These proposed rules build on the Family Smoking Prevention and Tobacco Control Act, which banned characterizing flavors (other than tobacco and menthol) in cigarettes in 2009. FDA connected these proposed rules to the Biden administration’s Cancer Moonshot, which seeks to reduce the cancer death rate by 50 percent over the next 25 years. As proposed, these prohibitions — which apply to manufacturers, distributors, wholesalers, importers and retailers — would become effective one year after the date of publication of the final rules.
FDA is particularly concerned with younger users of flavored tobacco products. In its announcement, FDA highlighted that characterizing flavors make tobacco products (cigars and cigarettes) more appealing to young users. FDA believes these product standards would “reduce the appeal of cigars, particularly to youth and young adults, and decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular use.”
FDA’s announcement also quoted Health and Human Services Secretary Xavier Bacerra, who opined that “[these] proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit. Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities.” FDA Commissioner Robert Califf noted in the announcement that “the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives.”
FDA provided a list of factors that are relevant in determining whether a tobacco product has a characterizing flavor, and thus, would be subject to the proposed rules. These factors include:
- The presence and amount of artificial or natural flavor additives, compounds, constituents or ingredients, or any other flavoring ingredient in a tobacco product, including its components or parts.
- The multisensory experience (i.e., taste, aroma and cooling or burning sensations in the mouth and throat) of a flavor during use of a tobacco product, including its components or parts.
- Flavor representations (including descriptors), either explicit or implicit, in or on the labeling (including packaging) or advertising of tobacco products.
- Any other means that impart flavor or represent that a tobacco product has a characterizing flavor.
The proposed rule, as currently drafted, does not appear to apply to e-cigarette products. In this regard, FDA noted, “While we recognize that some smokers could try to add menthol e-cigarette liquids (or e-liquids) to non-menthol cigarettes, we believe that the amount of e-liquid needed to impart a menthol characterizing flavor would make the cigarette unsmokeable.”
Banning Characterizing Flavors in Cigars
The proposed rule prohibits the use of characterizing flavors, other than tobacco, in cigars and cigar components and parts. This would include tobacco, filters and wrappers.
The proposed rule defines “cigar” as a tobacco product that:
- is not a cigarette, and
- is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco.
The proposed rule includes in its definitions of “characterizing flavors” any herbs and spices, such as strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, coffee, mint and menthol.
Cigars with tobacco as a characterizing flavor would not be subject to the rule’s standards, because “tobacco-flavored cigars do not currently appear as attractive [to those who experiment with cigars] as other characterizing flavors.” However, FDA has reserved the right to act in the future to ban tobacco as a characterizing flavor in cigars.
Banning Menthol in Cigarettes
As noted, characterizing flavors (other than tobacco and menthol) are already banned in cigarettes, under the Family Smoking Prevention and Tobacco Control Act. FDA noted that menthol “interacts with nicotine in the brain to enhance nicotine’s addictive effects” and “increases the likelihood that youth who start using menthol cigarettes will progress to regular use” while “mak[ing] it more difficult for people to quit smoking.”
The proposed rule prohibits the use of menthol as a “characterizing flavor” not only in cigarettes, but also in cigarette components and parts, including those sold separately to consumers. This would include tobacco, filters, wrappers and paper. Under the rule, no person may “manufacture, distribute, sell, or offer for distribution or sale” a cigarette, cigarette component or cigarette part that contains menthol as a constituent or additive.
Comment Period Open
The public comment period for each proposed rule is open through July 5, 2022. Comments can be submitted via the Federal eRulemaking Portal or via paper submission. FDA has also scheduled public listening sessions for June 13 and June 15. Commissioner Califf noted in the announcement that “[t]hrough the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.” Only after all public comments have been received and reviewed will FDA determine whether to issue final product standards.