On December 10, 2024, the U.S. Food and Drug Administration (FDA or the Agency) Center for Tobacco Products (CTP) advanced a proposal to set a maximum nicotine level in cigarettes and certain other combusted tobacco products. The Agency requested the White House Office of Management and Budget (OMB) expedite a proposed tobacco product standard in what has been characterized as a “last-ditch” effort to drastically reduce the nicotine content in cigarettes. If finalized, the rule will have significant implications for Big Tobacco and its stakeholders, as it seeks to make cigarettes and other combusted tobacco products minimally addictive or non-addictive. The proposed tobacco product standard would likely not apply to electronic nicotine delivery systems (ENDS) or modern oral nicotine products (e.g., pouches), which are not combusted tobacco products. FDA’s continued pursuit of the nicotine product standard for cigarettes comes after the commercial failure of the only MRTP-authorized, very low-nicotine cigarettes marketed by 22nd Century Group Inc.
FDA’s authority to establish tobacco product standards comes from the Family Smoking Prevention and Tobacco Control Act (TCA), 21 U.S.C. 387g(a)(4), which authorizes FDA to issue such standards that are appropriate for the protection of the public health (APPH). With respect to nicotine yields, the TCA prohibits the Agency from “banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or … requiring the reduction of nicotine yields of a tobacco product to zero….” 21 U.S.C. 387g(d)(3).
On March 15, 2018, during the first Trump Administration and following then-Commissioner Scott Gottlieb’s announcement of FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation, FDA issued an advance notice of proposed rulemaking (ANPRM) (Docket FDA-2017-N-6189) seeking public comment on issues and questions related to a potential nicotine product standard. FDA sought comments on:
- Whether the scope of the nicotine reduction standard should include only cigarettes or also other tobacco products such as Roll-Your-Own (RYO) tobacco, cigars, pipe tobacco, and water pipe tobacco;
- The appropriate nicotine level, with studies suggesting that 0.5 mg per rod could be an effective threshold; and
- Additional questions addressing implementation time frames, analytical testing methods, technical feasibility, and potential countervailing effects (e.g., illicit market growth, dual use, and product switching)
See our detailed analysis of the ANPRM here: FDA Issues Advanced Notice of Proposed Rulemaking on Potentially Lowering Nicotine Levels in Combustible Cigarettes to Minimally or Non-Addictive Levels | The Continuum of Risk.
Nearly 8,000 comments were submitted. Industry stakeholders are concerned that the proposed nicotine limits would not be technically achievable and could have unintended consequences, such as fueling the growth of contraband and an unregulated black market for cigarettes.
The proposal is currently under review by the OMB’s Office of Information and Regulatory Affairs (OIRA). However, it remains uncertain whether the Biden Administration will take any steps to advance the rule to a Notice of Proposed Rulemaking (NPRM) in its final days in office. Any future NPRM would again be open for public comment before finalization.
We will discuss this and other potential tobacco product standards at Keller and Heckman’s 2025 Annual E-Vapor and Tobacco Law Symposium on January 27-28, 2025, in Las Vegas, Nevada. Details and registration information can be found here.