FDA PROPOSES REGULATIONS PROHIBITING MENTHOL IN CIGARETTES AND CHARACTERIZING FLAVORS IN CIGARS

The U.S. Food and Drug Administration issued a press release announcing two new proposed tobacco product standard regulations. One regulation would prohibit the use of menthol as a characterizing flavor both in cigarettes and in cigarette components and parts, including those that are sold separately to consumers. The second regulation would ban characterizing flavors (other than a tobacco flavor) in cigars, cigar components, and parts.

A tobacco product standard regulation is a power granted to the FDA under the Family Smoking Prevention and Tobacco Control Act to reduce or eliminate an ingredient or constituent in a tobacco product or tobacco smoke. Since the proposed regulations would ban the use of menthol in cigarettes, cigarette components and parts and prohibit characterizing flavors in cigars, cigar components, and parts, the regulations are known as tobacco product standards.

Menthol Cigarette Tobacco Product Standard: The proposed tobacco product standard would provide that a cigarette or any of its components or parts (i.e., cigarette tobacco, cigarette filters, cigarette wrappers and papers) shall not contain as a constituent or a smoke constituent or additive, menthol that is a characterizing flavor of the tobacco product or tobacco smoke. Under the proposed regulation, no person may manufacture, distribute, sell, or offer for distribution or sale within the United States a cigarette or cigarette component or part that contains a characterizing flavor of menthol.

The FDA is proposing that any final regulation that may be issued prohibiting the use of menthol as a characterizing flavor both in cigarettes and in cigarette components and parts become effective one year after the date of the publication of the final rule. A copy of the proposed tobacco product standard accompanies this bulletin.

Characterizing Flavors in Cigars Tobacco Product Standard: The proposed tobacco product standard would provide that a cigar, cigar components and parts (i.e., tobacco, filter, or wrapper) must not contain as a constituent or a smoke constituent or additive, an artificial or natural flavor (other than tobacco flavor) 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. Under the proposed regulation, no person may manufacture, distribute, sell, or offer for distribution or sale within the United States a cigar or any of its components or parts that contains a characterizing flavor (other than a tobacco flavor).

The FDA is proposing that any final regulation that may be issued prohibiting the use of characterizing flavors (other than tobacco flavor) in cigars, cigar components and parts become effective one year after the date of the publication of the final rule. A copy of the proposed tobacco product standard accompanies this bulletin.

No Enforcement Against Individual Consumers: If these proposed tobacco product standards are finalized and implemented, FDA enforcement will only address 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. These proposed tobacco product standards do not include a prohibition on individual consumer possession or use. State and local law enforcement agencies do not independently enforce the Federal Food, Drug and Cosmetic Act and do not, and cannot, take enforcement actions against any violation of FDA’s tobacco authorities, including its regulations, on the FDA’s behalf.

Publication of the Proposed Tobacco Product Standards: The FDA states that both tobacco product standards plan to be published in the Federal Register on May 4, 2022.

Public Comments on the Proposed Tobacco Product Standards: The FDA is providing the public 60 days after the date the tobacco product standards are published in the Federal Register to submit comments on the regulations to the agency. Provided that the tobacco product standard regulations are published in the Federal Register on May 4th, comments would need to be submitted to the FDA by July 5, 2022. When the public comment period expires, the FDA must review each of the comments submitted, make any changes to the proposed tobacco product standards, have the White House Office of Management and Budget conduct a final review of the regulations, then publish the final regulations.