Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
Published Date: 1/16/2025
Proposed Rule
Summary
The FDA wants to limit how much nicotine cigarettes and some other smoked tobacco products can have to make them less addictive. This change aims to help people quit more easily and stop new users from getting hooked. Tobacco companies will need to follow these new rules, and the public can share their thoughts by September 15, 2025.
Analyzed Economic Effects
5 provisions identified: 2 benefits, 2 costs, 1 mixed.
Maximum nicotine capped at 0.70 mg/g
FDA proposes to cap nicotine content in cigarettes and certain combusted tobacco products at a maximum of 0.70 milligrams (mg) of nicotine per gram of total tobacco. For comparison, the average nicotine content in the top 100 cigarette brands in 2017 was 17.2 mg/g, so this cap is intended to make these products minimally addictive or nonaddictive.
Projected large public-health and economic benefits
FDA's population model projects that by 2100 about 48 million youth and young adults who would otherwise have become habitual cigarette smokers would not, and that 12.9 million additional people would quit smoking within 1 year of implementation (19.5 million within 5 years). The model estimates 1.8 million tobacco-related deaths averted by 2060 and 4.3 million by 2100, with 19.6 million life years gained by 2060 and 76.4 million by 2100. Over a 40-year horizon (2% discount), annualized monetized benefits are estimated at $1.1 trillion versus annualized costs of $2.07 billion.
Which products are covered or excluded
The proposed standard would cover combusted cigarettes, cigarette tobacco, roll-your-own tobacco, cigars (including little cigars and cigarillos but excluding premium cigars), and pipe tobacco (excluding waterpipe/hookah tobacco). The proposal would exclude noncombusted cigarettes such as heated tobacco products (HTPs), waterpipe tobacco, electronic nicotine delivery systems (ENDS/e-cigarettes), and smokeless tobacco.
Manufacturer testing, sampling, and records required
Manufacturers would be required to analyze nicotine levels using an analytical test method validated in an analytical laboratory, implement a sampling plan covering each finished product batch, perform product testing prior to U.S. commercial distribution, maintain records of testing and sampling plans, use a manufacturing code to identify production batches, and establish procedures to control and disposition nonconforming products. FDA also expects that new tobacco products that comply with the standard will require premarket review.
Two-year implementation and sell-through rules
FDA proposes the final rule (if issued) would become effective 2 years after publication of the final rule. Wholesalers, retailers, and related entities would be able to sell existing stock of finished tobacco products that do not comply with the new standard prior to the effective date but would not be permitted to sell such stock after the effective date.
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