The FDA is considering setting a maximum nicotine level in cigarettes for the first time to make them less addictive and is seeking public feedback ahead of issuing a proposed rule.
Lowering nicotine levels will make it harder for future generations to become dependent on cigarettes and make it easier for current smokers to quit or switch to less harmful products, Commissioner Scott Gottlieb said in a statement.
The nicotine rule is one of a number of tobacco-related regulations FDA is working on. The agency will soon seek comment on the role that flavors like menthol play in tobacco use, and to get feedback and data concerning the possible regulation of premium cigars. It’s also working to modernize its approach to the development and regulation of nicotine replacement products like gum and patches.
Combined, the moves bring tobacco regulation to a prominence not seen since the tenure of David Kessler, who led the agency during the George H.W. Bush and Clinton administrations.
On the nicotine limit, the FDA also is seeking comment on whether a maximum level should be implemented at once or gradually. And it wants to know about unintended consequences, such as the potential for an illicit cigarette market.
The agency said it is particularly interested in comments about the merits of nicotine levels at 0.3, 0.4 and 0.5 milligrams of nicotine per gram of tobacco filler, in an advanced notice of proposed rulemaking issued this morning.
A 2013 survey paper estimated that reducing total nicotine content of cigarettes to 0.5 milligrams per cigarette would minimize addictiveness, but new data indicate the level may need to be lower.
Tobacco use, primarily from cigarettes, kills more than 480,000 Americans every year, costing the country nearly $300 billion in direct health care costs and lost productivity, FDA said.
The FDA cited a New England Journal of Medicine analysis that lowering nicotine levels could cause about 5 million more adult smokers to quit within one year of implementation. By 2100, the analysis estimates more than 33 million people would have avoided becoming regular smokers, leading to more than 8 million fewer tobacco-related deaths.