1 National Partners Webinar Updates from the Center for Tobacco Products Lawrence R. Deyton, M.S.P.H., M.D. Director, Center for Tobacco Products Ann Simoneau, J.D Director, Office of Compliance and Enforcement May 26, 2011

22 To make tobacco- related death and disease part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every family. Vision Statement Center for Tobacco Products

33 Family Smoking Prevention and Tobacco Control Act 3

4 TOBACCO CONTROL

5 Product Regulation Means: Requiring manufacturers to register Requiring ingredient reporting Requiring health document reporting Evaluating new products before they are marketed Evaluating products claiming to be substantially equivalent Evaluating the accuracy and impact of proposed modified risk claims

6 Product Regulation Does Not Mean: An end to the tobacco epidemic An end to the need for good scientific studies An end to the need for public health action Tobacco product regulation is one more tool to reduce the disease and death caused by tobacco use

77 The First 20 Months of FDA Tobacco Product Regulation Establishing the regulatory framework for tobacco product regulation FDA has met all statutory requirements FDA has interacted with a number of stakeholders

88 Listening to Stakeholders Meaningful communication is important for a regulatory agency Meaningful communication is important when implementing a new law Trust can be improved in all directions Everyone is new to tobacco product regulation called for in the Tobacco Control Act FDA wants and needs input from every stakeholder including manufacturers, retailers, public health advocates, tobacco consumers, and all citizens

9 Stakeholder Discussions State and Local Tobacco Control Officials –October 3, 2010 (Atlanta, GA) – Tobacco Product Manufacturers, Growers, and Warehousers –December 8, 2010 (Raleigh, NC) – Minority Communities and Groups Affected by Tobacco-Related Health Disparities –February 8, 2011 (Oakland, CA) – 9

10 Upcoming Stakeholder Discussions Public Health Advocates – June 9, 2011 (Rockville, MD) American Indians/Alaska Natives – June 28, 2011 (Gila River Indian Community, Near Phoenix, AZ) Distributors, Importers, Retailers, Wholesalers –August 24, 2011 (Dallas, TX) Youth –September 13, 2011 (Boston, MA) 10

11 Status - Menthol Critically important issue Illustrates the complexities of tobacco product regulation TPSAC Menthol report (advising FDA) –TPSAC does not set policy, it advises FDA

12 TPSAC Findings in the Menthol Report TPSAC did not make any specific recommendations about what FDA actions would be most appropriate to achieve its findings: Evidence most strongly supported that: –Menthol cigarettes increase experimentation and the transition to regular smoking. –Menthol cigarettes increase the likelihood of addiction and the degree of addiction in youth smokers. –Menthol cigarettes result in lower likelihood of smoking cessation success in African-Americans. –Menthol cigarettes increase the prevalence of smoking in the general population and African Americans. –Menthol cigarette marketing increases the prevalence of smoking for the whole population, youth and African Americans. TPSAC concluded that, “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”

13 FDA’s Actions Underway - Menthol FDA’s scientific review activities have been underway for months and include: An analysis of health documents that were submitted by the tobacco industry. An examination of the peer-reviewed science- based literature. An independent analysis of available large-scale and national studies. If the science dictates action, the TCA gives FDA many options to protect public health

14 Status – Dissolvable Tobacco Products Tobacco Control Act requires the FDA to review and allow the marketing of tobacco products introduced after February 15, 2007 –Feb FDA requested information from Star Scientific and RJR on dissolvables (received in March) –March 2010 FDA opened a docket requesting comments on the nature, use and impact of dissolvable use on the public health; research and data on ways these products are used by children/youth; how the risks are perceived by users and non-users; and how they affect health

15 Dissolvable Tobacco Products (cont’d) –Oct 2010 FDA announced intention to require tobacco companies to submit their internal documents relating to marketing practices and research on health, toxicological, behavioral and physiological effect of dissolvables Tobacco Control requires the TPSAC to study and issue a report by March 2012 on the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children.

16 Status – E-Cigarettes U.S. Court of Appeals decision – e-cigarettes and other products “made or derived from tobacco” can be regulated as “tobacco products” and are not/drugs/devices unless they are marketed for therapeutic purposes Tobacco products other than cigarettes, smokeless tobacco and roll-your-own tobacco are not currently regulated by FDA

17 Status – E-Cigarettes (cont’d) Letter to Stakeholders issued April 25, 2011 outlining FDA’s intended actions: –Proposing a regulation extending the Agency’s “tobacco product” authorities –Considering whether to issue a guidance and/or a regulation on “therapeutic claims” –Finalizing a draft guidance on prohibition of marketing of “tobacco products” in combination with other FDA regulated products –Issued draft guidance to manufacturers on requesting a determination for “grandfathered” product

