October 21, 2015 Presented by Mitch Zeller Center Director FDA Center for Tobacco Products FDA’S REGULATION OF TOBACCO: A YEAR IN REVIEW

October 21, 2015 | FDLI 1 OVERVIEW OF TODAY’S PRESENTATION Implementing the Tobacco Control Act Updates on Strategic Priorities

October 21, 2015 | FDLI IMPLEMENTING THE TOBACCO CONTROL ACT 2

October 21, 2015 | FDLI 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 3

October 21, 2015 | FDLI USING OUR REGULATORY AUTHORITY 4 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

October 21, 2015 | FDLI 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 5

October 21, 2015 | FDLI 6 UPDATE ON STRATEGIC PRIORITES Product Standards Comprehensive FDA Nicotine Regulatory Policy Pre- & Post-Market Controls: Regulations & Product Reviews Compliance and Enforcement Public Education

October 21, 2015 | FDLI PRODUCT STANDARDS 7

October 21, 2015 | FDLI 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 8

October 21, 2015 | FDLI COMPREHENSIVE FDA NICOTINE REGULATORY POLICY 9

October 21, 2015 | FDLI 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 10

October 21, 2015 | FDLI 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 LOOKING AT NICOTINE DIFFERENTLY 11

October 21, 2015 | FDLI LOOKING AT NICOTINE DIFFERENTLY 12 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 13 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

October 21, 2015 | FDLI PRE- & POST-MARKET CONTROLS – REGULATIONS AND PRODUCT REVIEWS 14

October 21, 2015 | FDLI SETTING PRE- & POST-MARKETING POLICY 15 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

October 21, 2015 | FDLI MEASURING PROGRESS IN MAKING SE DECISIONS 16 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 action Provisional Reports Resolved 15% via Order letter, Refuse-To-Accept letter or withdrawal Data as of 10/1/15 Provisional 3,591 64%

October 21, 2015 | FDLI TAKING ACTION ON PROVISIONAL TOBACCO PRODUCTS 17 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

October 21, 2015 | FDLI 18 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

October 21, 2015 | FDLI COMPLIANCE AND ENFORCEMENT 19

October 21, 2015 | FDLI 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 20 Data as of 10/1/15

October 21, 2015 | FDLI 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 21

October 21, 2015 | FDLI PUBLIC EDUCATION 22

October 21, 2015 | FDLI EDUCATING THE YOUTH ON THE DANGERS Million General “At Risk” Market Multicultural Rural American Indian/ Alaska Native LGBT Prevention Investing in our Future

October 21, 2015 | FDLI THE REAL COST CAMPAIGN 24

October 21, 2015 | FDLI MEASURING EFFECTIVENESS 25 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.”

October 21, 2015 | FDLI FRESH EMPIRE CAMPAIGN 26

October 21, 2015 | FDLI THE IMPORTANCE OF REACHING MULTICULTURAL YOUTH 27 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

October 21, 2015 | FDLI THE FRESH EMPIRE CAMPAIGN 28 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

October 21, 2015 | FDLI CAMPAIGN OVERVIEW 29 Placeholder for Director X video

October 21, 2015 | FDLI LAUNCH PLAN 30 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

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