FDA CENTER FOR TOBACCO PRODUCTS AND & ITS TOBACCO REGULATORY - - PowerPoint PPT Presentation

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 by Dana M. van Bemmel, PhD, MPH Assistant Deputy Director for Research Office of Science

March 27, 2017 | CASEL Webinar

CENTER FOR TOBACCO PRODUCTS 1

• 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

CARRYING OUT HISTORIC LEGISLATION

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• 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

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

March 27, 2017 | CASEL Webinar

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

3 10 15 15 10 6 3 7 10 15 19 4 5 10 15 17 6 3 3 43 94 101 110 20 40 60 80 100 120 140 160 2010 2011 2012 2013 2014 2015 Number of Active Projects Fiscal Year NIH Contracts/Other NCTR CDC

Note that a project maybe be active in multiple fiscal years

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CTP FUNDED PROJECTS BY RESEARCH CATEGORY FISCAL YEARS 2010-2015

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1 3 1 8 4 5 1 4 2 2 6 4 7 6 6 24 2 10 27 7 24 22 12 27 11 17 31 17 23 15 7 16 3 5 21 9 15 17 15 20 2 5 23 9 17 20 40 60 80 100 120 140 Addiction Chemistry and Engineering Communication Economics and Policy Health Outcomes Knowledge, Attitudes, and Behaviors (KAB) Marketing Toxicity and Carcinogenicity

Number of New Research Projects 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