Greenville, MI

Pete Calkins, Owner The Vape Shop Hazel Park, MI

Marc Slis, Owner 906 Vapor, LLC Houghton, MI

Kimberly Manor, Owner Moose Jooce Vape Shops Houghton Lake, MI

Scott Church, COO KVS Licensing Company, LLC Kalamazoo, MI

Michael Lowery, Owner Nature Vaper Lowell, MI

John Miller, Owner Johnny’s Juice Macomb Township, MI

Eric Curtis, Owner Rustic Vapor Ecigs, Inc. Marquette, MI

Alice Engelman, Owner Cig Free Vape Shop Midland, MI

Carol Akiyama, Owner/Operator Vaped Ape Vapor Shop Mount pleasant, MI

Mark Mills, Owner E-Cig Outlet Muskegon, MI



Ryan Dalga, Owner PushVape, LLC Portage, MI

Bill Kosinski, CEO Tattoo Vape Premium E-Juice Saginaw, MI

Chris Hilanto, Owner Inline Vape Shelby Charter Township, MI

Samuel Kis, Owner Heritage Vapor Bar Taylor, MI

Michael Mead, Owner EVC Labs & Vapor Lounge Wayne, MI

Lloyd Patton, Owner LDP Designs, LLC Westland, MI

Stephen Knight, CEO Vapejoose, Inc. Wyoming, MI

Bill Boldenow, Owner Infinite Vapor Alexandria, Burnsville, Coon Rapids & Minneapolis, MN Darren Tollakson, Owner Pops Vape Shop Aitkin, MN

Christopher Potvin, Owner E Cig Innovation Becker, MN

Heather Bewley, Owner Northern Vapes Bemidji, MN

Nathan Ruesch, CEO The E-cig Café, LLC Blaine, MN

Eric Trotter, Owner Thee Fantastics Bloomington, MN

Jesse & Angie Griffith, Owners Smokeless Smoking, Inc. Bloomington, MN

Tim Koester, Owner Smokeless Smoking, Inc. Bloomington, MN

John Dundas, Owner Vapor North Brainerd, MN

Melissa Plotnick, Partner Vapor North Brainerd, MN

Tom Murray, Owner Lakes Vape Supply Brainerd, MN

Tyler Burg, Owner Smokin Monkey Buffalo, MN

Brian Annis, Owner/President Lake Effect Vapor, Inc. Duluth & Hermantown, MN

Justin Danberry, Owner Lincoln Vapors, LLC Fergus Falls, MN

Candy Carsella-Kee, Owner Northland Vaporium, LLC Grand Rapids, MN

Mike Harris, Owner PBDragon, LLC Inver Grove Heights, MN

Brandon Alshouse, Owner eCig Market Maple Grove, MN

Jason Thompson, Owner Black Sun Minneapolis, MN

Andrea Ramaglia, Owner The Plume Room, LLC Minneapolis, MN

Michael Wolberg, Owner The Plume Room, LLC Minneapolis, MN

Jason T Wiler, Owner Twisted Vape Shop Montevideo, MN

Ryan Wolff, Owner Midwest Vapers, LLC New Brighton, MN

Sally Phelps, Co-owner Ohm Premier Vaping Ramsey, MN

Sean Condon, Owner eCig Store Shakopee, MN

Tony Spoden, Owner MegaVapes St Cloud, MN

Susan Sindt, Co-owner/CEO Simply Vapour St. Paul, MN

Brian La Rochelle, Owner CBs Custom Vape Biloxi, MS

Rob Roberts, Owner Nu Way Vape Columbus, MS

Allen & Ashley Hollman, Owner Southern Vape Company Ellisville, MS

Ann Jennings, Owner Delta Vapors, LLC Greenville, MS

Bill Wikstrom, Owner Vaporized Hatteisburg, MS

Floyd Gray, Owner Cloud 9 Vapors Hattiesburg, MS

Jim Shearon, Owner Camelot Distribution Hattiesburg, MS

Joann Wilson, CEO/Owner/Operator Paradigm Distro Hattiesburg, MS

Robert Brad Labiche, Owner A1 Vapor, LLC Hattiesburg, MS

Joie Barbieri, Owner Olde Style Vape Company, LLC Olive Branch, MS

Taylor Upchurch, Owner Cloud 9, LLC Oxford, MS

Kristina Leach, Owner Pops Vape Shop, LLC Philadelphia, MS



Belinda Dudziak, Owner Big Time Vapes Picayune, MS

Bryan Robbins, Owner Pbr Vapors Pontotoc, MS

Ryan Armstrong, Owner Mystic Joose Purvis, MS

Mike Jefcoat, Owner Magnolia Vapes, LLC Ridgeland, Laurel & Richland, MS

Amanda Stone, Owner Amaza Vapors Tupelo, MS

Josef Enfinger, Owner 1810 Vapors Tupelo, MS

Jason Terrell Kornman, Owner Kornman, LLC dba Vaporied Wiggins, Biloxi, Ocean Springs & Laurel, MS Stewart Finertie, Owner Vape Cape Cape Girardeau, MO

Kevin Lacey, Owner Pinnacle Vapor Carthage, MO

Jeff Hicks, Owner USA Vapor Trails Farmington, MO

John Huck, Owner E-cig Mania, LLC Fenton, MO

Rose Fogarty, Owner Fogarty's House of Vapor Florissant, MO

Darrel & Debbie Wood, Owners VaporWyse, LLC Gladstone, MO

Wyeth Ervin, Owner VaporWyse, LLC Gladstone, MO

Annette Burns, Owner Stella Blues Vapors, Inc. High Ridge, MO

Michael Bracken, Owner 510 Vapers, LLC Imperial, MO

John Baker, Owner Twizted Vapes, LLC Joplin, MO

Mitchel W. Bush, Owner The Vapor Lab, LLC Kansas City, MO

Wyeth Ervin, Owner VaporWyse, LLC Kearney, MO

Zackwrie Parr Sr., Owner Three P Investments, LLC Kennett, MO

Rhonda Shafer, Owner Ozarks Vapor, LLC Lebanon, MO

Brenda & John Callaghan, Co-owners Nina & Phil Brown, Co-owners Vapur Of Lee’s Summit Lee's Summit, MO

Shane Deines, Owner Jesters Juices, LLC Neosho, MO

Shelly Morrow, Owner 4 State Vapors Neosho, MO

Cole McDonald, Owner McDonald Consolidated Contractors New London, MO

April Aubuchon, Owner Kaleidosmok, LLC Pacific, MO

Wesley Bringer, Owner Blind Rabbit Vape Supply, Grindhouse Eliquid, LLC, Fog Chaser Vapes, Elusive & Salvage Poplar Bluff, MO Leonard Young, Owner Def Liquids, LLC Saint Charles, MO

Zach Parsons, CFO Tri Guys Vapor Salem, MO

Joe Forsee, Owner Joe Vales, LLC Sedalia, MO

Alisha Shepard, Owner Nimbus Cloud Lounge St Louis, MO

Avery Evans, Owner Gillbert & Parsons, LLC St. Louis, MO

Bryan Grubbs, Owner Gillbert & Parsons, LLC St. Louis, MO

Chris Clinton, Owner Sy2 Vapor, LLC St. Louis, MO

Joseph Butler, Owner Cloud Creators E-Juice, LLC St. Louis, MO

Robert Boesing, Owner Lemay Vapor St.louis, MO

Travis Huddleston, Owner NU2U Vapors Warrenton, MO

Sally Haley, Owner Custom Vapors, LLC Weldon Spring, MO

Frank Vanhorn, Owner Firehouse Vapes, LLC Willow Springs, MO

Jason Cornfeld, Owner Old Skool Vape Society Billings, MT

Matt Culley, Owner SMJ Co. Kalispell, MT

Tony Dobbs, Owner Liberty Smoke, Inc. Missoula, MT

Brett Erpelding, CEO Northland Vapor Company Fargo, NE

Lane Shannon, Owner Celtic Elixirs, Phoenix Elixirs & Kearney Vaper Supply Kearney, NE James Newell, Owner Lefthand Vapors, LLC LaVista, NE



Chad Svoboda, Owner Big Red Vapor Lincoln, NE

Joel Jedlicka, Owner Creative Juices Premium Elixir Lincoln, NE

Sarah Linden, Founder & CEO Generation V Lincoln, NE

Jacob Vrbka, Owner Hardknock Hooligans, LLC Malcolm, NE

Tooryalai Gul, Owner Vapor Laze Omaha, NE

Ann TeVelde, Owner Smokin Hot Vapors Henderson, NV

Christopher Tan, Owner Elephant Vapor Henderson, NV

Erika Pearce, Owner Local Vape Enterprises, Inc. Henderson, NV

Juan Gonzalez, Owner VapeSling, LLC Henderson, NV

Thomas Harmon, Owner Sin City Vapor, LLC Henderson, NV

Nicholas Mullen, Owner Vapor Rage, LLC Henderson & Las Vegas, NV

Alex Mazzola, Owner Mob Liquid Labs Las Vegas, NV

Brandi Mazzola, Owner Flavor Vapors, LLC Las Vegas, NV

Catherine Wong, Owner One 2 Vapor Las Vegas, NV

Chris Finch, Owner Vapetasia Las Vegas, NV

Christopher Stanley, COO Alt Zero, Inc. Las Vegas, NV

Elmer Yumul, Managing Partner The Vapery Las Vegas, NV

Greg Belcher, Owner Vapeco Las Vegas, NV

Jamie Reza Homampour, President Blue Diamond Vapors Las Vegas, NV

Joey Chung, Owner Vape Avenue Vegas Las Vegas, NV

Kevin Whelan, Owner Decent Juice Co., LLC Las Vegas, NV

Matthew Lewis, Owner Cape City, LLC Las Vegas, NV

Michael A Torsiello, Managing Partner Vegas Vapor Emporium Las Vegas, NV

Nicholas Mercado, Owner Desu, LLC & Vapeverine, LLC Las Vegas, NV

Patrick Blount, Owner Fillco, Inc. Las Vegas, NV

Penn Elletson, Owner Pink Spot Vapors Las Vegas, NV

Alex & Brandi Mazzola, Owners Mob Liquid Labs Las Vegas, NV

Joseph Landolfi, Managing Member Hot Shot Vapor, LLC. dba Ohms 2 Vapor Las Vegas, NV

Wendy Pierce, Owner Vape Pros Laughlin, NV

Travis Centers, Owner Inked ATTY Pahrump, NV

Nathan Evans, Owner The School of Vape Reno, NV

Gary Janczura, Owner Black Rock Vapor Sparks, NV

Cavan & Jackie Westlund, Owners Guardian Angel Vapor Company & Wicked Angel Vape Company Belmont, NH Alex Moody, CEO Kinetik Enterprises, LLC Franklin, NH

Kara Tibbetts, Owner Lineage Vapors Nashua, NH

Kyle Ezzio, Owner Lineage Vapors Nashua, NH

Max Hager, Co-Owner Route 9 Vapors Somersworth, NH

Tom Slawniak, Owner Raven Vapes Tilton, NH

Chris Cook, Owner Coil & Co. Vape Supply Asbury Park, NJ

Bruce Guest, Owner Dream Drip Brick, NJ

Russ Jurczyk, Owner Gorilla Vapes, LLC E Brunswick, NJ

Robert Eichenberger, Owner Popies Vapor Lounge Evesham Township, NJ

Dan Donahue, Owner Good Karma Vapor Fair Lawn, NJ

Shobi Iqbal, Owner Good Guy Vapes Fairfield, NJ

Mark Anton, President What A Smoke, LLC Flanders, NJ



Amber Brown, Owner Glassboro Vapor House Glassboro, NJ

Alicia Pizza, Owner The Vape Shop, LLC Hamilton, NJ

Scott Thompson, Owner Cloudride Vapor Hamilton Township, NJ

Carol Costello, Owner OK 2 VAPE Lakewood, NJ

Patricia Fusaro, Owner Liquid Labs, LLC Lakewood, NJ

Michael Terkildsen, Owner MTERK LLC & MTERK INC Manasquan, NJ

Maria Egberts, Owner Maja Flava Vape Den Marlton, NJ

Andrea Di Paolo, Owner Vaporistic - 4 locations Ocean Township & Brick, NJ

Peter Montanaro, Owner 23 Vape Lounge Pompton Plains, NJ

Vincent Mattia, Owner/General Manager The Vapor Vault, LLC Pt Pleasant Beach, NJ

AnaMaria Silva, Owner Clouds Cafe, LLC Skillman, NJ

Gene Crane, Owner Vapor City Plus, LLC Sussex, NJ

A.J. Holland, Owner Holland Coil Co. Wall, NJ

Kristy Hartman, Owner Middlesex Vapes Watchung, NJ

Danish Iqbal, CEO Medusa Distribution, LLC West Caldwell, NJ

Anthony Brown, Owner/Operator All City Vapes Woodland Park, NJ

Sheryl Agro, Owner Inno Vapes, LLC Wrightstown, NJ

Ralph Lermayer, Owner Peace Out Alamogordo, NM

Damian Barth, Owner Electric Clouds, Inc. Albuquerque, NM

Dylan Levenson, Owner Betamorph E-Cigs Albuquerque, NM

Lukas Lowery-Ross, Vice President Ludovico, Inc. Albuquerque, NM

Kane Oueis, CEO Oasis Vape Albuquerque, NM

Melanie Estrada, Owner The 505 Vapor Room, LLC Bernalillo, NM

Cindy David, Owner Jacx Enterprise, Inc. Carlsbad, NM

Tammy Garrison, Owner Everything Vapor Farmington, NM

Jarrod Friedenberg, Owner Planet Vape Farmington, NM

Denese Peterson, Owner Kraz-e Vapes Hobbs, NM

Missy Pilkington, Owner Vape Scape Hobbs, NM

Keith Thomas, CEO Cloud 9 Vapor Products, LLC Portales & Clovis, NM

Daniel Montano, Owner D&D Vapor Co., LLC & I-Vape Clouds Santa Fe, NM

James Lucas, Owner Pro Vapors NY, LLC Amsterdam, NY

Ross Walker, Owner RW Vapors Batavia, NY

Michele Siderius, Owner South Shire Vapor Lounge Blue Point, NY

Matthew Butler, Owner Vapor World Brockport Brockport, NY

Andrew Hurtado, Owner Unholy Water, LLC Brooklyn, NY

Andrew Kaye, CEO PANANAL INC. VapeBand® Brooklyn, NY

Andre Liszka, CEO The House of Vapor, LLC Buffalo, NY

Andrew Osborne, Owner/President Vapor Trail Electronics Buffalo, NY

Jon Glauser, Owner Demand Vape Buffalo, NY

Joshua Pettit, Owner Yeti Vape Buffalo, NY

Brian Ellis, Vice President Yeti Vape Buffalo, NY

Collin Tansey, Owner Prohibition Juice Company Deer Park, NY

Joey Dammacco, Owner Prohibition Juice Company Deer Park, NY

Nick Callister, Owner Prohibition Juice Company Deer Park, NY

Adam Kielczewski, Owner Kie industries Deer Park, NY



Anthony Bottaro, Owner Absolute Vapor, Inc. Depew, NY

Tom Snider, Owner Cloud Chasers Depew, NY

Tammy Mink, Owner Shore Vapes Glen Cove, NY

Luciano Manente, Owner Honest Vapor, Inc. Harrison, NY

Christopher Goode, Owner Goode Vapes Kingston, NY

Cheryl L. Richter, Owner Cherry Vape, LLC New Rochelle, NY

Mike Ebrahimi, Owner Vapor Authority New York, NY

Spike Babaian, Owner VapeNY New York, NY

Brian Burke, Owner Majestic Vapors, LLC Niagara Falls, NY

Shaun B Casey, President Flavourart Niagara Falls, NY

Brian Hitchcock, Owner Cloud Haus 28 North Creek, NY

Ryan Hallisey, Owner Priority Vape Orange County & Warwick, NY

Donna Menz, Owner Southtowns Vape Orchard Park, NY

Matthew Salter, Owner Vape Rescue, LLC Philadelphia, PA

Michael M Frennier, President MT Vapes, LLC Plattsburgh, NY

Charlene, Owner Super Smoke n Save & Upstate NY Vapes Queensbury, NY

Michael, Owner BlackWaterVapor Sayville, NY

Christopher Johnson, Owner The ZFO Spencerport, NY

Robert scribner, Owner Scribners E-Vapors Vernon Center, NY

Corey Olivieri, CIO Fresh Vapes Warsaw, NT

Amir Gombiner, Owner Scripted Brands Warwick, NY

Michael Bowers, Owner White Plains Vapors White Plains, NY

Carla M Bowers, Co-owner The Vape Cave Yonkers, NY

Jeff Barry, Owner Fresh Vapes, Penna Crude E-liquid & Jack’s E-Liquid Yorkshire, Dansville & Warsaw, NY Mike Biles, Owner Cozmik Vapes Albemarle, NC

David Eason, Owner EZ eJuice Angier, NC

Carol Oster, Owner Chasing Clouds Vapor Apex, NC

Robert Yelton, Owner My Freedom Smokes Apex, NC

Thomas Tilley, Owner Southbound Vapes Ararat, NC

Michael Cotellese, President Asheville Vapor, Inc. Asheville, NC

Jozef Lenders, Co-owner Smoky Mountain Retail, LLC Bryson City, NC

Bradley Howell, Manager/Co-owner Juice Vapeorium Cary, NC

Robert Long, Owner The Vape Escape, LLC Cary, NC

Charles Harris, Owner H&T Capital, LLC Chapel Hill, NC

Andro Ringl, Owner The Great Vape Escape Fayetteville, NC

James Boyd, Owner Coil Werx Fayetteville, NC

Johna Deroy, Owner J&M Vapor Fayetteville, NC

Justin Walters, President Black Diamond Vapor Co. Garrisburg, NC

Steven St. Germain, Owner Juice Maniacc LLC Graham, NC

Ron & Terri Peeples, Owners BMF Labs Greensboro, NC

Ronald Peeples Jr, Owner/President The Refinery Vaping Company Greensboro, NC

Jordan Beresko, President The Big Vape Theory Greenville, NC

Jacob Twisdale, Owner Redd Dragon Vapor Henderson, NC

Benjamin Owen, Owner Kingdom Vapors, LLC Hendersonville, NC

Jeff Bracken, Owner VAPE ON, LLC Hendersonville, NC



Mike Wayne Staley, Owner Peace Out Vapes Hickory Tree, NC

Pete Angelopoulos, Owner Vaporland Jacksonville, NC

David Marlow, Owner CAF Coils Kannapolis, NC

Christine M Beasley, Owner Outer Vapes Kill Devil Hills, NC

Robert Wagner, Owner Vapor Market, Inc. & Wagco Distribution, Inc. Knightdale, NC Mark Hoogendoorn, Founder Madvapes Mooresville, NC

Sherwin Mena, Owner Trinity Vapor Lounge, Inc. Raleigh, NC

Rondell Mckoy, Owner Durham Vape Lounge Raleigh, NC

Steve Sizemore, Owner 910 Vape Shop Red Springs, NC

Wanda Ridlon, Owner Lunar Vapes Reidsville, NC

Jami Mannion, Owner 7 Wonderz Vapor, LLC Reidsville, NC

Paul Radziewicz, Owner Rolling Fog Vapor Company Salisbury, NC

Josh Bartlett, Owner Deep Blue Vapors Shallotte, NC

David Sparks, Owner Magic Vaper Sparta, NC

Brian Osterheldt, Owner UnderGround Vapes Spindale, NC

Frans Gandasasmita, Owner Sanctuary Vape Destination Thomasville, NC

Mark Byrd, Owner Byrdman, LTD Vilas, NC

Ben Roberson, Owner ENC Vape Williamston, NC

Bill Boldenow, Owner Infinite Vapor Bismark, Fargo, Grand Forks & Minot, ND Cassandra Collins, Owner Steam Junkies Vapor, LLC & Mrs. Blankenship’s House of Vape Dickinson, ND Darius Endres, Owner Sports Vape Fargo, ND

Todd Fiechtner, Managing Partner Lazy Llama, LLC Fargo, ND

Matthew Clark, Owner Dutchman Vapor Grand Forks, ND

Ty Cox, Owner Dutchman Vapor Grand Forks, ND

Avery Kraemer, Owner Omologato Ecigs West Fargo, ND

Jocelyn Ledin, Owner Omologato Ecigs West Fargo, ND

Glenn Bivins, Owner Wraps Coils, LLC Akron, OH

John Potter, President/CEO Cloud Chamber Vapor Lounge & Emporium Avon Lake, OH Tim & Nola Lyons, Owners Rapture Vapor Beavercreek, OH

April Hardy, Owner E Vapor Hut Bryan, OH

Jason Ensinger, Owner Kurux Vapes Canton, OH

Jason Gang, Owner Westside Vapor, LLC Massillon, OH Jason Gang, Owner Vapor Station Canton, Hartville, Akron, Alliance, Pataskala, Canal Winchester, Logan & Chillicothe, OH Nate Lane, Owner EcigN8- Carrollton Vape Shop Carrollton, OH

Bo McCoy, Co-Owner Vapors of Ohio, Inc. Chillicothe, OH

Charles Black, Owner Vapors, Inc. Chillicothe, OH

Marcus Clarke, Owner Vapors, Inc. Chillicothe, OH

Ryan Mock, President 3rd Rock Vapor, Inc Chillicothe & Dayton, OH

Jacqueline Cooper, Vice President 3rd Rock Vapor, Inc Chillicothe & Dayton, OH

Frank Cahall, Owner Altsmoke Cincinnati, OH

Jeff & Patty Kathman, Owners Cincy Vapors Cincinnati, OH

Zach Odell, Owner Scarlet Smoke, LLC Cincinnati, OH

Emily & Nathan Overcash, Owners Cincinnati Vapor Trail Cincinnati, OH

Maan Yousef, Owner Jojo’s OH10 Vapes Cleveland, OH



Thomas Marolt, Co-owner Cloud Brothers, LLC Cleveland, OH

Alan Pfeuffer, Owner Evolved Vapors, LLC & EV Liquids, LLC Columbus, OH

Bryan & Adelle Keller, Owners Twinspired Ejuice Columbus, OH

James Jarvis, Owner Jarvis Vaping Supply Columbus, OH

Jonathan Kosakowski, Owner/Franchisee White Horse Vapor Columbus Columbus, OH

Lowell Meade, Owner Uprite Vapor, Inc. Columbus, OH

Nathan Williams, Owner Vapor State, LLC Columbus, OH

Omar Mousa, Owner Vapor State, LLC Columbus, OH

Jason & Randilynn Thompson, Owners Poor Girls Vapor Columbus, OH

Scott Pendley, Owner Vapor Haus Dayton, OH

Evan M. Nartker, Owner Cloud Queen Vapors, LLC Dublin, OH

Jared Moody, Owner Smokeless J Vape Shop East Liverpool, OH

Adrian Delgado, Owner Vapor House, LLC Eastlake, OH

Marc glowka, Owner Ohm Town Vapes Eaton, OH

Laura Salem, Owner Euphoria Vapor of Fairview Park, LLC Fairview Park, OH

Jamie Mundy, Owner Vapor Emporia Findlay, Marion, Tiffin & Kenton, OH

Kenneth Jones, Owner Vape Cloud 7, LLC Fremont, OH

Joshua Chitwood, Owner Underdog E-Liquids, LLC Hamilton, OH

Larry Mead, Owner Underdog E-Liquid, LLC Hamilton, OH

Mario Esposito, Owner Galaxy Vapors Harrison, OH

Justin Gang, Owner Heath Vapor Station Heath, OH

James Jarvis, Owner Vapor Station Hilliard, Clintonville, Gahanna, London & Columbus, OH Scott Landon, Owner CFJ Liquids Hillsboro, OH

