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FDA Proposes Maximum Nicotine Content for Cigarettes and Other Combusted Tobacco Products

Guilherme Ferrari Faviero, Esq., MS, MPH

FDA Proposes Maximum Nicotine Content for Cigarettes and Other Combusted Tobacco Products
Peter Dazeley via Getty Images

The FDA has issued a proposed rule to cap nicotine content in cigarettes and other combusted tobacco products. The rule aims to reduce nicotine to sub-addictive levels, thereby making it easier for current smokers to quit while reducing the likelihood that experimental users, particularly adolescents and young adults, develop an addiction. Under the proposed rule, the maximum nicotine content allowed would be 0.70 mg per gram of total tobacco — roughly 25 times lower than the 17.2 mg/g average for the top 100 US cigarette brands in 2017.

The proposed nicotine limit and rationale for the proposed rule are based on scientific studies showing that cigarettes with very low nicotine content reduce dependence, lower daily consumption, and mitigate withdrawal symptoms while increasing quit attempts. FDA estimates that more than 12.9 million smokers could benefit by quitting within one year of its implementation. Combustible tobacco products remain the leading cause of preventable disease and death in the United States, accounting for an estimated 480,000 premature deaths due to smoking-related diseases every year.

To implement this proposed rule, FDA proposes an immediate, one‐step reduction in the nicotine content of these combusted tobacco products on the market, rather than a gradual, stepwise approach. FDA cites studies that suggest this immediate reduction minimizes compensatory smoking behavior, whereby smokers adjust their smoking patterns, for example, by taking longer, deeper, or more frequent puffs or even smoking more cigarettes to maintain their usual nicotine intake. FDA also notes that this approach is expected to produce lower costs for manufacturers, who would not need to develop multiple product formulations for review under a gradual reduction approach.

The proposed rule also requires manufacturers to analyze nicotine content using validated laboratory methods, as well as implement sampling plans to ensure that each batch complies with the proposed standard prior to sale or distribution in the U.S. market. While the proposed rule applies to cigarettes and other combusted tobacco products, it excludes premium cigars, water pipe tobacco, and heated tobacco products. It also notably excludes electronic nicotine delivery systems, such as electronic cigarettes or vape products, raising questions about whether smokers might switch to these alternatives once nicotine levels are substantially reduced in more traditional products.

FDA is granted statutory authority to adopt tobacco product standards—including provisions to reduce nicotine yields—as long as it does not mandate reducing nicotine to zero, which is expressly prohibited under Section 907(d)(3) of the FD&C Act.