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FDA Sends Final Menthol and Flavors Rule to OMB

Nov 06, 2023 | Daniel Hamilton

In 2009, the Food Drug Administration (FDA) was granted authority to regulate the manufacturing, distribution, and marketing of tobacco products through the Family Smoking Prevention and Tobacco Control Act.1 Flavor bans were included in this act because flavored tobacco products are often perceived as less harmful than tobacco flavored tobacco products and are often a starter product for youth.2 However, menthol was excluded from the flavor ban, and the flavor ban was limited to just cigarettes and did not include other tobacco products, such as cigars and cigarillos.

The ban on flavors in cigarettes helped reduce the rate of youth cigarette use, however youth shifted to other combustible forms of tobacco use, such as cigars and cigarillos, where flavors were not banned. Among youth who ever tried a cigar or cigarillo, nearly 70% of cigarillo users and over half of cigar users reported that the first cigar they tried was flavored.3

Tobacco-related illness is among the leading causes of death for African Americans and excluding menthol from the ban on flavors for cigarettes may further exacerbate health inequities problems among several populations. The tobacco industry has heavily marketed menthols to African Americans, which has led to more than 85% of African American smokers using menthol cigarettes, compared to 30% of non-Hispanic White smokers.4 Among LGBTQ smokers, more than 36% smoke menthols compared to all other flavors.5 Menthols are considered easier to use, and thus menthol smokers are less likely to successfully quit compared to non-menthol smokers.5 These disparities have led communities across the country to take action and ban menthol cigarettes, including Chicago, Los Angeles, San Francisco, and the state of Massachusetts.6

To reduce these health disparities and reduce youth experimentation, the FDA proposed rules which would prohibit the sale of menthol as a characterizing flavor from cigarettes, and all other characterizing flavors from cigars, on April 28, 2022.7 Since then, the FDA has been reviewing comments submitted by the public on the proposed rules. After a lengthy review process, the FDA recently finalized the rules which would prohibit the sale of menthol cigarettes and flavored cigars and sent them over to the Office of Management and Budget (OMB) for their review.8

The Office of Information and Regulatory Affairs (OIRA) is part of OMB and is responsible for reviewing all regulatory action deemed significant. This is the last step of the rulemaking process in which the agency responds to public comment on the proposed rule and makes appropriate revisions before publishing the final rule in the Federal Register to become effective. Tobacco companies are expected to sue in response to final rule.

References

1U.S. Food and Drug Administration. (2009). Family smoking prevention and tobacco control act. U.S. Food and Drug Administration. Retrieved March 29, 2022, from https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview

2Stanton, C. A., Villanti, A. C., Watson, C., & Delnevo, C. D. (2016). Flavoured tobacco products in the USA: Synthesis of recent multidiscipline studies with implications for Advancing Tobacco Regulatory Science. Tobacco Control, 25(Suppl 2), ii1–ii3. https://doi.org/10.1136/tobaccocontrol-2016-053486

3U.S. Food and Drug Administration. (2021). FDA on track for actions to address tobacco-related health disparities. U.S. Food and Drug Administration. Retrieved March 29, 2022, from https://www.fda.gov/news-events/fda-voices/fda-track-take-actions-address-tobacco-related-health-disparities#:~:text=Much%20like%20it%20sounds%2C%20a,(including%20menthol)%20in%20cigars

4 The Center for Black Health & Equity. (n.d.). Menthol: The Center for Black Health & Equity. The Center. Retrieved April 28, 2022, from https://www.centerforblackhealth.org/mentholandissues

5Outlast Tobacco - National LGBT Cancer Network. National LGBT Cancer Network -. (2022, May 2). https://cancer-network.org/out...

6Campaign for Tobacco-Free Kids. (2022). States & localities that have restricted the sale of Flavored Tobacco Products. Campaign for Tobacco-Free Kids. Retrieved March 29, 2022, from https://www.tobaccofreekids.org/assets/factsheets/0398.pdf

7U.S. Food and Drug Administration. (2022, April 28). FDA proposes rules prohibiting menthol cigarettes and flavored cigars to prevent youth initiation, significantly reduce tobacco-related disease and death. https://www.fda.gov/news-events/press-announcements/fda-proposes-rules-prohibiting-menthol-cigarettes-and-flavored-cigars-prevent-youth-initiation#:~:text=Today%2C%20the%20U.S.%20Food%20and%20Drug%20Administration%20is,all%20characterizing%20flavors%20%28other%20than%20tobacco%29%20in%20cigars.

8Office of Management and Budget. (n.d.). Pending EO 12866 regulatory review. https://www.reginfo.gov/public/do/eoDetails?rrid=341268


About Daniel Hamilton

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