Zack & Anna Coffman, Owners Vapor Town, LLC & Atmosphere Eliquid Hillsboro, OH

Shane Daniel Guillozet, Owner Vapor Kings Huber Heights, OH

Antonio Russo, Owner Cleveland Vape Lakewood, OH

Thea Ramey, Owner Glass City Vapory Lancaster, OH

Ron Crouse, Owner Rons Vapor Station Corp. Lima, OH

John McKinney, Owner Bunny’s Vapor Lounge, LLC Louisville, OH

Justin Parrott, Owner Ohm Slaw Vapors Loveland, OH

Richard Wellington, Owner Jade Vapor Mansfield, OH

Kellie Waller, Owner Vapor Station Massillon, OH

Tom Davis, Partner Vivid Vapor Massillon, OH

Erez Braun, Owner American Vape Company Mentor, OH

Juan Ortiz, Owner Rhino Vapors, LLC Mentor & Willowick, OH

Sarah Hofmeister, Owner My Custom Vapes, LLC Miamisburg, OH

Randy Burch, Co-owner Euphoria Vapor, LLC Middleburg Heights, OH

Tim Jacobs, Owner Phantasm Vapors Milford, OH

Arron Hayes, CEO Vapology, Inc. Monroe, OH

Sonny Varma, Owner Sonny’s Vape Shop Mount Orab, OH

Rodney Mowery, Owner Rock Vapor Scissors, LLC Mount Vernon & Newark, OH

Jeremiah & Carida Stevens, Owners Epic Vapes Express Napoleon, OH

Lawrence Conti, Owner The Vapors Choice North Lima, OH

Rhonda Burch, Co-owner Euphoria Vapor, LLC Parma, OH

Thear Abusharif, Owner Just Vape Ohio Parma, OH



Justin Gang, Owner Picktown Vapor Station Pickerington, OH

Bo McCoy, General Partner Vapors Portsmouth Portsmouth, OH

Larry Mead, Owner Max’M Vape, LLC Reading, OH

JoLynne Gates, Owner Reynoldsburg Vapor Station Reynoldsburg, OH

Jeff Queen, Owner Atmosphere Eliquid Seaman, OH

Carrie Mitchell, Owner Totally Awesome Juice Shelby, OH

Cole & Christine Naylor, Owners Ohio Valley Vapor Station St. Clairsville, OH

JC Perry, Co-Owner Nicecloud Vapor Toledo, OH

Muhamed Jomaa, Owner Smoke Out Corp. Toledo, OH

Terrence Pounds, Owner Smoke Out Corp. Toledo, OH

James Shearer, CEO Infinite Vapor USA, LLC Toledo, OH

Kelliegh Stewart, Owner Mean Old Dog Vapes Toronto, OH

Nicholas Stewart, Owner Rescued Eliquid Toronto, OH

David Looper, Owner JoJo Vapes Troy, OH

William Samaco, owner Awesome Sauce Vapor, Inc. Wadsworth, OH

Amanda Newton, CFO Ground Zero Vaping West Chester, OH

Eric Anderson, Owner Cloud Nine Vapor Lounge West Chester, OH

Robert Newton, Owner Ground Zero Vaping West Chester, OH

Brian Burke, Owner VaporKings Lounge West Union, OH

Samantha Fitzgerald, Owner Jojos OH10 Vapes Westlake, OH

Sarah Rutland, Owner Top Notch Vapor Worthington, OH

Cory Linthicum, Owner Monkey Hut Vapor Lounge Ada, OK

Tera Schooley, Owner Dig Lyfe Vapor Co. Bartlesville, OK

Jeremiah Watts, Owner Vape Out Bethany, OK

Michelle Phillips, Owner Black Dog Vapes Bethany, OK

Ronda L McBrayer, Owner Main Street Vapors Bristow, OK

Fady Srour, Owner Vapor USA Broken Arrow, OK

Jennifer Burton, Owner Vape This Broken Arrow, OK

Michael Shrier, Owner Juiceguys Vapor Lounge & Juiceguys Distribution Broken Arrow, OK Stacy Reid, Owner The Vape Escape Durant, OK

Jack McCormack, Owner Plague MFG Edmond, OK

Jerald & Justin Holt, Owners Enid Vapor Emporium Enid, OK

Janine L Davenport, CEO Vapers Tek LLC Grove, OK

Katheryn Watson, Co-owner The Vapor Hut Newcastle, OK

Matthew Pelter, Owner/Operator Vape It Newcastle, OK

Hong Ritchal, CEO OKC Vapes Oaklahoma City, OK

Jason Waldron, CFO/Owner Heartland Vapes, LLC Oklahoma City, OK

Matthew Eaton, Owner Captivape, LLC Oklahoma City, OK

Melissa Bennett, Co-owner The Vapor Hut, LLC Oklahoma City, OK

Nadeem Khan, Owner Vapor Plus OK Oklahoma City, OK

Randy Eacret, Owner RLE Enterprises, LLC dba N2 Vapes Oklahoma City, OK

Steven Roper, Owner Ecig Depot Sapulpa, OK

Kristen Shelby, Owner Victory Vapor, Inc. Tecumsah, OK

Howard Parton, President Ecosmoke Tulsa, OK

Jeffery S Jacobi, CEO JEL Marketing, LLC, DBA Lifesaver Vapors Tulsa, OK



Jim McEntire, Owner Rollin Vapor, LLC Tulsa, OK

Krystle Moore, Managing Member LoneStar Vapor Shop Tulsa, OK

Michelle Ragan, Owner Vapor Kings Tulsa, OK

Nick & Melissa Muller, Owner Elite Vapor Weatherford, OK

Spencer Knowles, Owner High Mountain Mist, LLC Bend, OR

Steve Johnson, Managing Partner High Mountain Mist, LLC Bend, OR

Kimberly Thorsgard, Owner Vape Junkies, LLC Coos Bay, OR

Jessica Black, COO Cloud9 Vapor Cornelius, OR

Colin Rau, CEO Emerald Vapors Holdings, Inc. Eugene, OR

Shaun D'Sylva, Founder Fatboy Vapors Gresham, OR

Timothy Porter, Owner Saver E Smoke, LLC Mcminnville, OR

Bob Foote, CEO ECBlend Flavors Medford, OR

Janna Collingwood, Member Smoke Free, LLC Portland, OR

Jason Weber, CEO Vape Crusaders Roseburg, OR

Jeremy Ellison, Owner Valley Vapors Salem, OR

Will Krause, Co-owner Northwest Vapors Salem, OR

Greg Gilfillan, Owner Liquivana Vape Shop, LLC & SnobJuice E-liquid Siverton, OR Eric Pinnell, Owner Oregon Vape Society Springfield, OR

Gary Vaughan, Owner Silver Lining Vape Shop Sweet Home, OR

Pam McBurney, Co-owner Vapor Galleria Allentown, PA

Carmine Dellamarco, Owner Casual Vapes Vaping Kicks Ash Bensalem, PA

Bonnie J & Harley Butz, Owners The Vaping Oasis & Tidal Distribution International Bethlehem, PA Daniel Artim, Owner The Vaping Oasis & Tidal Distribution International Bethlehem, PA Eric Cooper, Owner Vapor Tease Bethlehem, PA

Mariah J Bankes, Owner The Juice Vaporium Bloomsburg & Berwick, PA

Lea & Mike Scavello, Owner World’s Finest Vape Shop Bridgeport, PA

Raffi Farraj, Owner Vegas Vapes Bryn Mawr, PA

Adam Piper, Owner Cloud 9 Vapor, LLC Butler, PA

Ben Oesterling, Vice President Kingdom Vapor Butler, PA

Bob Oesterling, President Kingdom Vapor Butler, PA

Jack Riley, Owner Guntown Vape Canonsburg, PA

Christian Rider, CFO Fathom Vapor Carlisle, PA

Jay Ewideh, Owner Puff & Bean, Inc. Carlisle, PA

Steven Kane II, Owner Vast Vapor Chambersburg, PA

Jessica Oesterling, Owner Kingdom Vapor Wholesale Clarion, PA

Randy Shicks, Owner Shicks Gift and Tobacco Clarion, PA

John Dolan, Owner Smooth Vape, LLC Cleona, PA

Tracy Burk, Owner Goose Vapes, LLC Columbia, PA

Trevor Chrysler, Owner Iron Vapor, LLC Danville, PA

Anthony Cooper, Owner VaporCrux, LLC Downingtown, PA

Kenneth Cala, Co-owner/Manager The Local Vapor Doylestown, PA

Mick Duvall, Owner MaddCraft Vapors, LLC Duncansville, PA

Carrie Krouse, Owner Carrie's Smoke Shop Easton, PA

Ryan Strauss, Owner Final Boss Vapes Easton, PA

Cody Brown, Owner Tesla Vaping Elizabethtown, PA



David Petrozzo, Owner Get Your Vape On, LLC Emmaus, PA

Kerry Medina, Owner Vapor Café Ephrata, PA

Marty Blevins, Owner Mother Vapors Gettysburg, PA

Mike Kaminkow, Owner Mother Vapors Gettysburg, PA

Amelia & Ismael Rivera Jr., Owner Sabor Vapors Hamburg, PA

Kelly Friedlander, Owner Vapors Paradise, Inc. Hanover, PA

Michael Curry, Owner LifeSmoke Vapors Hanover, PA

Dan Messner, Owner Elevape Worldwide, Inc. Harrisburg, PA

Dave Norris, Owner Blue Door Vaping & Foundation Vapor E-Liquid Harrisburg, PA Alan Fox, Owner VaporPhoxxe, LLC Hatboro, PA

Shannon Slane, Owner The Vape Shoppe Irwin, PA

Christopher Hare, Owner Nomad Vapors, LLC Jeanette, PA

Bill Nichols, Owner Top Grade Vapors & Rip It Vapors Kennett Square, PA

William Nichols, Owner Rip It Vapors, LLC Kennett Square, PA

Holly Freshwater, Owner The Vape Lab Kittanning, PA

Walter Wright, Owner The Vape Lab Kittanning, PA

Anh Mai, Owner King’s Vapor Lancaster, PA

Nancy Parrillo, Owner Nirvana Culture & Vapor Shop Mansfield, PA

James Martin, Co-Owner Photography by Renee and James Monaca, PA

Jesse Shore, Owner Jay Shore Liquids, LLC Monaca, PA

David Durley, Owner The Vape Spot Murrysville, PA

Chris McGrath, Owner Octopus Ink Vapor, LLC Natrona Heights, PA

Sarah Kastner, Owner Lehigh Vapor Nazareth, PA

Brian Wilson, Owner Fog Vapes New Castle, LLC New Castle, PA

Stanley Adelsheinrr, Owner Beer4Less New Castle, PA

Dan Messner, Owner DMV Distribution New Cumberland, PA

Jas Smith, Owner Kick’n Butts Vape House, LLC Oakdale, PA

Kathleen Dvorsky, Owner Kick’n Butts Vape House, LLC Oakdale, PA

Kenny Strickland, Owner Ken You Dig It? Vapor Philadelphia, PA

Robert Wiley, Owner Philly Vape Society, LLC Philadelphia, PA

Brent Brookstein, Owner Artifax Philadelphia, PA

Steven Rosenfeld, Co-owner Vapor Funky Monkey Philadelphia, PA

Eric & Clairissa Bordas, Owners EB Vape Attix Philipsburg, PA

Kate & Marc Conn, Co-owners Steel City Vapors & SCV Distribution Pittsburgh, PA

Michael Simko, Owner Zuro Enterprises & Vaper Shack Pittsburgh, PA

Olga Bazhutin, Owner SCV Distribution, LLC Pittsburgh, PA

Olga Bazhutin, Co-owner Steel City Vapors & SCV Distribution Pittsburgh, PA

Todd Zuro, Owner Zuro Enterprises & Vaper Shack Pittsburgh, PA

Eric Zurlo, Owner Swirling Wind Vapors Pittsburgh, PA

Gina Henkle, Owner Cool Vapes Pittsburgh, PA

Bethe' Boe-Corriere, CFO/Administrator Mountain Vaporz North Pocono Summit, PA

Jessica Matharu, Owner Six One Vapor Pottsville, PA

Christopher Wanner, President/Founder Dominant Vapor, LLC Reading, PA

Sheree King, Owner The Vapor Den Scottdale, PA

James & Leigh Anne Dargocey Infamous Vape Shop & Infamous E Liquid Scranton, PA



Sean Slane, Owner Uis Vapes Somerset, PA

Todd Harhager, Owner Hopper's Retro Gaming & Vaping Union City, PA

Serena Richter, Owner/CEO Rich Vapors Uniontown, PA

Joshua Whoolery, Owner the Vaporium, LLC Waynesburg, PA

Mike Burgoyne, Owner MN Vapes Corp, dba Vapor Shark West Mifflin, PA

Lawrence Scholl, Owner Creekside Vapes, LLC White Oak, PA

Anthony Crook, Owner Apb VAPES, LLC Cranston, RI

David Cervone, Owner Tvlri Providence, RI

Lisa Ciarlone, Founder Vaporetti, LLC Rumford, RI

Keith Cohen-Skali, CEO/Owner Sunshine Vape Warwick, RI

Stan & Devon Holcombe, Co-owners Electric City Vapor Anderson, SC

Billy Bales, Owner Pirates Cove Vapor Lounge Bluffton, SC

Brad Rubright, Owner Mutiny Vapors, Airavata Vapors & Avalon Vapor Charleston, SC Ron Titus, Owner Columbia Vapes Columbia, SC

Lee Lance, Partner/COO Carolina Vapor Mill Greenville, SC

Deborah Gibbens, Owner One Stop Smoke Shop, LLC Hardeeville, SC

Jodi Steffen, Owner Smart Choice Vapors Lexington, SC

David OBrien, Owner The Mad Vaper Mauldin, SC

Joseph Battista, CEO iVape Myrtle Beach, SC

Orit Deverell, Owner Warlock Vapes, LLC, dba Zuluvape Myrtle Beach, SC

Shiela Wood, Owner Whim Wham Vapes, LLC Pendleton, SC

Joseph Cook, Owner Vapor in a Bottle Piedmont, SC

Jeffrey Wilkinson, Owner Pairadice Vapin Seneca, SC

Matthew Rhone, Owner Pairadice Vapin Seneca, SC

Michael Grant, Owner Pairadice Vapin Seneca, SC

Richard Lee Henning, Owner NicVape Spartanburg, SC

Noah long, Owner Noble Vapor Spartanburg, SC

Celeste Rosensteel, Owner Sully Vapes Sumter, SC

Brent Ellis, Owner Family Vape Shop Williamston, SC

Rebecca Smith, CFO Family Vape Shop Williamston, SC

Domanick Vary, Owner Handcheck Vapors Rapid City, SD

Greg Mumm, President City Vapes, Inc. Rapid City, SD

Kevin Quick, Owner Down Ohm Vapors, Down Ohm Drips & Cloud 9 R.C. Rapid City, SD Mitch Carlson, Owner Psyclone Mods Rapid City, SD

Mitchel Carlson Jr, Owner Psyclone Mods Rapid City, SD

Tyler Burdis, Managing Member Black Hills Vapors Rapid City, SD

Zane Jones, Co-Owner Down Ohm Vapors Rapid City, SD

Karn Elofson, Owner The Cloud & CloudT3n, LLC Sioux Falls, SD

James & Sandy Luther, Owners Blown Away Vaping, Inc. Sioux Falls, SD

Paul Provorse, Co-Owner Crow Peak Vapor, LLC Spearfish, SD

Andrew Harrod, Owner Friendly City Vapors Athens, TN

Scarlett White, Owner Elk River Vapor Shop Belvidere, TN

Misty Pinkerton, Owner Angela Duschl, Managing Member FF Vapors, LLC Milan, TN Pramod Potluri, Owner Chattanooga Vapor CO Chattanooga, TN

Buckley Pepper, Owner Nova Vapors Clarksville, TN



David Sykes, Owner Pro Vapor Clarksville, TN

Daniel Osment, Owner Osment Enterprises, LLC, dba The Vapor Apothecary Cleveland, TN Steve Nair, Owner Moutain Oak Vapors, LLC Cleveland, TN

Steven Nair, Owner Mountain Oak Vapors Cleveland, TN

Tim LeGrand, Owner Golden Vapors, LLC Cleveland, TN

Jason Knowles, Owner Discount Vape Cookeville, TN

Karen & Glenn Morin, Owners West Tennessee Vapors Dyersburg, TN

Kathie Simpson, Owner Laughing Kat Vapors Elizabethton, TN

Johnathan Pitt, Owner Greeneville Vapor of TN, LLC Greeneville, TN

Morris Abernathy, Owner Victory Vapor North Jackson, TN

Donald Grayer, Owner Volunteer Vapors Johnson City, TN

David Justin Nelson, Owner Rocky Top Vapor, LLC Johnson City & Jonesborough, TN

Joe Harvey Nelson, Jr., Owner Rocky Top Vapor, LLC Johnson City & Jonesborough, TN

Dwight Spears, Owner Savvy Enterprises Kingsport, TN

Adam & Toni Gafford, Owner Secret City Vapor Knoxville, TN

David Moyer, COO L7 Vapors a Subsidiary of The Rabid, Inc. Knoxville, TN

Glenn Cate, Owner Vintage Vapors Knoxville, TN

Katherine A Cornelius, Co-owner/VP The Rabbit Hole Vaporium Knoxville, TN

Lysette Aviles, CEO L7 Vapors Knoxville, TN

Philip Harrell, Owner The Vape Shop, LLC Knoxville, TN

Adam and Toni Gafford, Owner Secret City Vapor Knoxville, TN

Bill & Teresa Livezey, Owners Knoxville Vapor, LLC Knoxville & Sevierville, TN

Kirby Fuller, Owner Monkey Vapors Knoxville, TN

Richelle Richmond, Owner Tennessee Vapor Factory Knoxville, TN

Kem Denton, Owner Smoke Busters Vapor Ecig Shop 2, LLC Lebanon, TN

Teri Dixon, Owner Smoke Busters Vapor Ecig Shop 2, LLC Lebanon, TN

Chris & Destiny Hatton, Owners Vapor Boss, Inc. Lenoir City, TN

Kim Liles, Owner Mellow Vape Madison Hermitage, TN

Richard Banaski, Owner Mid-TN Vapor Shop & Mastermix E-liquid Manchester, TN

Brian Jones, Owner Vintage & Vapor Marketplace Martin, TN

Tru luong, Owner Tru Vapors Maryville, TN

Sara N Kennedy, Owner Vape Street Lounge Maryville, TN

Chris Grezeszak, Owner Dieselbycg Mckenzie, TN

Chris Leigh, Owner Mid South Vapors Memphis, TN

Ken & Karla Roadinger, Owner Chase the Vape, LLC Memphis, TN

Carl Groll, Owner The Vape Place Mount Juliet, TN

Gina Ritter, Owner Vapesboro, LLC Murfreesboro, TN

Kim Liles, Owner Skull & Roses Juice Co. Nashville, TN

Curtis G Hance, CEO Vivian Cameron, COO H&H Vapors, LLC Newport, TN Jill Gregg, Owner Newport Vapor Newport, TN

Kirk Hines, Owner Ranger Vapes, LLC Palmyra, TN

Gary Hovis, Owner The Vape Hut Paris, TN

Amanda Castillo, Owner E-Vaperz Spring Hill, TN

Sam Oechslin, CEO Old School Vapor Co. Spring Hill, TN

Tamara Yount, Co-Owner The Vapor Vendor Springfield, TN



Roger Brockman, Owner Sweet Vapor Sweetwater, TN

Kim Hammond, Owner Electric Smoke Vapor House Tullahoma, TN

Donnie Jones, Owner Vintage & Vapor Marketplace Union City, TN

Tarl & Caren Kendall, Owners Secret City Vapor Winchester & Oak Ridge, TN

Stephen W Chitty, Owner Bang Bang Vapors, LLC Amarillo, TX

Cory Blankenship, Owner Lucky Ruckus Vape Shop Amarillo, TX

Terrie Connelly, Owner Vape Aroma Andrews, TX

Abbas Khatri, Owner Vapor Pulse Arlington, TX

Beau Boniface, Owner PC Vapes, LLC & KCB&B Distributors Austin, TX

Darrell Suriff, CEO American Vapor Company Austin, TX

Ian Kistler, Owner PC Vapes, LLC & KCB&B Distributors Austin, TX

Kenneth T Greenwood, Owner DrippersnDroppers Austin, TX

Lanette Yoakle, Owner New Freedom Vapor Austin, TX

Lukas Gilkey, CEO Hometown Hero Austin, TX

Michael Laughlin, Founder Austin Vapor, LLC Austin, TX

Tyler cohen, Owner PC Vapes, LLC & KCB&B Distributors Austin, TX

Scott & Betty Hamett, Owners MNP Vape Bastrop, TX

Larry Jackson, Owner Captain Jacks Elixirs Baytown, TX

Greg Johnson, Managing Member Boomtown Vapor, LLC Beaumont, TX

Lauren Wynn, Owner Phattys E-Liquid Bedford, TX

Chad Lasater, Owner Big Spring Vape Big Spring, TX

Michael R. Goodwin, Owner MRG Ventures, LLC dba Mikes Vape Shop Boerne & Kerrville, TX Charles Sproles, Owner CESME Essentals Cosmic Charlies Vapor Bowie, TX Sherry Gray, Owner Peace Pipe Vape Shop Brenham, TX

