The Food and Drug Administration unveiled a proposal on Wednesday to limit the amount of nicotine allowed in cigarettes and some other combustible tobacco products, a final step for the agency before the Trump administration takes over next week.
The FDA first announced it would pursue regulatory changes to maximum nicotine levels in combustible smoking products in 2022 in an effort to reduce the public health effects related to addiction and minimize youth uptake.
The agency is seeking public comment on the rule, but the proposal’s fate is unclear given the coming change in administration.
“Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” said FDA Commissioner Robert M. Califf. “I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.”
The rule released Wednesday would limit the maximum nicotine in certain combustible tobacco products to 0.70 milligrams per gram of tobacco. The average nicotine content in the 100 most popular cigarette brands in 2017, the FDA notes, is 17.2 mg per gram of tobacco.
Each year, according to the U.S. Surgeon General, more than 490,000 people die in the U.S. from a smoking-related disease, and about 28 million adults and 380,000 youth currently smoke cigarettes.
The rule states that while cigarettes cause the “largest amount of harm to public health in the United States,” limiting the proposal to only cigarettes could result in users shifting to other similar combusted tobacco products, which would reduce the efficacy of the nicotine standard.
In addition to cigarettes, the rule would apply to roll-your-own tobacco, cigarette tobacco, cigars and pipe tobacco excluding waterpipe tobacco.
If finalized as written, the rule would go into effect two years after publication in the Federal Register. It would require tobacco companies to immediately reduce nicotine levels to below the proposed ceiling by that date rather than in a tapered approach over time. It would also require manufacturers to develop protocols for preventing the sale and distribution of tobacco products that do not meet the standards required.
“FDA is not seeking to require the reduction of nicotine yields in any tobacco product to zero,” the agency wrote, adding that doing so would violate a law known as the Federal Food, Drug, and Cosmetic Act of 1938.
Yolonda C. Richardson, president and CEO of the anti-tobacco organization Campaign for Tobacco-Free Kids, called the proposal “game changing,” and said it would save millions of lives.
“Given these enormous benefits, we urge the incoming Trump administration to move forward in finalizing and implementing this rule,” she said. “Few actions would do more to fight chronic diseases such as cancer and cardiovascular disease that greatly undermine health in the United States, and that the incoming administration has indicated should be a priority to address.”
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