october 21, 2015 presented by mitch zeller center director fda center for tobacco products fda’s...

October 21, 2015

Presented byMitch ZellerCenter DirectorFDA Center for Tobacco Products

FDA’S REGULATION OF TOBACCO: A YEAR IN REVIEW

October 21, 2015 | FDLI2

OVERVIEW OF TODAY’S PRESENTATION

• Implementing the Tobacco Control Act

• Updates on Strategic Priorities


IMPLEMENTING THE TOBACCO CONTROL ACT


CTP has authority to regulate tobacco products intended for human consumption to reduce harm across the population• Regulate the manufacture, marketing, and

distribution of cigarettes, cigarette tobacco, roll-your-own, and smokeless

• Assert jurisdiction over other products that meet the definition of a tobacco product, including e-cigarettes, cigars, and hookah

CARRYING OUT HISTORIC LEGISLATION


USING OUR REGULATORY AUTHORITY

• Understand the regulated products• Restrict product changes to protect public health• Prohibit modified risk claims that state/imply reduced exposure

or risk without an order • Restrict marketing and distribution to protect public health• Decrease the harms of tobacco products• Ensure industry compliance with FDA regulation through

education, inspections, and enforcement• Educate the public about FDA’s regulatory actions • Expand the science base for regulatory action and evaluation


• Regulatory– Deeming Final Rule • Legislative

– House FY ‘16 Agriculture Appropriations Bill– Child Nicotine Poisoning Prevention Act of 2015

and local legislation • Litigation

– TPSAC Reconstitution – Substantial Equivalence (SE) FAQ Guidance

UPDATING REGULATORY, LEGISLATIVE & LITIGATION ACTIONS


UPDATE ON STRATEGIC PRIORITES

• Product Standards• Comprehensive FDA Nicotine Regulatory

Policy• Pre- & Post-Market Controls:

Regulations & Product Reviews• Compliance and Enforcement • Public Education


PRODUCT STANDARDS


• Advancing a product standard strategy that yields strong standards to improve public health

• Exploring potential standards for:– Addictiveness– Toxicity – Appeal

IMPLEMENTING ONE OF THE LAW’S MOST POWERFUL TOOLS


COMPREHENSIVE FDA NICOTINE REGULATORY POLICY


• Establish an integrated, FDA-wide policy on nicotine-containing products that is public health-based

• Understand implications for tobacco, drug, and device regulatory policy

LOOKING AT NICOTINE DIFFERENTLY


avoid consumer confusion

Related actions include:• Finalize Deeming regulation• Working with CDER and CDRH to determine how

regulation of therapeutic nicotine products (Rx, OTC, drugs, devices) could evolve

• Exploring options for expedited premarket review policy based on relative toxicity and risk

• Issued Jurisdictional Proposed Rule– Describes circumstances in which a product made or derived

from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the FD&C Act

– Intended to provide direction to regulated industry and – Comment period open until November 24




• Recognize that there is a continuum of nicotine-containing products• Understand that people smoke for the nicotine but die from the tar• Acknowledge public health opportunity• Also acknowledge role that flavored tobacco products may play in

holding back progress in harm reduction

COMBUSTIBLES NRT

October 21, 2015 | FDLI

THE NICOTINE REALITY

14

• It’s not the drug…it’s the delivery mechanism• The disease and death is primarily due to combusting tobacco

products• So if Michael Russell was right 40 years ago, how should we be

thinking about nicotine today?• The “net” assessment of population-level impact is key

– Potential benefit to currently addicted smokers unable or unwilling to quit who completely substitute

– Clear harm from any initiation by kids– Unknown longer-term impact of dual use rather than complete

substitution– Unknown impact on cessation rates


PRE- & POST-MARKET CONTROLS – REGULATIONS AND PRODUCT REVIEWS


SETTING PRE- & POST-MARKETING POLICY

New rules & guidances issued in August & September 2015: • Investigational Tobacco Products (ITP) Draft Guidance

– FDA’s current thinking on the definition of ITPs and kind of information FDA intends to consider when making enforcement decisions

– Comment period open until November 23• Substantial Equivalence (SE) FAQ Final Guidance

– FDA’s current thinking on changes to tobacco products’ label, product quantity in the package, additives, or specifications

• Nicotine Exposure Warning & Child-Resistant Packaging for E-Liquids ANPRM– Seeking information related to nicotine exposure warnings and child-resistant

packaging for liquid nicotine, nicotine-containing e-liquid(s), and other tobacco products

