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Update on Status of FDA Tobacco Regulations
On January 4, 2023, the Biden Administration released an updated Unified Agenda and Regulatory Plan. This plan includes an update on both new regulations that federal agencies plan to propose and the status of pending regulations that have been proposed.
Federal law requires that a federal agency follow a nine-step rulemaking process to propose and adopt a new regulation. The accompanying chart shows this nine-step regulatory process.
Regarding tobacco-related regulations under consideration by the U.S. Food and Drug Administration (FDA), the Unified Agenda and Regulatory Plan released last week provides updates on three regulatory actions that would impact tobacco retailers, wholesalers and manufacturers.
Regulation to Prohibit the Use of Menthol in Cigarettes and RYO Tobacco: In April of 2022, the FDA published a proposed product standard regulation prohibiting the use of menthol as a characterizing flavor in cigarettes, RYO tobacco, and heat-not-burn products. This publication of the proposed regulation was Step 5 of the nine-step regulatory process. The public comment period under Step 6 of the regulatory process ended on August 2, 2022. The Unified Agenda and Regulatory Plan reports that a final rule/regulation is expected to be adopted by the FDA sometime in August of 2023. This would encompass Steps 7, 8, and 9 on the rulemaking process chart and includes drafting the final rule/regulation, obtaining final approval of the rule/regulation by the White House Office of Management and Budget (OMB), and publishing the final rule with an effective date.
When it issued this proposed rule/regulation in April of 2022, the FDA requested public comments on delaying the effective date two-years from the date the final rule is published rather than the usual one-year effective date delay. Some public comments submitted to the agency requested an effective date of six years after the final rule is published. If the FDA does publish a final rule in August of 2023, this means that the FDA may be considering making the ban on menthol in cigarettes, RYO tobacco, and heat-not-burn products effective in August of 2024, August of 2025, or possibly a later date. In addition, if litigation is brought against the FDA’s menthol regulation, the effective date may be extended beyond the one-year or two-year effective date.
Link to status of rule prohibiting the use of menthol as a characterizing flavor in cigarettes:
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0910-AI60
Regulation to Prohibit the Use of Characterizing Flavors in Cigars: Also, in April of 2022, the FDA published a proposed product standard regulation prohibiting the use of characterizing flavors in cigars, except tobacco flavor. Just as with the menthol regulation, the publication of the proposed regulation was Step 5 of the nine-step regulatory process. The public comment period under Step 6 of the regulatory process ended on August 2, 2022. The Unified Agenda and Regulatory Plan reports that a final rule/regulation banning characterizing flavors in cigars is expected to be adopted by the FDA sometime in August of 2023. This would encompass Steps 7, 8, and 9 on the rulemaking process chart and includes drafting the final rule/regulation, obtaining final approval of the rule/regulation by the White House Office of Management and Budget, and publishing the final rule with an effective date.
When it issued the proposed rule/regulation in April of 2022, the FDA stated that the effective date would be one year after the date the final rule is published. If the FDA does publish a final rule in August of 2023, this means that the FDA would likely make the ban on characterizing in cigars effective in August of 2024. However, if litigation is brought against the FDA’s flavored cigar ban regulation, the effective date may be extended beyond the one-year effective date.
Link to status of rule prohibiting the use of characterizing flavors in cigars (except tobacco):
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0910-AI28
Potential Regulation for Maximum Nicotine Level in Cigarettes/Other Tobacco Products: In June of 2022, the FDA announced that the agency would propose a new regulation setting a maximum level of nicotine in cigarettes and certain other tobacco products. The other tobacco products that could be subject to maximum nicotine levels were not specified by the agency.
The Unified Agenda and Regulatory Plan reports that a proposed rule/regulation is expected to be published sometime by October 2023. This means that the FDA is currently on Step 3 of the rulemaking process chart, which is the stage at which a new regulation is being drafted. Then, Step 4 would require the FDA to obtain White House Office of Management and Budget approval of the proposed rule followed by Step 5 when the proposed rule would be published for public comment. When the proposed rule is published for the first time under Step 5, the FDA may state in the proposed rule a timeframe for the new rule to go into effect.
Link to status of proposal to set a maximum level of nicotine in cigarettes and other tobacco products:
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0910-AI76
For more information, please contact Shannon Campagna, CDA policy advisor, at scampagna@capitoldecisions.com or Tom Briant, NATO Executive Director, at info@natocentral.org.
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