Regulatory Science

1. Regulatory Science Public Education & Communications Laws & Policies Compliance & Enforcement FDA’s Action Plan to Combat the Public Health Threat of Tobacco Use June 26, 2013 The information in these materials is not a formal dissemination of information by FDA and does not represent agency position or policy.

2. Public Health Impact • Smoking causes more than 440,000 deaths per year in the United States • Each day over 3,800 youth under 18 smoke their first cigarette • Nearly 9 out of 10 adult daily smokers used their first cigarette by age 18 (88%) • Approximately 69% of current US adult smokers report that they want to quit using tobacco

3. AI/AN Tobacco-Related Health Facts • AI/AN adults are, overall, more likely than any other racial/ethnic subgroup to be current smokers • 31.5% of AI/AN adults smoke • Lowest rates are in the Southwest (21.2%), and highest rates are in the Northern Plains (44.1%) and Alaska (39.0%) • Smokeless tobacco use among adults and youth in the U.S. is highest among AI/AN

4. Presentation Overview • The Tobacco Control Act and FDA • FDA Center for Tobacco Products (CTP) • FDA and the Larger Tobacco Control Community • FDA’s Public Health Regulatory Framework for Tobacco • Collaboration: Important Ways to Work with FDA • Questions

5. June 22, 2009: The Family Smoking Prevention and Tobacco Control Act was signed into law

6. FDA Authority Under the Tobacco Control Act • Grants authority to regulate tobacco products intended for human consumption (products marketed for use in smoking cessation are regulated as drugs) • Recognizes FDA as the “primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products” • Gives FDA direct authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco • Enables FDA to assert jurisdiction over other tobacco products through rulemaking (cigars, pipe tobacco, hookah, e-cigarettes that do not make drug claims, etc.). FDA has announced its intent to do so

7. Specific Authorities Include: • Tobacco manufacturer registration with FDA • Listing of products and ingredients • Reporting levels of harmful and potentially harmful constituents by brand and sub-brand • Establishing tobacco product standards • Premarket submissions for new and modified risk tobacco products to protect the public health • Health warnings on labels and in advertising • Advertising and promotion restrictions • Authority to conduct public health education and research to support tobacco product regulation

8. Tobacco Control Act – Limitations In general, CTP’s regulatory authorities do not extend to: • Setting tax rates for tobacco products • Regulating therapeutic products, such as those marketed to treat tobacco dependence • Setting clean indoor air policies • Regulating tobacco growing • Requiring the reduction of nicotine yields to zero • Banning all cigarettes, smokeless tobacco products, little cigars, other cigars, pipe tobacco, or roll-your-own tobacco products

9. Impact of Tobacco Control Act on State, Territorial, and Local Policy • Section 916 of the Federal Food Drug and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act: • Preserves the authority of state, local, and tribal governments to regulate tobacco products in certain specific respects (e.g., taxation)  • Prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FDCA relating to specified areas (tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products)

10. Tobacco Control Now Includes Tobacco Product Regulation Tobacco Product Regulation

11. FDA’s Regulatory Tools • FDA’s authority is derived from a set of laws: • The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the primary federal law that governs FDA’s work • The Tobacco Control Act amends the FD&C Act to give FDA the authority to regulate tobacco products

12. FDA’s Regulatory Tools FDA routinely issues regulations and guidance documents to implement and explain these laws • FDA guidance describes the agency's current thinking on a regulatory issue---guidance is a generally recommended approach for meeting a legal requirement, but it is not legally binding on the public or FDA • FDA regulations have the force and effect of law, and create requirements with which regulated industry must comply • FDA uses the best available scientific evidence in developing its regulations and guidance

13. FDA Tobacco Regulation Uses a Public Health/Population Health Standard • Tobacco products cannot be regulated using FDA’s traditional “safe and effective” standard • The Tobacco Control Act mandates tobacco product regulation using a population health standard that takes into account both users and non-users of tobacco products

14. CTP Vision and Mission • Vision: • 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 • Mission: • To protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others

15. CTP’s Public Health Goals • Prevent youth tobacco initiation • Encourage youth and adults who use tobacco to quit • Reduce product harms and addictiveness • Expand the science base and continue meaningful product regulation to reduce the toll of tobacco-related disease, disability, and death

