The Food and Drug Administration on Thursday took the first concrete action to reduce nicotine levels in cigarettes to make them less addictive — an action that the agency’s top official called “historic.”
Commissioner Scott Gottlieb announced the issuance of an “advanced notice of proposed rulemaking,” the earliest step in what is likely to be a complicated regulatory effort to lower nicotine levels. According to the notice, which will be published Friday in the Federal Register, an evaluation of one potential policy scenario found a nicotine standard could save 8 million lives by the end of the century. “an undeniable public health benefit,” Gottlieb said in a statement.
The agency is asking for public comment on several aspects of the issue.
On Twitter, Gottlieb called the FDA’s move “a historic first step” to make cigarettes minimally addictive or nonaddictive.
Today #FDA took a historic first step to advance our rulemaking process to render combustible cigarettes minimally or non addictive through regulation of nicotine levels under the FDA’s tobacco product standard https://t.co/Wqs8XH0boX
— Scott Gottlieb, M.D. (@SGottliebFDA) March 15, 2018
The action follows his announcement last summer that the agency would pursue a comprehensive plan on tobacco and nicotine regulations in an effort to avoid millions of tobacco-related deaths.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, an antismoking group, said the move will have “enormous significance” — if the agency moves quickly through the process of developing and adopting a final rule.
“It would be the most significant public health proposal we have seen from the U.S. government in the last 20 years,” he said. He added that no regulatory agency anywhere in the world has seriously proposed reducing nicotine in cigarettes.
“While this issue has been discussed conceptually for years,” Myers said, “this is first time we have a government agency saying it is achievable, feasible and can be implemented in a way that doesn’t cause serious negative consequences.”
Still, he added, the process will be challenging, especially considering likely opposition of the tobacco industry.
In his statement, Gottlieb said the agency was seeking public input on critical questions such as what should be the maximum nicotine level in cigarettes and whether such a limit should be implemented all at once or gradually. Other issues, he said, include the potential for illicit trade in high-nicotine cigarettes and whether addicted smokers would compensate for lower nicotine levels by smoking more.