UPDATE ON FDA CENTER FOR TOBACCO PRODUCTS Mitch Zeller Director, CTP April 23, 2015 OVERVIEW OF TODAY’S PRESENTATION • Background on FDA’s authority • Update on regulatory activities • Update on research 1 | January | NATO – April 9, 23,2015 2015 BACKGROUND ON FDA’S AUTHORITY 2 | January | NATO – April 9, 23,2015 2015 CARRYING OUT HISTORIC LEGISLATION 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 3 | January | NATO – April 9, 23,2015 2015 DEFINING A PUBLIC HEALTH STANDARD • The Tobacco Control Act created the Center for Tobacco Products (CTP) to regulate tobacco products under a new standard “appropriate for the protection of the public health.” • The ultimate public health objective is to reduce death and disease from the use of tobacco products. • As regulators, we have to assess risks and benefits for the population as a whole, including among users and non-users of tobacco products. 4 | January | NATO – April 9, 23,2015 2015 USING OUR REGULATORY AUTHORITY • 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 5 | January | NATO – April 9, 23,2015 2015 EXPLAINING LIMITATIONS OF THE TOBACCO CONTROL ACT 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 (regulated by other parts of FDA) • Setting clean indoor air policies • Regulating tobacco growing • Requiring the reduction of nicotine yields to zero • Providing cessation services • Banning all cigarettes, smokeless tobacco products, little cigars, other cigars, pipe tobacco, or roll-your-own tobacco products • Raising the minimum age to purchase tobacco 6 | January | NATO – April 9, 23,2015 2015 UTILIZING USER FEES EXCLUSIVELY • Entirely funded through industry-paid user fees based on market share (not applications) • User fees are the sole allowable source for FDA tobacco program spending, and the FDA tobacco program is the sole allowable use of the funds • TCA permanently authorizes CTP collections and spending; • Funding levels started at $85M in 2009, grow to $712M in 2019, and remain at that level 7 | January | NATO – April 9, 23,2015 2015 UPDATE ON REGULATORY ACTIVITIES • Deeming • FDA-Wide Nicotine Policy • Product Standards • Pre and Post Market Pathways • MRTPA • Compliance and Enforcement • Public Education 8 | January | NATO – April 9, 23,2015 2015 DEEMING • April 2014: FDA proposed a new rule that would extend CTP’s authority to cover additional tobacco products – Received over 135,000 comments • Products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of tobacco product – Includes e-cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco • Automatic provisions (e.g., industry registration, product listing, ingredient listing, and the adulteration and misbranding provisions of the statute) • Additional provisions (e.g., minimum age and identification restrictions, health warnings, and prohibition of vending machine sales unless in a facility that never admits youth) • Unified Agenda Goal to publish final rule by end of June 9 | January | NATO – April 9, 23,2015 2015 NICOTINE POLICY Looking at nicotine differently… • 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 COMBUSTIBLES 10 | January | NATO – April 9, 23,2015 2015 NRT NICOTINE POLICY • Ongoing related actions: – Finalizing Deeming regulation – Developing jurisdiction policy on nicotine-containing products across FDA – Working with CDER and CDRH to determine how regulation of therapeutic nicotine products (Rx, OTC, drugs, devices) could evolve – Exploring options at CTP for an expedited premarket review policy based on principle of relative toxicity and risk 11 | January | NATO – April 9, 23,2015 2015 PRODUCT STANDARDS • One of the law’s most powerful tools • Advancing a product standard strategy that yields strong standards to improve public health and can withstand legal challenge • Exploring potential standards for: – Addictiveness – Toxicity – Appeal 12 | January | NATO – April 9, 23,2015 2015 SUBSTANTIAL EQUIVALENCE (SE) • Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to FAQs guidance issued March 2015 • SE Review Process graphic page added 13 | January | NATO – April 9, 23,2015 2015 SUBSTANTIAL EQUIVALENCE (SE) 4,710 SE Submissions • 97% of acceptance reviews (jurisdiction and administrative) are complete Regular Reports • Resolved 53% 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. For FY15: • • • Regular 1,115 24% Provision al 3,595 76% Finalize acceptance reviews and issue letter as appropriate for 50% of SE reports within 21 days of FDA receipt Review and act on 50% of original SE reports within 90 days of FDA receipt Review and act on 50% of regular SE reports resubmissions within 90 days of FDA receipt Provisional Reports • Reviews have begun 14 | January | NATO – April 9, 23,2015 2015 Data as of 4/14/15 MODIFIED RISK TOBACCO PRODUCT (MRTP) FDA will allow reduced risk claims only when scientifically proven and an order is issued by FDA. Modified risk Pre-market review required if the label, labeling, or advertising represents explicitly or implicitly that: • The tobacco product presents a lower risk of disease or is less harmful than one or more marketed products. • The tobacco product or its smoke contains a reduced level or presents a reduced exposure to a substance or is free of a substance. • The label, labeling, or advertising uses the descriptors “light,” “mild,” “low,” or similar descriptors. 