FDA Center For Tobacco Products & Its' Tobacco …...Decrease the harms of tobacco products Ensure...
Transcript of FDA Center For Tobacco Products & Its' Tobacco …...Decrease the harms of tobacco products Ensure...
CENTER FOR TOBACCO PRODUCTS
Disclaimer: This is not a formal dissemination of information by FDA and does not represent Agency position or policy.
March 27, 2017
FDA CENTER FOR TOBACCO PRODUCTS AND & ITS TOBACCO REGULATORY SCIENCE PROGRAM
Presented byDana M. van Bemmel, PhD, MPHAssistant Deputy Director for ResearchOffice of Science
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• Since 2009, CTP had authority to regulate tobacco productsintended for human consumption to reduce harm across thepopulation
• Regulate the manufacture, marketing, and distribution of cigarettes,cigarette tobacco, roll-your-own, and smokeless
CARRYING OUT HISTORIC LEGISLATION
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• On August 8, 2016 regulation went into effect that “deems” allproducts meeting the statutory definition of tobacco product,including components or parts (but excluding accessories), to besubject 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
PROTECTING AMERICANS THROUGH NEW REGULATION
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TOBACCO REGULATORY SCIENCE
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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 TOBACCO REGULATION USES A PUBLIC HEALTH/POPULATION HEALTH STANDARD
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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
ELEMENTS OF THE FDA’S PUBLIC HEALTH FRAMEWORK FOR TOBACCO
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.
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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.
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• 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
TOBACCO REGULATORY SCIENCE
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THE SCIENCE OF TOBACCO REGULATION
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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
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CTP FUNDED PROJECTS
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CTP PRIORITY RESEARCH AREAS
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Addiction Chemistry and Engineering Knowledge, Attitudes, and Behaviors Toxicity and carcinogenicity Health consequences Communication Marketing Economics and policy
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CTP RESEARCH PROGRAM
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CTP funds research through collaboration with Federal agencies & contracts with non-HHS organizations that
have particular expertise
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ACTIVE CTP PROJECTS BY FISCAL YEAR
310 15 15 10 6
37 10 15 19
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1015 17
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2010 2011 2012 2013 2014 2015
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Contracts/Other
NCTR
CDC
Note that a project maybe be active in multiple fiscal years
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CTP FUNDED PROJECTS BY RESEARCH CATEGORYFISCAL YEARS 2010-2015
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1 0 3 1 08 4 0
5 14 2 2
64 7
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2 10
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724
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27
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31
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1517
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23
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Addiction Chemistry andEngineering
Communication Economics andPolicy
HealthOutcomes
Knowledge,Attitudes, and
Behaviors (KAB)
Marketing Toxicity andCarcinogenicity
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CTP Research Category
FY15
FY14
FY13
FY12
FY11
FY10
Research categories are not mutually exclusive
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COMPANION FUNDING ANNOUNCEMENT
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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
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THANK YOU