Advertisement

The Food and Drug Administration's Regulation of Tobacco

The Center for Tobacco Products' Office of Science
      The Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law on June 22, 2009, and provided the Food and Drug Administration (FDA) broad regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products. The three public health goals of the Center for Tobacco Products (CTP), FDA, are to prevent youth initiation of tobacco use, decrease harm and/or addictiveness of tobacco products, and encourage tobacco use cessation. The CTP has established an Office of Science to ensure that sound science exists with which to develop regulatory actions. Although there is a vast and sound science base with regard to numerous provisions within the TCA, new research will not only help assess the impact of FDA regulatory authority over tobacco products but will inform future regulatory activities. In order to meet the broad science demands within the TCA, the CTP developed seven research priority areas:
      • 1
        understanding the diversity of tobacco products;
      • 2
        reducing addiction to tobacco products;
      • 3
        reducing toxicity and carcinogenicity of tobacco products and smoke;
      • 4
        understanding adverse health consequences of tobacco use;
      • 5
        understanding communications about tobacco products;
      • 6
        understanding tobacco product marketing; and
      • 7
        understanding economics and policies on tobacco use and perceptions.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Preventive Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • U.S. Department of Health, Education, and Welfare
        Smoking and health: report of the Advisory Committee of the Surgeon General of the Public Health Service.
        Public Health Service, Rockville MD1964
        • Syamlal G.
        • Mazurek J.M.
        • Malarcher A.M.
        Current cigarette smoking prevalence among working adults—U.S., 2004–2010.
        MMWR Morb Mortal Wkly Rep. 2011; 60: 1305-1309
        • CDC, Office on Smoking and Health
        Cigarette use among high school students—U.S., 1991–2009.
        MMWR Morb Mortal Wkly Rep. 2010; 59: 797-801
        • Eaton D.K.
        • Kann L.
        • Kinchen S.
        • et al.
        Youth risk behavior surveillance—U.S., 2009.
        MMWR Morb Mortal Wkly Rep Surveill Summ. 2010; 59: 1-142
        • CDC, Office on Smoking and Health
        State-specific prevalence of cigarette smoking and smokeless tobacco use among adults—U.S., 2009.
        MMWR Morb Mortal Wkly Rep. 2010; 59: 1400-1406
      1. Family Smoking Prevention and Tobacco Control Act, Pub. L. No.111-31, 123 Stat 1776, 2009.
        • DHHS
        Ending the tobacco epidemic: a tobacco control strategic action plan for the U.S. Department of Health and Human Services.
        Office of the Assistant Secretary for Health, Washington DCNovember 2010 (www.hhs.gov/ash/initiatives/tobacco/tobaccostrategicplan2010.pdf)
        • Leischow S.J.
        • Zeller M.
        • Backinger C.L.
        Research priorities and infrastructure needs of the Family Smoking Prevention and Tobacco Control Act: science to inform FDA policy.
        Nicotine Tob Res. 2012; 14: 1-6
        • Hatsukami D.K.
        • Biener L.
        • Leischow S.J.
        • Zeller M.
        Tobacco and nicotine product testing.
        Nicotine Tob Res. 2012; 14: 7-17
        • Hecht S.S.
        Researching opportunities related to establishing standards for tobacco products under the Family Smoking Prevention and Tobacco Control Act.
        Nicotine Tob Res. 2012; 14: 18-28
        • O'Connor R.J.
        Postmarketing surveillance for modified risk tobacco products.
        Nicotine Tob Res. 2012; 14: 29-42
        • Ribisl K.M.
        Research gaps related to tobacco product marketing and sales in the Family Smoking Prevention and Tobacco Control Act.
        Nicotine Tob Res. 2012; 14: 43-53
        • DiFranza J.R.
        Research opportunities concerning youth and the Family Smoking Prevention and Tobacco Control Act.
        Nicotine Tob Res. 2012; 14: 54-61
        • Hammond D.
        Tobacco packaging and labeling policies under the U.S. Tobacco Control Act: research needs and priorities.
        Nicotine Tob Res. 2012; 14: 62-74
      2. Sottera Inc v US Food and Drug Administration, 627 F3d 891 (DC Cir 2010).
      3. Tobacco Products subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act; Notice of proposed rulemaking. 76 Federal Register 130(7 July 2011):40061–2.
        • Brody A.L.
        • Mandelkern M.A.
        • Olmstead R.E.
        • et al.
        Ventral striatal dopamine release in response to smoking a regular vs a denicotinized cigarette.
        Neuropsychopharmacology. 2009; 34: 282-289
        • Nonnemaker J.
        • Farrelly M.
        • Kamyab K.
        • Busey A.
        • Mann N.
        Experimental study of graphic cigarette warning labels: final results report prepared for Center for Tobacco Products, Food and Drug Administration.
        (Contract No. HHSF-223-2009-10135G)
        • National Cancer Institute
        The role of the media in promoting and reducing tobacco use.
        DHHS, NIH, National Cancer Institute, Bethesda MDJune 2008 (NIH Pub. No. 07-6242)
        • Cummings K.M.
        • Hyland A.
        • Pechacek T.F.
        • Orlandi M.
        • Lynn W.R.
        Comparison of recent trends in adolescent and adult cigarette smoking behaviour and brand preferences.
        Tob Control. 1997; 6: S31-S37
        • DHHS
        Reducing tobacco use: a report of the Surgeon General.
        DHHS, CDC, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta GA2000
      4. The Regulatory Flexibility Act (5 USC Sec. 601–612) 1980.
      5. Notice of Intent to Publish a Request for Application for Centers of Excellence for Research Relevant to the Family Smoking Prevention and Tobacco Control Act.
        (Notice No.: NOT-DA-12-007)