FDA Seeks Comments on its Proposed Rule on Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products

What: On January 16, 2025, the Food and Drug Administration (FDA) published a proposed rule to require a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. FDA proposes that any final rule it may issue based on this proposed rule become effective 2 years after the date of publication of the final rule.  The proposed rule does not include an economic impact analysis on small businesses, but the FDA anticipates the imposed costs on the tobacco industry to include a reduction in revenues and costs to the broader to repurpose land, labor, and capital impacted by the product standard. 

Specifically, the FDA’s proposed product standard for nicotine regulates to:

• limit the nicotine yield of cigarettes and certain other combusted tobacco products by setting a maximum nicotine content level of 0.70 milligrams (mg) of nicotine per gram of total tobacco.
• require manufacturers to analyze the nicotine levels of cigarettes and certain other combusted tobacco products covered by the rule using an analytical test method that has been validated in an analytical test laboratory.
• require tobacco product manufacturers to design and implement a sampling plan that covers each batch of finished tobacco product that they manufacture. 
• require tobacco product manufacturers to establish procedures for the control and disposition of tobacco products that do not conform to the requirements of this rule. 
• require the use of a manufacturing code to serve as a common identifier for production and distribution records.
• require that manufacturers establish and maintain records regarding the results of testing conducted on each batch to determine conformance with the proposed standard.

Why: FDA requests comments, data, and information on the scope of this rule, including the following:

• the selection of an immediate reduction strategy to reach the proposed maximum nicotine level to limit additional toxicant exposure and minimize manufacturing costs
• proposed effective date of this proposed rule
• the proposal to exclude noncombusted cigarettes and/or waterpipe tobacco from the scope of this proposed rule, including any data that could justify otherwise
• the proposed maximum nicotine level and the economic impacts of a nicotine tobacco product standard
• data or other scientific support, regarding the FDA’s Tobacco Products Laboratory method, CRM No. 62, CRM No. 87, or other available methods, that could test the proposed scope of tobacco products at the proposed maximum nicotine level
• the feasibility and technical achievability of compliance with this proposed product standard, including information concerning the existence of patents that may impact the ability to comply by the proposed 2-year effective date of this proposed rule
• the methods and options smaller manufacturers may use to comply with this proposed product standard
• changes manufacturers may make to their tobacco products to comply with this proposed product standard
• increase in the potential for illicit trade
• selloff period (e.g., 60 days after the effective date of the final rule) for retailers to sell through their current inventory of nonconforming product

Action: Submit comments to the FDA on or before September 15, 2025.

FEDERAL REGISTER NOTICE:

Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products

CONTACT:

Will Purcell

EMAIL:

will.purcell@sba.gov

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Regulatory Alerts