An Update on FDA Regulations

    From premarket tobacco product applications to the ban on menthol cigarettes and flavored cigars

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    One of the proposed regulations would prohibit menthol as a flavor in cigarettes, roll-your-own cigarette tobacco and heated tobacco products. The second regulation would also prohibit any flavors in cigars. Federal law requires that an agency request comments from the public about proposed regulations.

    The FDA received more than 175,000 comments on the menthol cigarette ban and almost 72,000 comments on the flavored cigar ban by the August 2, 2022, submission deadline. In addition, a Gallup poll conducted in August 2022 found that less than a majority of Americans, only 42 percent, are in support of banning menthol cigarettes.

    In response to this significant number of comments, the FDA issued an announcement that it “will need ample time to comprehensively review and analyze all of the comments.” In addition, a Gallup poll conducted in August 2022 found that less than a majority of Americans, only 42 percent, both Democrats and Republicans, are in support of banning menthol cigarettes.

    Because the FDA announced it will need “ample” time to read all of the comments, it could take nine to 12 months—or possibly longer—for the agency to read through the comments on the menthol ban and flavored cigar ban. The FDA will then decide whether to draft any changes to the proposed regulations, and if it does, that process may take up to three months.

    After any changes are made, the FDA will need to send the final proposed regulations to the White House Office of Management and Budget (OMB) for its final review and decision on whether the FDA can proceed with implementing the regulations. During this time, the OMB will meet with members of the public for their input on the final regulations. This process may take up to two months or longer.

    Also, in the proposed regulations, the FDA asked for the public’s feedback on making the effective date of the regulations two years after the final regulations are published instead of the usual one-year time period before the regulation takes effect. Some manufacturers recommended in their comments that the FDA consider making the regulations effective six years after the final regulations are published. Then, there is also the possibility that lawsuits could be brought against the FDA regarding the proposed regulations, which may further delay an effective date.

    So, by adding up the estimated time periods for the FDA to read comments, make changes and obtain OMB final approval, it could take almost a year and a half before the final regulations would be published. Then, when publishing the final regulations, the FDA will need to determine if the regulations will actually go into effect in one year or two years. When adding up all of these time periods, the estimated time when the menthol cigarette ban and flavored cigar ban may go into effect is approximately two and a half to possibly three and a half years from now.

    This story first appeared in the November/December 2022 issue of Tobacco Business magazine. You can view the entire issue online for free by clicking here.

    Contributed by Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO)