FDA Releases Menthol Ban Proposals

The rulemaking would affect menthol cigarettes and all flavored cigars.

April 28, 2022

Cigarettes stacked up

ALEXANDRIA, Va.—The U.S. Food and Drug Administration (FDA) today released two proposed tobacco product standards. The first would ban menthol as a characterizing flavor in cigarettes (RIN 0910-AI60) and the second (RIN 0910-AI28) would ban all characterizing flavors, including menthol, in cigars.

“FDA will issue two proposed tobacco standards,” FDA Commissioner Robert Califf said this morning at a congressional subcommittee hearing. “One prohibiting menthol as a characterizing flavor in cigarettes, and another prohibiting characterizing flavors,” Califf said.

The Office of Management and Budget last week cleared both proposed rules for release.

In January 2022, the agency announced its plans to issue proposed rules on two tobacco product standards, following up on its April 2021 commitment to advance rulemaking on menthol cigarettes and menthol and other-flavored cigars.

“History has proven that prohibition of a legal product that has an established user base doesn’t work and has negative consequences for our communities,” stated Anna Blom, NACS director of government relations. “Unfortunately, many current users of these products will seek out illicit sources who don’t check IDs and who sell counterfeit products smuggled into the country.”

NACS is reviewing the proposals from FDA and plans to file public comments on behalf of the industry. NACS has expressed strong concerns about the potential for these proposals in the past because of the likelihood that they would lead to increases in the illicit market for these products.

The rulemaking process includes a comment period in which the agency will consider input from the public before finalizing the rule. NACS will help facilitate comments from retailers on the proposed rules.

The comment period opens May 4. The agency will convene public listening sessions on June 13 and 15 on the proposals.

FDA in its statement released today noted that the agency “cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If these proposed rules 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 regulations do not include a prohibition on individual consumer possession or use.”