Docket No. FDA-2017- N-6565                                                                                      June 21, 2018
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE: Docket No. FDA-2017—N-6565 (83 Fed. Reg. 12,294, March 21, 2018) Advance Notice of Proposed Rulemaking on Regulation of Flavors in Tobacco Products

Dear Commissioner Gottlieb,

We write to you out of concern on the proposed rule-making regarding the use of flavors in tobacco products. While the FDA’s initiative is driven by the perceived problem that flavors make tobacco products attractive to young people and thus increase initiation and consumption of tobacco products, we are particularly concerned about the effects that such regulation could have on reduced risk alternatives. The FDA recognizes that non-combustible products can provide benefits by reducing combustible tobacco use. In fact, Commissioner Scott Gottlieb, has acknowledged:

It’s possible for flavors to do both harm and good. The troubling reality is that e-cigarettes are the most commonly used tobacco product among middle and high school students, and flavors are identified as one of the top three reasons for use […] At the same time, we’re aware that certain flavors may help currently addicted adult smokers switch to potentially less harmful forms of nicotine-containing tobacco products.[1]

There are several issues that the FDA will have to consider to prove that any proposed rule directed at flavors in non-combustible tobacco/nicotine products is “appropriate for the protection of public health,” as required by the Tobacco Control Act. We believe that unintended consequences that arise from ill-conceived rule-making designed to reduce the attractiveness of alternatives to smoking have their own harmful impacts—on both young people and adults.

This is because to the extent that flavors contribute to the appeal that causes smokers or potential smokers to switch to vaping instead, the flavors themselves actually provides a public health benefit. Accordingly, the FDA does a disservice to the possibility of efficacious rulemaking when it frames the flavor issue as a trade-off between adult benefits and adolescent harms.

On the contrary, it is more likely than not that vaping is net beneficial to youth, as regular youth vaping is highly concentrated in current, former and potential smokers. Thus, where vaping displaces smoking there is a large benefit to smokers. And indeed, even where vaping displaces abstinence, there is only a small detriment to vapers – and this is true among both adolescents and adults.

It may be appropriate for the FDA to revisit the role that flavors play in the uptake of smoking, especially among adolescents, but we urge the FDA to deeply consider the role that e-cigarettes and vaping has in changing the landscape of tobacco use – and the resulting improvements in the health of our populace.

Enclosed in this document, please find our Executive Summary followed by a more detailed report on considerations the FDA must address in a rule-making regarding flavored tobacco products.

Sincerely,

Carrie Wade, Harm Reduction Policy Director
R Street Institute
Clive Bates, Founder and Director
Counterfactual

EXECUTIVE SUMMARY

When considering flavor restrictions it is imperative that regulators recognize the contributions that e-cigarettes may have had in reducing smoking rates among adults. Since 2010 smoking rates have declined at a more rapid rate than in the previous decade. Although we cannot know exactly to what extent the uptake of vaping by adults has caused the sharp improvement in the rate of decline shown in the chart, four recently published studies that use large, national-U.S. datasets suggest that e-cigarettes are associated with smoking cessation.[2]

Furthermore, the prevalence of smoking among adolescents has declined steadily (and more rapidly since 2010) since 1996. This decline suggests that current tobacco control policies aimed at adolescents are working and that e-cigarettes are not acting as a gateway to combustible use.

When considering approaches to regulate flavors there are several factors that should be taken into account including:

Categorical considerations
Combustible products
Smokeless products
Vapor products
Behavioral considerations
Diversion from combustible use in adolescents
Gateway effects
Smoking cessation
Toxicity considerations
Absolute risk
Relative risk compared to combustible products

The potential for significant unintended consequences needs to be addressed including, but not limited to:

An uptake in combustible use
Quitting deterrence
Adulterated e-liquids that are more toxic than banned e-liquids
Illicit trade and a higher burden on law enforcement

Furthermore, there is, to date, little evidence demonstrating that potentially “problematic” flavors can be identified – and that those flavors result in the uptake of combustible products and are distinctly different from flavors that encourage smoking cessation.

To shape reasonable policy regarding flavored tobacco products, the FDA will have to demonstrate that resulting rules or restrictions are “appropriate for the protection of public health” – meaning that new rules will have to benefit the population as a whole, including users and non-users alike. This burden of proof is demanded of companies applying for marketing approval of new products or reduced-risk claims and should also be applied to the FDA showing that its intervention will reduce rather than increase harms.

[1] “Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products,” Statement from FDA Commissioner,” U.S. Food and Drug Administration, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601690.htm.

[2] See, e.g., Shu-Hong Zhu et al., “E-cigarette use and associated changes in population smoking cessation: evidence from US current population surveys,” British Medical Journal (2017) p. 358. http://www.bmj.com/content/358/bmj.j3262; Daniel P Giovenco et al., “Prevalence of population smoking cessation by electronic cigarette use status in a national sample of recent smokers,” Addiction Behavior 76: (2018) pp. 129–34. http://www.sciencedirect.com/science/article/pii/S0306460317302915; Su Hyun Park et al., “Characteristics of Adults Who Switched From Cigarette Smoking to E-cigarettes,” American Journal of Preventative Medicine 53:5 (2017) pp. 652–60. https://www.ajpmonline.org/article/S0749-3797(17)30363-X/fulltext; David T. Levy et al., “The Relationship of E-Cigarette Use to Cigarette Quit Attempts and Cessation: Insights From a Large, Nationally Representative U.S. Survey,” Nicotine and Tobacco Research (2017). https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/ntx166/4096490?redirectedFrom=fulltext.