Investing.com — The U.S. Food and Drug Administration (FDA) has proposed a groundbreaking rule to reduce nicotine in cigarettes and specific other tobacco products to minimally addictive or nonaddictive levels. This initiative could make the United States the first country to mandate such a significant cut in nicotine content, aiming to save lives and alleviate the impact of smoking-related diseases.
The FDA announced this proposal today, following its initial declaration of intent in 2018. The agency is now inviting public and expert input through a comment period and its Products Scientific Advisory Committee. The rule wouldn’t outlaw cigarettes or other tobacco products but would limit nicotine to 0.7 milligrams per gram of tobacco, a significant reduction from present levels.
FDA Commissioner Robert M. Califf, M.D., underscored the potential of this initiative to deter young individuals from starting to smoke and aid existing smokers in quitting or switching to less harmful products. FDA models project substantial long-term public health impacts, suggesting that by 2100, the rule could prevent 48 million U.S. youth from starting to smoke and lead to 12.9 million current smokers quitting within a year of the rule becoming effective.
The proposed nicotine reduction could prevent 1.8 million tobacco-related deaths by 2060 and 4.3 million by the end of the century. The FDA expects the benefits, including medical cost savings and productivity gains, to surpass $1.1 trillion per year over the first four decades after implementation.
The proposed rule targets cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars, and pipe tobacco. However, it does not include e-cigarettes, nicotine pouches, noncombusted cigarettes, waterpipe tobacco, smokeless tobacco products, and premium cigars.
Brian King, Ph.D., M.P.H, director of the FDA’s Center for Tobacco Products, said the proposal starts an essential discussion on addressing the damage caused by tobacco products and transforming the U.S. tobacco use landscape.
The public comment period for this proposal begins on January 16 and lasts until September 15, 2025. During this time, the FDA will consider feedback on various aspects of the proposal, such as the products covered, the proposed nicotine limit, the suggested two-year compliance period, and potential impacts on illicit trade.
This initiative is a part of the FDA’s continuous efforts to create policies that steer the nation towards improved health outcomes. The agency stresses that, although switching to lower-risk tobacco products could benefit adults who smoke, no tobacco product is deemed safe, and non-users are advised against starting.
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