Tobacco

FDA Tobacco Regulatory Outlook

Proposed final rules banning menthol cigarettes, flavored cigars will not be published until at least March: Spross
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In 2024, The Food and Drug Administration’s Center for Tobacco Products (CTP) will continue to be front and center with the tobacco industry through its announcements, product applications review, enforcement actions and its rules/regulations.

In December, CTP announced that it will not publish final rules to ban menthol cigarettes and characterizing flavors in cigars until at least March. The Office of Management and Budget (OMB) has been holding stakeholder meetings, which is step eight of the nine-step federal rulemaking process. During the review process, OMB evaluates whether to clear the rule for final publication or send it back to FDA for further review. At least 100 of these meetings have occurred or will take place with the OMB.

Last month, the National Association of Tobacco Outlets (NATO) met with representatives from OMB, the Executive Office of the President, FDA and the Department of Health and Human Services (HHS) advocating that these rules not be finalized because:

  • They would have a substantial negative economic impact on reputable, licensed and regulated retail businesses;
  • They would severely negatively impact government revenues and the public programs they fund;
  • They would result in significant unintended consequences, including the fact that the supply of these products will shift from licensed and regulated retailers to an already flourishing illicit market; and
  • Licensed and regulated retailers, like NATO’s members, sell tobacco products responsibly and follow all laws and regulations, which already prevents youth access to menthol cigarettes and flavored cigars.

CTP has stated that finalizing these rules remains a top priority for the agency. If these rules are finalized, they will likely not take effect for at least one year following publication.  Anticipated industry challenges in court could further delay (or altogether prevent) their implementation. 

Additionally, CTP has recently announced that it intends to publish in April a proposed rule to reduce nicotine levels in cigarettes, but the Agency rarely meets these timelines. Regardless, this will involve a multi-step process that will span many years before the rule takes effect (if at all).

At the end of last year, CTP released a five-year strategic plan, which laid out objectives and outcomes across five goals.  These goals include:

  • Develop and communicate comprehensive tobacco regulations and guidance;
  • Ensure timely, clear and consistent product application review;
  • Strengthen compliance, including robust enforcement actions;
  • Enhance knowledge of the risks associated with tobacco product use, which includes education on tobacco harm reduction; and
  • Advance operational excellence from a talent perspective.

David Spross is the executive director of NATO, a tobacco retailing association based in Lakeville, Minnesota. Reach him at david.spross@natocentral.org.  To learn more about NATO, visit www.natocentral.org.

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