Challenges and Opportunities: Implementing the Tobacco Control Act Lawrence R. Deyton, M.S.P.H., M.D. Director, Center for Tobacco Products April 5, 2011 1 To make tobaccorelated 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 2 1
Challenges and Opportunities: Implementing the Tobacco Control Act Public Health Facts About Tobacco Use in the United States 3 Tobacco Use in the United States Leading preventable cause of death in the United States Approximately 443,000 deaths yearly from cigarettes; 8.6 million smokers have at least one serious illness due to smoking $96 billion in medical costs attributed to smoking $30.9 billion in Medicaid costs $27.4 billion in Medicare costs $97 billion in lost productivity attributed to smoking from premature deaths After decades of progress, adult smoking rates have stalled Since 2005, smoking rates have stalled at ~ 20% More worrisome, the decline in youth tobacco use has slowed 26% of high school students report current use 4,000 kids start smoking and 1,000 kids become regular smokers every day 90% of adult smokers started tobacco use as a teen 4 2
Percent Percent 45 40 35 30 Cigarette Smoking Trends Among Adults, U.S., 1965-2009 Since 2005, smoking rates have stalled at ~20% 25 20 15 10 5 2020 Healthy People objective is 12% smoking prevalence 0 1965 1968 1971 1974 1977 1980 1983 1986 1989 1992 1995 1998 2001 2004 2007 2010 Year Adults who were current cigarette smokers, National Health Interview Surveys, 1965-2009. 5 Cigarette Smoking* Trends Among 9th-12th Graders, U.S., 1991-2009 60 50 40 30 20 10 Since 2003, smoking rates have stalled at ~20% 0 1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2020 Healthy People objective is 16% smoking prevalence Year * Smoking on 1 or more of the previous 30 days. Source: Youth Risk Behavior Surveillance Survey 6 3
Public Health: Challenges and Opportunities Tobacco use has been part of our culture; 20% of the population use tobacco Tobacco use is the leading cause of preventable disease, disability and death 75 people in the US will die of tobaccorelated disease during this discussion 90% of adult smokers started as kids 70% of current smokers would like to quit 7 Challenges and Opportunities: Implementing the Tobacco Control Act Aggressive Statutory Requirements of the Tobacco Control Act 8 4
FDA Tobacco Milestones 2009 - Present June 2009 Family Smoking Prevention and Tobacco Control Act enacted August 2009 CTP established, staff recruitment began Tobacco Products Scientific Advisory Committee (TPSAC) charter published September 2009 Began implementation of the mandated prohibition on the manufacture, distribution and marketing of cigarettes with certain fruit and candy characterizing flavors. November 2009 Issued guidances regarding the requirements of tobacco product domestic establishment registration, product listing, and ingredient listing. 9 FDA Tobacco Milestones June 2010 Restrictions on access and marketing of cigarettes and smokeless tobacco products to youth went into effect: Prohibits sales to people younger than 18 Prohibits sales of cigarette packs with fewer than 20 cigarettes Prohibits distribution of free samples of cigarettes and restricts free samples of smokeless tobacco products Prohibits tobacco brand name sponsorship of athletic, musical, or other social events and of teams and entries in those events Prohibits the sale or distribution of items, such as hats and tee shirts, that have tobacco brand names, logos, or selling messages Prohibits sale of tobacco products in vending machines, selfservice displays or other impersonal modes of sale except in very 10 limited circumstances 5
June 2010 (cont.) FDA Tobacco Milestones Required new health warnings for smokeless tobacco products Prohibited the misleading marketing terms light, low, and mild for tobacco products that do not have an order from FDA November 2010 Proposed graphic health warning regulations for public comment January 2011 Issued substantial equivalence guidance March 2011 TPSAC report on menthol 11 Graphic Health Warnings: Examples From FDA s NPRM Conducted 18,000-person consumer research study on proposed images and publishing findings for public comment 12 6
Early Statutory Requirements: Challenges and Opportunities Forced march establishing the regulatory framework for tobacco product regulation FDA has met all statutory requirements Necessitated less-than-ideal communication with stakeholders as we built our staff capacity FDA does appreciate the significant input provided by all stakeholders 13 Challenges and Opportunities: Implementing the Tobacco Control Act Building Relationships With Relevant Stakeholders 14 7