15 | January | NATO – April 9, 23,2015 2015 MODIFIED RISK TOBACCORISK PRODUCT (MRTP) UPDATE ON: MODIFIED TOBACCO PRODUCT (MRTP) Phase 0 • Pre-MRTPA Meetings Phase 1 • Acceptance Review Phase 2 • Filing or Refuse to File Phase 3 • • • • Public Comment Scientific Review TPSAC Meeting Final Action Reapplication/Renewal 16 | January | NATO – April 9, 23,2015 2015 Phase 4 • Post-market Surveillance for Authorized MRTPs MODIFIED RISK TOBACCO PRODUCT (MRTP) • Swedish Match MRTP applications accepted for filing and review in August 2014 • Made applications available for comment for 180 days – Comment period closed Monday, February 23, 2015 – The Tobacco Products Scientific Advisory Committee meeting held April 910 discussed scientific issues related to the Swedish Match North America modified risk tobacco product applications currently under scientific review at CTP. • Published Draft Guidances – Draft Guidance for Industry and Staff: Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products – Draft Guidance for Industry: Modified Risk Tobacco Products Applications 17 | January | NATO – April 9, 23,2015 2015 TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE Based on its review, FDA identified several critical scientific issues for TPSAC discussion: • With respect to the relative health risks to individuals: – The strength of association between snus use and the risk of tooth loss and gum disease – The strength of association between snus use and the risk of oral cancers. – The risks of snus use as compared to cigarettes. • With respect to the impacts on initiation and cessation: – The applicability of the Swedish experience to infer impacts on the U.S. population. • With respect to the ability of the public to comprehend the modified risk information: – The impacts of providing modified risk information in the context of a warning. 18 | January | NATO – April 9, 23,2015 2015 COMPLIANCE AND ENFORCEMENT • Conducted over 400,000 retailer inspections covering 56 states and territories • Issued more than 23,800 Warning Letters • Issued over 3,000 civil money-penalty actions against tobacco retailers • Awarded FDA’s first contracts to Tribal Governments to conduct tobacco retail inspections within their jurisdictions Data as of 4/10/15 19 | January | NATO – April 9, 23,2015 2015 EDUCATING YOUTH ON THE DANGERS General “At Risk” Market Multicultural Rural American Indian/ Alaska Native LGBT 10 Million Prevention 20 | January | NATO – April 9, 23,2015 2015 Investing in our Future MEASURING EFFECTIVENESS Reach Reaching over 90% of teens more than 20x a quarter, exceeding goal of 75% reach Engagement Engaged 6M unique visitors from all 50 states on the website Motivation to rethink their relationship with tobacco Produced 1.26M campaign-related unique conversations via social media “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.” 21 | January | NATO – April 9, 23,2015 2015 “I always thought smoking was foul and killed people. The only difference is now I understand how.” “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.” UPDATE ON RESEARCH • IOM Minimum Age Report • PATH Study (Preliminary Findings) • NYTS Study 22 | January | NATO – April 9, 23,2015 2015 IOM MINIMUM AGE REPORT • Contracted with Institute of Medicine (IOM) to conduct a report on the public health implications of raising the minimum age to purchase tobacco • Per the TCA, FDA does not have authority to raise the age • Individual states can, and have, raised age • Analyzed implications of raising to 19, 21 and 25 • FDA to submit report to Congress under Section 104 of the statute Data as of 4/10/15 23 | January | NATO – April 9, 23,2015 2015 POPULATION ASSESSMENT OF TOBACCO & HEALTH • First look: Data from first 20,000 participants initially shared at SRNT in February • National, longitudinal study of 46,000 people 12 and over, including tobacco users and nonusers • Designed to identify factors associated with, and implications of, quitting tobacco, switching among different tobacco products, and using multiple tobacco products • First look at preliminary data – 40 percent of both youth and adult tobacco users report currently using two or more products – Of the youth and adults who use 2 or more tobacco products, 50% are using e-cigarettes. – Almost 30% of adults and about 8 ½% of youth report use of tobacco product of any type within the past 30 days. Joint study with NIH and FDA 24 | January | NATO – April 9, 23,2015 2015 2014 NATIONAL YOUTH TOBACCO SURVERY • Joint findings with CDC released April 2015. Data from 2013 to 2014 showed: – E-cig use tripled, hookah use doubled in one year – E-cigs were most-used product – Overall tobacco use stayed the same • Increases in e-cig and hookah are threatening progress made with traditional cigarettes • Early exposure to nicotine is a real concern • Underscores importance of FDA regulation 25 | January | NATO – April 9, 23,2015 2015 FDA AND NATO • Landscape of tobacco products is changing rapidly but proper retailer compliance and cooperation is still key for protecting the health of your patrons, particularly youth • Final deeming rule will require cooperation and communication on many new provisions • Stay tuned for additional guidances and new educational materials for retail establishments that further explain how to comply with the law 26 | January | NATO – April 9, 23,2015 2015 THANK YOU | January 9, 2015
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