• National Environmental Policy Act (NEPA) Categorical Exclusions Final Rule– Adds exclusions to certain types of actions that do not normally cause significant

environmental effects


MEASURING PROGRESS IN MAKING SE DECISIONS

5,574 SE Submissions• 99% of acceptance reviews (jurisdiction and

administrative) for full, regular reports are complete

Regular Reports• Resolved 65% via Order letter, Refuse-To-Accept

letter or Withdrawal• Review of new regular reports starts upon

receipt, as there is no backlog• Established performance measures for review

and actionProvisional Reports• Resolved 15% via Order letter, Refuse-To-Accept

letter or withdrawal

Regular1,98336%

Data as of 10/1/15

Provisional3,59164%


TAKING ACTION ON PROVISIONAL TOBACCO PRODUCTS

• September 2015: Issued 4 provisional NSE orders to R.J. Reynolds cigarettes, including Camel Crush Bold

• Failed to demonstrate that increased yields of HPHCs, higher levels of menthol, and/or the addition of new ingredients – when compared to the predicate products – did not raise different questions of public health

– Camel Crush Bold - failed to demonstrate that the addition of a menthol capsule in the filter did not affect consumer perception and use

• Products can no longer be sold, distributed, imported or marketed in interstate commerce; 30-day period of enforcement discretion for retailers has expired


MODIFIED RISK TOBACCO PRODUCT (MRTP)

• Swedish Match North America, Inc. MRTP applications accepted for filing and review in August 2014• Made applications available for comment for 180 days

– Comment period for amendments closed August 31, 2015– The Tobacco Products Scientific Advisory Committee meeting held April 9-

10, 2015 discussed scientific issues related to the Swedish Match North America, Inc. modified risk tobacco product applications currently under scientific review at CTP

• Published Draft Guidance – Draft Guidance for Industry: Modified Risk Tobacco Product Applications


COMPLIANCE AND ENFORCEMENT


• Conducted over 508,000 retailer inspections covering 56 states and territories

• Issued more than 35,700 warning letters• Issued over 5,200 civil money-penalty (CMP)

actions against tobacco retailers• Issued final guidances

– No-Tobacco-Sale Order in August 2015– CMP & NTSO FAQ Final Guidance in May 2015

MEASURING COMPLIANCE PROGRESS TO DATE

Data as of 10/1/15


• Issued warning letters to three tobacco manufacturers for describing cigarettes on product labeling as “additive-free” and/or “natural” in August 2015

• MRTP claims being made without authorization

- Winston cigarettes with the MRTP claim “Additive-free”

- Natural American Spirit cigarettes with the MRTP claims "Natural” and “Additive-free”

- Nat Sherman cigarettes with the MRTP claim “Natural”

TAKING COMPLIANCE AND ENFORCEMENT ACTION


PUBLIC EDUCATION


EDUCATING THE YOUTH ON THE DANGERS

10 Million

General “At Risk” MarketMulticultural

RuralAmerican Indian/

Alaska NativeLGBT

Prevention Investing in our Future


THE REAL COST CAMPAIGN


MEASURING EFFECTIVENESS

Reach• Reached over 90% of teens more than 20x a quarter, exceeding 75% goal

Engagement• Attracted 9M unique visitors from all 50 states to the website

Motivation to rethink their relationship with tobacco• Produced 2.1M campaign-related unique conversations via social media

“Struggling to breathe has been happening while I sleep...I try to stop

but it’s a really hard addiction to

get over.”

“I don’t think it’s cool… Not my fault

I got addicted. Tryna quit.”

“I used to think it made people look cool until I saw my

teeth getting yellow and I got sores on my

gums all the time.”

“I always thought smoking was foul and killed people.

The only difference is now I understand

how.”


FRESH EMPIRE CAMPAIGN


THE IMPORTANCE OF REACHING MULTICULTURAL YOUTH

• The campaign targets youth who have historically been underserved by previous tobacco control efforts and are considered a hard-to-reach population

• The 2012 Preventing Tobacco Use Among Youth and Young Adults Surgeon General Report reported that there is “sufficient evidence to conclude that there is a causal relationship between peer group social influences and the initiation and maintenance of smoking behaviors during adolescence”

• Tobacco use contributes to a range of negative health outcomes, such as cancer, heart disease, and respiratory illness, and these consequences disproportionately affect some minority racial groups, with African Americans experiencing the greatest health burden


THE FRESH EMPIRE CAMPAIGN

The Fresh Empire campaign leverages the peer crowd approach to reach at-risk Multicultural youth (ages 12-17) – specifically African-American, Hispanic, Asian/Pacific-Islander – and encourage them to live tobacco-free


CAMPAIGN OVERVIEW

Placeholder for Director X video


LAUNCH PLAN

May 2015• Campaign pilot launched in four cities in the Southeast (Atlanta,

GA; Charlotte, NC; Raleigh-Durham, NC; and Birmingham, AL)

October 2015• Campaign ads started airing nationally, as well as in 36 local

markets, the week of October 12, 2015

THANK YOU

FOLLOW US ON TWITTER: @FDATOBACCO

october 21, 2015 presented by mitch zeller center director fda center for tobacco products fda’s...

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