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

March 27, 2017 | CASEL Webinar CENTER FOR TOBACCO PRODUCTS1

• 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

CENTER FOR TOBACCO PRODUCTS8

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

CENTER FOR TOBACCO PRODUCTS10

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

CENTER FOR TOBACCO PRODUCTS11

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

4

5

1015 17

6

3

3

43

94101

110

0

20

40

60

80

100

120

140

160

2010 2011 2012 2013 2014 2015

Num

ber o

f Act

ive

Proj

ects

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 CATEGORYFISCAL YEARS 2010-2015

CENTER FOR TOBACCO PRODUCTS13

1 0 3 1 08 4 0

5 14 2 2

64 7

66

24

2 10

27

724

22

12

27

11

17

31

17

2315

7

16

3

5

21

9

1517

15

20

2

5

23

9

17

0

20

40

60

80

100

120

140

Addiction Chemistry andEngineering

Communication Economics andPolicy

HealthOutcomes

Knowledge,Attitudes, and

Behaviors (KAB)

Marketing Toxicity andCarcinogenicity

Num

ber o

f New

Res

earc

h Pr

ojec

ts

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