December 20, 2017
Dr. Scott Gottlieb, MD
Commissioner
United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20857
Re: a framework for considering the appeal of flavors in nicotine products
Dear Dr. Gottlieb:
Following FDA’s announcement of a comprehensive nicotine strategy on 28 July, we write regarding one aspect of the strategy: the possible rule-making with respect to flavored nicotine products. We are concerned that some prominent commentary about flavors in low-risk tobacco and nicotine products, including that provided in the Surgeon General’s 2016 report, is overly simplistic in presuming that the primary purpose and consequence of offering flavors is to recruit current non-users, especially youth, to nicotine use.
A proper assessment requires a deeper analysis, and must at least consider the possibility that these low-risk products can function as alternatives to combustibles, not only for adults, but also as a diversion from youth smoking uptake and as support for youth smoking cessation. In that case, the attractiveness and appeal of such non-combustibles may be a positive factor in reducing the use of the far more harmful products, such as cigarettes. This harm-reduction benefit may apply for both adult and adolescent users.
Any justification for an intervention must show that a rule is appropriate for the protection of public health and that it is reasonable to conclude that harms will outweigh benefits. To show this is likely would require a long chain of reasoning, supported by credible data. Is a flavor attractive? Is it differentially attractive to youth, versus adults? If it is differentially attractive, does it change behavior? If it changes behavior, is the change harmful or beneficial? How would an intervention affect behavior? Would an intervention reduce harm or reduce benefits in youth and adult populations? What are the potential mechanisms for unintended consequences?
The attached memo discusses the analysis that is necessary to show that harms (or benefits) arise from flavored nicotine products. We hope that the ANPRM on flavors will reflect these issues at the point of publication. This will provide a more realistic foundation for public comment and help to raise the level of public and political debate about this important and controversial issue.
Yours sincerely,
Thomas J. Miller
Attorney General of Iowa, Des Moines, Iowa, United States
David B. Abrams PhD
Professor. Department of Social and Behavioral Sciences, NYU College of Global Public Health. New York University, United States
Clive D. Bates
Director, Counterfactual, London, Former Director Action on Smoking and Health, London, United Kingdom
Raymond S. Niaura PhD
Professor. Department of Social and Behavioral Sciences, NYU College of Global Public Health, New York University, United States
David T. Sweanor J.D.
Adjunct Professor, Faculty of Law, Centre for Health Law, Policy & Ethics, University of Ottawa, Canada