Tyler Jones, Owner Jones Vape Lounge Brownfield, TX

Bryan Scogins, Owner Burleson Vapor Burleson, TX

Kathleen Russell, Owner Vapor Depot, LLC Burleson, TX

Jamie Walker, Owner Vaping Elements, LLC Burnet, TX

Dell Mashburn, Owner Dell Vapers Canyon, TX

Stephen Robertson, Owner Vaperz Cedar Park & Liberty Hill, TX

Christopher Bowman Primitive Vapor Co. & The Vapor Cave College Station, TX

Brett Coppolo, President Texas Select Vapor Conroe, TX

Judi DeHaan, Owner Absolute Vapor, LLC Cypress & Houston, TX

Alvon, CEO Third Eye Management Group, LLC Dallas, TX

Kris McClain, Owner All Vapes Dallas, TX

Luan Huynh, Owner Centerpoint Vapes Dallas, TX

Rick Leyba, President Vapor Candy, LLC Dallas, TX

Steve Stovall, Owner Tribal Vapor, LLC Dallas, TX

William Darin Guynes, Owner Denton Vape Shoppe Denton, TX

Dylan Thompson, COO Vaporescence SQ, LLC Denton, TX

Renee McMahon, Owner D Town Vapes Duncanville, TX

Christopher Garcia, Owner Vape30 Eagle Pass, TX

Jonathan Golden, Owner Golden Vapor Co., LLC El Paso, TX

Mandi Tory, Owner Paranormal Blends, LLC Farmersville, TX

Shamecka Dittman, Owner Dittmans Vapor and Gift Shop Flint & Tyler, TX



Chase Price, Owner Vapor Source DFW Fort Worth, TX

Jason Tamplin, Owner Steamist Vape Supply Fort Worth, TX

Micheal Rasor, Owner Steamist Fort Worth, TX

Troy Johnston, Owner Vapor Salon Fort Worth, TX

Gerry Clark, Partner Vapor ‘Licious Fredericksburg, TX

John Young, Owner Underground Vapes Gainesville, TX

Jake Southers, Owner Bombvapor, LLC Garland, TX

Todd Rhoades, Owner/COO Posh Vapors Garland, TX

Johann Phipps, Owner Antique Clouds, LLC Gatesville, TX

Desiree Tillman, Owner Me Haslet, TX

Marwan Mahmoud, Owner 2nd Wife Vape Haslet, TX

Neaman Cain, Managing Member Electrik Smoke, LLC Hawkins, TX

Holly L Benton, CEO One Vapor Place, LLC Helotes, TX

Erasmo Franco Jr, Owner Vape King Houston, LLC Houston, TX

Katy Aitken, Owner Elysian Labs & K and C Aitken, LLC Houston, TX

Max & Zach Jones, Owners Max & Zachs Vapor Shops, Caterpillar eJuice, British Vapor Co. & Royal Distro Co. Houston, TX Dawn Rogers, Owner Ecig & Vapor Lounge Humble, TX

Garrett Kilcrease, Owner NerdEJuice, LLC Joshua, TX

Mark Lusk, Founder Vape Militia Katy, TX

Penelope McCormick, Owner Sweet Carolina Vapors Katy, TX

Twanda Brown, Owner Kerrville Vape Station Kerrville, TX

Aaron Smith, COO AAA Strate Vape Killeen, TX

David Pavelsky, Owner Amazing Vapor, LLC Killeen, TX

Dylan Drews, Co-Owner 7 Seas Vapor Company, LLC Killeen, TX

Tammy Rhodes, Owner Trenchant Vapes, LLC Lagrange, TX

Chad Lasater, Owner Lamesa Vape Lamesa, TX

Tim Meredith, Owner Valeo Ventures, LLC Lewisville, TX

Kenneth Brattain, Member The Mod Squad Vape Shop Lewisville, TX

Don Weckler, Owner Starlite Vapor, LLC Liberty Hill, TX

Jordan Weckler, Owner Starlite Vapor Liberty Hill, UT

Jackie Arnold, Owner Paradise Vapor Lindale, TX

Veronica Mora, Owner Electric Cloud Vapors & Social Vapes Lubbock, TX

Joanne Heston, Owner The Vape House Lytle, TX

Jeffrey Lee Bradford, Owner Four Horsemen Productions Mansfield, TX

James Slater, Owner Vicious Vapors, Inc. Mansfield, TX

Toby Gooch, President Jaded Vapors, LLC Mansfield, TX

Daniel Matocha, Managing Co-Owner Fog on the Lake Mathis, TX

Larry & Dennisa Moore, Owners Joosie Vapes Mesquite, TX

Mark Zuccaro, Owner Great Vapes, LLC Midlothian, TX

Steven Belcher, Owner Mid Cities Vapor, LLC North Richland Hills, TX

Melvin Herron, Co-Owner Vape Shack, LLC Odessa, TX

Justin Gibson, Co-founder/President Vintage Vapor, LLC Pflugerville, TX

Christopher Adams, Owner Xtreme Vapes, LLC Plano, TX

David Davila, Owner Moore Than Vapes Portland, TX

Ashlie A Gantt, Owner Fuzzy Juice, LLC Powderly, TX



Chris Snuffer, Owner Vape Dudes Richardson, TX

Crystal Clausen, Owner Great White Vapes Royse City, TX

Juan M Benavides IV, Owner Desertwind Vapors San Angelo, TX

Bill & Jennifer Maxey Bad Wolf Vape & Mayhem Vapor Products San Antonio, TX Chris Lumsden, Owner Mayhem Vapor San Antonio, TX

Janet Binder, Owner The Vapor Room S.A. Inc. San Antonio, TX

Keith Stasney, Owner Wise Vice Vapors San Antonio, TX

Michel Barillet, Owner Valkyrie Vapor Shop, LLC San Antonio, TX

William Hildebrand, President Hildebrand Ventures, Inc. San Antonio, TX

Gary & Shirley Wood, Owners Wood Creek Vapory Schertz & Converse, TX

Charlotte Owen, Owner Matrix Minds Seguin, TX

John Stowe, Owner The Smoker’s Alternative Sherman, TX

Nikolai D Dimitrov III, Owner Spring Vapor, LLC Spring, TX

Shane Robbins, Owner Krazy Ape Vapor Spring, TX

Shawn Burke, Owner That Smoke Shop Temple, TX

Layla Hicks, Owner Vape Girl Terrell, TX

Michael Shane Weeks, Co-owner Vape Girl Terrell, TX

Larry & Dennisa Moore, Owners Rusty Rail Vapor Co., Tyler, TX

Don & Rhonda Dameron, Partners BreezEsmokes, LLC Waco, TX

Misty Burke, Owner Cloud Chasers Vapor Shop Woodway, TX

William Thomas, Owner Unicorn Vapors Wylie, TX

Lewie Lambros, Owner Vapor Dreams Bountiful, UT

Whitney Black, Owner Urban Vapor, LLC Bountiful, UT

Edward Mock, CEO Vape Affliction Ogden, UT

Kyle Bertagnolli, Owner Nolli Designs Ogden, UT

Tyler Malan, Owner Nolli Designs Ogden, UT

Chris Talbot, CEO Ovapes Orem, UT

Paul Evans, Co-owner Vapor Craziness Riberton, UT

Riley Farr, Owner Vapor Craziness Riberton, UT

Grant Hiller, Owner iVape Salt Lake City, UT

Brandon Farnsworth, Owner The Chubby Baker South Jordan, UT

Weston Jarvis, Owner Freedom Vapors Spanish Fork, UT

Tysen Johnsen, Owner Cloud 9 St. George, UT

Kevin Henrie, Owner Rebel Goat, Inc. Tooele, UT

Juan Bravo, Owner VIP Vapors Vineyard, UT

Brendon Gunn, Owner Cloud 9 Systems, LLC Washington, UT

Farhan Iqbal, Owner Alternatives West Jordan, UT

Ahmad Kabir, Owner Liberty Vapors, LLC Ashburn, VA

Jennie Baxter, Owner Steam Mill, LLC Blacksburg, VA

Deborah Markwith, Owner Cape Vapes Cape Charles, VA

Tami Taucher, Owner Mom and Pop Vapor Shop Charlottesville, VA

Jay Taylor, Owner Voltage Vapin, Inc. Chester, VA

Jaimie Dobra, Owner Cushymod Chesterfield, VA

Yan Gleyzer, Owner Vape Guys, Inc. Colonial Heights, VA

Alexandra Morano, Owner The Valley Vape Company, LLC Essex Junction, VT



Daniel George, Owner I95 Vapors Fredericksburg, VA

Kristen Pryor, Owner RVA Vapes Glen Allen, VA

Michael Maculley, Owner 7 Cities Vapes Hampton, Newport News, Gloucester & Virginia Beach, VA Don Sr, Don Jr & Andrew Henley, Owners DNA Enterprise, LLC, dba Mech Sauce Lynchburg, VA

Leonard Wright, Owner Lake Anna Vapes, LLC Mineral, VA

Justin & Amanda Jacobson, Co-Owners Dr. Fogsmiths Vaporium & SVC Distribution Moneta, VA Dennis Davis, Owner 7 Cities Vapes Newport News, VA

Alex Batista, Owner Vape Xotix, LLC Norfolk, VA

David Masker &, Owner Maskervape Plus, Inc. Norfolk, Newport News, Virginia Beach, Enterprise, Toano & Simpsonville, VA Phillip Condrey, Owner Maskervape Plus, Inc. Norfolk, Newport News, Virginia Beach, Enterprise, Toano & Simpsonville, VA Paul & Angela Harvey, Owners Cloud System Solutions, LLC Pearisburg, VA Sammy Gaita, Owner Frontline Vapes Poquoson, VA Andrew Byrd, Owner The Last Machine, LLC & Pinkies up, LLC Richmond, VA Chip Anderson, Owner Zen RVA Richmond, VA

Rodolfo Reyes, Owner Juiced Up Vapes, LLC Richmond, VA

Charles M. Hutsell WC Vapor Company & WC Vapor Distro Roanoke, VA

Jason L Williams, Owner Pro Vapes, LLC Roanoke, VA

Michael Provost, Owner Vapamotive Stafford, VA

Claudia Kabir, Owner Liberty Vapors 2, LLC Sterling, VA

Hoyt Adickes, Owner Driptography Suffolk, VA

Duane Lassiter, President 7 Cities Vape Virginia Beach, VA

Phillip Thompson, Owner Master Vapor Virginia Beach, VA

Randall Steele Smith, Owner Vapor Chasers Virginia Beach, VA

Elhoussin & Amy Baddi, Owners VA Vape Shop, LLC Virginia Beach, VA

Roger Gregoire, President Roovapes Waynesboro, VA

Denise Ann Forney, Owner Vapezone Williamsburg, VA

Tracy Musgrove, President Revolutionary Vapes, LLC & Colonial Vapes Williamsburg, VA Chelsea Karche, Owner Ohana Vapors, LLC Winchester, VA

Tanya Cagle, Co-owner Vaporzz, LLC Winchester, VA

Chris Davis, Owner Puffin Vape Allyn, WA

Eugene T Lee, Owner i-vape NW Auburn & Federal Way, WA

Patricia Haven, Owner Vapor Haven Enumclaw, WA

Levi Brennan, Owner Clouds the Limit, LLC Everett, WA

Michael Clark, Owner Vapor Cloud, LLC Federal Way, WA

Eric Green, Owner Voodoo Vapors Gig Harbor, WA

Gary Delgado, Owner Two Knight Vapors Gig Harbor, WA

Kathy Delgado, Owner Two Knight Vapors Gig Harbor, WA

Gary Fletcher, Owner SmokeStop Vapor, Inc. Kennewick, WA

Margo Ross, Owner Dr GoodVape Kennewick, WA

Craig A Bradford, Owner Tri City Vaperz Kennewick, WA

Austin McKinney, Owner Mega Vape Lynnwood, WA

Margo Ross, Owner Cloud 509 Moses Lake, WA

James Hoy, Owner Northwest Fog, LLC Oak Harbor, WA

Alex Lewis-Young, Owner South Sound Vapor Lounge Olympia, WA



Allan Kettle, Owner Vape D Lish & Trekker Vapors Olympia, WA

Larry Pierini, Owner Miomi Ejuice Olympia, WA

Sopheara Buth, Owner South Sound Vapor Lounge Olympia, WA

Margo & Lawrence Pierini, Owners South Sound Vapor, LLC Olympia, WA

Shane Brooks, Owner Clandestine Vapes Pullman, WA

Jayson Silva, Owner Vape Fusion USA, LLC & VF Liquids, Inc. Puyallup, WA

Richard & Lisa Sauve, Owners MAXX Vape Puyallup, WA

Greg Todd, Owner Vapehead Origins Richland, WA

Gabriel Laurant, Owner/VP Sales Vertigo Vapor Seattle, WA

Kevin Knapp, Owner Pure Vapor Seattle, WA

Aaron Crisp, Owner Crisp Vapes Silverdale, WA

Chris Bateman, Owner Vapor Select Spokane, WA

Krew Cunnington, Owner Krew’s Vape Shop Spokane, WA

Judy Courchaine, Owner Freedom E-Cig, LLC Spokane Valley, WA

Kimberly Thompson, Owner The Vaporium Tacaom, WA

Margo & Lawrence Pierini, Owners MiOmi Ejuice Tumwater, WA

Aaron Oxford, Owner Vapor Factory Vancouver, WA

Josheph Fennen, Owner Vapor Factory & Avg Joes Juice, LLC Vancouver & Spokane, WA

Clint Pettee, Co-Owner River Reserve Eliquid Vancouver, WA

Shaun D'Sylva, Founder Fatboy Vapors Vancouver, Battle Ground, Hazel Dell, Belfair & Silverdale, WA Kristin Sealock, Owner All Things Vape N Smoke West Richland, WA

Roger Stout, Owner The Vaping, LLC Bridgeport, WV

Tiler W Lockhart, Owner Third Eye Elixir Charleston, WV

Andrew Hilts, Owner Capital City Vapors Charleston, WV

Marta & Robert Hays, Owners Vandalia Mist Extracts and Vapors Charleston, WV

Kevin Raymond Walker Schoolcraft, CEO Vapescape Clendenin, WV

Jason Lewis, Owner Elk River Fog Vapor, LLC Elkview, WV

Nicole & Burl Barker, Owners Fairmonts Vapor Lounge, LLC Fairmont, WV

Shawn Dunn, Owner Evapor, LLC Fairmont, WV

Christopher Aldrich, Co-Owner Dustin & Jessica Boggess, Co-Owners Full Steam Vapor Hurricand & Huntington, WV

Casey & Janel Adams, Owners CJ Vapors, LLC Inwood, WV

Frank Pauley, Owner Fabulous E Puffs Oak Hill, WV

Aurelius Jeffrey, Owner Soul Vapor Princeton, WV

Cheryl Lockhart, Owner Hazy Hollow Vapors, LLC South Charleston, WV

Scott Gillenwater, Owner Gillen Pine LLC, dba Vape Escape St. Albans, WV

Ryan Caplinger, CEO/Owner Elite Vapors, Inc. Vienna, WV

Jessica Hall, Owner Ella Vape, LLC Weirton, WV

Bill Boldenow, Owner Infinite Vapor Madison, Milwaukee, Waukesha & West Allis, WI George Packard, Owner Xtreme Vape, LLC Antigo, WI

Benjamin Grothe, Proprietor Good Nature EVAPOR Appleton, WI

Brad Busse, Owner Fox Valley Vapor Appleton, WI

Kari Knabenbauer & Khris Fischer, Owners E-Cig Store, LLC Appleton, WI

Todd Smith, Owner/CEO That’s No Smoke, LLC Bulter, WI

Debbie Hille, Owner Medford Vapor Dorchester, WI

David Beaupre, CEO TruVibe, Inc. & Vapor Station FDL Fond du Lac, WI



Kevin DeBauch, President Hydra Puff Vapes, Inc. Madison, WI

Patti Arnold, Owner Central City Vapors Marshfield, WI

Jason Clark, Owner Smokes on State Mauston, WI

Michael Budish, Owner The Vapor Stop Mayville, WI

Kathy Aiello, Member Hugh G. Vapes Mequon, WI

Matthew W Murphy, Co-owner Lakeview Vapor Milwaukee, WI

Yash Patel, Owner Fortune, Inc. Oak Creek, WI

Charles Bilek, Owner Vapewaukee Pewaukee, WI

Cory James Koziczkowski, President Outlaw Vapor Limited Plover, WI

Alyssa Sweeney, Owner Cloud 10.0 Portage, WI

Clay Pry, Owner Midwest Vapery Racine, WI

Timothy Frey, Owner Ignite Vapor & Tobacco Spooner, WI

Kaesey Chojnacki, Owner Vipaka Vape and Glass Stevens Point, WI

James Chamberlain, Owner/Operator Ignite Vapor and Tobacco Superior, WI

Fred Wojciechowski, Owner Pro Clouds Trevor, WI

Jesse Musha, CEO/Owner The Vape Spot, LLC & Yo Vape Sauce Waterford, WI

Alyssa Sweeney, Owner Friday Vapes Waupaca, WI

Don Muehlbauer, Owner Securience, LLC dba Durasmoke Wauwatosa, WI

Todd Buckley, CEO The Vapor Stop USA West Bend, WI

Alyssa Sweeney, Owner Adrenaline Vapors Wisconsin Dells, WI

Steven Howe, Managing Member Flutterby Services, LLC, DBA Norse Vapor Casper, WY

Amy Williams, Owner Straight Line Vapors Cheyenne, WY

Kellie Rogers, Owner Juicity Vapor Evanston, WY

Spencer D. Pittman, Owner Steam Vapour Co., LLC Laramie, WY

Arron Brown, Owner The Vape Spot Thayne, WY

Levi Carlston, Owner The Vape Spot Thayne, WY

Rachelle Brown, Owner The Vape Spot Thayne, WY


Attachment B


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Director Mitch Zeller ([email protected]) February 11, 2019

U.S. Food and Drug Administration

Center for Tobacco Products

Office of the Center Director

10903 New Hampshire Avenue

Silver Spring, MD 20993

Re: Smoke-Free Alternatives Trade Association Response to January 23,

2019 Meeting at the Center for Tobacco Products; Impact of Flavored

Vapor Products on the Public Health and Youth Surge

Dear Director Zeller,

On behalf of the Smoke-Free Alternatives Trade Association (SFATA), we would like to

thank you and your team for taking the time to meet with us on January 23, 2019, to discuss

important issues regarding the vapor industry. We especially appreciate the opportunity to

present our ideas for how we can work together to protect youth from tobacco while encouraging

harm reduction for adult smokers. The purpose of this email is to follow-up on a particular topic

that came up during our conversation; namely, the impact of flavors on the public health and the

recent surge in underage use of certain types of e-cigarettes.

Appropriate Marketing for Vapor Products

At the outset, as we discussed, SFATA and its members are vehemently opposed to

underage use of any vapor or tobacco product. Our Statement of Principles makes clear that

vapor products are intended for adults of legal age only, and that companies should avoid any

marketing that may be viewed as targeting minors. Indeed, for the reasons noted herein, SFATA

maintains that the use of flavors in vapor products should not, in and of itself, be considered an

attempt to target minors, but rather as a necessary tool to help adult smokers make the switch.

More critical to the youth issue, as evidenced by the recent Food and Drug Administration

(FDA) and Federal Trade Commission (FTC) warning letters, is how such flavored products are

packaged, labeled and marketed. In this regard, we are developing marketing guidelines for our

members to help ensure that their products do not, for example, overly appeal to children or

inappropriately imitate youth-oriented products. We would be glad to keep you updated on this

and would appreciate any FDA feedback on our marketing guidelines.

Public Health Benefit of Flavored Vapor Products

With respect to the use of flavors in vapor products (beyond how they are packaged and

marketed), we are concerned that any regulatory action that could (1) restrict access to these

products by adults or (2) result in these products being effectively banned, will be severely


mailto:[email protected]

of 8

detrimental to the public health. The growing body of scientific evidence supports not only that

vapor products are far less harmful than combustible cigarettes and nearly twice as effective as

cessation aids compared to existing nicotine replacement therapies (NRTs)1, but that flavors are

crucial to getting adult smokers to make the switch and stay away from cigarettes. We encourage

you to review the thousands of personal stories from former smokers who now use flavored

vapor products that were submitted to the docket for the Advance Notice of Proposed

Rulemaking (ANPRM) on the Regulation of Flavors in Tobacco Products, FDA-2017-N-6565

(Mar. 21, 2018)2 at Commissioner Gottlieb’s request.3

Moreover, as detailed in SFATA’s own comment to the ANPRM4, numerous published

studies also support these anecdotes and highlight the important role of flavored vapor products

for harm reduction. Recently, for example, the Harm Reduction Journal published the results of

an extensive online survey which assessed the first and current vapor product flavors used by a

non-probabilistic sample of 20,836 adult frequent vapers in the United States.5 Differences in

vapor product flavor preferences between current smokers, former smokers, and never-smokers,

as well as trends in the first flavor used when initiating vapor products, were assessed. The

results were telling – cigarette smokers who switch to vapor products are doing so increasingly

with a variety of fruit and other non-tobacco flavors. These results were buttressed by another

recently completed survey of more than 69,000 adult vapers, the largest survey ever on e-

1 We note that on January 30, 2019, the New England Journal of Medicine published a new UK study that

reported the results of a one-year randomized, clinical trial in which e-cigarettes were compared to NRT to aid

smoking cessation. The study found that e-cigarettes were more effective for smoking cessation than NRT when

both products were accompanied by behavioral support. Specifically, the “1-year abstinence rate was 18.0% in the e-

cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence

interval [CI], 1.30 to 2.58).” See A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy,

available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1808779?query=featured_home.

2 Regulations.gov: Docket comments available at

https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&D=FDA-2017-N-

6565.

3 See U.S. Food and Drug Administration, Statement from FDA Commissioner Scott Gottlieb, M.D., on

efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including

menthol ‒ in tobacco products, (March 20, 2018),

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601690.htm.

4 See Regulations.gov: https://www.regulations.gov/document?D=FDA-2017-N-6565-22951 (ID: FDA-

2017-N-6565-22951; Tracking Number: 1k2-94dd-ewp5).

