5 Years of the Tobacco Control Act: Progress and Challenges

Stacy L. Ehrlich

Partner Kleinfeld Kaplan & Becker LLP

April 24, 2014

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User Fees

•  Through 12/31/2013, collected almost $1.75 billion and spent nearly $1.42 billion

•  As of end of FY12, FDA had spent less than half of user fee funds collected

•  $115 million spent for “The Real Cost” campaign, launched in Feb. 2014

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Youth Sales

•  Retailer education materials •  Tobacco retail compliance webinars •  State contracts •  Retailer compliance checks •  Warning letters •  “The Real Cost” advertising campaign

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Flavor Ban

•  Characterizing flavors (not menthol or tobacco)

•  Applies to papers and RYO, but not to smokeless

•  Cited products labeled as pipe tobacco where overall presentation suggests intended for use in cigarettes

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Descriptors •  “Light,” “mild,” or “low” •  Claims re “natural” components •  Claims re nicotine or tar levels •  Claims re filter technology •  Snus claims regarding lower nitrosamines •  Information regarding change in product

names in response to descriptor ban (WL and 904(b) requests)

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Marlboro Onsert

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HPHCs •  Sec. 904 Draft Guidance March 2012: abbreviated list of

HPHCs by 9/22/12 (STPMs by 12/22/12) •  Sec. 915 required testing regulations by 4/1/13 (with

extra time for STPMs) •  FDA was required to publish the list of HPHCs “in a

format that is understandable and not misleading to the lay public” by April 2013

•  FDA “Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents”

•  Risk Communication Advisory Committee & Tobacco Products Scientific Advisory Committee Joint Meeting (8/15/13)

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Marketing Orders •  PMTA: 4 RTFs •  SE Exemptions: 35 RTAs •  SE Reports

– First SE orders issued in June 2013 – 17 SE orders (2 cigs, 4 RYO, 3 paper, 8

snuff) – 17 NSE orders (4 provisional) – 247 withdrawals

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SE Reports •  ~3,165 provisional, 750 regular •  Priority review for regular SE reports •  As of 4/4/14, review process concluded for

23.6% of 981 regular SE Reports that were received before 3/31/14

•  As of 3/24/14, all complete regular SE reports will undergo immediate substantive review upon submission

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SE Reports (cont.) •  3 phases of review: (1) jurisdiction; (2)

completeness; (3) scientific •  Administrative Advice and Information (AI)

Letters (30-60 days to respond) •  Notice of scientific review (45 days to amend) •  Chemistry, engineering, toxicology, social

science, addiction •  Preliminary Finding (PFind) letter (30 days to

respond)

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SE Reports (cont.) •  Last guidance (draft Q&A) Sept. 2011 •  Last webinar April 2013 •  NSE orders

– Inadequate information on predicate, design features

– No HPHC data – Change in smokeless characterizing

flavor 11

New Performance Measures •  Announced April 18, implemented October 1 •  FY15 50%, FY16 60%, FY17 70%, FY18 80% (except

meeting requests 80-90%) •  Regular SE reports

–  Jurisdiction/completeness: 21 days – Review and act on original, resubmission: 90 days

•  Exemption from SE requests: 60 days •  MRTP applications: 360 days •  Meeting requests: 21 days •  None for provisional SE reports

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Enforcement As of 4/7/14 •  155 non-retailer warning letters

– Lacks warning statement – Flavored cigarettes – Modified risk descriptors (cigarettes and snus) – Brand name sponsorship

•  13,712 retailer WLs, 1317 retailer civil money penalty complaints

•  4 stop sale orders (Feb. 2014)

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Small Business Issues •  Office to Assist STPMs: “The Secretary shall

establish within the Food and Drug Administration an identifiable office to provide technical and other nonfinancial assistance to small tobacco product manufacturers to assist them in complying with the requirements of this Act” (§901(f))

•  Lack of guidance, transparency •  HPHC testing •  SE data, documentation requirements

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Stacy L. Ehrlich www.kkblaw.com sehrlich@kkblaw.com

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