Regulatory Public Laws Compliance & Education Policies Science & Enforcement & Communications The FDA Center for Tobacco Products (CTP): Its Role in Reducing Tobacco Use Mitch Zeller, Director, Center for Tobacco Products, FDA September 19, 2013 Kansas Public Health Association The information in these materials is not a formal dissemination of information by FDA and does not represent agency position or policy. 0
Presentation Outline The Family Smoking Prevention and Tobacco Control Act (TCA) CTP s Public Health Goals FSPTCA Provisions and Limitations Regulatory Tools and Public Health Framework for Tobacco Product Regulation Current Priorities Looking Ahead Working Together to Make Change Happen 1
Evolution of FDA Tobacco Product Regulation 1996: FDA moves to regulate tobacco products. Using its existing authority under the FD&C Act, FDA asserted jurisdiction and began regulation of tobacco products. The effort was overturned by the Supreme Court in 2000. 2
Tobacco Control Now Includes Tobacco Product Regulation Tobacco Product Regulation 3
FDA Authority Under the Family Smoking Prevention and Tobacco Control Act (TCA) June 22, 2009: The Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law: 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 4
FDA Authority Under the TCA (Continued) Gives FDA direct authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco Enables FDA to assert jurisdiction through rulemaking over other products that meet the definition of a "tobacco product" 5
CTP s Public Health Goals Prevent youth tobacco initiation Encourage adults who use tobacco to quit Reduce product harms and addictiveness Develop a science base and continue meaningful product regulation to reduce the toll of tobacco-related disease, disability, and death 6
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 FDA assesses the net population level health impacts of tobacco products 7
Provisions of the Tobacco Control Act Include: Requiring tobacco manufacturer registration with FDA Requiring listing of products and ingredients Requiring reporting levels of harmful and potentially harmful constituents (HPHC) by brand and sub-brand Establishing tobacco product standards Establishing limits on the sale and distribution of tobacco products Requiring premarket review for new and modified risk tobacco products (MRTPs) to protect the public health Requiring health warnings on labels and in advertising Establishing limits on advertising and promotion of tobacco products 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 categories of tobacco product (e.g. cigarettes, smokeless tobacco products, little cigars, other cigars, pipe tobacco, or roll-yourown 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 o e.g., taxation, minimum age requirements, and the sale, distribution, advertising, and promotion of tobacco products - 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: o tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products 10
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 11
FDA s Public Health Framework for Tobacco Product Regulation FDA is using our regulatory authority to: 1. Understand the regulated products 2. Control product changes that affect public health 3. Prohibit false or misleading product claims that state or imply reduced risk 4. Decrease harms of tobacco products 5. Expand the science base for regulatory action and evaluation 6. Restrict marketing and distribution to protect public health 7. Ensure industry compliance with FDA regulation 8. Educate the public about FDA's regulatory actions 12
FDA Regulation of Tobacco Products: CURRENT PRIORITIES 13
Current FDA Priorities Substantial Equivalence (SE) Menthol Deeming Enforcement 14
Substantial Equivalence (SE) One review path a manufacturer may choose to sell a new tobacco product Must have the same characteristics as a predicate tobacco product (one that was on the market on February 15, 2007), or have different characteristics but not raise different questions of public health. If the new tobacco product raises different questions of public health, the product is not substantially equivalent (NSE) and cannot be sold FDA s first tobacco product review decisions: June 2013 15
Menthol Seeking additional information to make informed decisions about potential regulatory options related to menthol in cigarettes (period for public comment extended through late November) Supporting research efforts to better understand the difference between menthol and non-menthol cigarettes Developing a youth education campaign focused on preventing and reducing tobacco use, including menthol cigarettes 16
