February 6, 2023

Volume XIII, Number 37

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February 03, 2023

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Will FDA’s Proposed Ban on Flavored Tobacco Products Ever be Implemented?

On April 28, 2022, the U.S. Food and Drug Administration (FDA) released two proposed rules that would ban menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors such as strawberry and menthol in cigars. The proposed rules were in response to efforts to reduce youth initiation and help current smokers quit, and are part of the FDA’s efforts to reduce tobacco-related health disparities.

FDA’s first proposed rule (Menthol Product Standard) would prohibit the use of menthol as a characterizing flavor in cigarettes and cigarette components and parts, including those that are sold separately to consumers. Specifically, under the proposed rule, no person may manufacturer, distribute, sell, or offer for distribution or sale, a cigarette or cigarette component, or part, in the U.S. that is noncompliant with the Menthol Product Standard. With respect to the purpose of this proposed rule, FDA stated that “menthol’s flavor and sensory effects reduce the harshness of cigarette smoking and make it easier for new users, particularly youth and young adults, to continue experimenting and progress to regular use.” Furthermore, FDA stated, “data show that menthol cigarettes contribute to greater nicotine dependence in youth and young adults than non-menthol cigarettes.”

FDA’s second proposed rule (Flavored Cigar Product Standard) would prohibit characterizing flavors (other than tobacco) in cigars and cigar components and parts. When finalized, the Flavored Cigar Product Standard would prohibit a person from manufacturing, distributing, selling, or offering for distribution or sale in the U.S., a cigar or any of its components or parts that contains characterizing flavors. Under this proposed standard, a cigar or any of its components or parts cannot contain “an artificial natural flavor (other than tobacco) or an herb or spice, including, but not limited to, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, coffee, mint, or menthol that is a characterizing flavor of the tobacco product or tobacco smoke.”

In a press release, FDA declared that it will not bring enforcement actions against individual consumers for possession or use of menthol cigarettes or flavored cigar once these rules are finalized. Instead, FDA stated it would focus on “manufacturers, distributors, wholesalers, importers, and retailers who manufacture, distribute, or sell such products within the U.S. that are not in compliance with applicable requirements.”

Flavored tobacco products have been on the market for a very long time. FDA’s regulations prohibiting the use of flavors in cigarettes, cigars, and components thereof, will likely be the target of significant legal challenges. We will continue to follow this situation to see what the future holds for flavored tobacco products.

Interested stakeholders can submit comments on the proposed rules through July 5, 2022 through these dockets, Docket No. FDA-2021-N-1349 and Docket No. FDA-2021-N-1309.

© 2023 Foley & Lardner LLPNational Law Review, Volume XII, Number 146

About this Author

Devaki Patel Healthcare Lawyer Foley and Lardner

Devaki (Devki) Patel is an associate with Foley & Lardner LLP, based in the firm’s Washington D.C. office, where she is a member of the firm’s Government Solutions and FDA Regulatory Practices. She is also a member of the Life Sciences, Food and Beverage and Cannabis Industry Teams. In addition to being an attorney, she is a licensed pharmacist. Devaki is admitted to practice only in Maryland. She is practicing under the supervision of a member of the District of Columbia Bar.

Prior to joining Foley, Devaki worked for the Food and Drug Administration as a legal intern,...

David L. Rosen, Foley Lardner, FDA Regulatory Lawyer, Life Science Industry Attorney,

David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.

Mr. Rosen was...