FDA Center for Tobacco Products: Tobacco Research and the Population Assessment of Tobacco and Health (PATH) Study Regulatory Public Laws Compliance & Education Policies Science & Enforcement & Communications American Psychological Association Strengthening Psychology s Role in Reducing Tobacco Health Disparities December 10, 2012 Nicolette Borek, Ph.D. Office of Science, CTP, FDA 1
Disclaimer DISCLAIMER The information in these materials is not a formal dissemination of information by FDA and does not represent agency position or policy. 2
Outline Tobacco Control Act (TCA) and FDA Regulatory Authorities CTP Research Priorities and Collaborations Population Assessment of Tobacco or Health (PATH) Study Resources 3
Tobacco Control Act FDA was granted the authority to regulate tobacco products under the Tobacco Control Act which was passed with bipartisan majorities in the House and Senate and signed into law on June 22, 2009. 4
FDA/CTP Public Health Goals Prevent Americans especially youth from starting to use tobacco Encourage current users to quit Decrease the harms of tobacco product use 5
FDA s Authority Under the Tobacco Control Act TCA gave the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. 6
FDA s Authority Under the Tobacco Control Act Gives FDA direct authority over cigarettes, roll-your-own and smokeless tobacco products. Tobacco product is defined as any product made or derived from tobacco that is intended for human consumption, including any component part, or accessory of a tobacco product. This definition does not include drugs, devices or combination products. FDA announced that it will propose a rule deeming products that meet the definition of a tobacco product to be subject to FDA s jurisdiction (e.g., cigars, pipe tobacco, hookah, e-cigarettes) CTP funded solely via user fees from tobacco company assessments - $505 million for FY13; caps at $712 million in FY19 7
Tobacco Control Act Specific Authorities include: Restrictions on youth access to tobacco products Premarket applications for new and modified risk tobacco products Testing and reporting levels of harmful and potentially harmful constituents by brand and sub-brand Establishing tobacco product standards Health warnings on cigarettes and smokeless tobacco product packages and ads Advertising and promotion restrictions Industry registration and ingredient listing Conduct research to support tobacco product regulation 8
Tobacco Control Act The TCA does not authorize FDA to: Ban certain specified classes of tobacco products Require the reduction of nicotine levels to zero FDA is generally not involved with: Taxing tobacco products at point of sale Regulating the farming of tobacco leaf 9
FDA Regulatory Authority While FDA regulates therapeutic products to treat tobacco dependence, that authority does not reside within the Center for Tobacco Products 10
CTP Uses a Public Health/ Population Health Regulatory Standard Tobacco products cannot be regulated using the FDA s traditional safe and effective standard. The TCA mandates the regulation of tobacco products using a population health standard including both users and non-users of tobacco products.
Tobacco Control Act Key Accomplishments to Date Required industry registration and product listing Required industry submission of ingredient listing Restricted access and marketing of cigarettes and smokeless tobacco products to youth Prohibited misleading marketing terms ( Light, Low, and Mild ) for tobacco 12
Tobacco Control Act Key Accomplishments to Date (continued) Required larger warning labels for smokeless tobacco products and advertisements Issued guidance for new product applications and for new products that are substantially equivalent based on the public health standard Requiring graphic cigarette health warnings on cigarette packages and advertisements Under litigation 13
CTP/FDA Research Priorities Diversity of Tobacco Products Reducing Addiction Reducing Toxicity and Carcinogenicity Adverse Health Consequences Communications Marketing of Tobacco Products Economics and Policies 14
CTP Important Populations Important to understand tobacco use and impact of regulatory activities within various groups: Age Gender Race/ethnicity Income Occupation Geographic location People with mental health and/or medical co-morbidities Military/veterans LGBTQ community Pregnant women/women of reproductive age 15
16 Research Priorities Diversity of Tobacco Products - Examples Understanding the constituents, components, ingredients, additives, and design features Use behaviors Perceptions, attitudes and beliefs about conventional and new/emerging tobacco products
Diversity of Tobacco Products in the U.S 17
Research Priorities Reducing Addiction - Examples Understanding dependence in relation to nicotine level How reductions in nicotine affect use behaviors Other constituents and components beyond nicotine that affect addiction of combustible and non-combustible tobacco products 18
Research Priorities Reducing Toxicity and Carcinogenicity - Examples Understanding how reductions in toxicity of tobacco products affect use behaviors and perceptions What level of reduction in harmful and potentially harmful constituents results in decreased disease risk What assays best compare toxicity between different tobacco products 19
Research Priorities Adverse Health Consequences - Examples Understanding health risks of multiple tobacco types What biomarkers of disease risk can be associated with measures of tobacco exposure What novel biological and physiological markers are predictive of tobacco-related adverse health outcomes 20
Research Priorities Communications - Examples Understanding how to effectively convey information regarding risks associated with tobacco products and use Understanding how to effectively convey FDA s regulatory authority over tobacco products 21
