Gone in a Puff of Smoke? FDA’s Proposed Rule on Maximum Nicotine Levels

During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine level in cigarettes and other combusted tobacco products, including most cigars and pipes, through its authority under Section 907 of the FD&C Act to adopt tobacco product standards. This proposed rule follows FDA’s March 2018 advance notice of proposed rulemaking (ANPRM) regarding a potential maximum nicotine level for cigarettes.

The rule, if finalized, would set the maximum level of nicotine at 0.7 milligrams of nicotine per gram of tobacco. This is a dramatic reduction (nearly 2500%) from the average 17.2 milligrams of nicotine per gram of tobacco that many cigarettes currently contain, according to one study that FDA cited in the proposed rule.

More specifically, the proposed rule would apply to combusted cigarettes (including roll-your-own) tobacco, cigars (excluding premium cigars due to a court order that excluded premium cigars from FDA’s legal authority), and pipe tobacco (excluding waterpipe tobacco).  It would not apply to electronic nicotine delivery systems (ENDS) smokeless tobacco products, nicotine pouch products, or other non-combusted tobacco/nicotine products.

FDA’s primary purpose of the proposed rule is to take aim at what it considers to be at the heart of the country’s leading cause of preventable deaths: nicotine addiction. FDA did not mince words in the opening line of the proposed rule’s executive summary, stating that each year, 480,000 people die prematurely from a smoking-attributable disease, and “[n]early all these adverse health effects are ultimately the result of addiction to the nicotine in combusted tobacco products” (emphasis added). FDA’s focus on combustion is significant. Although the Agency has long been concerned with the effects and influence of smoking on children and young adults (see our previous posts here, here, and here), the proposed rule does not apply to noncombusted products that contain nicotine, such as ENDS. In addition, although the 2018 ANPRM contemplated only applying to combusted cigarettes, FDA was concerned that users would then turn to other combusted tobacco products, thereby “undermining the public health benefits” of its proposal. Now, the current proposed rule covers the combusted tobacco products that FDA describes as “the most toxic and widely used tobacco products.”

Relying on findings from the case, United States v. Philip Morris USA, Inc. et al., FDA stated that cigarette companies have designed the levels of nicotine in its products to “create and sustain addiction.” By making cigarettes and other tobacco products less addictive (FDA specifically stated that the rule is intended to make these tobacco products “minimally or nonaddictive”), FDA intends to work towards the intertwined public health goals of helping current smokers quit, preventing others (and particularly young people) from becoming addicted smokers, and reducing tobacco-related diseases and deaths. FDA predicts that the proposed rule, if finalized, would prevent approximately 48 million youth and young adults from initiating habitual cigarette smoking by 2100, and would allow more than 12.9 million additional people to quit smoking cigarettes within one year after implementation of the proposed standard.

Acknowledging the possibility that reducing the level of nicotine in cigarettes will simply result in people smoking more cigarettes to get the same nicotine yield, FDA referenced studies showing that extended use of “very low nicotine content” (VLNC) cigarettes does not result in more cigarettes smoked per day. In addition, FDA went all-in with its reduction plan, which it calls an “immediate nicotine reduction approach” (i.e., a single-target approach to reach the proposed maximum nicotine level) as opposed to introducing an incremental reduction plan, in order to avoid “compensatory smoking” (for example, taking deeper puffs) and increased manufacturing costs (i.e., manufacturers would not need to formulate multiple products and prepare and submit premarket review applications at each phase of a gradual reduction approach).

This proposed rule would also require manufacturers of products covered under the rule to employ various new procedures for compliance, including analyzing nicotine levels using methods that have been validated in an analytical test laboratory, designing and implementing sampling plans for each batch of product, and establishing procedures for dealing with nonconforming products. The proposed rule would also impose additional requirements on tobacco manufacturers, such as using a manufacturing code and recordkeeping. FDA provided various ways that the nicotine reduction can be achieved, including tobacco blending, chemical extraction, genetic engineering, and different farming methods. The effective date of any final rule based on this proposed rule would be two years after the final rule is published, providing tobacco manufacturers with some time to get into compliance with the final rule’s requirements, sell remaining stock of finished tobacco products, and subject applications for new tobacco products that comply with the finalized product standard.

Strong opposition is expected from the tobacco industry, including legal challenges to the rule, if finalized. Even if the rule ultimately survives any such challenges, whether FDA will also attempt to reduce the levels of nicotine in e-cigarettes will remain an open question, although we note that the Agency hasn’t always had the best luck in that area, and given the Trump administration’s recent withdrawal of FDA’s proposal to ban menthol cigarettes, it seems at least possible that the new administration could similarly withdraw this proposed rule.

Comments on the proposed rule may be submitted until September 15, 2025.