FDA should extend the scope of the proposed flavor standard to prohibit flavors in all tobacco products, including e-cigarettes and smokeless tobacco, to make them less appealing to adolescents and young adults

The UCSF TCORS submitted the following public comment to the FDA on August 1, 2022. The Comment Tracking Number is l6c-lwj1-vcu7. Click here to download the PDF.

FDA should extend the scope of the proposed flavor standard to prohibit flavors in all tobacco products, including e-cigarettes and smokeless tobacco, to make them less appealing to adolescents and young adults

Docket No. FDA-2021-N-1309

for “Tobacco Product Standard for Characterizing Flavors in Cigars”

Benjamin Chaffee, DDS, MPH, PhD; Lauren Kass Lempert, JD, MPH; ​
 Bonnie Halpern-Felsher, PhD;^a Stanton Glantz, PhD; 
Stuart Gansky, DrPH; Daniel D. Han, BA; Andre Luiz Oliveira Da Silva, PhD; 
Vira Pravosud, PhD, MPH, MS; Hai-Yen Sung, PhD;
Pamela M. Ling, MD, MPH

UCSF TCORS

^a.  UCSF TCORS and Stanford University

August 2, 2022

We generally support FDA’s proposed product standard prohibit flavors in cigars because it will reduce initiation rates of smoking cigars and will significantly reduce premature deaths and illnesses related to tobacco use. However, to meet its mandate to protect the public health, especially the health of adolescents and young adults, FDA should extend the scope of the proposed standard to prohibit flavors in all tobacco products, including e-cigarettes.

In the proposed rule, FDA requests comments regarding whether the scope of the product standard should be expanded to cover waterpipe and/or pipe tobacco in addition to cigars, and asks what advantages and/or disadvantages could be expected from extending the scope of the standard to include all combusted tobacco products, and whether there would be a risk that consumers would substitute and/or migrate to other combusted tobacco products if FDA limits the standard to cigars.[1] However, FDA does not consider expanding the scope to include e-cigarettes, smokeless tobacco, and other products, which do pose significant risks to consumers, especially adolescents and young adults, who are often motivated to try and continue to use these products due to their flavors. 

Without providing scientific evidence, FDA states:

FDA is not including non-combusted tobacco products, such as ENDS [i.e., electronic nicotine delivery systems, e.g., e-cigarettes] and smokeless tobacco products, in the scope of this proposed standard. As discussed previously, characterizing flavors in a variety of tobacco products have appealing effects, particularly among youth and young adults. And youth and young adult use of any tobacco product remains a significant concern for FDA. However, at this time, FDA is focusing this proposed rule on characterizing flavors in cigars because this action would help to prevent youth and young adults’ use of combusted tobacco products. Combusted tobacco products are responsible for the majority of death and disease due to tobacco use. [2]

FDA is well aware of the overwhelming evidence that flavors in tobacco products attract and keep adolescent and young adult users. Indeed, a July 2022 paper[3] by Brian King, the current director of the Center for Tobacco Products, citing evidence from the 2021 National Youth Tobacco Survey (NYTS), states:  

Flavors remain a major driver of youth e-cigarette use.[4] A majority of youths who currently use e-cigarettes report flavors are a reason they used the products, and in 2021, 84.7% of youths who used e-cigarettes reported using a flavored product⁴ …

The 2021 NYTS reported that among students who reported using any tobacco product, 79.1% reported using flavored tobacco products, including 84.7% who used flavored e-cigarettes, 70.1% used flavored smokeless tobacco, 61.6% used flavored nicotine pouches, 46.6% used flavored hookahs (waterpipe), 44.4% used flavored cigars, 44.0% used flavored heated tobacco products, 38.8% used flavored (menthol only) cigarettes, and 34.4% used flavored pipe tobacco.⁴In other studies, adolescents report that they initiate with and continue to use e-cigarettes because they are available in flavors not found in traditional tobacco products.[5]^{, [6], [7], [8], [9], [10]}   

Moreover, comprehensive measures that prohibit flavors in all tobacco products are necessary to reduce racial inequalities in tobacco-related disease.  Use of flavored tobacco products is particularly common among Black and Hispanic/Latinx tobacco users of all tobacco products.[11]  

Additionally, several recent papers demonstrate that flavors in tobacco products affect consumers’ (and especially adolescents’ and young adults’) perceptions of these products. Flavors in e-cigarettes and flavors in smokeless tobacco cause youth to view those products with more curiosity and to consider them as being less dangerous.[12]  Flavors in smokeless tobacco, notably wintergreen, may have direct effects on the brain that make the product more desirable and more addictive.[13] Regardless of the type of product, flavored tobacco is viewed as less harmful and is a common reason to try using a tobacco product.[14]

The evidence is clear: flavors in any tobacco product – especially e-cigarettes and smokeless tobacco – attract adolescents and young adults to use these products.

Conclusion

While we generally support FDA’s proposed product standard prohibiting characterizing flavors in cigars, the scope of the standard should also include non-combusted tobacco products.  Flavored tobacco products of all types, especially flavored e-cigarettes and flavored smokeless tobacco, are especially appealing to adolescents and young adults and to Black and Hispanic/Latinx tobacco users. Comprehensive measures that prohibit flavors in all tobacco products are necessary to reduce youth use and racial inequalities in tobacco-related disease.  Therefore, we urge FDA to expand the scope of the proposed product standard prohibiting flavors in cigars to include e-cigarettes, smokeless tobacco, heated tobacco, and all other tobacco products under FDA’s jurisdiction.

[1] US Food and Drug Administration, Tobacco Product Standard for Characterizing Flavors in Cigars, May 4, 2022, Proposed Rule, 87 FR 26396 at 26435.