Energy Marketers Oppose FDA’s Proposed Nicotine Reduction Rule: A Threat to Small Businesses and Public Safety

On January 16, 2025, the Food and Drug Administration (FDA) published a proposed rule, “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products” (Docket No. FDA-2024-N-5471), which would cap nicotine levels in cigarettes and machine-made cigars at 0.70 milligrams per gram of tobacco. The Energy Marketers Association (EMA), alongside 48 state and regional energy marketing trade associations representing tens of thousands of small business convenience store owners, strongly opposes this rule because it is impractical, unsupported by evidence, illegal under federal law, and detrimental to public health, the economy, and regulated markets.

The Family Smoking Prevention and Tobacco Control Act (TCA) explicitly prohibits the FDA from banning cigarettes or reducing nicotine levels to zero, including actions with equivalent effects. The proposed rule, by setting an unattainably low nicotine cap, would effectively eliminate nearly all consumer-acceptable cigarettes and machine-made cigars. Research shows that very low nicotine cigarettes are widely rejected by adult tobacco consumers and may not be feasible to produce at scale, rendering the rule a de facto ban in violation of the TCA.

Moreover, smoking rates in the U.S. are at historic lows. According to the CDC’s 2024 National Youth Tobacco Survey, overall youth smoking is at 1.4%, with high school cigarette smoking at just 1.7%, a 95% decline since its peak in the mid-1990s. Responsible retailers have played a pivotal role in this progress by verifying age, selling only FDA-regulated products, adhering to marketing restrictions, and paying required taxes. Further reductions can be achieved through education and increased access to reduced-risk alternatives like e-cigarettes and nicotine pouches, not prohibitionist measures.

The proposed rule threatens to destabilize the tobacco supply chain, causing irreparable harm to farmers, manufacturers, distributors, retailers, and state and local economies. A December 2024 Tax Foundation study estimates that the rule would reduce legal cigarette sales by 90%, costing governments approximately $33 billion annually in tax revenue from a current total of over $37 billion. Additionally, a National Association of Tobacco Outlets (NATO) report from Chmura Economics & Analytics, dated December 12, 2024, projects the loss of 154,478 jobs and $21.7 billion in annual revenue losses for state and local governments, including excise taxes, sales taxes, and Master Settlement Agreement payments.

The ripple effects extend beyond tobacco. Small business gas station owners, who rely on tobacco sales for revenue, may struggle to pay for fuel deliveries, potentially disrupting motor fuel supply chains and driving up prices at the pump. These small businesses, already operating on thin margins, cannot absorb such losses without severe consequences. EMA argued rather than pursuing prohibitionist measures, the FDA should adopt a Tobacco Harm Reduction policy that prioritizes preventing underage use, supports adult choice, and maintains a legal, regulated market. Responsible retailers have demonstrated success in reducing youth access to tobacco while offering FDA-regulated products. Expanding access to reduced-risk alternatives and investing in public education would further drive down smoking rates without destabilizing economies or empowering criminal networks.

EMA urged the FDA to withdraw this flawed proposed rule and engage with stakeholders to develop evidence-based, practical solutions.

Click here to read EMA’s comments.