CTP Stakeholder Interactions Public Health and Advocacy Groups Academic and Scientific Groups Industry Retailers Government Tribal Face-to Face meetings (small and large) Phone calls/call Center E-mails Correspondence Webinars/Training Conferences Interactions With CTP Ombudsman's Office 154 complaints, disputes and inquiries/comments received: Inquiries/Comments: 58% Complaints (actions CTP is taking/not taking): 36% Disputes: 6% 93% resolution rate 15 Interacting With CTP For Formal Correspondence, Speech, and Meeting Requests: Email ctpexecsec@fda.hhs.gov For meeting requests, please provide a proposed agenda and list of attendees. 16 8
Stakeholder Discussions State and Local Tobacco Control Officials October 3, 2010 (Atlanta, GA) http://www.fda.gov/tobaccoproducts/newsevents/ucm224215.htm Tobacco Product Manufacturers, Growers, and Warehousers December 8, 2010 (Raleigh, NC) http://www.fda.gov/tobaccoproducts/newsevents/ucm233921.htm Minority Communities and Groups Affected by Tobacco-Related Health Disparities February 8, 2011 (Oakland, CA) http://www.fda.gov/tobaccoproducts/newsevents/ucm240182.htm 17 Upcoming Stakeholder Discussions Public Health Advocates April 13, 2011 (Chicago, IL) 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) 18 9
Stakeholder Relationships: Challenges and Opportunities Meaningful communication is a challenge for a regulatory agency particularly 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 All stakeholders say they have appreciated FDA reaching out FDA wants and needs stakeholder input 19 Challenges and Opportunities: Implementing the Tobacco Control Act Engaging Retailers as Partners to Obtain Voluntary Compliance with the Law 20 10
Retailer Training FY 2010 Five live 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 Topics included: age & access restrictions, types of tobacco products covered by the regulation, promotional restrictions, and the flavored cigarette ban Tape of the sessions and materials available on the CTP website 21 Retailer Training FY 2011 Planned series of six monthly webinars of compliance training for tobacco retailers Each webinar consists of short presentation followed by Q & A Planned topics: warning letters; review of the age, access, and promotional restrictions, and civil money penalties CTP will also solicit stakeholders for topics to be covered in future webinars 22 11
Break the Chain Campaign Targeted to retailers, national regulatory education campaign designed to help keep tobacco out of the hands of America's youth through voluntary compliance. Learn about FDA Tobacco Regulation 23 23 FDA State Enforcement Contracts FY 2010 24 12
FDA State Enforcement Contracts FDA now regulates approximately 1-2 million US retailers who sell tobacco products Tobacco Control Act requires FDA to contract with States, US Territories and Tribal Nations for enforcement 15 contracts awarded to date: Alabama, Arkansas, Arizona, Colorado, Idaho, Kansas, Maine, Maryland, Massachusetts, Mississippi, Missouri, Illinois, Pennsylvania, Tennessee, and Washington Use of minors for purchases of cigarettes and smokeless tobacco Obtain and document evidence of violations for use in enforcement actions Inspection results reviewed by CTP compliance officers who draft regulatory/enforcement actions 25 FDA State Enforcement Contracts (cont.) Over 100 Warning Letters issued to date. Posted on FDA s FOI website webpage:http://www.fda.gov/iceci/enforcementacti ons/warningletters/tobacco/default.htm More than 2,000 retailers inspected where no violations found Retailers passing inspection posted on special CTP webpage:http://www.fda.gov/tobaccoproducts/guid ancecomplianceregulatoryinformation/ucm232109. htm 26 13
FDA State Enforcement Contracts (cont.) Up to 75% of U.S. States/Territories in FY 2011 Estimate $55 million in State/Territorial awards 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 27 Engaging Retailers: Challenges and Opportunities Tobacco retailers are very important partners for FDA to help keep tobacco out of the hands of kids This is a large and diverse community, often with no experience with FDA Tobacco retailers want information and want to comply with the law FDA has and will continue to find ways to engage with tobacco retailers 28 14
What s Ahead Current Review of TPSAC menthol report TPSAC: removal of menthol cigarettes from the marketplace would benefit public health in the United States and no specific regulatory actions recommended. FDA will consider TPSAC s report and recommendations, the industry perspective document, and continue its ongoing review of the available science and regulatory options available under the Tobacco Control Act. CTP intends to provide its first progress report on its review of the science in June. 29 June 2011 What s Ahead Issue final rule on graphic health warnings July 2011 Issue final regulations on substantial equivalence exemptions March 2012 TPSAC report on dissolvable tobacco products to be submitted to FDA 30 15
What s Ahead 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 IOM) September 2012 Graphic health warning regulations takes effect 31 U.S. Food and Drug Administration Center for Tobacco Products http://www.fda.gov/tobaccoproducts/ 1-877-CTP-1373 16