5 See Christopher Russell, et al., Changing patterns of first e-cigarette flavor used and current flavors used

by 20,836 adult frequent e-cigarette users in the USA, 15 Harm Reduction Journal (2018), available at:

https://doi.org/10.1186/s12954-018-0238-6.


https://www.nejm.org/doi/full/10.1056/NEJMoa1808779?query=featured_home

https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&D=FDA-2017-N-6565

https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&D=FDA-2017-N-6565

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601690.htm

https://www.regulations.gov/document?D=FDA-2017-N-6565-22951

https://doi.org/10.1186/s12954-018-0238-6

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cigarette use by sample size. In this survey, just 16 percent identified tobacco, menthol, or mint

as flavors they used most often; the vast majority preferred fruit and dessert flavors.6

Recent Surge of Past 30-Day E-Cig Use Among Youth

The above surveys are just a few pieces of the growing body of research that shows that

flavors in vapor products play a critical role in attracting and retaining smokers into the reduced-

harm vaping category. Nevertheless, as important as flavors are for adult smokers, we

acknowledge that non-tobacco characterizing e-liquid flavors likely play a role in youth

experimentation. In this regard, you noted during our meeting that early Population Assessment

of Tobacco and Health (PATH) survey data indicated that “flavors” was one of the top reasons

cited by minors for trying e-cigarettes, which have become the most-used “tobacco product”

among youth.7

The initial interest in e-cigarettes in the early years of vaping (by both youth and adults)

was likely due, at least in part, to the curiosity factor observed when any innovative technology

product is introduced to the market, be it smart phones, hover boards or e-cigarettes. Importantly,

among high school students, that early interest in e-cigarettes was seen primarily among students

who were already smoking.8 But after the (expected) swell in youth experimentation from 2011-

2015, beginning in 2016 the percentage of high school students who used an e-cigarette at least

once in the past 30 days started to fall, nearly cutting in half in just one year, from 15.8 to 8.0

6 See Konstantinos Farsalinos, Submitting to the FDA the Findings of the Largest Ever Survey on E-

Cigarette Flavors Use by US Vapers, E-Cigarette Research: Blog (August 11, 2018, 6:54 p.m.), http://www.ecigarette-research.org/research/index.php/whats-new/2018-2/266-us-flav

7 Of course, it must be noted that while vaping has become more common, the cigarette smoking rate

continues to fall to all-time lows among all age groups. According to the CDC, in 2017, 7.6 percent of high school

students reported smoking cigarettes in the past 30 days—a decrease from 15.8 percent in 2011. See

https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index.htm. Among young adults

aged 18-24, 10.4 percent smoked cigarettes in 2017 – 21 percent decline since 2016, when the young adult smoking

rate was 13.1 percent, and a 45 percent decrease since 2011, when 18.9 percent young adults smoked. See

https://truthinitiative.org/news/young-adult-smoking-rate-drops-10. Among adults (older than 24), only 14 percent

reported smoking “every day” or “someday” – the lowest level ever recorded, down from 15.5 percent in 2016, and

a 67 percent decrease since 1965. See TW Wang, et al., CDC: Smoking Rate Among US Adults Reaches All-time

Low, Helio.com (November 8, 2018), https://www.healio.com/family-

medicine/addiction/news/online/%7B448d408a-6056-4376-be89-a7f2eb468284%7D/cdc-smoking-rate-among-us-

adults-reaches-all-time-low

8 See Jacob Sullem, CDC Belatedly Reveals That Smoking by Teenagers Dropped While Vaping Rose,

Forbes.com (November 20, 2013), available online at: http://www.forbes.com/sites/jacobsullum/2013/11/20/cdc-

belatedly-reveals-that-smoking-by-teenagers-dropped-while-vaping-rose/


http://www.ecigarette-research.org/research/index.php/whats-new/2018-2/266-us-flav

https://www.healio.com/family-medicine/addiction/news/online/%7B448d408a-6056-4376-be89-a7f2eb468284%7D/cdc-smoking-rate-among-us-adults-reaches-all-time-low



http://www.forbes.com/sites/jacobsullum/2013/11/20/cdc-belatedly-reveals-that-smoking-by-teenagers-dropped-while-vaping-rose/

http://www.forbes.com/sites/jacobsullum/2013/11/20/cdc-belatedly-reveals-that-smoking-by-teenagers-dropped-while-vaping-rose/

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percent.9 This potentially indicated that (1) industry-implemented age-verification and youth

prevention methods were working, and (2) the novelty of the available products, including the

flavored products that have been around since the very nascent stages of the industry, was

beginning to wane among minors.

But by mid-2018, FDA announced that early NYTS data revealed a sudden shift in past

30-day e-cigarette use among high schoolers, which had jumped to 20.8%.10 SFATA and its

members were just as alarmed by this as FDA, particularly because our membership, which

includes hundreds of small vapor businesses, retail shop owners and e-liquid manufacturers, had

not reported any similar increase in sales or illegal purchase attempts by minors. We reached out

to our members “on the ground” and quickly realized that the youth surge appeared to be

confined to a particular pod-based e-cigarette – the JUUL – that had gained access to the

convenience store distribution network normally reserved for Big Tobacco products.11

Commissioner Gottlieb acknowledged this in his September 2018 announcement when he noted

that “open-tank” vapor products are not the source of rising underage use.12 As you know, open-

tank products utilize refillable flavored e-liquids, represent about half of the total vapor market13,

and are primarily sold in independent vape shops and online, rather than in convenience stores,

pharmacies and gas stations – the recipients of the majority of FDA retailer warning letters and

No Tobacco Sale Orders (NTSOs) for illegal sales to minors.14

9 See Ahmed Jamal, et al., Tobacco Use Among Middle and High School Students – United States, 2011-

2016, MORBIDITY AND MORTALITY WEEKLY REPORT (MMWR) (2017), Figure 1, available at:

https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm#F1_down.

10 See Karen A. Cullen, et al., Notes From the Field: Use of Electronic Cigarettes and Any Tobacco Product

Among Middle and High School Students – United States, 2011-2018, MORBIDITY AND MORTALITY

WEEKLY REPORT, MMWR) (2018): https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm.

11 A review of Nielson data from 2017-18 indicates that the reported surge in underage e-cigarette use

corresponds almost exactly with JUUL’s rise to dominance of the convenience store channel. See Bonnie Herzog,

Nielsen: C-Store Data Through 1/27/18, 2/24/18, and 10/6/18; WELLS FARGO SECURITIES.

12 U.S. Food and Drug Administration, Statement from FDA Commissioner Scott Gotlieb, M.D., on new steps

to address epidemic of youth e-cigarette use, (September 12, 2018)” See


13 The vapor industry is very diverse and complex. Closed-system and pod-based e-cigarettes (like JUUL)

make up roughly 57.5% of the $6.6 billion U.S. vapor products market, with open-system vapor products (e.g.,

tanks, mods, e-liquids, etc.) making up approximately 42.4% in 2018, according to Wells Fargo. See Bonnie

Herzog, Nielsen: Tobacco All Channel Data Through 9/8, WELLS FARGO SECURITIES, (Sept. 8, 2018).

14 U.S. Food and Drug Administration, FDA pursues order barring specific retailers from selling tobacco

products as part of its continuing efforts to target youth tobacco use (February 7, 2019):

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630913.htm?utm_source=Eloqua&utm_me


https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm#F1_down

https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm


https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630913.htm?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=pressrelease&utm_campaign=CTP%20News%3A%20NTSO%20-%202619

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If Not the Flavors, Then What?

But while the JUUL comes in a handful of non-tobacco and non-menthol flavors, it was

clear to our members who have the unique ability to interact with young adults in their stores

(and have tried the product themselves), that flavors are not what is driving youth to the JUUL.

Rather, in the same way teenagers were never interested in smoking cigarettes for the tobacco

flavor, adolescents appear to be coming back to the JUUL because of the “buzz” that, in this

case, comes from the high concentrations (i.e., up to 50 mg) of protonated nicotine, commonly

referred to as nicotine salts, in the pre-filled e-liquid pods.

In addition, nicotine salts in e-liquid may actually play the role that flavor prohibitionists

assign to flavors. In other words, tobacco control advocates often assume that flavors are added

to e-liquids for the same reason they are added to combustible tobacco products – to reduce the

harshness of the “smoke” when inhaled. But this is based on a fundamental misunderstanding of

vapor products, which do not produce smoke or tar. To the extent there is a harshness or “throat

hit” associated with vaping freebase nicotine e-liquids, flavors simply do not do much to guise

that sensation, which adult smokers making the switch are used to.

Rather, the ability to vape non-tobacco flavors is what drove the development of these

products by industry entrepreneurs. Vapor products were invented by smokers for smokers

looking for less risky products that, put simply, did not smell or taste like combustible

cigarettes.15 Whether any particular e-liquid flavors allow for a smoother delivery compared to

others is unclear, and an area that needs to be researched. What does appear to be clear, however,

is that rather than flavors, the use of nicotine salts reduces the throat hit from vaping compared to

freebase nicotine. Combined with a host of other factors, e.g., the pod-based format, access at

all-age retailers like gas stations and convenience stores, user-driven social media and viral

memes, straw purchases by older friends and family, and lack of enforcement of existing age

dium=email&utm_term=stratcomms&utm_content=pressrelease&utm_campaign=CTP%20News%3A%20NTSO%

20-%202619

15 As a practical matter, we note that there is no such thing as an unflavored e-liquid. Unlike cigarettes or

other tobacco-containing products, there is simply no “natural” tobacco or other flavors inherent to e-liquids. Rather,

all flavors for these products, including tobacco and menthol, are chemically synthesized and added to the base

solution. Thus, unlike cigarettes, a ban on characterizing e-liquid flavors would effectively result in a ban of all

vapor products. See Dr. Michael Siegel, Glantz and Colleagues Essentially Call for a Ban on Electronic Cigarettes:

Banning Flavors Would Ban All Existing E-Cigarettes, THE REST OF THE STORY: TOBACCO AND ALCOHOL NEWS

ANALYSIS AND COMMENTARY, (July 19, 2018, 12:15 PM), http://tobaccoanalysis.blogspot.com/2014/06/glantz-and-

colleagues-essentially-call.html




http://tobaccoanalysis.blogspot.com/2014/06/glantz-and-colleagues-essentially-call.html

http://tobaccoanalysis.blogspot.com/2014/06/glantz-and-colleagues-essentially-call.html

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restrictions, among other things, the popularity and growth of the JUUL skyrocketed into what

FDA quickly termed a youth e-cigarette “epidemic”.16

Nicotine Salts

Our concern with the JUUL and the nicotine salt concentration in that product does not

mean that we do not believe that nicotine salts, which have become popular among adult users of

open-system vapor products, cannot play a significant role in tobacco harm reduction. A study

published in Internal and Emergency Medicine, for example, found that while delivering less

nicotine than a conventional cigarette, the use of nicotine salts in e-cigarettes enables cigarette-

like pulmonary delivery of nicotine that reduces the desire to smoke.17 For many adult smokers,

nicotine salt products could present an effective reduced-harm alternative.

In light of this, instead of focusing entirely on flavors to address the youth issue, we

encourage FDA to examine carefully the public health questions raised by the use of nicotine

salts, such as:

▪ Does a smoother nicotine “hit” from nicotine salts impact addictiveness and consumer

perceptions and initiation?

▪ Does a harsher nicotine hit from free base nicotine prevent “never users” from initiating

use of vapor products?

▪ Does the availability of a product with a higher nicotine concentration and greater

nicotine delivery attract current smokers to switch to vaping?

▪ Are nicotine salts a way to mitigate exposure to other aerosol constituents (i.e., if exposed

to a higher nicotine concentration per hit, will less liquid be consumed daily)?

▪ What nicotine salt concentration in e-liquid is appropriate for the protection of the public

health? While nicotine salt concentrations of 50 mg may be too high considering the

potential impact on youth initiation, we believe lower concentrations up to 36 mg may

provide effective alternatives for adults while not being as potentially addictive to

minors.

Next Steps

SFATA shares FDA’s serious concerns about underage e-cigarette use, but maintains that

flavors are not the primary cause of the recent rise in past 30-day use among teenagers. Flavored

16 See Clive Bates, The Great American Youth Vaping Epidemic. Really? Clivebates.com (January 23, 2019),

https://www.clivebates.com/the-great-american-youth-vaping-epidemic-really/ for a detailed analysis on the current

adolescent vaping situation in the United States.

17 See O’Connell G., Pritchard, J.D., Prue, C. et al. Intern Emerg Med (2019). http://doi.org/10.1007/s11739-

019-02025-3.


https://www.clivebates.com/the-great-american-youth-vaping-epidemic-really/

http://doi.org/10.1007/s11739-019-02025-3

http://doi.org/10.1007/s11739-019-02025-3

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vapor products are an important tobacco harm reduction tool for adult smokers, who typically

prefer a variety of fruit, dessert and other vapor product flavors. Accordingly, for the reasons

noted above, we believe the Agency’s efforts to restrict access to all flavored vapor products, as

well as threats to eliminate the August 8, 2022 Premarket Tobacco Product Application (PMTA)

compliance policy deadline for products on the market, is misplaced – and will ultimately harm

the public health. Attempting to solve the problem of youth use by focusing on flavors, rather

than examining other potential causes of the recent surge, risks losing out on all the upside of

vaping technology. Rather, a broader approach considering all of the likely causes of increased

youth initiation (e.g., high nicotine salt concentrations, social media, retailer access, straw

purchases, etc.), as well as enforcement of existing age-restrictions and FDA requirements,

would better protect vulnerable youth without eliminating a major “off ramp” for adult smokers.

* * * * *


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We thank you again for taking the time to meet with us last month and for considering

this response. We look forward to continuing to work together and hope that we can meet again

soon to discuss these important public health issues.


Mark Anton

Executive Director

SFATA

Cc:

Dr. Scott Gottlieb

FDA Commissioner

[email protected]

Ann Simoneau

Director, CTP Office of Enforcement

[email protected]

Kathleen Crosby

Director, CTP Office of Health Communication and Education

[email protected]

Beverly Chernaik

Director, CTP Office of Regulations

[email protected]

Eshael Johnson

Director, CTP Stakeholder Relations Office

[email protected]

David Oliveira

Deputy Director, CTP Stakeholder Relations Office

[email protected]








September 9, 2019 Motion to Stay

September 23, 2019 Motion to Stay Reply

EXHIBIT A EXHIBIT E


Washington, D.C. Brussels San Francisco Shanghai Paris

This document was delivered electronically. www.khlaw.com

1001 G Street, N.W.

Suite 500 West

Washington, D.C. 20001

tel. 202.434.4100

fax 202.434.4646

Writer’s Direct Access

E r i c P. G o t t i n g (202) 434-4269 g o t t i n g @ k h l a w. c o m

VIA CM/ECF

September 9, 2019

The Honorable Paul W. Grimm

U.S. District Court For the District of Maryland

6500 Cherrywood Lane, Suite 465A

Greenbelt, MD 20770

Re: American Academy of Pediatrics v. FDA, No. 8:18-cv-00883-PWG

Dear Judge Grimm:

In response to this Court’s August 12, 2019 Order (Dkt. #131), we respectfully submit this letter

motion to stay pending appeal the July 12, 2019 Memorandum Opinion and Order (“Remedies

Order”) (Dkt. #127) on behalf of the proposed intervenor trade associations.1 The trade

associations represent small U.S. businesses that manufacture, distribute, and sell vapor products

to adults. Under the Remedies Order, these manufacturers will be required to file compliant pre-

market tobacco applications (“PMTAs”) with the U.S. Food and Drug Administration (“FDA” or

“agency”) by May 2020 pursuant to the Family Smoking Prevention and Tobacco Control Act

(“Tobacco Control Act”). That order followed a May 15, 2019 Memorandum Opinion (Dkt. #73)

(“Merits Opinion”) in which the Court vacated an August 2017 FDA Guidance (“Guidance) that

had previously set an August 2022 filing deadline for currently marketed products.

Background – In the Merits Opinion, the Court vacated the August 2022 deadline on the

grounds that, in its view, the FDA Guidance violated the Administrative Procedure Act (“APA”)

because the agency did not follow notice and comment requirements. Id. at 6. However, the

Court also recognized that FDA has some discretion to set a PMTA filing deadline beyond the

date (i.e., August 2016) on which vapor products were subject to the Tobacco Control Act. Id. at

8, 29. While it was determined that FDA’s discretion is “circumscribed by the language of the

Act itself,” and therefore the August 2022 cutoff was set too far into the future, id. at 45, the

agency still has authority to establish a new date provided it complies with the APA and is

consistent with the Merits Opinion. As the Court noted, “[a]ny Guidance providing for a

compliance period will, of course, have to adhere to the notice and comment requirements of the

APA.” Id. at 53; see also Letter Order (Dkt. #84) at 2 (“Indeed, any remedy will involve further

action by the FDA, which may well have to comply with the APA notice and comment process.

1 A list of the proposed intervenor trade associations appears in our August 9, 2019 notice of intent to file a motion

to intervene for purposes of appeal and a motion to stay pending appeal. Dkt. #130 at n.1.


KELLER AND HECKMAN LLP


Page 2 of 5

This document was delivered electronically.

At such time, [the trade associations] would have ample opportunity to be heard regarding the

deadlines the FDA proposes to implement and the opportunity to protect their interests.”).

But the Court reversed course in the Remedies Order. It acknowledged that “[u]nder settled

principles of administrative law, when a court reviewing agency action determines that an

agency made an error of law, the court’s inquiry is at an end: the case must be remanded to the

agency for further action consistent with the corrected legal standards.” Memo. Op. and Order at

5-6 (citations omitted). However, in taking direction from the D.C. Circuit, the Court stated that

it may “issue detailed remedial orders” under “extraordinary circumstances.” Id. at 6 (quoting

N.C. Fisheries Ass’n v. Gutierrez, 550 F.3d 16, 20 (D.C. Cir. 2008)). The Court then accepted,

without requiring notice and comment, FDA’s suggestion during the remedies phase that the

PMTA deadline be set for 10 months after the remedies decision (i.e., May 2020). The Court

cited a recent “epidemic” rise in underage vaping as constituting “extraordinary circumstances”

and justifying a court-imposed deadline. Id. at 10; see id. at 6 (“The issue is whether this case

presents those ‘extraordinary circumstances’ that call for more than a simple remand or

vacatur.”). Finally, when proceeding under the “extraordinary circumstances” exception, the

Court found additional support in the APA, Sections 706(1) and (2). 5 U.S.C. §§ 706(1), (2).

Stay Requirements – This Court applies the traditional four-factor test when deciding whether to

grant a stay pending appeal: (i) whether the claimant has made a strong showing that it is likely

to succeed on the merits; (ii) whether the claimant will be irreparably injured absent a stay; (iii)

whether the issuance of the stay will substantially injure the other parties interested in the

proceeding; and (iv) where the public interest lies. U.S. v. Various Articles of Drug, 1996 U.S.

Dist. LEXIS 22868, at *3-4 (D. Md. 1996). Under this approach, “[e]ach factor . . . need not be

given equal weight. Instead the court assesses [the] movant’s chances for success on appeal and

weighs the equities as they affect the parties and the public.” U.S. Home Corp. v. Settlers

Crossing, LLC, 2015 U.S. Dist. LEXIS 83903, at *22 (D. Md. 2015) (citations omitted). As

demonstrated below, these factors favor granting the requested stay.

Likelihood of Success – Demonstrating a likelihood of success “does not mean that the trial

court needs to change its mind or develop serious doubts concerning the correctness of its

decision in order to grant a stay pending appeal.” Goldstein v. Miller, 488 F. Supp. 156, 172 (D.

Md. 1980). Rather, while the movant must typically make a “strong showing” of likely success,

it is enough that the appeal raises “serious and difficult questions of law.” U.S. Home Corp.,

2015 U.S. Dist. LEXIS 83903, at *22 (citation omitted). This holds particularly true where the

Fourth Circuit has yet to weigh-in on the relevant matter. Northrop Grumman Tech. Servs. v.

DynCorp Int’l LLC, 2016 U.S. Dist. LEXIS 78864, at *6-10 (E.D. Va. 2016) (noting the Fourth

Circuit had not addressed the pertinent issue and there was no controlling Fourth Circuit decision

that would dictate the outcome of the case). The “Court must determine whether there is a strong

likelihood that the issues presented on appeal could be ‘rationally resolved’ in favor of

claimant.” Various Articles of Drug, 1996 U.S. Dist. LEXIS 22868, at *6 (quoting United States

v. Fourteen Various Firearms, 897 F. Supp. 271, 273 (E.D. Va. 1995)); see also Northrop




Page 3 of 5


Grumman, 2016 U.S. Dist. LEXIS 78864, at *6 (applying the “rationally resolved” approach

regarding questions that the Fourth Circuit “has yet to evaluate”).

In the instant case, the remedies issue – and in particular whether the Court properly set a PMTA

deadline instead of remanding back to FDA for further consideration – turns on the appropriate

application of the D.C. Circuit’s “extraordinary circumstances” exception. Yet we are not aware

of any case in which the Fourth Circuit has applied that principle, and it appears that the D.C.

federal courts have interpreted that phrase very differently than the Court did here. In the

Remedies Order, “extraordinary circumstances” was defined broadly by the interests of third

parties (i.e., minors) and public policy concerns (i.e., underage vaping). Memo. Op. and Order at

6, 10. This stands in stark contrast to the approach taken by the D.C. courts. There, the courts

focus on the authority of the government agency and whether it has discretion to decide a given

issue. See Gurrola v. U.S., 751 F.3d 629, 634-35 (D.C. Cir. 2014) (refusing to impose on remand

a specific tax refund procedure where the IRS retained discretion to “design the [procedure’s]

details”); Baptist Med. Ctr. v. Sebelius, 855 F. Supp. 2d 1, 3 (D.D.C. 2012) (refusing to dictate

specific legal standards governing recalculation of Medicare reimbursements where agency was

entitled to have an “opportunity to reconsider the issues on remand”). As such, it is certainly

possible that the Fourth Circuit could adopt the D.C. courts’ narrow application. And this would

have significant implications for the Remedies Order as this Court found (and the parties agreed)

that FDA retains some discretion on the appropriate PMTA deadline.

Moreover, there are legitimate questions regarding this Court’s reliance on APA Sections 706(1)

and 706(2). As to the former, a court may only impose a specific remedy where agency action

has been “unlawfully withheld” or “unreasonably delayed” if the agency has “no discretion” to

act. Norton v. S. Utah Wilderness Alliance, 542 U.S. 55, 62-63 (2004) (citation omitted). Section

706(1) “rules out judicial direction of even discrete agency action that is not demanded by law.”

Id. at 65; see City of New York v. U.S. Dept. of Defense, 913 F.3d 423, 432 (4th Cir. 2019)

(plaintiff must identify an action that is “legally required”) (quoting Norton, 542 U.S. at 63).

With respect to the Remedies Order, while the agency does not have unlimited discretion here, it

does have authority to set a reasonable deadline within a range of time periods consistent with

the Merits Opinion – i.e., a 10-month deadline was not the only option. Thus, the Fourth Circuit

could find that Section 706(1) does not support this Court’s approach.

Further, Section 706(2) only allows a court to “set aside” unlawful agency action, not dictate the

remedy. As the FDA pointed out, the APA limits a reviewing court to vacating and remanding

agency action. FDA Remedy Br. at 2-3 (Dkt. #120); Joint Indus. Br. at 9-10 (Dkt. #113). The

parties have not cited any contrary Fourth Circuit authority. As such, the Fourth Circuit may

disagree with the cases cited by this Court and the Plaintiffs from other circuits where injunctive

relief was imposed. FDA Remedy Br. at 3 n.2 (noting Plaintiffs’ cases are distinguishable

because, unlike here, they involved a long history of agency non-compliance).

Finally, despite having found that any future guidance setting forth a PMTA deadline would

need to comply with APA notice and comment requirements, and that the trade associations




Page 4 of 5


would then have an opportunity to protect their interests through such proceedings, the Court

simply adopted the 10-month cutoff. Memo. Op. and Order at 12. This is not equivalent to a

notice and comment process. The 10-month suggestion was made by Mitch Zeller, Director of

the Center for Tobacco Products, in a declaration (Dkt. #120-1 at 11). However, there is no

indication that Mr. Zeller or FDA adequately considered or weighed the type of evidence

relevant to how long vapor product manufacturers, and particularly small businesses represented

by the trade associations, will actually need to complete high quality and compliant applications.

