On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products.
Maximum Nicotine Level
FDA proposes to “make cigarettes and certain other combusted tobacco products minimally addictive or nonaddictive by limiting the nicotine yield of these products.” Specifically, the proposed rule would set a maximum nicotine content level of 0.70 milligrams of nicotine per gram of total tobacco. This would represent a drastic reduction in nicotine content. By comparison, one recent study — which FDA cited in the proposed rule — reported that the average nicotine content in the top 100 cigarette brands of 2017 was 17.2 milligrams of nicotine per gram of total tobacco.
“Nicotine yield” refers to the amount of nicotine in smoke — i.e., the amount of nicotine to which a user may be exposed while smoking. “Nicotine content” refers to the amount of nicotine present in tobacco filler. FDA states that it targets nicotine content rather than nicotine yield because nicotine content is a fixed characteristic, while the nicotine yield varies based on users’ behaviors — i.e., inhaling more deeply/shallowly or taking longer/shorter puffs. The agency explains that restricting nicotine content “places an absolute maximum limit on the amount of nicotine present in tobacco smoke available for intake by users of these products.”
Scope of Products Covered
The proposed rule covers combusted cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, cigars (excluding premium cigars), and pipe tobacco (excluding waterpipe tobacco). It does not apply to electronic nicotine delivery systems (ENDS), smokeless tobacco, pouch products, or other non-combusted tobacco/nicotine products. The proposed rule explains that “FDA is focusing this proposed rule on nicotine levels in cigarettes and certain other combusted tobacco products because combusted tobacco products are responsible for the majority of death and disease due to tobacco use.”
Importantly, the proposed rule also excludes heated tobacco products that otherwise meet the definition of “cigarette” in the Food, Drug, and Cosmetic Act (FDCA), see 21 U.S.C. § 387(3). FDA explains that it “recognized that tobacco products exist on a continuum of risk, with combusted cigarettes being the deadliest, and that certain non-combusted cigarettes pose less risk to individuals who use cigarettes or certain other combusted tobacco products or to population health than other products meeting the definition of cigarette.” However, the proposed rule also welcomes the submission of “comments, data, and research regarding the proposal to exclude noncombusted cigarettes from the scope of this proposed rule, including any data that could justify otherwise.”
FDA also explicitly excludes premium cigars from this proposed rule. This is consistent with the 2023 vacatur of FDA’s deeming rule with respect to premium cigars. Further, FDA excludes waterpipe tobacco from the proposed rule because “FDA believes there is little risk of switching under the proposed product standard.” In other words, FDA believes that users of other combusted products are unlikely to switch to waterpipes if the amount of nicotine in such other combusted products is capped.
Implications for Premarket Review
The products covered by the proposed rule would require premarket authorization once they are reformulated with reduced nicotine content. Generally speaking, the Tobacco Control Act requires all “new tobacco products” to receive premarket authorization from FDA. 21 U.S.C. § 387j(a)(2). A “new tobacco product” is “(A) any tobacco product . . . that was not commercially marketed in the United States as of February 15, 2007; or (B) any modification (including a change in . . . the content, delivery or form of nicotine, or any other addictive ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.” Id. § 387j(a)(1). Given that the vast majority of combustible tobacco products sold today exceed the maximum nicotine content under this proposed rule, the products would require modification to comply with the new product standard. However, a modification in nicotine content would render any such product a “new tobacco product” subject to premarket authorization requirements.
As proposed, the nicotine content product standard would become effective two years after the final rule is published in the Federal Register. Absent an exercise of enforcement discretion by FDA, this would give companies only two years to obtain authorization to market their modified products. Based on current premarket tobacco product application (PMTA) review timing, FDA appears unprepared to handle such a volume within two years. For instance, some PMTA applicants have been waiting four or more years for an authorization decision from FDA.
Why It Matters
An FDA-mandated maximum nicotine content for cigarettes and certain other combustible tobacco products would represent an unprecedented constraint on the U.S. tobacco industry. This proposal will surely draw comments from a wide range of stakeholders, with the scope of products covered being the most likely topic of interest. Other commenters might discuss the unintended effects of a maximum nicotine level on consumer behavior. As many have observed in the ENDS space, consumers could turn to illicit products when they lack authorized versions of the products they seek. As the balance of power shifts in Washington, D.C., it remains to be seen how FDA would handle this active proposal under its incoming new leadership.
The comment period is open through September 15, 2025. If you have questions about the implications of the proposed rule as it pertains to your business, our team is happy to assist.