On January 15, 2025, the U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register titled “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products (90 Fed. Reg. 5032).”
The proposed rule would establish a maximum nicotine level of 0.70 milligrams per gram of total tobacco in cigarettes and certain other combusted tobacco products. The FDA’s stated intent of the proposed rule is to reduce the addictiveness of cigarettes and other combusted tobacco products. The FDA predicts the proposed rule would require small tobacco farms and manufacturers to either shut down production operations or transition land, capital, labor, and other resources to comply with the new product standards.
Small entities, including tobacco farmers, manufacturers, wholesalers, retailers, and local government jurisdictions with populations less than 50,000, commented on the extremely harmful economic impacts the proposed rule would have on the tobacco industry. The Regulatory Flexibility Act (RFA) gives small entities a voice in the rulemaking process by requiring federal agencies to assess the impact proposed regulations will have on small entities and to consider less burdensome alternatives. Advocacy recommends that the FDA withdraw this proposed rule to address the concerns of small entities and to consider less burdensome alternatives.
COMMENT LETTER
Tobacco Product Standard for Nicotine Yield
(PDF, 274KB)
CONTACT:
Will Purcell
EMAIL:
Letters to Agencies