The U.S. Food and Drug Administration (FDA), as part of a Spring 2023 Regulatory Agenda issued by the White House Office of Management and Budget through the Office of Information and Regulatory Affairs, released updates on pending tobacco regulations, according to a National Association of Tobacco Outlets (NATO) newsletter.
NATO outlined the following FDA updates:
Menthol in Cigarettes/Characterizing Flavors in Cigars: In May of 2022, the FDA published a proposed product standard that would prohibit the use of menthol in cigarettes, roll-your-own tobacco and heated tobacco products. FDA also published a proposed product standard that would prohibit characterizing flavors (other than tobacco flavor) in all cigars. The public comment period regarding both ban regulations ended on July 5, 2022, with the FDA receiving 175,535 comments in response to the prohibition of menthol and 71,641 comments in response to the ban of flavored cigars. The majority of these comments opposed the ban.
In this Spring 2023 Regulatory Agenda, the FDA reiterates its intent to publish final regulations sometime in August. The FDA has been considering making the menthol regulation effective either one year or two years after the date the final regulation is published. The actual effective date of a ban on characterizing flavors in all cigars will be included in the final published version of the regulation.
Sale of Tobacco Products to Those Younger Than 21: On Dec. 20, 2019, the federal Consolidated Appropriations Act of 2020 was signed into law. This law contained a provision raising the federal minimum age for anyone to purchase tobacco products from 18 to 21 years. As a part of this law, the FDA was required to update its federal tobacco regulations to conform to the new age 21 requirement. The Spring 2023 Regulatory Agenda states that the FDA plans to publish a final regulation with these legal age updates sometime in April of 2024.
Nicotine Level of Certain Tobacco Products: In June of 2022, the FDA announced that the agency was considering a new regulation that would place a cap on the maximum amount of nicotine allowed in cigarettes and possibly other combustible tobacco products. The cap would likely be a significant reduction in the amount of nicotine allowed in these tobacco products. While the FDA had previously stated that this proposed “very low nicotine” regulation would be published by October, the Spring 2023 Regulatory Agenda now states that the proposed regulation is expected to be published in December.
Nicotine Toxicity Warnings: The FDA is planning to issue a proposed regulation that would establish acute nicotine toxicity warning requirements for liquid nicotine and nicotine-containing e-liquids. This proposed regulation may also apply to other tobacco products including dissolvables, lotions, gels and drinks. The main purpose of this proposed regulation would be to increase consumer awareness and knowledge of risks of acute toxicity due to accidental nicotine exposure from these nicotine-containing products. The Spring 2023 Regulatory Agenda states that the proposed regulation is expected to be published in October of 2024.
ENDS Safety Standards: The FDA is considering the issuance of proposed regulations to set safety standards for toxicants and impurities in nicotine, propylene glycol and vegetable glycerin used in electronic cigarettes and nicotine vapor products. The proposed regulation would establish limits on the level of toxicants that are appropriate for the protection of the public health. According to the Spring 2023 Regulatory Agenda, the proposed regulation is expected to be published in December of 2024.