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

26 May 2022 Health Care Law Today Blog
Author(s): Devaki Patel David L. Rosen

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.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.

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