Deeming The law grants FDA direct authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco It enables FDA to assert jurisdiction over other products that meet the statutory definition of a tobacco product FDA is currently drafting plans to broaden the scope of its regulatory program to encompass other products 17
18 Enforcement Tobacco retailer inspections to check on compliance with FDA regulations Alaska FDA contracts with 45 jurisdictions Hawaii DC More than $91 million in compliance check inspection contracts awarded to date American Samoa Guam Northern Mariana Islands Puerto Rico U.S. Virgin Islands
Enforcement in Kansas Since, Sept. 2010, FDA has awarded over $1.9m to the KS Department of Revenue, Alcohol Beverage Control for an enforcement contract First Inspection Completed: 2/2011 Current contract period runs through: 9/29/14 Total # of Inspections Completed (through 7/31/13): 5563 Total # of Warning Letters issued (through 7/31/13): 102 Total # of CMP s (through 7/31/13): 3 Total # of Inspections with no violations observed (through 7/31/13): 5458 19
FDA Regulation of Tobacco Products LOOKING AHEAD 20
Future FDA Priorities Launching youth education campaign via multiple media to prevent initiation and experimentation Growing the science base for tobacco product regulation Product standards Comprehensive nicotine regulatory policy 21
Youth Education Media campaigns aimed at vulnerable, at risk 12 to 17 year olds Campaigns targeting general market, multi-cultural, LGBT and rural youth A campaign educating consumers at tobacco retail locations across the nation 22
Growing the Science Base for Tobacco Product Regulation Investing in laboratory science at FDA, NCTR and CDC Supporting the Population Assessment of Tobacco or Health (PATH) Collaboration with CDC on National Adult and Youth Tobacco Surveys (NATS, NYTS) Creating new research centers for tobacco regulatory science 23
Product Standards Exploring potential for product standards to reduce product and/or addictiveness, toxicity and appeal Investing in research to support potential product standards 24
Comprehensive Nicotine Regulatory Policy Continuum of different nicotine-delivering products Individual-level risk versus population-level harm Regulatory opportunity for FDA 25
Modified Risk Tobacco Products (MRTP) The Tobacco Control Act prohibits all direct and indirect claims that a regulated tobacco product reduces exposure or harm, but empowers FDA to permit such claims in certain cases Issues related to MRTP are complex Theoretical pack-a-day smoker 26
FDA Regulation of Tobacco Products WORKING TOGETHER TO MAKE CHANGE HAPPEN 27
How You Can Be Part of FDA s Work Actively engage in FDA rulemaking Support compliance and enforcement (report potential violations to us via web, phone and e-mail) FDA s reporting form can be downloaded at: http://www.fda.gov/tobaccoproducts/protectingkidsfromtobacco/ ucm330160.htm Identify new opportunities for TCA-relevant state/local policies Amplify FDA health education campaigns 28
How You Can Be Part of FDA s Work (Cont.) Notify FDA of new tobacco product marketing initiatives Participate in Tobacco Products Scientific Advisory Committee (TPSAC), other public gatherings, and CTP listening sessions Stay informed and connected with FDA 29
Tools to Understand the Act http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryi nformation/ucm298595.htm How to Comment http://www.fda.gov/downloads/tobaccoproducts/guidancecompliance RegulatoryInformation/UCM314421.pdf Comment Opportunities http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryi nformation/ucm198169.htm NIH Tobacco Regulatory Science Program (including CTP s Research Priorities) http://prevention.nih.gov/tobacco/ Resources for You 30
Resources for You General CTP Information you can use and share http://www.fda.gov/tobaccoproducts/resourcesforyou/breakthechain/uc m237760.htm List of State Agencies awarded Tobacco Retailer Inspection Contracts http://www.fda.gov/tobaccoproducts/resourcesforyou/ucm228914.htm Searchable Database of Compliance Check Inspections of Tobacco Retailers http://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching. cfm How to Report Potential Violations http://www.fda.gov/tobaccoproducts/protectingkidsfromtobacco/ucm3301 60.htm 31
Resources for You Public Health Liaison Branch: CTPOfficeofPolicy@fda.hhs.gov Consumer Questions: AskCTP@fda.hhs.gov or 1-877-287-1373 Formal correspondence, and executive speech and meeting requests: ctpexecsec@fda.hhs.gov CTP Ombudsman: les.weinstein@fda.hhs.gov 32