18 Status – Graphic Health Warnings Proposed rule issued on November 12, 2010 Issuance of final rule is required by June 22, 2011 FDA plans to assess the impact of the required warnings via comprehensive research and evaluation mechanisms to enable us to adapt and enhance effectiveness of messaging

19 Status – New Product Review New tobacco product defined as: –“Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007;” or –“Any modification*... of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007” (section 910(a)(1)) * including change in design, any component, any part or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient

20 New Product Review (cont’d) Pathways for legally marketing tobacco products: –Grandfathered products – 2/15/2007 –3 potential pathways to market a “new tobacco product” Substantial equivalence (SE) reports SE exemption (pursuant to regulation) Premarket tobacco product applications (PMTA) Pathway for legally marketing tobacco products with modified risk claims: –Modified risk tobacco product applications (MRTP) Separate guidance or regulation

21 Office of Compliance and Enforcement Ann Simoneau, Director Enforcement and Manufacturing Group –Joanna Weitershausen, Acting Group Leader Promotion, Advertising, and Labeling Group –Ele Ibarra-Pratt, Group Leader State Programs Group –Terry McDonald, Group Leader

22 State Programs Coordinates implementation of FDA tobacco retailer inspection contracts Provides commissioning and training for inspectors Reviews results from compliance check inspections Initiates enforcement actions for violations

23 FDA Tobacco Retail Inspection Contracts 15 States were awarded 1 year contracts in FY 2010 Up to 75% of U.S. States/Territories in FY 2011 Currently reviewing contract proposals submitted by States for FY 2011 Contracts will be awarded to all jurisdictions that wish to participate in FY 2012

24 States Awarded FDA Tobacco Enforcement Contracts in FY 2010 (Alabama, Arkansas, Arizona, Colorado, Idaho, Kansas, Maine, Maryland, Massachusetts, Mississippi, Missouri, Illinois, Pennsylvania, Tennessee, and Washington)

25 Inspection Results/Enforcement Actions A warning letter will be issued by FDA if violations are found during the first time compliance check inspection of a retailer All warning letters are posted on the FDA website A list of retailers that were inspected and where no violations are found is posted on the FDA website

26 Inspection Results/Enforcement Actions After a tobacco retailer receives a warning letter, FDA intends to conduct follow-up compliance check inspections at that outlet If violations are found during follow-up compliance check inspections at that retail outlet, FDA will seek civil money penalties Other enforcement actions may include no- tobacco-sale orders, seizures, and/or injunctions

27 Compliance Check Inspections As of May 19, 2011: Total Number of retailer compliance check inspections:9,418 Total number of warning letters issued to retailers: 337

28 Enforcement Actions Ban on flavored cigarettes –30 Warning Letters Light, low, or mild cigarettes –11 Warning Letters –Tobacco-Related Health Fraud

29 Compliance Training for Tobacco Retailers FDA is committed to finding more ways to educate tobacco retailers Tobacco retailers make up a large and diverse community – often with no experience with FDA Tobacco retailers need information and education about the Tobacco Control Act

30 Compliance Training for Tobacco Retailers In FY 2010, OCE held five training retailer sessions held in Boston, Atlanta, Chicago, Dallas, and Los Angeles Over 1,000 retailers, their representatives and trade associations attended in person, via live webcasting and/or telephone Sessions provided information about how to comply with the law and opportunity to ask questions on federal tobacco product regulations 30

31 Compliance Training for Tobacco Retailers FY 2011 Tobacco Retailer Compliance Webinars –Upcoming: June 28, July 26, September 20 –Topics include warning letters for violations; civil money penalties; age, access, and promotional restrictions, impersonal modes of sale, smokeless tobacco packaging and advertising –FDA will also solicit stakeholders for topics to be covered in future webinars 31

32 Working with FDA Educate retailers on the Tobacco Control Act and its implementing regulations using the information on our website Report potential violations

33 Reporting Tobacco-Related Complaints/Violations to CTP CTP.1373 (press #3 to report a violation) Correspondence: CTP’s Office of Compliance and Enforcement Electronic Tobacco Violations Reporting Form (in development)

34 Looking Ahead June 2011 Issue final rule on graphic health warnings CTP will issue a status report on menthol Issue FY2011 State contract awards (thru Sept. 2011) March 2012 TPSAC report on dissolvable tobacco products to be submitted to FDA April 2012 Establish list of harmful/potentially harmful constituents Issue guidance or regulations on scientific evidence to be used in assessing modified risk products (to be developed in consultation with the Institute of Medicine) September 2012 Graphic health warning regulations takes effect 34

U.S. Food and Drug Administration Center for Tobacco Products CTP-1373 For Formal Correspondence