FDA Sends Final Menthol Rule for Review

SILVER SPRING, Md. — More than a year after stating it would move to ban menthol from tobacco products, the U.S. Food and Drug Administration (FDA) is making its final push.

According to numerous reports, the agency submitted a final product standard that would prohibit the use of menthol in cigarettes, roll-your-own tobacco and heated tobacco products to the White House Office of Management and Budget (OMB) for final review.

The OMB reviews potential regulations to assess their economic impact — a necessary step before the FDA's rule can be implemented.

In late April 2022, the FDA proposed two product standards, one to prohibit menthol as a characterizing flavor in cigarettes and the other to prohibit all characterizing flavors (other than tobacco) in cigars. The public comment period regarding the menthol ban regulation ended on July 5, 2022, with the FDA receiving 175,535 comments in response to the prohibition of menthol, the majority of which opposed the ban, as Convenience Store News reported.

The product standard targeting flavored cigars is also before the OMB.

[Read more: FDA Issues Updates on Tobacco Regulation Agenda]

"The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit," Health and Human Services Secretary Xavier Becerra said at the time. "Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities."

Several groups stand in support of the ban, including the American Lung Association, which is urging the Biden Administration to act quickly to finalize the rules that would end the sale of menthol cigarettes and flavored cigars.

"Once finalized, rules to end the sale of menthol cigarettes and flavored cigars rule will be the most significant actions that the FDA's Center for Tobacco Products has taken in its 14-year history. The American Lung Association is eager for these lifesaving rules to be implemented and urges the White House to finalize these rules before the end of the year," said the association's President and CEO Harold Wimmer.

The Campaign for Tobacco-Free Kids also welcomed the news that the FDA sent its rules to end the sale of menthol cigarettes and flavored cigars to OMB for final review, and echoed the call for the administration to expedite the review and issue final regulations by the end of the year.