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FDA Issues Updates on Tobacco Regulation Agenda

New rules address the use of menthol in cigarettes and updated restrictions on the sale of tobacco products to anyone under age 21.

WASHINGTON, D.C. As a part of the Spring 2023 Regulatory Agenda, the Food and Drug Administration (FDA) has issued updates on various pending and upcoming tobacco-related regulations.  

[Read more: FDA Cracks Down on Illegal Sales of Disposable E-Cigarettes]

As outlined by the National Association of Tobacco Outlets, relevant new updates include:

Tobacco Product Standard for Menthol in Cigarettes

In May 2022, the FDA published a proposed regulation known as a "product standard" that would prohibit the use of menthol in cigarettes, roll-your-own tobacco and heated tobacco products. 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. 

The agency still intends to publish a final regulation, also known as a final rule, sometime in August 2023. However, this does not mean any ban would go into effect immediately, with the agency anticipating any regulation would only begin enforcement either one year or two years after the date the final regulation is published. 

Prohibition of Sale of Tobacco Products to Persons Younger than 21 Years of Age

As a result of the passage of the Consolidated Appropriations Act of 2020, which raised the federal minimum age for anyone to purchase tobacco products from 18 to 21 years, the FDA was required to update its federal tobacco regulations to conform to the new age requirement. The FDA plans to publish a final regulation with these legal age updates sometime in April 2024. 

Tobacco Product Standard for Nicotine Level of Certain Tobacco Products

In June 2022, the FDA proposed a new regulation that would place a cap on the maximum amount of nicotine allowed in cigarettes and possibly other combustible tobacco products and would likely result in a significant reduction in the amount of nicotine allowed in those products. While the FDA had previously stated that this proposed "very low nicotine" regulation would be published by October 2023, the proposed regulation is now expected in December 2023.

[Read more: FDA's Tobacco Regulatory Efforts Face Congressional Scrutiny]

Nicotine Toxicity Warnings

The FDA plans to issue a proposed regulation that would establish acute nicotine toxicity warning requirements for liquid nicotine and nicotine-containing e-liquids, which may also apply to other tobacco products such as dissolvables, lotions, gels and drinks. The main purpose would be to increase consumer awareness and knowledge of risks of acute toxicity due to accidental nicotine exposure from these nicotine-containing products. The proposed regulation is expected to be published in October 2024.

Further information regarding agency action on nicotine and tobacco products may be found on the FDA regulatory tracker page.

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