Research Priorities Marketing of Tobacco Products - Examples Understanding the impact of specific types of tobacco products marketing on use behaviors, perception, attitudes and beliefs among youth and other vulnerable populations Understanding the impact of marketing via social media campaigns and other non-traditional communication strategies 22
Research Priorities Economics and Policies - Examples Estimating the economic impact of FDA regulatory actions Understanding the impact of FDA regulatory actions on tobacco use and on overall morbidity and mortality 23
Research Collaborations FDA/CTP collaborating with Federal agencies: - National Institutes of Health - Centers for Disease Control and Prevention - FDA National Center for Toxicological Research FDA/CTP contracting with non-hhs organizations that have particular expertise 24
NIH-FDA Tobacco Research Collaborations TCORS - Tobacco Centers of Regulatory Science (P50) P50 http://grants.nih.gov/grants/guide/rfa-files/rfa-da-13-003.html published July 10, 2012 Tobacco Control Regulatory Research R01, http://grants.nih.gov/grants/guide/pa-files/par-12-267.html R03, http://grants.nih.gov/grants/guide/pa-files/par-12-268.html R21, http://grants.nih.gov/grants/guide/pa-files/par-12-266.html published August 23, 2012 Population Assessment of Tobacco and Health Study (PATH) contract 25
Selected CDC-FDA Tobacco Research Collaborations Division of Laboratory Sciences Analyses of tobacco products and mainstream smoke Method development for biomarkers Method development for harmful and potentially harmful constituents Exposure assessments under actual use conditions Office of Smoking and Health National Adult Tobacco Survey National Youth Tobacco Survey 26
Research Selected Contracts RTI International Graphic Health Warnings study Consumer perceptions of tobacco products and claims research American Association of Poison Control Centers Poison reports from tobacco product use Battelle Memorial Institute Topography of little cigars 27
Research How can FDA monitor and assess the behavioral, social, and health impact of tobacco use to inform and assess tobacco regulations? Tobacco product standards Health warnings Marketing and advertising of new or modified risk products FDA public health campaigns 28
PATH Study 29
What is the PATH Study? The PATH Study is a large, national, representative longitudinal cohort study of tobacco use and health in the United States which will measure tobacco use behaviors and related health effects. Baseline data collection, N ~ 59,000, is scheduled for the Fall of 2013 with a cohort of never, current, and former users of tobacco products in the U.S. ages 12 and over. - The cohort will then be followed annually for at least two additional data collection waves. 30
PATH Study PATH will collect survey data from adults, youth, and parents and biospecimens (Urine, Buccal Cells, Blood) from adults. PATH will provide an evidence base for informing FDA s current and future regulatory actions in meeting its mandate under the Tobacco Control Act. 31
The PATH Study PATH is a landmark collaboration between the National Institute on Drug Abuse (NIDA)/National Institutes of Health (NIH) and the Center for Tobacco Products (CTP)/ Food and Drug Administration (FDA). PATH is conducted through an IAA with NIDA/NIH via a contract to Westat, the prime contractor for the study. Roswell Park Cancer Institute is the scientific lead for the Westat team and Andy Hyland PhD is the Scientific Principle Investigator. FDA is also collaborating with the Centers for Disease Control and Prevention (CDC) for biospecimen analysis and on study design. 32
PATH Design National representative sample of U.S. civilian, non-institutionalized population Three waves of assessment this contract period Baseline (N=~59,600): - Households screened: ~101,000 - Adults (18 years and older) completing full interview: ~42,700 o Adult current tobacco users: ~ 24,100 o Adult daily users: ~ 19,200 - Youth (12-17 years old) completing full interview: ~16,900 33
Specific Aims of the PATH Study Identify trends in tobacco use patterns, including use of new products, dual use, poly use and switching; Characterize tobacco use initiation, dependence, cessation, and relapse patterns; Monitor change in risk perceptions and other attitudes such as product preferences; 34
Specific Aims of the PATH Study Compare intermediate endpoints and ultimately, short- and longterm incidence/prevalence of health outcomes and cause-specific mortality among users of different types of products; Assess differences between and within critical subgroups including youth, young adults, daily users, racial/ethnic minority groups, and users of new tobacco products; and Collect biospecimens to analyze biomarkers of interest. 35
Behavioral and Health Outcomes PATH Study Tobacco Use: General Use Patterns Initiation Cessation/Quitting Addiction/Dependence Relapse New Products Switching Dual Use Health Outcomes: Short and Long-term 36
Tobacco Products Assessed PATH Study Cigarette E-cigarette Cigar, cigarillo, little filtered cigar Pipe Hookah Smokeless, including snus chewing tobacco, dip, moist snuff Dissolvable tobacco Bidis and Kreteks (youth) 37
Mediators / Moderators PATH Study Mediators/Moderators - Demographics - Knowledge, Attitudes, Beliefs, and Risk Perceptions - Tobacco Addiction/Dependence - Peer, Environmental, Contextual influences - Mental Health/Substance Abuse Co-morbidities 38
PATH Study PATH will be able to track changes in tobacco use every year among Age groups Race/ethnicity groups SES groups Regions Lesbian, gay, bisexual, transgender Co-morbidities 39
www.fda.gov/tobaccoproducts 40
www.fda.gov/tobaccoproducts 41
http://dccps.nci.nih.gov/nih-fda/ 42
Contacts Thank you. CTP: askctp@fda.hhs.gov : PATHstudyteam@mail.nih.gov Nicolette Borek: Nicolette.Borek@fda.hhs.gov 43