Mr. Zeller stated that “I believe” that 10 months will be adequate. Zeller Decl. at 11. But “belief”

tells us little about the basis of FDA’s decision.

By way of example, Mr. Zeller notes that some applications will need “clinical” studies to gauge

a given product’s impact on public health. Id. at 15. There is no analysis, however, of how much

time is required to conduct such studies. An amicus brief filed by one of the trade associations

earlier in this case (Dkt. #37-1) clearly demonstrates that clinical and epidemiological studies

take many years to complete. Tellingly, the average estimate for completing clinical trials and

epidemiological studies in federally-funded tobacco studies was 6.67 years and 5.11 years,

respectively. Id. at 12. Thus, even if the trade association members had initiated their own

studies on the day vapor products were deemed covered by the TCA, many would still be

nowhere near done. Indeed, FDA’s own epidemiological (PATH) study of tobacco and e-

cigarette use has taken eight years and is still ongoing. Id. Despite these realities, and the fact

that FDA possesses all of this data, there is no indication that they were considered.

Similarly, FDA argues that any uncertainties or outstanding questions regarding what is required

of a PMTA can be resolved through pre-application meetings. Memo. Op. and Order at 8. But

this completely ignores how long such back-and-forth actually takes to play out. Based on our

experience, it takes months or more for FDA to review and comment on a single company’s

proposed testing and research approach, with multiple exchanges of information and other

discussions. Anton Decl. at ¶ 14 (Dkt. #113-F); Benson Decl. at ¶ 14 (Dkt. #113-G). For

example, there were nearly two years of such communications on the IQOS PMTA after Philip

Morris submitted its initial application, with FDA requesting additional information and/or

corrections at least 12 times. Benson Decl. at ¶ 16. It is not simply a matter of meeting with FDA

once and then filing the PMTA. The agency knows full well that this is not how it works. These

real-world dynamics must be considered when setting a compliance date given the number of

PMTAs FDA expects and the many questions regarding testing protocols and other application

requirements that remain, even with the final PMTA guidance. Anton Decl. at ¶¶ 10-11; Benson

Decl. at ¶ 10-13. Unfortunately, while Mr. Zeller recognizes the “expected complexity of [such]

applications” and the need for “high-quality” PMTAs, there is no indication that FDA seriously

grappled with these issues vis-à-vis the filing deadline. Zeller Decl. at ¶¶ 6, 18-20.

As this Court initially recognized, industry must have a chance to raise these points through

notice and comment procedures. Short-cutting this process based on a conclusory declaration

does not suffice. Indeed, the Fourth Circuit will be left wondering how FDA justifies a 10-month

cutoff when it could not for a moderately shorter 4-month deadline.




Page 5 of 5


Irreparable Harm – The trade associations’ members will undoubtedly suffer irreparable harm

absent a stay. For those members currently working on PMTAs, they risk filing incomplete

applications that FDA might quickly reject without: (i) adequate time to meet with and respond

to FDA’s questions; (ii) further direction from FDA as it continues to formulate the “rules of the

road” through additional PMTA rulemakings and guidance; (iii) sufficient time to finish long-

term studies and environmental assessments; and (iv) adequate third party lab testing capacity.

See, e.g., Joint Amicus Br. at 4-5 (citing PMTA NPRM) (Dkt. #113); Anton Decl. at ¶¶ 10-13;

Benson Decl. at ¶¶ 8-9, 24. Timewise, it may be impossible for those members to fully comply.

As to the other members, most of whom are small businesses and “Mom and Pop” vape shops,

they will have no choice but to shut down given that it makes no sense to continue investing in

this industry when the arbitrary 10-month deadline cannot be met. Anton Decl. at ¶¶ 17-23.

No Substantial Injury To Parties – By virtue of FDA’s own conduct we know that the agency

will not suffer substantial injury with a stay pending appeal. Just three months before the agency

filed its remedy brief, it had proposed an August 2021 PMTA deadline, see Zeller Decl. at ¶ 9,

thus indicating that a temporary delay will not impact FDA’s interests. Moreover, the Plaintiffs’

only alleged injury is a lack of information from PMTAs to educate patients and the public. But

there are literally thousands of publicly-available, peer-reviewed papers on vaping products, with

over 100 articles being published each month. Benson Decl. at ¶ 21. Indeed, the recent National

Academies of Sciences report evaluated over 4,000 such publications. Id. The FDA’s ongoing

PATH study, which is investigating the same issues as PMTAs, has also released three waves of

extensive population data regarding vaping. Benson Decl. at ¶¶ 14-16 (Dkt. # 37-4). As such, the

Plaintiffs will not be substantially prejudiced by a limited delay for the appeal.

Public’s Interests – FDA repeatedly warns against the public health impacts of moving too fast

on PMTAs which could result in a mass exit of less harmful vapor products and a migration of

former adult smokers back to dangerous combustible products. Zeller Decl. at ¶¶ 12, 15 (“[I]it is

likely that some ENDS products may reduce harm at the individual level and that some addicted

adult smokers use these products with a goal to” stop smoking). Yet Mr. Zeller never explains

why this is a risk with a 4-month, but not a 10-month, deadline, thus highlighting the need for

notice and comment. This Court should not adopt what could be an arbitrary and capricious

PMTA cutoff. See, e.g., Creosote Council v. Johnson, 555 F. Supp. 2d 36, 40 (D.D.C. 2008)

(there is a “general public interest in open and accountable agency decision-making”); 21 C.F.R.

§ 10.115(g) (FDA requiring notice and comment for agency guidance). These interests must be

balanced with the need to guard against underage use.

Sincerely,

Eric P. Gotting

Bar ID #20278


Washington, D.C. Brussels San Francisco Shanghai ParisThis document was delivered electronically. www.khlaw.com

1001 G Street, N.W. Suite 500 West Washington, D.C. 20001 tel. 202.434.4100 fax 202.434.4646 Writer’s Direct Access

E r i c P. G o t t i n g (202) 434-4269g o t t i n g @ k h l a w. c o m

VIA CM/ECF

September 23, 2019

The Honorable Paul W. Grimm U.S. District Court For the District of Maryland 6500 Cherrywood Lane, Suite 465A Greenbelt, MD 20770

Re: American Academy of Pediatrics v. FDA, No. 8:18-cv-00883-PWG

Dear Judge Grimm:

We submit this letter reply on behalf of national and state vapor industry trade associations in response to oppositions filed by the parties (Dkt. #144, #145) regarding the motion to stay.

Public and Party Interests – Several mischaracterizations made by the parties and, in particular, the Plaintiffs, require correction. Based on publicly available information, the sudden outbreak of acute illnesses and deaths is not being driven by commercial, nicotine-containing e-cigarettes made by the trade associations’ members. Rather, the overwhelming majority (at least 90%) of such cases have a common denominator – illicit cannabis and tetrahydrocannabinol (THC) liquids. Various medical conditions seen in these individuals can be explained by biological mechanisms associated with those products. See Minton Decl. (Ex. A). The CDC also has concluded that “[m]ost patients have reported a history of using e-cigarette products containing THC.”1 FDA agrees.2 Plaintiffs provide no analysis to the contrary.

It is also highly unlikely that Plaintiffs would ever have access to information regarding these illicit products through PMTAs. These products contain illegal drugs. Either these products are not subject to the Tobacco Control Act because they do not contain tobacco-derived ingredients, see 21 U.S.C. § 321(rr), or the drug dealers selling them would never risk criminal prosecution by disclosing their identity to the FDA. On a separate note, Plaintiffs overstate their access to PMTA product-specific data for nicotine products; much of what is submitted in a PMTA is protected as confidential and is accessible only by FDA and other agencies. 21 U.S.C. § 387f(c).

1 CDC, Outbreak of Lung Injury Associated with E-Cigarette Use, or Vaping (Sept. 19, 2019), https://tinyurl.com/y2yrb5bc. 2 FDA, Lung Illnesses Associated with Use of Vaping Products (Sept. 13, 2019) (noting that “many of the samples tested” during the investigation contain THC and the cutting-agent vitamin E acetate), https://tinyurl.com/y3bgtdtx.


KELLER AND HECKMAN LLPPage 2


Finally, the trade associations agree that underage use must be confronted head-on. However, the parties fail to acknowledge that the trade associations’ members and their products are not propelling increased vaping rates in this group. Nielson data show that the surge in underage use corresponds almost exactly with the rise of pod systems – like JUUL – in convenience stores. Anton Supp. Decl. at ¶ 9 (Ex. B). The trade associations’ members, however, manufacture open systems sold primarily in vape shops and online. Id. Former FDA Commissioner Gottlieb came to the same conclusion – “open-tank” products are not the source of rising underage use. Id.

Likelihood of Success – Plaintiffs (but not FDA) ask this Court to apply a test for showing likelihood of success that is contrary to the clear majority of courts in this Circuit, including at least three decisions issued in this district. In those cases, movants must show that there are “serious and difficult questions of law” or that there is a strong chance the issues appealed could be “rationally resolved” in movant’s favor.3 Further, many of those decisions post-date one or both of the two cases cited by Plaintiffs (Dkt. #145 at 3-4 n.12), which were issued by a single judge in another district.4 Plaintiffs would require movants to “clearly demonstrate that it will likely succeed on the merits.” See Ohio Valley Envtl. Coalition, Inc. v. U.S. Army Corps of Eng’rs, 890 F. Supp. 2d 688, 691 (S.D.W. Va. 2012) (citation and quotation omitted). But as this Court explained in Goldstein, “[p]rior recourse to the initial decision-maker would hardly be required as a general matter if it could properly grant interim relief only on the prediction that it has rendered an erroneous decision.” 488 F. Supp. at 172-73 (citation and quotation omitted).

Nevertheless, the trade associations satisfy even Plaintiffs’ heightened standard. During the remedies phase, FDA maintained that this Court had no authority to issue an injunction (i.e., a new PMTA compliance date) beyond vacatur and remand. Dkt. #120 at 2-6; see Joint Indus. Amicus Br., Dkt. #113 at 8-10. Nowhere in Plaintiffs’ letter opposition, however, do they dispute that: (i) the D.C. Circuit has never applied the “extraordinary circumstances” test based on third party interests; (ii) the U.S. Supreme Court has held that 5 U.S.C. § 706(1) cannot be used to impose an injunction where the agency otherwise has authority to exercise discretion (and both the Court and Plaintiffs agree that FDA has such authority with regard to compliance periods); (iii) no litigant has cited any Fourth Circuit decisions supporting injunctive relief under 5 U.S.C. § 706(2); and (iv) the Court set a PMTA deadline without notice and comment, contrary to its holding in the Merits Opinion. Dkt. #139 at 2-3. Indeed, it is telling that FDA did not dispute the trade associations’ showing of a likelihood of success. Dkt. #144 at 1.

3 U.S. Home Corp. v. Settlers Crossing, LLC, 2015 U.S. Dist. LEXIS 83903, at *22 (D. Md. 2015); U.S. v. Various Articles of Drug, 1996 U.S. Dist. LEXIS 22868, at *6 (D. Md. 1996); Goldstein v. Miller, 488 F. Supp. 156, 173 (D. Md. 1980); see Brea Union Plaza I, LLC v. Toys “R” Us, Inc., 2018 U.S. Dist. LEXIS 123049, at *5-6 (E.D. Va. 2018); Realvirt, LLC v. Lee, 220 F. Supp. 3d 704, 706 (E.D. Va. 2018); Northrop Grumman Tech. Servs. v. DynCorp Int’l LLC, 2016 U.S. Dist. LEXIS 78864, at *6 (E.D. Va. 2016); United States v. Fourteen Various Firearms, 897 F. Supp. 271, 273 (E.D. Va. 1995). 4 The other case cited by Plaintiffs – Wollard v. Sheridan, 863 F. Supp. 2d 462, 477-78 (D. Md. 2012) – does not reject these standards and only stands for the unremarkable notion that a stay pending appeal is not “required” where the remaining factors favor the non-movant.




Irreparable Harm – The parties completely ignore extensive record evidence demonstrating a likelihood of irreparable harm. First, as the motion makes clear, some trade association members are working to meet the May 2020 deadline, but face a significant risk those applications will be deemed incomplete and rejected by FDA. Dkt. #139 at 5. The parties do not address the numerous bottlenecks and sources of delay that will prevent the filing of compliant applications within that timeframe (e.g., the many months or even years FDA requires to meet with an individual applicant and make follow-up requests before a PMTA is filed). Stay Mot., Dkt. #139 at 3-5; Anton Decl., Dkt. #113-7 at ¶¶ 10-14; Benson Decl., Dkt. #113-8 at ¶¶ 9-26; Amicus Br., Dkt. #37-1 at 12 (citing Benson Decl., Dkt. #37-4 at ¶ 12); Anton Supp. Decl. at ¶¶ 4-8. All FDA and Plaintiffs offer are conclusory statements that manufacturers can meet the May 2020 cutoff.

Second, FDA admitted that a 4-month deadline would force the vast majority of the industry out of the marketplace, Dkt. #120-1 at 12, but then failed to provide any evidence (beyond mere “belief”) that the situation would be any different with a 10-month deadline. Dkt. #139 at 3-4. Mr. Anton’s original and supplemental declarations corroborate FDA’s statements, the latter of which includes a recent letter to FDA, which was signed by him and over 1,400 vapor companies, indicating they will likely go out of business. See Anton Decl. at ¶ 19; Anton Supp. Decl. at ¶ 8. Further, neither party reconciles the expert report (Dkt. #37-4), based on federal data regarding tobacco research, showing that manufacturers would still be conducting their long-term studies today even if they had started their PMTAs in August 2016. This is concerning. The parties have been presented with this evidence numerous times and never once have they addressed it, let alone factored it into their own overall analyses. Their silence speaks volumes.5

Third, a finding of irreparable injury is not limited to legal injuries. A stay is warranted where the existence of a moving party’s business is threatened and no remedy exists to repair that injury. Goldstein, 488 F. Supp. at 175 (citing Wash. Metro. Area Transit Comm’n v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C. Cir. 1977)). That is the case here. Nevertheless, at a minimum, this Court held that stakeholders, including manufacturers, have a procedural right to notice and comment when FDA adopts a PMTA deadline. Dkt. #73 at 53; Dkt. #84 at 2. Yet the 10-month due date adopted by this Court was not subject to such procedures. This is significant given the lack of any evidence presented by FDA explaining how manufacturers will be able to file compliant PMTAs by May 2022. Stay Mot., Dkt. #139 at 4-5. And those products would not be on the market illegally. This Court and the parties all agree that FDA has some discretion to allow the continued marketing of products beyond the August 2016 deeming date.

Fourth, the parties argue that FDA will be issuing a new guidance document that will prioritize immediate enforcement against non-tobacco flavored vapor products. But that policy has yet to be released and, as such, this Court’s 10-month PMTA filing period is still in force. The new guidance will also be challenged in Court and potentially subject to a stay. It is pure speculation as to when, if at all, that policy will actually be enforced.

5 It is irrelevant that two manufactures out of thousands plan to file PMTAs by May 2020. JUUL and NJOY are valued in the billions of dollars. The trade associations’ members are mostly small businesses (many “Mom and Pop” outfits) who will bear the brunt of an arbitrary and capricious deadline (Anton Decl., Dkt. #113-7 at ¶ 18).




Sincerely,

Eric P. Gotting Bar ID #20278


EXHIBIT F




Plaintiffs,

v. Civil Action No. 8:18-cv-883-PWG

UNITED STATES FOOD AND DRUG ADMINISTRATION, et al.,

Defendants.

DECLARATION OF MITCHELL ZELLER

I, Mitchell Zeller, declare as follows:

1. I am the Director of the Center for Tobacco Products (“CTP”), United States Food

and Drug Administration (“FDA”), a position I have held since March 2013. In this role, I direct

the development and implementation of programs and policies for regulating the manufacture,

marketing, and distribution of tobacco products. In my capacity as Director of CTP, I am fully

familiar with the instant matter and the facts stated herein.

2. I have dedicated my career to working on FDA issues (nearly 37 years), including

the last 25 years focused on tobacco regulation. I am a graduate of Dartmouth College and the

American University Washington College of Law. I began my career as a public interest

attorney in 1982 at the Center for Science in the Public Interest working on FDA food safety and

nutrition issues. In 1988, I served as counsel to the Human Resources and Intergovernmental

Relations Subcommittee of the House of Representatives Government Operations Committee,

where I conducted oversight of enforcement of federal health and safety laws, including human

and animal drugs, dietary supplements, and food policies at FDA. In 1993, I joined the staff of

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then-FDA Commissioner, Dr. David Kessler, M.D., on a two-week assignment to examine the

practices of the tobacco industry. This assignment led to my serving as associate commissioner

and director of FDA’s first Office of Tobacco Programs where I led FDA’s efforts to craft the

agency’s 1996 tobacco regulations. In this capacity, I represented FDA before Congress, federal

and state agencies, and served as an official United States delegate to the World Health

Organization Working Group for the Framework Convention on Tobacco Control. In 2000, I left

FDA to continue my work in tobacco control as executive vice president of the American Legacy

Foundation, where my responsibilities included marketing, communications, strategic

partnerships, and creating the foundation’s first Office of Policy and Government Relations. I

later joined Pinney Associates as senior vice president in 2002, where I remained until I took my

current position as Director of CTP. In that role, I provided strategic planning and

communications advice on domestic and global health policy issues involving the treatment of

tobacco dependence and the regulation of tobacco products and pharmaceuticals.

3. The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

123 Stat. 1776 (2009) (“TCA”) gave FDA authority to “deem” additional tobacco products

subject to Chapter IX of the FDCA through notice and comment rulemaking. On May 10, 2016,

FDA issued the “deeming rule,” which subjected all other tobacco products (except accessories)

to the requirements in Chapter IX of the FDCA, including electronic nicotine delivery systems

(“ENDS”) and cigars. 81 Fed. Reg. 28,974.

4. FDA has used and will continue to use its authority under the TCA and the

deeming rule to address serious concerns about tobacco products, including youth use of ENDS

and flavored cigars. We are committed to keeping tobacco products out of the hands of youth,

and have used our authority and resources forcefully to prevent youth access, curb the marketing



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of tobacco products aimed at youth, and educate teens and their families about the health risks of

vaping and other tobacco product use. Specifically, since early 2018, these actions have

included: (1) in May 2018, issuing 17 warning letters to manufacturers and retailers for selling

e-liquids that resembled kid-friendly food products, which prompted all of the recipients to stop

selling the violative products;1 (2) in summer 2018, conducting a nationwide undercover

investigation that resulted in over 1,300 warning letters and civil money penalty actions against

retailers who illegally sold ENDS products to minors;2 (3) in January 2019, holding a public

hearing to discuss strategies to eliminate youth use of ENDS with a focus on the role of drug

therapies to help young people quit using e-cigarettes and other tobacco products;3 (4) in March

and April 2019, publicly admonishing thirteen national chain stores and franchises with high

rates of violations for illegal sales of tobacco products to minors, and requesting plans that

describe how these retailers will address and mitigate illegal sales to minors;4 (5) in June 2019,

sending four warning letters jointly with the Federal Trade Commission for violations related to

online posts by social media influencers;5 and (6) continuing robust public education efforts to

prevent youth use of tobacco, including expanding its tobacco prevention campaign—called

“The Real Cost”—to ENDS products with messaging that has been seen by teens nearly 500

million times.6 Other CTP actions to address youth use are described in a March 2019 draft

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!2!See FDA News Release, available at https://www.fda.gov/news-events/press-announcements/fda-warns-more-companies-stop-misleading-kids-e-liquids-resemble-kid-friendly-foods-part-youth.2 See FDA News Release, available at https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-address-epidemic-youth-e-cigarette-use-including-historic-action-against-more. 3 See Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies Public Hearing, Jan. 18, 2019, https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/eliminating-youth-electronic-cigarette-and-other-tobacco-product-use-role-drug-therapies-public. 4 See https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-forceful-new-actions-focused-retailers-manufacturers.5 See https://www.fda.gov/news-events/press-announcements/fda-ftc-take-action-protect-kids-citing-four-firms-make-sell-flavored-e-liquids-violations-related.!7!See https://www.fda.gov/tobacco-products/public-health-education-campaigns/real-cost-campaign.

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guidance document.7

5. This case relates to the premarket review of deemed tobacco products that are

new tobacco products as defined in 21 U.S.C. § 387j(a)(1). I describe the various pathways in

which tobacco products may be legally marketed below:

a. Grandfathered Tobacco Products. Products that were commercially

marketed in the United States as of February 15, 2007, are considered “grandfathered”

and do not require prior authorization to be legally marketed. See 21 U.S.C. § 387j(a)(1).

They also may serve as a predicate tobacco product for a substantial equivalence (SE)

report, described below. FDA has made 1,651 grandfathered determinations for deemed

products (e.g., cigars, pipe tobacco, and waterpipe tobacco).8 !Seeking an FDA

grandfather determination is a voluntary process and there are likely many additional

grandfathered products being marketed.

b. Substantial Equivalence (SE). A substantially equivalent tobacco product

is a new tobacco product that has been found by FDA either to have the same

characteristics as a predicate tobacco product or to have different characteristics than the

predicate tobacco product, but, in the latter case, the substantial equivalence report

submitted by the manufacturer demonstrates that it is not appropriate to regulate the new

tobacco product under the Premarket Tobacco Application (PMTA) pathway because the

product does not raise different questions of public health. 21 U.S.C. § 387j(a)(3)(A). A

predicate tobacco product that an applicant can use is one that was commercially

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!7 See Modifications to Compliance Policy for Certain Deemed Tobacco Products, Draft Guidance (Mar. 2019) at 5, available at https://www.fda.gov/media/121384/download. 8 See Grandfathered Tobacco Products, available at https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/grandfathered-tobacco-products (page last viewed June 12, 2019).

!



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marketed in the United States as of February 15, 2007 (a grandfathered tobacco product),

or has previously been found to be substantially equivalent by FDA, and is in compliance

with the requirements in Chapter IX of the FDCA. FDA has issued guidance documents9

and a proposed rule on April 2, 2019,10 which address SE reports. As of April 30, 2019,

FDA has authorized 1070 products with SE orders. For deemed products, FDA has

received 313 SE reports and issued four orders authorizing SE reports.11

c. Substantial Equivalence Exemption. A new product may be exempt from

the need to demonstrate substantial equivalence if it is modified by adding or deleting a

tobacco additive or by increasing or decreasing the quantity of an existing tobacco

additive, and such a modification would be a minor modification of a legally marketed

product and an SE report is not necessary for the protection of public health. 21 U.S.C.

§ 387e(j)(3). As of April 30, 2019, FDA has issued 199 SE exemption orders, including

21 orders for deemed products.12 FDA issued a final rule establishing procedures for

requesting an exemption from the substantial equivalence requirements in 2011. See 76

Fed. Reg. 38,961 (Jul. 5, 2011). In addition, information about this pathway is available

in the SE guidance documents referred to above.

