LAKEVILLE, Minn. — The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) Director Mitch Zeller posted a statement on the FDA’s website announcing that the agency “remains on track to advance two proposed product standards” by this spring. In April 2021, the FDA announced that it would issue these product standard regulations within one year, or by April 2022.
One of these product standards would prohibit the use of menthol in cigarettes and a second product standard would prohibit all characterizing flavors (including menthol) in cigars. A product standard is a power granted to the FDA by Congress under the Family Smoking Prevention and Tobacco Control Act to reduce or eliminate an ingredient in a tobacco product or a constituent in tobacco smoke. This is the power that the FDA is utilizing to draft these two product standard regulations to ban menthol in cigarettes and flavors in cigars.
Once the FDA drafts the proposed product standard regulations, there are several steps the agency needs to take before the regulations take effect. These steps include the following:
- Submitting the proposed regulations to the White House Office of Management and Budget (OMB) for review. The OMB needs to approve of any proposed regulations that would have a significant impact on the country’s budget and economy.
- Publishing the proposed regulations in the Federal Register so the public can review the regulations.
- Providing the public a period to submit comments to the agency about the proposed regulations. Usually, the FDA allows 60 to 90 days for public comments.
- Deciding whether any changes are to be made to the proposed regulations after reviewing all the public comments submitted. Once the comments are reviewed, then the FDA makes any needed changes to the proposed regulations.
- Re-submitting the final version of the proposed regulations to the OMB a second time for an additional review and approval.
- Publishing the final regulations in the Federal Register and setting a date for the regulations to go into effect.
In his announcement, Zeller said “[i]f implemented, the FDA’s enforcement of any prohibition on menthol cigarettes and flavored cigars would only address manufacturers, distributors, wholesalers, importers and retailers. The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any other tobacco product.”
Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at info@natocentral.org.
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