16. CTP Priorities: 2009 to 2013 • Build the Center, including staff, infrastructure, and processes • Meet statutory deadlines • Develop the FDA tobacco product public health regulatory framework

17. CTP Organization

18. Statutory Milestones

19. FDA’s Public Health Framework for Tobacco Product Regulation FDA is using our regulatory authority to: • Understand the regulated products • Control product changes that affect public health • Prohibit false or misleading product claims that state or imply reduced risk • Decrease harms of tobacco products • Expand the science base for regulatory action and evaluation • Restrict marketing and distribution to protect public health • Ensure industry compliance with FDA regulation • Educate the public about FDA's regulatory actions

20. 1. Understand the Regulated Products • Registration and listing • Companies must register manufacturing facilities and provide a list of all their regulated products • Ingredient reporting • Companies must provide a list of ingredients for regulated products Harmful and potentially harmful constituents (HPHC) reporting by brand and sub-brand • Final guidance issued January 2011 defining HPHC as constituents that cause or have the potential to cause direct harm (toxicity, addictiveness) or indirect harm (increases initiation or decreases cessation) to users or nonusers

21. 2. Control Product Changes That Affect Public Health • The law requires manufacturers to inform CTP of any changes to existing products or about new tobacco products over which we have jurisdiction • New products cannot be introduced to market without FDA evaluating the science and making a decision to permit marketing

22. 2. Control Product Changes That Affect Public Health • Under these provisions, there are four ways a tobacco product can be available for distribution or retail: a. "Grandfathered” tobacco products • Products on the market as of February 15, 2007and unchanged since that date b. New tobacco product applications • Premarket review required  • Permitting the product to be marketed would be appropriate for the protection of public health

23. 2. Control Product Changes That Affect Public Health c. Substantial equivalence • An alternative pathway to new product applications where characteristics are the same as grandfathered products or the change does not raise different questions of public health d. Substantial equivalence exemption • An alternative to substantial equivalence in which a modification to the tobacco product is minor and where the only change is to an additive and where other statutory conditions are met

24. 3. Prohibit False/Misleading Claims of Reduced Risk • FDA will allow reduced risk claims only when scientifically demonstrated and an order is issued by FDA • Modified risk application guidance: • Pre-market review required • Marketing of the product will (or is expected to) reduce the risk of tobacco-related disease and benefit the population as a whole • Draft guidance issued in April 2012 outlining the scientific evidence FDA requests for its pre-market review

25. 4. Decrease Harms of Tobacco Products • Cigarette flavor ban • Cigarettes cannot have fruit, candy or herb characterizing flavors (except tobacco or menthol) • Deeming regulation • FDA has announced its intent to expand jurisdiction to include other tobacco products • Product standards • FDA can issue standards appropriate for the protection of public health including to make regulated products less addictive and/or less harmful • FDA cannot set nicotine yields to zero

26. 5. Expand Science for Regulatory Action and Evaluation • To expand the scientific foundation for FDA tobacco product regulation, FDA is conducting research and partnering with other agencies • Research supported through: • Supplements to existing NIH grants or cooperative agreements • FDA will be funding Tobacco Regulatory Science Centers of Excellence in areas of importance to FDA tobacco product regulation • PATH tobacco longitudinal cohort study • Survey implementation with CDC • CDC laboratory activities • Contracts

27. 6. Restrict Marketing and Distribution • To reduce youth initiation FDA restricts access and marketing of cigarettes, cigarette tobacco, and smokeless tobacco. • FDA prohibits(implemented June 2010): • Sales to people younger than 18 • Sales of cigarette packs with fewer than 20 cigarettes • Distribution of free samples of cigarettes and restricting the distribution of free samples of smokeless tobacco products • Brand name sponsorship of athletic, musical, or other social events and of teams • Hats and tee shirts, etc., with brand names or logos • Sales in vending machines or self-service displays except in adult-only facilities

28. 7. Ensure Industry Compliance - Retailers • Tobacco retailer inspections to check on compliance with FDA regulations • FDA contracts with 45 States and Territories • More than $62 million in compliance check inspection contracts awarded to date Alaska Hawaii DC Puerto Rico American Samoa U.S. Virgin Islands Guam Northern Mariana Islands

29. Ensure Industry Compliance – Retailers, Cont. • Support Compliance & Enforcement • Provisions of the Tobacco Control Act, including those related to the retail sale of tobacco products, also apply to tribal jurisdictions (Indian Country). • Tobacco Control Act directs FDA to contract with States, Territories, and Indian tribes, where feasible. • FDA wants to collaborate with federally-recognized tribes and other tribal entities to ensure understanding of the provisions and comply with the law.

30. 8. Educate the Public • Public education campaigns related to statutory authorities and regulatory actions • Raise public awareness about FDA regulatory actions • Banned flavored cigarettes • Prohibited misleading advertising (e.g., “low,” “light,” and “mild”) • Established list of harmful and potentially harmful constituents (HPHCs)

31. How You Can Be Part of FDA’s Work • Know the Tobacco Control Act • Support compliance and enforcement by reporting potential violations and promoting educational materials • ACTIVELY engage in FDA rulemaking • Amplify FDA health education campaigns • Stay informed and connected with FDA activities

32. Know the Tobacco Control Act Visit www.fda.gov/TobaccoControlAct to: • See our overview of the Act for a snapshot of its significance and FDA authorities for tobacco product regulations • Search the Act by “Audience,”“Type of Tobacco Product,” and “Topic” to more easily find relevant sections • Check out our graphic timeline of the Act to learn about its history, key events, and milestones

33. Support Compliance and Enforcement • Submit potential violations: • Phone: 1.877.CTP.1373 (option #3) • Email: CTPCompliance@fda.hhs.gov • Electronic reporting form: http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/ucm330160.htm • Write: FDA Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD 20850

34. Ways to Engage CTP • Disseminate information about -- and submit comments as appropriate -- concerning draft guidance and proposed regulations through relevant dockets http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm • Attend and participate in public meetings • Collect and share relevant research, surveys, evaluation and surveillance data • Share policy direction and innovation with CTP

35. Current AI/AN Engagement Activities • Collaboration with the National Native Network • Individual Tribal Outreach • Dear Tribal Letter – April 2013 • Outreach to National Indian Organizations • NCAI • NIHB • NCUIH • AICF • AAIP • Outreach to Regional Area Indian Health Boards • All 12 IHS Regions contacted and assigned a Tribal Policy Analyst

36. Current AI/AN Engagement Activities – Cont. • Outreach to Tribal Epi-Centers • All regional Tribal Epi-Centers contacted • Listening Sessions • NIHB and NCUIH Listening Session – June 2013 • Meet and Greet • HHS Office of Intergovernmental and External Affairs • NIHB – June 2013 • NCUIH – June 2013 • NCAI – Projected July 2013

37. Current AI/AN Engagement Activities – Cont. • National Forums • National Indian Health Board Tribal Public Health Summit – June 2013 • 7 Generations Conference – April 2013 • NCAI Mid-Year and Annual Conferences • Projected – NIHB Annual Consumer Conference • Federal Meetings • IHS • CDC

38. Amplify CTP Communications • Work with partners to share messages through new technologies • Visit www.fda.gov/tobacco to • Find more information • Order materials • Sign up for email subscriptions, like “This Week in CTP” • Join us on Twitter • Promote Break the Chain of Addiction Retailer Education Campaign Materials. • Free materials available at: www.fda.gov/BreaktheChain

39. Stay Informed and Connected • Office of Policy - Public Health Liaison Branch: Paul.Allis@fda.hhs.gov • Consumer Questions: AskCTP@fda.hhs.gov or 1-877-287-1373 • Formal correspondence, and speech and meeting requests: ctpexecsec@fda.hhs.gov • CTP Ombudsman: les.weinstein@fda.hhs.gov

40. Regional Approach to Indian Country • Capt. Gail Cherry Peppers, Tribal Policy Analyst • Gail.Cherry-Peppers@fda.hhs.gov • Albuquerque • Billings • California • Navajo • Oklahoma • Phoenix • Tucson

41. Regional Approach – Cont. • Paul R. Allis, Pool Tribe, Tribal Policy Analyst Paul.Allis@fda.hhs.gov • Aberdeen • Alaska • Bemidji • Billings • Nashville

42. Office of Compliance and Enforcement Contacts Heather Althouse heather.althouse@fda.hhs.gov Evonne Bennett-Barnes, Navajo/Comanche evonne.bennett-barnes@fda.hhs