FDA’s Proposed Menthol Cigarette, Flavored Cigar Bans Reach Final Review Stage

Next step would include publishing an effective date of regulations
Menthol cigarette
Photograph: Shutterstock

The Food and Drug Administration’s proposed rules on banning menthol cigarettes and flavored cigars are one step closer to becoming reality. The agency has submitted rules for both proposals to the Office of Management and Budget for final review, according to the OMB’s website.

“Finalizing these two product standards remains a top priority for the FDA,” FDA’s Center for Tobacco Products Director Brian King said in a statement to CSP Daily News. “The posting of both rules on the OMB website means they have reached the final step of review for regulatory documents.”

This is the end of a multi-step process that the FDA must take to put in effect new tobacco product standards. Once the OMB completes its final review, the next step would be for the FDA to publish the final regulations in the Federal Register, which would include the effective date of the regulations.

The National Association of Tobacco Outlets, Lakeville, Minnesota, has said the rules will likely be effective one year after publication, but that could be pushed out further, or never happen, if the rules are challenged in court by the industry.  

If finalized, the product standards will cause significant business disruption, including higher prices and fewer options for consumers, NATO said in a statement to CSP Daily News.

“Consequences at retail will include significant lost revenue, coupled with job losses across the country,” the trade association said. “Further, the supply of these products will shift from responsible, licensed and regulated retailers to drastically expand an already existing illicit marketplace.”

However, organizations like the Campaign for Tobacco-Free Kids are calling on the White House and OMB to expedite their review and make the final regulations effective by the end of the year.

“These rules represent truly historic action to drive down tobacco use—the No. 1 cause of preventable death in the United States. Once implemented, they will protect kids from tobacco addiction, advance health equity and save hundreds of thousands of lives, especially Black lives,” the Campaign for Tobacco-Free Kids said in a statement.

It is estimated that about 40% of excess deaths due to menthol cigarette smoking in the U.S. between 1980 and 2018 were those of African Americans, despite African Americans only making up about 12% of the U.S. population, according to the Centers for Disease Control and Prevention. This is due to the tobacco industry targeting its marketing to certain populations, including young people, women and Black people, the CDC said.

The FDA has said that nearly 74% of youth aged 12 to 17 who use cigars say they smoke cigars because they come in flavors they enjoy.

The FDA in April 2022 announced it would be releasing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors other than tobacco in cigars. The agency said it received nearly 250,000 comments on the rules, which it had to review as part of the rulemaking process.

The OMB did not immediately respond to CSP’s request for comment on how long it would take to complete its final review of the FDA’s proposed rules.

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