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!9 See Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (Jan. 2011), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/section-905j-reports-demonstrating-substantial-equivalence-tobacco-products. FDA has also issued another Guidance, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions, most recently revised in December 2016 (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-equivalence-new-tobacco-product-responses-frequently-asked-questions). 10 See Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports, 84 Fed. Reg. 12740 (Apr. 2, 2019). 22!See https://www.fda.gov/tobacco-products/substantial-equivalence/marketing-orders-se (Jan. 29, 2019 order for Black & Mild Shorts). SE orders are generally publicly available at the website above, but commercially confidential information must be redacted before posting. Three of the four SE orders referred to above have not yet been posted. 12 See SE Exemption Order for John Middleton Co., Black & Mild (Sept. 7, 2018), available athttps://www.fda.gov/tobacco-products/exemption-substantial-equivalence/marketing-orders-exemption-se. !



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d. Premarket Tobacco Application (PMTA). All other new tobacco

products must be authorized through the PMTA pathway, which requires applicants to

demonstrate that the new tobacco product is appropriate for the protection of the public

health, which is determined with respect to the risks and benefits to the population as a

whole, including users and non-users of tobacco products, and taking into account the

increased or decreased likelihood that existing users of tobacco products will stop using

such products, and those who currently do not use tobacco products will start using such

products. 21 U.S.C. § 387j(b), (c). FDA issued a guidance specifically for ENDS

products, which are likely to be reviewed through the PMTA pathway, on June 11, 2019

(“PMTAs for ENDS Guidance”).13 The PMTAs for ENDS Guidance is intended to assist

applicants to prepare PMTAs for these products and explains, among other things, when

a PMTA is required, general procedures for review of an ENDS PMTA, what

information the FDCA requires applicants to submit in a PMTA, and what information

FDA recommends applicants submit in an ENDS PMTA to show whether permitting

such new tobacco product to be marketed is appropriate for the protection of the public

health. In addition, FDA intends to issue a proposed rule in the near future to further

specify application contents and FDA’s review and communication procedures under this

pathway.14 As of April 30, 2019, FDA has received 401 PMTA applications, 373 of

which are for deemed products. FDA has authorized the marketing of 12 total products

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!24!See Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems Guidance for Industry (June 2019), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery-systems-ends. 25!See Premarket Tobacco Product Application and Recordkeeping Requirements, RIN: 0910-AH44, available athttps://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201904&RIN=0910-AH44.

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under two different product types (non-combustible cigarettes and smokeless tobacco),15

and closed out 369 of the 373 applications it has received for deemed products as

insufficient to accept or file, primarily for failure to file an adequate environmental

assessment, as required by 21 C.F.R. § 25.15. Only four PMTA applications are pending

with the agency at this time for deemed products, none of them for an ENDS product.

Thus far, FDA has provided information about the PMTA application process through

public seminars and workshops,16 and regularly meets with sponsors to discuss FDA’s

expectations for these applications.

6. By statute, all deemed products require marketing authorization unless they are

grandfathered. No deemed products had authorization when the deeming rule went into effect.

Thus, when the deeming rule took effect on August 8, 2016, all deemed products on the market

were suddenly noncompliant with the statute. Accordingly, in the preamble to the deeming rule,

FDA announced a compliance policy under which, as an exercise of enforcement discretion, it

intended to defer enforcement of various provisions for limited periods of time to give

manufacturers time to come into compliance. With respect to premarket review, for products

that were on the market as of August 8, 2016, FDA provided staggered compliance dates for

submission of applications depending on the type and complexity of the application; in addition,

if an application was submitted within the compliance period, the preamble further stated that the

agency did not intend to initiate enforcement for lack of a marketing order from FDA for one

year after submission while FDA reviewed the application. Id. at 28,977-78. As explained in the

preamble, this policy was based on balancing complex and competing public health and resource

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!15 See Premarket Tobacco Product Marketing Orders, available at https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-orders. 16 See Useful Links for PMTA, available at https://www.fda.gov/media/101179/download (Oct. 17, 2016).



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considerations, primarily that products would remain available without having undergone

scientific review, concerns regarding the effect that flavors have on use of tobacco products by

youth and young adults, the potential for some net public health benefits if flavored ENDS

remain available, the different risks posed by different classes of products, the fact that some

flavored combusted products are grandfathered, the expected complexity of applications,

efficiently managing the flow of incoming applications, and encouraging high-quality

applications. Id.

7. In July 2017, FDA announced a new comprehensive approach to tobacco and

nicotine. The approach included many components, the centerpiece of which was developing a

regulation aimed at reducing nicotine in cigarettes to minimally addictive or non-addictive

levels. In a world where cigarettes were minimally addictive or non-addictive, access to

alternative and less harmful forms of nicotine would be essential. Other components included

advancing rules to lay out what needs to be in SE and PMTA applications; determining whether

and how FDA should regulate youth-appealing flavors in ENDS and other tobacco products; and

seeking new information that may inform consideration of the regulation of so-called premium

cigars. As one part of this comprehensive public health package, where each component was

intended to work alongside the others in striking an appropriate balance, FDA stated that it

would further defer enforcement of the premarket review provision for deemed products to

encourage development of innovative tobacco products that had the potential to be less

dangerous than cigarettes and to provide manufacturers additional time to develop higher quality

applications informed by additional guidance and rules and products standards from the agency.

8. On August 8, 2017, FDA issued a revised guidance extending the compliance

dates for the submission of premarket review applications for deemed products until August 8,



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2021, for combustible new tobacco products (including cigars) and until August 8, 2022, for

noncombustible new tobacco products (including most ENDS products)—but only for products

that were on the market as of August 8, 2016. See Guidance for Industry: Extension of Certain

Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Aug. 2017)

(“Guidance”). The Guidance also indicated that FDA expected that these products would remain

on the market while their premarket applications were under review (or were withdrawn).

9. In the summer of 2018, data from the annual National Youth Tobacco Survey

showed a significant increase in youth use of ENDS products. This followed two years of a

reduction or leveling off in youth ENDS prevalence rates. These data prompted FDA to consider

revising the compliance policy for premarket review set forth in the Guidance. On March 13,

2019, FDA issued a draft guidance proposing to modify that compliance policy.17 This new

draft guidance reiterated that all deemed products without a marketing order (except

“grandfathered” products on the market as of February 15, 2007) were on the market in violation

of the statute and therefore potentially subject to enforcement. It outlined FDA’s enforcement

priorities to help address youth use, particularly youth use of certain flavored products. The draft

guidance reflects a careful rebalancing of public health considerations based on new information.

It revises the prior deferred-enforcement policy with respect to broad categories of e-cigarette

and cigar products, and proposes prioritizing enforcement of the premarket review provisions

against: e-cigarette products targeted to minors or likely to promote use by minors; flavored e-

cigarette products (except tobacco, mint, and menthol flavors) offered for sale in ways that pose

heightened risks of youth access; flavored e-cigarette products (except tobacco, mint, and

menthol flavors) offered for domestic sale after August 8, 2021, for which the manufacturer has

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!17 See Modifications to Compliance Policy for Certain Deemed Tobacco Products, Draft Guidance (Mar. 2019) at 5, available at https://www.fda.gov/media/121384/download.

Ecug!9<29.ex.11994.RYI!!!Fqewogpv!231.2!!!Hkngf!1702302;!!!Rcig!;!qh!27


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not submitted a premarket application; and flavored cigars. Evidence shows that tobacco, mint

and menthol flavors are preferred more by adults than minors, and in the draft guidance FDA

noted it is concerned by the potential that adult former smokers who switched to ENDS could be

at risk of migrating back to combustible products if there were an abrupt market exit of ENDS.18

Remedies

10. FDA has continued to invest significant resources into addressing the recent surge

in youth ENDS use and developing the draft March 2019 guidance, and is committed to

finalizing the guidance within 120 days. FDA has thus far received over 15,000 comments on

the draft guidance and has reviewed the more substantial comments. FDA expects to complete

consideration of the comments, draft the final guidance, and publish it on this highly accelerated

120-day timeframe.

11. The general framework of the March 2019 guidance, when finalized, would allow

FDA to strike an appropriate balance of complex and competing public health and agency

resource considerations, including addressing the rapid rise in youth use of ENDS versus the

availability of potentially less harmful products for currently addicted adult users of combustible

products. I believe that finalizing this guidance – which focuses on restricting youth access to

flavored ENDS products – is one of the most critical public health steps that FDA can take to

curb youth vaping.

12. I understand that plaintiffs seek a remedy that would order FDA “to ensure that no

new tobacco product” that was subject to the Guidance’s extended compliance dates “may

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!29!See Schneller, L.M., M. Bansal-Travers, M.L. Goniewicz, et al., “Use of flavored electronic cigarette refill liquids among adults and youth in the US—Results from Wave 2 of the Population Assessment of Tobacco and Health Study (2014-2015),” PLoS ONE 13(8): e0202744 (2018), available at: https://doi.org/10.1371/journal.pone.0202744; Harrell, M.B., Weaver, S. R., Loukas, A., et al., “Flavored e-cigarette use: Characterizing youth, young adult, and adult users. Preventive Medicine Reports, 5, 33-40, (2017), doi: 10.1016/j.pmedr.2016.11.001.



! 11

remain on the market without being subject to FDA enforcement action” unless an application

for premarket review has been received within 120 days of a remedial order from the Court. It is

my firm belief that plaintiffs’ proposed 120-day submission deadline creates a genuine risk of

migration from potentially less harmful ENDS products back to combustible tobacco products

within the population of addicted adult smokers who have completely switched to ENDS. This

is a public health outcome that should be avoided if at all possible, while still achieving the

public health benefits of earlier premarket review for deemed products, especially with respect to

curtailing youth use.

13. If the Court nevertheless finds it necessary to enter an injunction requiring the

submission of premarket applications by a date certain, it should not set a deadline sooner than

10 months from now—a date that I believe would at least make it feasible for more

manufacturers to develop and submit complete and high quality applications, and for FDA to

publish a proposed PMTA rule and be close to finalizing the SE and PMTA rules. It would also

enable ENDS manufacturers to consider and strengthen their applications based on the final

PMTA for ENDS guidance. Similarly, if the Court enters an injunction limiting the compliance

period for products with timely premarket applications on file to one year, as Plaintiffs also

request, it should not disturb the FDA’s discretion to defer enforcement on a case-by-case basis

with respect to applicants who have provided the needed information and made substantial

progress toward completion, as was the case under the original compliance policy. See 81 Fed.

Reg. at 29,012.

14. This approach, although not as accelerated as Plaintiffs’ proposal, would better

protect the public health. Products lacking an application after 10 months would be subject to

enforcement, as would products lacking an authorization after a one-year review period.



! 12

Critically, in the interim, all deemed new products would be subject to enforcement in

accordance with the priorities set forth in the March 2019 draft guidance, when finalized, even

before the 10-month submission and one-year review time periods elapse.

15. Plaintiffs’ proposed remedy, by contrast, would cause significant public health

concerns, as well as implementation challenges. First and foremost, from the public health

perspective, Plaintiffs seek to clear the market of any new and unauthorized deemed products for

which no application is submitted within 120 days. Given the nearness of that deadline and the

very limited number of companies (fewer than 10) that have sought pre-submission meetings

with FDA to discuss potential premarket applications for ENDS products, I believe that, if

plaintiffs’ proposed remedy were granted, it is likely that there would be a mass market exit of

ENDS products. For cigarette smokers who completely switch to ENDS, these products may be

less harmful at an individual level than combustible tobacco products. It is possible some of

these products may have a net positive effect on public health at a population level, depending on

several factors, including patterns of use. Overall population level impact remains uncertain

today, especially given youth uptake of ENDS. We do not yet know the general public health

impact of these products, but it is likely that some ENDS products may reduce harm at the

individual level and that some addicted adult smokers use these products with a goal to end use

of combustible tobacco products. Given this, mass market exit of such products would limit the

availability of a potentially less harmful alternative for adult smokers seeking to transition or stay

away from combustible tobacco products. Dramatically and precipitously reducing availability

of these products could present a serious risk that adults, especially former smokers, who

currently use ENDS products and are addicted to nicotine would migrate to combustible tobacco

products, even if particular ENDS products ultimately receive marketing authorization and return



! 13

to the market later. And, although there has been great recent progress in declining use of

cigarettes for all age groups, I am concerned that these declines could be slowed or reversed in

the case of very sudden and very dramatic reductions in availability.

16. Second, there are important programmatic and logistical considerations. Of

course, manufacturers may submit premarket applications for these products at any time, and

there is no legal barrier to filing. Indeed, CTP has accepted, filed and authorized applications

through each of the available pathways based on statutory criteria even in the absence of rules or

product-specific guidance. However, I am concerned that many ENDS manufacturers will be

unlikely to submit quality PMTA applications (e.g., applications that are sufficiently complete

and organized to enable CTP to efficiently conduct the required scientific review) for deemed

products within a 120-day period. Instead, a longer period of time (10 months) would be

appropriate to help ensure that manufacturers are better able to prepare quality submissions.

Their efforts will be aided by FDA’s publication of the PMTAs for ENDS Guidance, which

provides important recommendations to help this newly regulated segment of industry develop

their applications. Most significantly, that guidance describes the types of information required

by the statute for submission in a PMTA, provides recommendations for how to address specific

public health concerns, and suggests ways to demonstrate that a product is appropriate for the

protection of public health. I am concerned that 120 days is an insufficient amount of time to

permit some manufacturers to consider and implement the recommendations in the guidance.

17. In addition, there will also be logistical impediments for CTP to receive and

review large numbers of applications without being able to meaningfully prioritize among them.

The Final Regulatory Impact Analysis (RIA) from 2016 estimates that manufacturers will apply

for marketing authorization for 5,424 to 6,764 deemed products (of all types) in the initial



! 14

compliance period (two years). AR 23,995 (RIA at 84). Of these, an estimated 1,250 to 2,000

would be PMTAs for e-liquids, as well as 360-450 for ENDS delivery devices. Id. These

numbers are based on estimates in the context of significant uncertainty, and it is possible that

manufacturers will seek premarket authorization for many more products, particularly if the

products’ continued marketing is contingent on the filing of an application. One concern here is

that low-quality applications, many of which could be time-consuming to review due to their

poor quality, will be submitted merely to prolong marketing.

18. For ENDS PMTAs, these are first-ever applications for a previously novel and

unregulated category of products. Thousands of these applications are expected to be submitted

very close in time. This expectation is based on the dynamics of the deadline coming earlier than

many applicants previously anticipated. It is also informed by our experience with provisional

SE applications, as discussed below. Many applicants will be newly regulated entities lacking

experience with FDA, and based on our experience to date, the applications are anticipated to be

lower in quality and less complete than current-day applications for other FDA regulated

products. A large volume of incomplete or haphazard applications in which the information is

not clearly presented or is missing data will cause further delay because it will divert valuable

agency resources into the painstaking effort of reviewing those submissions and communicating

deficiencies. In addition, there may be technological challenges to accepting and processing

large applications if they come in all at once, especially if the deadline were as soon as 120 days

after a court order, allowing FDA less time to continue preparations.!!!

19. For comparison, in 2011, at a parallel point in time with a submission deadline

approaching, approximately 3,000 of 3,600 provisional SE applications were submitted within



! 15

the last several days leading up to a March 22, 2011 deadline.19 While FDA has put many more

systems in place since then, and has created a robust application review process within CTP’s

Office of Science, there is no doubt that the agency will be flooded with applications in the final

days leading up to any court-ordered submission deadline. I expect that FDA will receive

roughly 5,424 to 6,764 applications for three different authorization pathways. This will

undoubtedly put a strain on the agency. Additional time to file applications would provide more

planning time for FDA and applicants, more time to build out operational systems, and more

time to issue guidance and rules to reduce the volume of low-quality applications.

20. Most ENDS products are relatively novel and are unlikely to be substantially

equivalent to a valid predicate and so will need to be authorized through the PMTA pathway.

Among other things, a PMTA application must include:

a. Full reports of all information concerning investigations which have been

made to show the health risks of the new tobacco product and whether such product

presents less risk than other tobacco products;

b. Full statement of the components, ingredients, additives, and properties,

and of the principle(s) of operation of the new tobacco product; and

c. Full description of the methods used in, and the facilities and controls used

for, the manufacture, processing, packing and installation of the new tobacco product.

21. In addition, some applications may need new nonclinical and clinical studies if

the product’s potential impact on the public health has not yet been sufficiently reviewed, though

in some cases it may be possible to support a marketing order for an ENDS product without

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!2;!See FDA Update on Provisional Substantial Equivalence (SE) Review Process (Apr. 5, 2018), available athttps://www.fda.gov/tobacco-products/ctp-newsroom/fda-update-provisional-substantial-equivalence-se-review-process.



! 16

conducting new nonclinical or clinical studies. For example, if there is an established body of

evidence regarding the health impact (individual or population) of a product or a similar product

that can be adequately bridged to product that is the subject of the application, such as data from

the published literature or government-sponsored databases, these data may be sufficient to

support a PMTA.

22. Plaintiffs’ proposed 120-day deadline for the submission of premarket

applications does not account for the sheer number of expected applications, the complexity of

those applications and the scientific review process, or the public health and operational concerns

I have described. I believe that a submission deadline at least 10 months away would reflect a

much better balancing of the competing concerns and, though still accelerated, would at least

reduce the potential for administrative disruption and the risk of a mass market exit that could

adversely affect the public health.

!!

I declare under penalty of perjury that the foregoing is true and correct to the best of my

information, knowledge, and belief.

Dated: Silver Spring, Maryland

June 12, 2019

_____________________________________ Mitchell Zeller Director, Center for Tobacco Products United States Food and Drug Administration


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EXHIBIT G


UNITED STATES DISTRICT COURT

DISTRICT OF MARYLAND

CHAMBERS OF 6500 CHERRYWOOD LANE PAUL W. GRIMM GREENBELT, MARYLAND 20770 UNITED STATES DISTRICT JUDGE (301) 344-0670 (301) 344-3910 FAX

October 2, 2019

LETTER ORDER

RE: AAP v. FDA PWG-18-883

Previously, trade associations from the vapor industry1 and other third parties sought leave “to intervene in this case for the purpose of addressing the appropriate remedy in light of the Court’s May 15, 2019 Order,” e.g., ITG Brands Ltr. 1, ECF No. 76; see also ECF Nos. 77, 79, 80, 81, and I denied the requests because they were untimely and the proposed intervenors did not “mount a strong showing” that the Government could not adequately represent their interests or show that the protection of their interests would be impaired without intervention. May 31, 2019 Ltr. Order, ECF No. 84 (quoting Stuart v. Huff, 706 F.3d 345, 352 (4th Cir. 2013)). I then issued a Memorandum Opinion and Order regarding the remedy in this case (“Remedy Order”), providing for a ten-month implementation period, which the Government had proposed. ECF No. 127. Believing that the Remedy Order was not in their best interest, the Vapor Associations appealed the order denying them leave to intervene. ECF No. 128. That appeal is pending before the Fourth Circuit.

Now pending in this Court are letter motions that the Vapor Associations, as well as the Cigar Association of America, the Premium Cigar Association (formerly International Premium Cigar and Pipe Retailers Association), and Cigar Rights of America (the “Cigar Associations”) have filed, seeking leave to intervene in this case for purposes of appealing the May 15, 2019 Memorandum Opinion and Order, ECF Nos. 73 & 74, and the Remedy Order, and asking to stay the Remedy Order, ECF No. 127, pending resolution of the proposed appeals. Vapor Ass’ns Mot. to Intervene, ECF No. 130; Vapor Ass’ns Mot. to Stay, ECF No. 139; Cigar Ass’ns Mot to Intervene, ECF No. 135; Cigar Ass’ns Mot. to Stay, ECF No. 140.2 The circumstances have

1 The vapor industry trade associations (“Vapor Associations”) are American E-Liquid Manufacturing Standards Association; American Vaping Association; Arizona Smoke-Free Business Alliance; Indiana Smoke-Free Association; Iowans for Alternative to Smoking and Tobacco; Kentucky Smoke-Free Association; Maryland Vapor Alliance; New York State Vapor Association; Ohio Vapor Trade Association; Right to be Smoke-Free Coalition; Smoke-Free Alternatives Trade Association (SFATA); SFATA-California; SFATA-Connecticut; SFATA-Hawaii; SFATA-Louisiana; SFATA-Rhode Island; SFATA-Texas; SFATA-Wisconsin; Tennessee Smoke-Free Association; and Texas Vapor Coalition. 2 The parties opposed the Vapor Associations’ Motion to Intervene, ECF Nos. 141, 142; the Vapor Associations’ Motion to Stay, ECF Nos. 144, 145; the Cigar Associations’ Motion to Intervene, ECF Nos. 142, 148; and the Cigar Associations’ Motion to Stay, ECF Nos. 147, 148. The Vapor


2

changed for the Vapor Associations, given that the Remedy Order imposed an earlier deadline for the manufacturers to submit pre-market tobacco applications (“PMTAs”); the Vapor Associations have no other opportunity to provide their views on the deadline imposed in the Remedy Order; and the Government’s objectives appear to have diverged from the interests of the Vapor Associations that seek to intervene. See Stuart, 706 F.3d at 350. Accordingly, I will grant the Vapor Associations’ Motion to Intervene exclusively for the limited purpose of filing an appeal of the May 15, 2019 Memorandum Opinion and Order and the Remedy Order and for no other purpose. The Cigar Associations have not submitted a timely motion, nor shown an interest in the subject matter of this litigation that would be impaired by this action, however, and therefore I will deny their Motion to Intervene. Accordingly, I will deny the Cigar Associations’ Motion to Stay as moot. I also will deny the Vapor Associations’ Motion to Stay because, as noted, the Remedy Order does not impose immediate deadlines, and the Vapor Associations have not shown that “a pressing need exists.” See Osei v. Univ. of Maryland Univ. Coll., No. DKC 15-2502, 2019 WL 2076105, at *2 (D. Md. May 10, 2019). The Vapor Associations may, of course, seek a stay from the Fourth Circuit.

Vapor Associations’ Motion to Intervene

I previously observed that intervention as of right by a third party is appropriate pursuant to Rule 24(a) when the third party submits a timely motion to intervene and “can demonstrate ‘(1) an interest in the subject matter of the action; (2) that the protection of this interest would be impaired because of the action; and (3) that the applicants’ interest is not adequately represented by existing parties to the litigation.’” Stuart v. Huff, 706 F.3d 345, 349 (4th Cir. 2013) (quoting Teague v. Bakker, 931 F.2d 259, 260–61 (4th Cir. 1991)); see Fed. R. Civ. P. 24(a)(2); CX Reinsurance Co. Ltd. v. B&R Mgmt., No. ELH-15-3364, 2017 WL 371800, at *3 (D. Md. Jan. 26, 2017 (“[T]imeliness is a ‘cardinal consideration’ of whether to permit intervention . . . .” (quoting Houston Gen. Ins. Co. v. Moore, 193 F.3d 838, 839 (4th Cir. 1999))).

