FDA CENTER FOR TOBACCO PRODUCTS AND & ITS TOBACCO REGULATORY SCIENCE PROGRAM Presented by Dana M. van Bemmel, PhD, MPH Assistant Deputy Director for Research Office of Science Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy. March 27, 2017 CENTER FOR TOBACCO PRODUCTS
CARRYING OUT HISTORIC LEGISLATION • Since 2009, CTP had 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 1 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
PROTECTING AMERICANS THROUGH NEW REGULATION • On August 8, 2016 regulation went into effect that “deems” all products meeting the statutory definition of tobacco product, including components or parts (but excluding accessories), to be subject to FDA’s tobacco product authorities, including: – ENDS (e-cigarettes, e-cigars, vape pens, etc.) – All cigars – Pipe tobacco – Nicotine gels – Waterpipe (hookah) – Dissolvables not already under the FDA’s authority – Future tobacco products 2 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
TOBACCO REGULATORY SCIENCE 3 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
FDA TOBACCO REGULATION USES A PUBLIC HEALTH/POPULATION HEALTH 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 4 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
ELEMENTS OF THE FDA’S PUBLIC HEALTH FRAMEWORK FOR TOBACCO 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 Ashley, Backinger, van Bemmel, and Neveleff. Regulatory Science in Tobacco Control: Research to Inform Regulatory Action at the Food and Drug Administration’s Center for Tobacco Products. Nicotine and Tobacco Research. 2014 Aug: 16(8):1045-9. 5 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
WHAT IS TOBACCO REGULATORY SCIENCE? Scientific inquiry specifically to inform potential regulatory decisions and actions to protect the public’s health Backinger C.L., et al . (2016). The FDA “Deeming Rule” and Tobacco Regulatory Research. Tobacco Regulatory Science. 2(3): 290-3. 6 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
TOBACCO REGULATORY SCIENCE • Tobacco regulatory science involves the application of the best available science to specific regulatory questions Tobacco regulatory research translates general scientific • knowledge into the specific scientific findings which serve as actionable information for regulatory decisions and actions • To do this tobacco regulatory science evaluates distinct situations to determine the effect on public health 7 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
THE SCIENCE OF TOBACCO REGULATION Product • Chemistry • Engineering • Microbiology Tobacco Product User • Toxicology • Pharmacology • Clinical medicine • Addiction • Product use behavior Population as a Whole • Environmental assessment • Epidemiology • Consumer perception • Statistical analysis • Evaluation 8 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
CTP FUNDED PROJECTS 9 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
CTP PRIORITY RESEARCH AREAS Addiction Chemistry and Engineering Knowledge, Attitudes, and Behaviors Toxicity and carcinogenicity Health consequences Communication Marketing Economics and policy 10 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
CTP RESEARCH PROGRAM CTP funds research through collaboration with Federal agencies & contracts with non-HHS organizations that have particular expertise 11 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
ACTIVE CTP PROJECTS BY FISCAL YEAR 160 140 120 Number of Active Projects 100 NIH 101 94 110 Contracts/Other 80 NCTR CDC 60 43 40 17 15 6 10 20 10 3 7 15 5 19 3 3 15 15 4 10 10 6 3 0 2010 2011 2012 2013 2014 2015 Fiscal Year Note that a project maybe be active in multiple fiscal years 12 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
CTP FUNDED PROJECTS BY RESEARCH CATEGORY FISCAL YEARS 2010-2015 140 120 Number of New Research Projects 23 100 20 21 80 17 FY15 FY14 16 15 60 FY13 17 31 FY12 9 27 23 FY11 15 40 5 9 15 FY10 5 27 17 22 7 17 20 2 24 24 3 12 7 6 11 6 10 4 4 6 2 8 5 7 2 4 3 2 0 1 1 1 0 0 0 Addiction Chemistry and Communication Economics and Health Knowledge, Marketing Toxicity and Engineering Policy Outcomes Attitudes, and Carcinogenicity Behaviors (KAB) Research categories are not mutually exclusive CTP Research Category 13 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
COMPANION FUNDING ANNOUNCEMENT 14 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
TOBACCO CENTERS OF REGULATORY SCIENCE (TCORS) Overall Objective Conduct multidisciplinary research that will inform FDA’s regulatory actions related to the manufacture, distribution, and marketing of tobacco products Essential Elements • Three hypothesis drive Research Projects with a scientific Integrated Theme • Administrative Core that includes funds for Rapid Response Projects • Career Enhancement Core to provide exposure and experience in tobacco regulatory science Companion Funding Opportunity: RFA-OD-17-006, U54 15 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
THANK YOU 16 CENTER FOR TOBACCO PRODUCTS March 27, 2017 | CASEL Webinar
Recommend
More recommend
