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. 2016 Jul;2(3):290-293.
doi: 10.18001/TRS.2.3.8.

The FDA "Deeming Rule" and Tobacco Regulatory Research

Cathy L Backinger  1 , Helen I Meissner  2 , David L Ashley  3
Affiliations

The FDA "Deeming Rule" and Tobacco Regulatory Research

Cathy L Backinger et al. Tob Regul Sci. 2016 Jul.

Abstract

In May 2016, the Food and Drug Administration extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product (Deeming Rule). This authority now includes, but is not limited to, electronic nicotine delivery systems (ENDS), such as electronic cigarettes, as well as all cigars, pipes, and hookahs (waterpipes). The FDA's Center for Tobacco Products has been able to fund research projects addressing these newly deemed tobacco products through a variety of mechanisms, including partnership with the Tobacco Regulatory Science Program, National Institutes of Health. In building the evidence base to inform the regulation of and communications about new and emerging tobacco products, it is important for investigators to be mindful of the goals of tobacco regulatory science, ie, scientific inquiry specifically to inform potential regulatory decisions and actions to protect the public's health. Having solid scientific evidence will allow the FDA to make the most appropriate regulatory decisions regarding newly deemed products.

Keywords: Food and Drug Administration; National Institutes of Health; research; tobacco regulation.

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Conflict of interest statement

Conflict of interest disclosure The authors have no competing interests to declare.

References

    1. US Department of Health and Human Services, Food and Drug Administration. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act (2016. 21 CFR Parts 1100, 1140, and 1143. [Accessed May 20, 2016]; Available at: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm....
    1. US Department of Health and Human Services, Food and Drug Administration. Family Smoking Prevention and Tobacco Control Act. [Accessed May 20, 2016];2009 Public Law 111-31, 22 June 2009. Available at: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm....
    1. Ashley DL, Backinger CL, van Bemmel DM, Neveleff DJ. Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration’s Center for Tobacco Products. Nicotine Tob Res. 2014;16(8):1045–1049. - PubMed
    1. US Department of Health and Human Services, Food and Drug Administration. CTP-Supported Tobacco Regulatory Research Projects. [Accessed May 20, 2016]; Available at: http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/Research/....
    1. US Department of Health and Human Services, National Institutes of Health, Office of Disease Prevention. Tobacco Regulatory Science Program. [Accessed May 20, 2016]; Available at: https://prevention.nih.gov/tobacco-regulatory-science-program.

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