Defendants argue that the Vapor Associations’ and Cigar Associations’ attempts to intervene are not timely “because they have known of the divergence of their interests from the FDA’s since at least September 2018.” Defs.’ Opp’n to Vapor Ass’ns Mot. 1; Defs.’ Opp’n to Cigar Ass’ns Mot. 1. Plaintiffs agree. Pls.’ Opp’n 1 (noting Vapor Associations’ only support for its position, Smoke v. Norton, 252 F.3d 468, 471 (D.C. Cir. 2001), “did not set an ironclad rule that post-judgment motions to intervene were timely”); id. at 2–4 (noting Cigar Associations’ repeated failure to raise arguments previously in this case). Indeed, in denying the Vapor Associations’ earlier attempt to intervene, I noted that their efforts were “anything but timely.” May 31, 2019 Ltr. Order 2.

This Court certainly has the discretion to deny a motion to intervene as untimely. See Columbus-Am. Discovery Grp. v. Atl. Mut. Ins. Co., 974 F.2d 450, 478 (4th Cir. 1992); Gould v. Alleco, Inc., 883 F.2d 281, 286 (4th Cir. 1989). In exercising its discretion, the Court considers

Associations have filed replies, ECF Nos. 146, 149, and the Cigar Associations filed a reply in support of both of their motions, ECF No. 152. Additionally, Plaintiffs filed a request to file a surreply regarding the Vapor Associations’ request to stay, ECF No. 151, and the Vapor Associations filed a reply to the surreply, ECF No. 153. A hearing is not necessary. See Loc. R. 105.6.


3

“how far the suit has progressed, the prejudice which delay might cause other parties, and the reason for the tardiness in moving to intervene.” Id. (citing Gould, 883 F.2d at 286).

Defendants argue that the FDA “is working to finalize a new policy in the coming weeks that would include prioritizing the agency’s enforcement of the premarket authorization provision against non-tobacco-flavored e-cigarettes,” such that “a successful challenge to the [Remedy] order … is unlikely to give the proposed intervenors the relief they seek,” and therefore “the prejudice ‘threatened by intervention’ outweighs ‘the advantages promised by it.’” Defs.’ Opp’n 2-3 (quoting May 31, 2019 Ltr. Order 3 (quoting Ohio Valley Envtl. Coal., Inc. v. McCarthy, 313 F.R.D. 10, 20 (S.D. W. Va. 2015))). Certainly, litigation in this Court has concluded with the issuance of a final judgment, see May 15, 2019 Order; Remedy Order, and the FDA asserts that it will be enforcing the regulations in an expedited fashion. Nonetheless, the Vapor Associations’ delay is justified and cannot cause prejudice with respect to the action in this Court because it has concluded, and all that remains is the resolution of any appeal of the final orders that have been issued.

Notably, in my earlier order denying leave to intervene, I observed that, “until a remedy is proposed and ordered by the Court, Applicants cannot show that their rights will be impaired.” May 31, 2019 Ltr. Order 2. Accordingly, under the circumstances of this case, although the Vapor Associations were on notice months earlier that the FDA, if unable to secure a dismissal, could fail to represent the Vapor Associations’ interests adequately, the Vapor Associations could not, practically speaking, successfully intervene until the harm to their interests was apparent. See id. Thus, the parties were not prejudiced by the Vapor Associations’ failure to seek intervention earlier than it did, as the motion would not have been granted before the Remedy Order issued; indeed, I denied their earlier motion. Therefore, I will not deny the Motion to Intervene based on timeliness. See Columbus-Am. Discovery Grp., 974 F.2d at 478; Gould, 883 F.2d at 286. See generally Outdoor Amusement Bus. Ass’n. v. Dep’t of Homeland Sec., No. ELH-16-1015, 2017 WL 2778820, at *9 (D. Md. June 26, 2017) (concluding that, “under the particular facts and circumstances of th[e] case, the filing of the Motion some ten months after the suit was initiated is not a basis to deny the Motion,” even though the proposed intervenors had “change[d] [their] strategy, from one of ‘deliberate forbearance’ to a more proactive course of conduct,” because “the case [was] still in its early stages” and there was no prejudice to the parties”).

Defendants also challenge the adequacy of the Vapor Associations’ interest in the subject matter of this case. Defs.’ Opp’n 2. While “Rule 24 does not specify what type of interest a party must have to intervene as a matter of right, . . . the Supreme Court has recognized that ‘[w]hat is obviously meant . . . is a significantly protectable interest.’” JLS, Inc. v. Pub. Serv. Comm’n of W. Va., 321 F. App’x 286, 289–90 (4th Cir. 2009) (quoting Teague v. Bakker, 931 F.2d 259, 261 (4th Cir. 1991) (quoting Donaldson v. United States, 400 U.S. 517, 531 (1971), superseded on other grounds by 26 U.S.C. § 7609)). The Vapor Associations assert that “[t]heir businesses and the products they sell to adult consumers are the very subject of the Plaintiffs’ lawsuit” and therefore the filing deadlines set in the Remedy Order and the FDA’s PMTA requirements apply to them. Vapor Ass’ns Mot. 2. Defendants insist that this is not “a significantly protectable interest.” Defs.’ Opp’n 2 (quoting Donaldson, 400 U.S. at 542). They argue:

They have no substantive right to avoid the Tobacco Control Act’s premarket review provision, 21 U.S.C. § 387j(a)(2), which by virtue of the deeming rule has applied to them since August 2016. And nothing in the challenged August 2017 compliance policy conferred any entitlement to deferred enforcement of that


4

provision. . . . Thus, although the proposed intervenors may now claim a practical interest in deferred enforcement of the premarket review provision, that interest is not a legally protectable one.

Id.

In JLS, the plaintiff, a motor passenger carrier, sought a declaration that it was subject only to federal regulation and not state regulation when it transported railroad employees “to and from different points along railroad lines,” even if the transportation did not cross state lines. 321 F. App’x at 287. The proposed intervenors were subject to the state regulations that JLS sought to avoid, and they “derive[d] substantial revenue from transporting railroad crews under their [state] authority.” Id. at 289–90. The JLS Court concluded that they had a protectable interest because the outcome of the case—i.e., whether JLS was subject to state regulation—“w[ould] determine the level of competition that Movants will have, and hence, the amount of income they can expect to earn.” Id.

In reaching its conclusion in JLS, the Fourth Circuit discussed its previous decision in Feller v. Brock, 802 F.2d 722 (4th Cir. 1986), in which individual, domestic apple pickers sought to intervene in litigation that apple growers brought against the Department of Labor regarding “the growers’ rights to be issued temporary foreign worker certifications.” 321 F. App’x at 289–90. The Feller Court held that the proposed intervenors “had an interest in the suit sufficient to support intervention as a matter of right” because the lawsuit’s effects on the availability of foreign workers in turn would impact the domestic workers’ wages. Id. at 290 (citing Feller, 802 F.2d at 730).

More recently, the Supreme Court held that “an intervenor of right must have Article III standing in order to pursue relief that is different from that which is sought by a party with standing.” Town of Chester, N.Y. v. Laroe Estates, Inc., 137 S. Ct. 1645, 1651 (2017). As I have discussed previously, a plaintiff (or proposed intervenor) has standing if

(1) [it] has suffered an “injury in fact” that is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical; (2) the injury is fairly traceable to the challenged action of the defendant; and (3) it is likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.

Am. Acad. of Pediatrics v. Food & Drug Admin., 379 F. Supp. 3d 461, 474 (D. Md. 2019) (quoting Zaycer v. Sturm Foods, Inc., 896 F. Supp. 2d 399, 408 (D. Md. 2012)).

Here, the businesses represented by the Vapor Associations manufacture and sell the e-cigarette products at issue in this case. Therefore, they are subject to the FDA’s PMTA requirements and they will be directly affected by the filing deadlines, which could impact sales that otherwise would be possible without the Remedy Order’s accelerated deadline, if the businesses and manufacturers are not able to meet the deadline and obtain approval for their sales. See Vapor Ass’ns Mot. 2. While the Defendants are correct that the Vapor Associations have known for a considerably long time about their obligation to comply with the FDA’s PMTA requirements, yet chose not to reach out to the FDA to begin the process of compliance, their “head in the sand” indifference to their obligations now may result in their inability to manufacture, advertise, and sell products, which, although the product of their own deliberate inaction, is an actual, concrete and particularized injury that will result from the FDA’s deadlines, unless they succeed in their appeal to the Fourth Circuit in obtaining an extension of those deadlines. Thus, I


5

am persuaded that the Vapor Associations have shown that they have standing and a protectable interest that justifies their intervention for the limited purpose of appealing my final rulings, as the Remedy Order affects the FDA regulations that control the businesses’ activities and ability to profit in the vapor industry. See Feller, 802 F.2d at 730; JLS, 321 F. App’x at 289–90; Am. Acad. of Pediatrics, 379 F. Supp. 3d at 474; Zaycer, 896 F. Supp. 2d at 408.

Further, they claim that the accelerated deadlines in the Remedy Order would be devastating to their industry, and the Government is moving toward enforcement rather than protecting their interests. See Vapor Ass’ns Mot. to Intervene 2; Remedy Order 12 (“[T]he FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule . . . , applications for marketing orders must be filed within 10 months of the date of this Memorandum Opinion and Order [July 11, 2019].”). The parties do not challenge whether “the protection of this interest would be impaired because of the action” or whether the parties adequately represent the Vapor Associations’ interest. See Stuart, 706 F.3d at 349. Thus, the Vapor Associations have demonstrated that they should be permitted to intervene as of right. See id.; Fed. R. Civ. P. 24(a)(2). Their Motion to Intervene is granted exclusively for the limited purpose of filing an appeal of the May 15, 2019 Memorandum Opinion and Order and the Remedy Order and for no other purpose.

Vapor Associations’ Motion to Stay

The Court “possesses broad discretion to stay proceedings as part of its power ‘to control the disposition of the causes on its docket with economy of time and effort for itself, for counsel, and for litigants.’” Osei v. Univ. of Maryland Univ. Coll., No. DKC 15-2502, 2019 WL 2076105, at *2 (D. Md. May 10, 2019) (quoting Landis v. N. Am. Co., 299 U.S. 248, 254 (1936)). To obtain a stay, the Vapor Associations must show “that a pressing need exists, and ‘that that need outweighs any possible harm to the interests of the non-moving party.’” Id. (quoting Mike’s Train House, Inc. v. Broadway Ltd. Imports, LLC, No. JKB-09-2657, 2011 WL 836673, at *1 (D. Md. Mar. 3, 2011); citing Landis, 299 U.S. at 255). Here, there simply is no pressing need. The Remedy Order does not impose an immediate deadline; rather, the deadline for submissions that the Vapor Associations seek to challenge is ten months from the issuance of the July 11, 2019 Remedy Order. Therefore, the Vapor Associations’ Motion to Stay is denied. See Osei, 2019 WL 2076105, at *2. They may, of course, seek a stay from the Fourth Circuit.

Cigar Associations’ Motions to Intervene and to Stay

The Cigar Associations seek to intervene because this case “potentially could disrupt the long-settled course of proceedings” in Cigar Association of America v. FDA, No. 16-1460, before Judge Mehta in the United States District Court for the District Court for the District of Columbia, an ongoing case in which they filed a challenge to the Deeming Rule in 2016. Cigar Ass’ns Mot. 1. According to the Cigar Associations, they recently were granted leave in that case “to amend their complaint and to seek a declaratory judgment that the deadline for substantial equivalence applications for cigars and pipe tobacco set forth in the August 2017 Guidance remains valid for those particular products or, in the alternative, for the Cigar Associations and their members.” Id. at 2. They also insist that “[t]he extension of the substantial equivalence deadline to 2021 for cigars and pipe tobacco was the product of negotiations with the Department of Justice and the agency, at the encouragement of the Court in Washington, to resolve (at least temporarily) certain aspects of the Cigar Association matter.” Id. As for their interest in this litigation, they assert:


6

The Cigar Associations and their members have relied on the deadline relief in the Guidance in managing the litigation in the Cigar Association case and agreeing to defer their challenges to the Deeming Rule’s substantial equivalence regime The Cigar Associations further have relied on the FDA’s assertions that they would have the necessary “rules of the road” before being required to prepare any substantial equivalence reports.

Id.

Plaintiffs argue that the Cigar Associations’ motion is untimely and that their “interest will not be ‘impaired’ if they are denied intervention,” because they never raised this issue in this case, and therefore they cannot raise it on appeal. Pls.’ Opp’n 2, 4. Defendants raise the same challenges that they asserted regarding the Vapor Associations’ proposed intervention: timeliness, adequacy of interest, and prejudice. Defs.’ Opp’n 1. They also contend that the grounds on which the Cigar Associations rely are “incorrect.” Id.

It is true that the Cigar Associations’ motion is untimely. The litigation in the District of Columbia preceded this case and they could have sought to intervene months earlier. And, unlike the Vapor Associations that could not previously show harm to their interests, the Cigar Associations have been aware for months that this litigation challenged the deadlines that they believed they had negotiated to extend. Yet they chose not to seek leave to intervene previously, waiting instead to see if the case would survive Defendants’ motion to dismiss and, when it did, to see what the remedy would be. “Such deliberate forbearance understandably engenders little sympathy.” Alt v. U.S. E.P.A., 758 F.3d 588, 591–92 (4th Cir. 2014) (noting that proposed intervenor “candidly acknowledge[d] that it had closely monitored the proceedings in Alt’s lawsuit and made a strategic decision not to devote its ‘limited resources’ to the matter at an earlier stage, believing the court would grant the EPA’s motion to dismiss,” and therefore it was not an abuse of discretion to deny the untimely motion to intervene).

The Cigar Associations have not provided any justification for their delay in raising their issues in this litigation. Further, a final judgment has been entered in this case, and the parties did not have the opportunity to address these issues in this Court previously. These factors weigh heavily in favor of exercising this Court’s discretion to deny the Cigar Associations’ Motion to Intervene, treated as either a motion for intervention as of right or permissive intervention. See Columbus-Am. Discovery Grp., 974 F.2d at 478; Gould, 883 F.2d at 286; Fed. R. Civ. P. 24(b)(3) (providing that Fed. R. Civ. P. 24(b)(1), pertaining to permissive intervention, requires the court, in the course of its analysis, to “consider whether the intervention will unduly delay or prejudice the adjudication of the original parties’ rights”); see also Md. Restorative Justice Initiative v. Hogan, 316 F.R.D. 106, 112 (D. Md. 2016) (“The decision to grant or deny permissive intervention ‘lies within the sound discretion of the trial court.’” (quoting Smith v. Pennington, 352 F.3d 884, 892 (4th Cir. 2003)).

Moreover, “issues raised for the first time on appeal generally will not be considered.” Gen. Ins. Co. of Am. v. U.S. Fire Ins. Co., 886 F.3d 346, 356 (4th Cir. 2018), as amended (Mar. 28, 2018) (quoting Muth v. United States, 1 F.3d 246, 250 (4th Cir. 1993)). Consequently, the Cigar Associations’ Motion to Intervene comes too late. See id. And, the delay that litigating new issues theoretically would cause after the issuance of a final judgment is not outweighed by the Cigar Associations’ potential success on appeal if permitted to intervene for the limited purpose of prosecuting an appeal, given that the Fourth Circuit does not hear new issues on appeal. See


7

id.; Fed. R. Civ. P. 24(b)(3). Their motion is denied. Because their Motion to Intervene is denied, their Motion to Stay pending their appeal is denied as moot.

In sum, the Vapor Associations’ Motion to Intervene, ECF No. 130, is granted. They may intervene exclusively for the limited purpose of filing an appeal of the May 15, 2019 Memorandum Opinion and Order and the Remedy Order and for no other purpose. The Vapor Associations’ Motion to Stay, ECF No. 139, and the Cigar Associations’ Motion to Intervene, ECF No. 135, and Motion to Stay, ECF No. 140, are denied.

Although informal, this is an Order of Court and will be docketed accordingly.

Sincerely, /S/ Paul W. Grimm United States District Judge

lyb


EXHIBIT H


1



Plaintiffs, v. FOOD AND DRUG ADMINSTRATION, et al.,

Defendants.


DECLARATION OF STACEY M. BENSON, Ph.D.

1. I, Stacey M. Benson, make this declaration pursuant to 28 U.S.C. § 1746.

Background Qualifications

2. I am an epidemiologist with over 14 years of professional experience conducting,

analyzing, and interpreting scientific data using well-accepted scientific methodology.

3. I currently serve as a Supervising Health Scientist and Epidemiology Practice

Area Lead at Cardno ChemRisk, a global consulting firm specializing in, among other areas,

product health and safety. My areas of expertise include environmental epidemiology,

occupational epidemiology, respiratory protection, and clinical research. I received my

undergraduate degree (B.S.) in physics from St. Lawrence University, my masters degree (M.S.)

in the field of exercise physiology from the University of Pittsburgh, and my Ph.D. in

Epidemiology from the University of Pittsburgh.

4. Prior to joining Cardno ChemRisk, I held positions as a lecturer at Carnegie

Mellon University and as an adjunct instructor at Point Park University, teaching scientific

research methods and concepts, as well as an Associate Service Fellow at the National Institute


2

for Occupational Safety and Health, where I conducted human subject experiments at the

National Personal Protective Technology Laboratory. I have published over 30 scientific articles

and provided 19 presentations at both national and international conferences on my research. In

addition, my scientific research has been cited over 350 times.

Epidemiological Research For PMTA Submissions To FDA

5. In 2016, the Food and Drug Administration (“FDA”) released a guidance

document regarding Premarket Tobacco Product Applications (“PMTA”) for Electronic Nicotine

Delivery Systems (“ENDS”). This document describes the types of data and information that

must be submitted in order to meet the Tobacco Control Act’s (“TCA”) requirement that a new

tobacco product be protective of public health. As detailed in the draft guidance, a

comprehensive assessment of each product requires an evaluation of the short and long-term

human health effects of initiation, cessation, and abuse liability, as well as the potential impact of

the product on vulnerable populations. The findings must be generalizable to the U.S.

population and include impacts on both users and non-users of the product (FDA, 2016).

6. Epidemiology is one field of science that is used to conduct human research to

assess the relationship between exposures to a substance or product and any health impacts.

7. A variety of epidemiologic study designs exist to evaluate associations between

health-related exposures and outcomes. Although no single epidemiologic study can be used to

identify a causal relationship, and each study design provides different value to this assessment, a

collective body of consistent evidence that is obtained from studies using valid techniques can be

used to assess causation. Conducting robust epidemiological studies with human subjects, and

evaluating causal relationships, takes time.


3

8. Set forth below is a description of several common epidemiological study

designs, which identifies the overall objective of each study type, as well as the ability (or

strength) of the design to assess associations between exposures and health impacts. These

descriptions also estimate the time needed to conduct each type of study when evaluating the

potential health effects of e-cigarettes and other ENDS devices. The time necessary to conduct

each of these study types may vary depending on the nature of the research question, the sample

size, study population, funding sources and various other study-related factors.

9. The following time estimates were determined by reviewing the reported

timetables for studies of e-cigarette and ENDS exposures that were federally funded in 2017

(Table 1). Federal RePORTER (https://federalreporter.nih.gov/) is a searchable database of

scientific awards provided by federal agencies like the National Institutes of Health, the National

Science Foundation, the Environmental Protection Agency, and others. The Federal ExPORTER

(https://federalreporter.nih.gov/FileDownload ) function was used to download data on Fiscal

Year 2017-funded studies, which includes information for project start and end dates.

10. A search was then performed using key “Project Terms” of “ENDS”,

“cigarettes/electronic cigarettes” and “NRT” (a/k/a “nicotine replacement therapies”) to identify

studies related to these types of products. Studies were further classified based on

epidemiological study type as classified in the “Project Terms,” namely clinical trial, cohort,

cross-sectional, ecological, and descriptive studies. Only epidemiological studies that met these

above specified inclusion criteria were then analyzed for total project duration by calculating the

difference between the project start and end dates, with results summarized in years. Averages

and ranges by epidemiological study type were then calculated.


4

Table 1. Brief Description of Common Epidemiological Study Designs and

Corresponding Study Length Estimates based on Federal RePORTER Data for Tobacco

Product* Federally Funded Research (2017)

Study Design Brief Description Follow-up Period

Required?

Average Anticipated Study Length in

Years (no. of studies)

Range of Anticipated Study

Lengths (years)

Strength of Study for

Evaluating Associations

Experimental Epidemiology

Randomized-Controlled

Trial

"Gold standard" epidemiological study design

that allows for the estimation of causal effects. Exposure is

randomly assigned to subset of participants. Typically high cost and substantial time investment.

Yes

6.67 (16)

1.83-17.68

+++

Observational Epidemiology Analytical Designs

Cohort

Healthy individuals observed over a follow-up period in order

to determine if exposure is longitudinally associated with a

specific health-related event. May be conducted prospectively or retrospectively using existing

records. Relatively high cost and time investment compared to other observational designs.

Yes 5.11 (11) 0.92-18.5 ++

Case-Control

Compares individuals with disease of interest (cases) to

those not affected by disease of interest (controls) in regards to

exposure history.

No NA (0) NA +/++

Cross-Sectional

Designed to examine population or sub-sample of reference

population at one time point. Relatively efficient design, but

incapable of determining causality.

No 2.75 (7) 1.92-4.83 +

Ecological

Utilizes group-level data to evaluate exposure-outcome

relationships on an aggregate level. Frequently employs the

use of publically available data.

No 1.92 (1) NA -

Descriptive Designs

Various Study

Designs

Various descriptive designs exist; however, these do not allow for the evaluation of

exposure-outcome relationships.

No 2.25 (3) 1.92-2.92 -

*Tobacco products included ENDS, combustible tobacco products, and waterpipes


5

Experimental Epidemiology And The Randomized Controlled Trial

11. Experimental (or clinical) epidemiology is a form of analytical epidemiology in

which investigators expose participants to a substance or product via a controlled process.

Specifically, the randomized controlled trial (“RCT”), considered the “gold standard”

epidemiological study design, requires that investigators randomly assign an exposure (often

treatment) to a proportion of study participants. Participants are then observed over a pre-

specified follow-up period, and participants who were exposed are compared to those

participants who were not in regards to the health outcome of interest.

12. When designed and properly conducted, RCTs allow investigators to estimate the

causal effects of an exposure on a specific health-outcome. RCTs, which are typically the most

expensive study design, are also limited by substantial time demands as they require a sufficient

follow-up period for the observation of health effects (Gordis 2009; Shadish et al. 2002; Szklo

and Nieto 2014). At least 16 RCTs specific to ENDS and/or combustible tobacco products were

funded by government agencies in 2017 and the anticipated timeframes ranged from just under

two years to over 17 years, with an average timeframe of over 6.5 years.

Observational Epidemiology

13. Observational epidemiology shares many characteristics with experimental

epidemiology; however, in observational studies, investigators only observe and measure

variables of interest (i.e., health conditions) among participants rather than specifically exposing

them to a substance or product. The following describes various types of observational studies:

Analytical Epidemiology Study Designs

• Cohort Design: Cohort studies follow a group, or cohort, of healthy individuals over

time in order to determine whether a specific exposure is associated with a health event. This


6

type of study may be designed to either prospectively observe a cohort over a sufficient follow-

up period and whether a certain health event has occurred, or may retrospectively identify a

cohort of healthy individuals through historical records and “follow” the individuals’ records to

the present time. An example of a retrospective cohort study would involve occupational

exposures. Industrial manufacturers and other industries working with hazardous materials often

keep personnel records with information scientists can use to trace employees, their exposures,

and disease endpoints over time. Overall, cohort studies allow investigators to determine the

relative risk of disease incidence associated with a specific exposure (Gordis 2009; Shadish et al.

2002; Szklo and Nieto 2014). Eleven cohort studies specific to ENDS, combustible tobacco

products and waterpipes received government funding in 2017, with the shortest study duration

being approximately one year to completion and the longest duration estimated to be 18.5 years.

The average estimated time to complete the cohort studies was over 5 years.

• Case-Control Design: Contrary to the cohort design, a case-control study begins with the

identification of individuals who have a disease of interest (cases) and otherwise similar

individuals who do not (controls). Cases and controls are then compared in regards to their

exposure to a substance or product. Case-control studies do not require follow-up of

participants, and therefore, are less costly and more efficient than cohort studies. However, this

design is particularly susceptible to bias, especially surrounding the identification of controls and

exposures (Gordis 2009; Shadish et al. 2002; Szklo and Nieto 2014). No case-control studies

specific to combustible tobacco products, ENDS or NRTs were funded in fiscal year 2017.

• Cross-sectional Design: Cross-sectional studies are designed to examine a population or

sub-sample of the reference population at a single point or “snapshot” in time. Similar to case-

control studies, the main advantages of cross-sectional studies are their efficiency and relatively


7

low cost. However, cross-sectional designs do not allow causality to be determined, as

temporality of the association cannot be ascertained from “snapshot” cross-sectional analyses

(Gordis 2009; Shadish et al. 2002; Szklo and Nieto 2014). Seven cross-sectional studies specific

to e-cigarettes, combustible tobacco products, and waterpipes were funded in 2017, with the

average time to completion just under three years and a maximum difference in estimated

starting and ending date of just under 5 years.

• Ecologic Design: Ecologic studies differ from the analytical study designs described

above in that they typically look at aggregate-level exposures and diseases within a defined

population as opposed to the individual level. Ecologic studies are commonly conducted using

publically available data and are convenient alternatives when individual-level data is

unavailable. However, because aggregate-level associations do not necessarily represent

associations that exist on an individual level, they are limited in their ability to evaluate

associations between individual-level exposures and outcomes (Gordis 2009; Shadish et al. 2002;

Szklo and Nieto 2014). Only one ecological study specific to e-cigarettes was funded in 2017,

and it was nested within a larger epidemiological investigation, with the estimated timeframe for

conducting this study just under two years.

Descriptive Epidemiology Study Designs

Descriptive epidemiological studies may be designed using a variety of strategies, but

typically these studies make use of existing public data to examine variation in disease rates

within a population. Although descriptive studies provide value in regards to the identification

of high-risk groups, they are not capable of evaluating associations between exposures and health

outcomes (Gordis 2009; Shadish et al. 2002; Szklo and Nieto 2014). Three descriptive studies

were funded in 2017 and had an average time to completion of just over two years.


8

FDA’s PATH Study

14. A specific example of an epidemiological study addressing ENDS is the FDA’s

Population Assessment of Tobacco and Health (“PATH”) Study. This study was initiated in

2011 to inform FDA regulatory activities under the Tobacco Control Act. This longitudinal,

prospective cohort study is a joint collaboration between the National Institute on Drug Abuse,

the National Institutes of Health, and FDA’s Center for Tobacco Products. PATH is specifically

designed to understand how tobacco use, behaviors, and health effects associated with the use of

tobacco products change over time. “Specifically, the design of the PATH Study will allow for

examination of between-person differences and within-person changes over time in patterns of

use of existing and emerging tobacco products, exposures and related biomarkers, risk

perceptions, and health conditions potentially related to tobacco use” (Kasza et al. 2017, p. 343).

When this study is completed and all the data have been analyzed, it may be a source of

information cited by vapor product manufacturers in their PMTAs.

15. One of the key features of the PATH Study is that it was designed to reflect

tobacco use for the entire U.S. population, which is also a key requirement for individual

PMTAs. As directed in the draft guidance, “FDA recommends that when you conduct studies,

you should ensure to the extent possible, that the study findings are generalizable to the

population of U.S. users and nonusers.” (FDA, 2016, p. 39).

16. Although the PATH Study has been underway for seven years, it is still not

complete. FDA is conducting four waves of data collection consisting primarily of participant

surveys and the collection of biospecimens. The third wave of survey data and the biomarker

data have recently become available; however, there have been no analyses of the third wave of

PATH survey data and no studies have been published that assess any of the biomarker data.


9

The third wave of survey data is critical for understanding changes in the use of tobacco products

over time, and the biospecimen data is crucial to understanding exposure and potential harm

related to the use of tobacco products. Overall, this data has taken a half-decade to gather, and

will take several more years to fully analyze. FDA’s PATH study demonstrates the length of

time necessary to address scientific questions for the PMTA. Moreover, until the study has been

completed and fully analyzed, manufacturers will not be able to effectively rely on or cite to the

PATH data in their applications to reduce their own clinical and long-term testing burden.

17. Sufficient time to conduct epidemiological investigations that accurately

evaluate e-cigarette and ENDS exposure in association with various health-related impacts is

paramount. Robust studies that adequately inform researchers on associations between exposure

and disease endpoints require large subject sample sizes and longer follow-up periods, which

increase the cost and time to complete such studies. Further, as with all human subjects research,

investigators interested in examining the potential health effects of these devices must seek and

receive the necessary approvals from an institutional review board to ensure that their study is

conducted ethically, such that participants are fully informed of the nature of the study and

understand their role as participants. All of these factors contribute to the amount of time

scientists need to conduct epidemiological investigations. For these reasons, not only was the

originally proposed PMTA filing deadline of August 8, 2018 insufficient for carrying-out safe

and comprehensive epidemiological evaluations, arguably applicants will need until at least

August 8, 2022, and potentially longer to adequately prepare applications under FDA’s current

interpretation of the PMTA requirements.


10


August 8, 2018.

Stacey M. Benson, Ph.D.


11

References

Gordis, L. (2009). Epidemiology (Fourth edition). Philadelphia, PA: Elsevier Saunders

Kasza, K. A., Ambrose, B. K., Conway, K. P., Borek, N., Taylor, K., Goniewicz, M. L., ... & Kaufman, A. R. (2017). Tobacco-product use by adults and youths in the United States in 2013 and 2014. New England Journal of Medicine, 376(4), 342-353.

Shadish, W., Cook, T., and Campbell, D. (2002). Experimental and Quasi-Experimental Designs for Generalized Causal Inference. Belmont, CA: Wadsworth, Cengage Learning.

Szklo, M., and Nieto, J. (2014). Epidemiology: Beyond the Basics. (Third Edition). Burlington, MA: Jones & Bartlett Learning, LLC, an Ascend Learning Company.

US Food and Drug Association (FDA). (2016). Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems. Guidance for Industry. Accessed: July, 2018. https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf


EXHIBIT I


1




Plaintiffs,

v.


Defendants.


DECLARATION OF STACEY M. BENSON, Ph.D.

1. I am an epidemiologist with over 15 years of professional experience conducting,

analyzing, and interpreting scientific data using well-accepted scientific methodology.

2. I currently serve as a Supervising Health Scientist and Epidemiology Practice

Area Lead at Cardno ChemRisk, a global scientific consulting firm specializing in, among other

areas, product health and safety. Cardno ChemRisk is a consulting firm that provides scientific

advice to the government, corporations, law firms and various scientific/professional

organizations.

3. My areas of expertise include environmental epidemiology, occupational

epidemiology, respiratory protection, and clinical research. I received my undergraduate degree

(B.S.) in physics from St. Lawrence University, my master’s degree (M.S.) in the field of

exercise physiology from the University of Pittsburgh, and my Ph.D. in Epidemiology from the

University of Pittsburgh.


2

4. Prior to joining Cardno ChemRisk, I held teaching positions at Carnegie Mellon

University and Point Park University, and served an Associate Service Fellow at the National

Institute for Occupational Safety and Health, where I conducted human subject experiments at

the National Personal Protective Technology Laboratory. I have published over 30 scientific

articles, presented 28 papers at both national and international conferences, and have been cited

in the scientific literature over 400 times.

5. Cardno ChemRisk has been providing consulting services to electronic nicotine

delivery systems (ENDS) clients for over five years and is currently supporting clients through

the Premarket Tobacco Application (PMTA) process. As such, we are familiar with the PMTA

procedures, at least as they stand today, as well as the many challenges and uncertainties facing

stakeholders attempting to meet the requirements set forth by FDA.

6. In 2016, the Food and Drug Administration (FDA) released a draft guidance

document regarding PMTAs for ENDS. While the draft discussed many aspects of the PMTA

process, including several types of non-clinical and clinical studies that must be completed, there

remained many unanswered questions about, among other issues, various testing protocol

requirements. It was not surprising that many manufacturers, and especially smaller companies

with limited financial resources, were hesitant to start the PMTA process, at least beyond the

early planning stages, based on only a draft guidance.

7. Given FDA’s statements regarding the draft guidance and PMTA process, this

hesitancy was understandable. The FDA Center for Tobacco Products indicated on their website

that the draft PMTA guidance document is “[n]ot for implementation” and “[c]ontains non-

binding recommendations” (FDA, 2018). According to the FDA, once the guidance document is

finalized it “will represent FDA’s current thinking on submitting PMTAs for ENDS products.”


3

(FDA, Accessed June 2019). In August 2018, Commissioner Gottlieb acknowledged that “[a]

key part of achieving [FDA’s] goals is issuing foundational rules and guidances to help industry

better understand what is needed to submit product applications.” He explained further that “in

the coming months,” FDA would “propose new rules to help industry on topics including

Substantial Equivalence, Premarket Tobacco Applications, Modified Risk Tobacco Product

Applications, and Tobacco Product Manufacturing Practices” that would “lay out a transparent,

modern, and science-based framework for manufacturing practices and the development of

tobacco product applications that meet the legal requirements.” (Gottlieb, 2018).

8. It was not until three years later, on June 11, 2019, that FDA released the finalized

PMTA guidance document (FDA, 2019). This document describes on some level the types of

data and information that must be submitted in order to meet the Tobacco Control Act’s (TCA)

requirement that a new tobacco product be protective of public health. As discussed in the

guidance, a comprehensive assessment of each product requires an evaluation of the short and

long-term human health effects of ENDS on the population. These investigations include

product testing, environmental assessments, toxicological studies, and human subject research.

The findings must be generalizable to the U.S. population and include impacts on both users and

non-users of the product (FDA, 2019).

9. Although the final guidance provides some additional insight into how FDA is

going to evaluate the PMTAs, there are still many issues that have not been resolved. For

example, the PMTA applicant must demonstrate high standards for product quality through good

manufacturing practices (GMP), supply chain assessment, and product testing. Applicants must

also demonstrate through an environmental assessment that their products do not have significant

impacts on the environment. Stakeholders, however, are in a tenuous position, because FDA has


4

not issued guidance on GMPs or methods/assumptions that need to be incorporated in the

environmental assessment.

10. To add to the continued uncertainty, the final guidance does not provide

manufacturing or testing standards for devices or e-liquids. For instance, the FDA does not

provide a standard device or device settings for e-liquid manufacturers. The guidance also does

not recommend a standard liquid or set of liquids for open-tank device manufacturers. Instead,

the FDA recommended that applicants conduct tests that reflect a “reasonable range” of

conditions (FDA, 2019 p. 28). Without further direction, however, the applicant runs the risk of

falling short of what FDA expects to see in a PMTA.

11. These details are extremely important as the study design and number of variables

to test in non-clinical and clinical studies can greatly influence the costs and time to execute and

perform these studies. By way of example, there are several variables that could influence

toxicological and clinical study design, execution, and findings regarding product testing: e.g.,

power settings, airflow settings, humectant composition, flavors, nicotine concentrations, and

nicotine type (free base v. nicotine salts). Thus, under one possible interpretation of the final

guidance, a clinical study of a closed device with one power setting, one airflow setting, two

nicotine concentrations, one PG/VG ratio, and three flavors would result in having to test six

potential ENDS use scenarios with the study participants. This type of study design would likely

take 12 to 18 months to plan, perform, analyze and summarize for the PMTA.

12. Further, a clinical study of an open-tank device with two power settings, two

airflow settings, three flavors, three PG/VG ratios, and three nicotine concentrations would be

even more involved and result in 108 possible ENDS use scenarios. This type of study would

likely take several years to complete.


5

13. It is clear that as the number of use scenarios increases, the costs to conduct

clinical studies also increases and, particularly for smaller companies, could easily become

prohibitive. Therefore, having an understanding, before developing and filing the PMTA, of

what the FDA considers adequate for the range of appropriate testing conditions would be

invaluable to the FDA and the applicant in at least two ways: ensuring FDA gets the information

it needs to fairly evaluate the product and to set reasonable limitations on the required research

so that both parties can optimize the use of limited resources.

14. For those of us who are working to complete PMTAs, this means that FDA will

be required to spend a significant amount of time with each applicant (and the consultants and

technicians who are helping them) leading up to the PMTA’s submission to work through

numerous issues so that the application is appropriately robust and complete for a substantive

review by FDA. I was not surprised at all when I reviewed the final guidance to see FDA

repeatedly urging applicants to meet with the agency to discuss particular issues. As just one

example, the finalized guidance recommends that applicants “meet with the FDA to discuss the

approach prior to preparing and submitting an application.” (FDA, 2019 p. 13). This back and

forth will take months, at a minimum, to get the applicant in a place where it can actually

conduct the required studies and research knowing that their efforts will provide useful

information to FDA and satisfy the PMTA requirements.

15. The risks associated with incomplete information and any uncertainties regarding

the PMTA process can even be seen when a sophisticated company is involved. Recently, Philip

Morris became only the second manufacturer to successfully get a tobacco product (in this case,

a heat-not-burn product called IQOS) through the PMTA process. Philip Morris still conducted

studies that ultimately did not weigh into FDA’s evaluation and marketing authorization of the


6

IQOS product. This is a testament to just how complicated and time-consuming PMTA issues

can be for both FDA and the applicants.

16. Philip Morris provided its initial PMTA submission on May 15, 2017. Over the

course of the FDA’s evaluation, the agency communicated and requested additional information

and/or corrected reports 12 times. FDA provided a decision on the IQOS products on April 30,

2019. The process that was undertaken for the IQOS PMTA illustrates two points. First, it took

approximately two years for the FDA to review, provide feedback, and ultimately issue a

marketing authorization for the IQOS product.

17. Second, even with likely communications between the FDA and Philip Morris

throughout the entire application process, there was information included in the PMTA that the

FDA did not consider relevant. For instance, the FDA indicated that the pharmacokinetic studies

conducted in rats were not relevant for informing on human health effects. Philip Morris

conducted a 90-day nose only inhalation study of Sprague-Dawley rats to compare the effect of

exposure to the IQOS Heatsticks, a reference cigarette, and filtered air. The FDA stated “[i]n

vivo studies, such as the 90-day inhalation study, can provide important information about non-

cancer toxicology endpoints, but are not generally sensitive enough to determine systemic

toxicities from chronic tobacco product use.” (CTP IQOS, 2019 p. 38).

18. Philip Morris also conducted several in vitro systems toxicology studies with

human organotypic tissues; the FDA stated the following:

“The experimental approach taken in these studies included using methods that are

exploratory, have not been independently validated, and have unknown utility for

regulatory use. The applicant attempts to extrapolate from acute exposure studies with

naïve tissues that have little or no genetic variability to predict toxicity in a diverse


7

population with a history of cigarette smoking. This limits the use of these data. Thus,

this data does not significantly contribute to the overall toxicological profiles of the

products under review in these applications.” (CTP IQOS, 2019 p. 58).

19. The FDA also provided comments on studies that were not conducted but that

could have, according to FDA, been relevant to determining whether the IQOS product is

appropriately protective of public health. For example:

“No biomarker studies of secondhand exposure to these products were conducted by the

applicant. This type of study could have helped to better understand potential risks to

non-users. There were also no comparisons between IQOS and other tobacco products

(e.g., e-cigarettes). Given that IQOS and e-cigarettes may both be considered by

consumers to be a substitute for cigarettes, a comparison of the differences in exposure

would be useful.” (CTP IQOS, 2019 p. 56).

20. FDA’s comments on the IQOS PMTA are informative, but also lead to

questions/concerns for future PMTA submissions regarding the types of non-clinical and clinical

studies FDA will consider pertinent and informative to evaluate the public health impacts of

newly deemed tobacco products, including ENDS.

21. Further complicating matters, the final guidance recommends that applicants

conduct systematic reviews of “all relevant publications.” (FDA, 2019). New research on these

products is published daily. The National Academy of Science released their report on “Public

Health Consequences of E-Cigarettes” which evaluated over 4,000 publications from the peer-

reviewed literature published prior to February or August of 2017 (depending on topic area)

(NAS, 2018). Since the release of the NAS report, hundreds to thousands of papers have been


8

published in the peer-reviewed literature (Briganti et al. 2019) and the current publication rate

for articles that include the key word “e-cigarette” is over 100 articles per month.

22. These preliminary literature reviews are encouraged by the FDA. Due to the

abundance of available literature, systematic reviews require the applicant to review and evaluate

hundreds of articles for their specific product. Toxicology reviews include in vitro and in vivo

summaries for the following topic areas: carcinogenesis, genotoxicity, mutagencitiy, reactive

oxygen species, inflammation, cytotoxicity, cardiovascular effects, respiratory effects, and

reproductive and developmental toxicity. Epidemiology reviews include the following topic

areas: trends in usage, factors that influence ENDS usage (susceptibility, perception, initiation,

and transition), cessation, respiratory health, cardiovascular disease, biomarkers of harm and

exposure, pharmacokinetics, abuse liability, topography, and population health. These

systematic reviews allow applicants to identify bridging opportunities and data gaps, and informs

the strategic planning for product testing, toxicological evaluations, and human clinical subject

study designs. Needless to say, these reviews will take a significant amount of time and money

to complete, spanning weeks or more as the applicant puts its PMTA together.

23. In addition, even if publicly available studies can be located that are relevant to

the product at issue, it is likely that many product-specific studies will need to be conducted due

to all of these numerous and product-specific variables. For instance, devices contain different

types of components to aerosolize the e-liquid. The e-liquids may also contain any range of

humectant combinations between propylene glycol (PG) and vegetable glycerin (VG). E-liquids

may also consist of free-base nicotine or nicotine salts, with very different nicotine delivery

efficiency. Regardless of the protocols involved, testing all of these variables is expensive and

takes weeks, months, and potentially years to complete (Benson Affidavit, 2018).


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24. Finally, lab capacity for product testing, in vitro tests, and clinical tests is also a

major concern for potential applicants. The labs should be accredited, follow good laboratory

practices, and have the research capabilities to conduct the necessary tests to demonstrate that an

e-cigarette is appropriately protective of public health. Not all laboratories have the capabilities

to perform all of the necessary testing. There are only a handful of laboratories across the

various research categories that have the experience and expertise to conduct these experiments.

As more and more applicants move forward with the PMTA process, laboratory capacity will

reach critical mass, making it impossible for future applicants to move forward with their

submissions in a timely fashion.

25. In the final analysis, we expect the typical PMTA application process – from the

initial planning stages to completion of FDA’s substantive review – to span at least 2 years, if not

more, depending on the tobacco products at issue. The estimated costs are anticipated to be in

the millions. All of this places a high premium on FDA providing predictability for the applicant

in terms of what is required in the PMTA process so that the company can manage risk, as well

as financial and time demands.

26. The process applicants must go through to demonstrate that their new tobacco

product (a device and/or e-liquid) is appropriate for the protection of public health is complex.

Both FDA and companies will need sufficient time to resolve complicated issues associated with,

among other things, protocols for testing and research. Providing rationale to and receiving

feedback from the FDA during the initial phase of the process will hopefully lead to high quality

PMTAs, but will nevertheless expand the timelines for the application process. For these

reasons, the current deadlines need to remain in effect (August 2021 and August 2022).


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June 12, 2019.

STACEY M. BENSON, Ph.D.

References

Benson Affidavit, Am. Academy of Pediatrics v. FDA, Case No. 8:18-cv-883-PWG (Aug. 14,

2018) (Dkt. 37-4).

Briganti, M., Delnevo, C.D., Brown, L., Hastings, S.E. and Steinberg, M.B., 2019. Bibliometric

Analysis of Electronic Cigarette Publications: 2003–2018. International journal of

environmental research and public health, 16(3), p.320.

CTP IQOS. (2019). Center for Tobacco Control. Food and Drug Administration. Technical

Project Lead Review. Philip Morris New Tobacco Product PMTA Submission. Marlboro

Heatsticks, Marlboro Smooth Menthol Heatsticks, Marlboro Fresh Menthol Heatsticks, IQOS

System Holder and Charger. April 30, 2019. Accessed June, 2019.

https://www.fda.gov/media/124247/download.

Gottlieb, S. 2018. Advancing Tobacco Regulation to Protect Children and Families: Updates

and New Initiatives (August 2, 2018), https://www.fda.gov/news-events/fda-voices-perspectives-

fda-experts/advancing-tobacco-regulation-protect-children-and-families-updates-and-new-

initiatives-fda.

National Academies of Sciences Engineering and Medicine (NAS). (2018). Public Health

Consequences of E-Cigarettes. A Consensus Study Report. Accessed: June, 2019.

https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes.

US Food and Drug Administration (FDA). (2016). Premarket Tobacco Product Applications for

Electronic Nicotine Delivery Systems. Guidance for Industry. Accessed: June, 2019.

https://www.fda.gov/media/97652/download.

US Food and Drug Administration (FDA). Draft Guidance: Premarket Tobacco Product

Applications for Electronic Nicotine Delivery Systems. Presentation by Paul Hart and Li-Lun

Chen. Accessed June 2019. https://www.fda.gov/media/97881/download.

US Food and Drug Administration (FDA). (2018). Guidance Document. Premarket Tobacco

Product Applications for Electronic Nicotine Delivery Systems (ENDS) Guidance for Industry.

May 2016. Accessed: June, 2019. https://www.fda.gov/regulatory-information/search-fda-

guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery-

systems-ends.


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