FDA Commissioner Scott Gottlieb described “one possible policy scenario” that would set a limit of 0.4 milligrams of nicotine per gram of tobacco. That’s about 97 percent lower than the nicotine levels in typical cigarettes.
In a bid to drastically reduce the number of U.S. deaths attributed to smoking each year, the Food and Drug Administration (FDA) on Thursday unveiled a tobacco-regulation plan that is notable for its breadth and simplicity: Strip cigarettes of their power over users by reducing their nicotine content to nonaddictive levels.
Breaking ranks with an administration bent on scrapping federal regulations, FDA Commissioner Scott Gottlieb described “one possible policy scenario” that would set a limit of 0.4 milligrams of nicotine per gram of tobacco. That’s about 97 percent lower than the nicotine levels in typical cigarettes.
If such a policy were implemented, the number of Americans who quit smoking would be expected to increase by roughly 5 million in one year, and the smoking rate would, in turn, plunge to 1.4 percent from its current level of 15 percent. More than 8 million lives would be saved by the end of the century, Gottlieb said, “an undeniable public-health benefit.”
These estimates come from research published Thursday by The New England Journal of Medicine that was conducted by scientists at the FDA and their colleagues from Sandia National Laboratories in Albuquerque, New Mexico.
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Although the effort announced Thursday is an advance notice of proposed rule-making — the first step in the creation of a regulation — it represents the FDA’s first effort to dictate what can and cannot be included in a cigarette, according to former Rep. Henry Waxman, D-Calif., who championed anti-smoking policies during his decades in Congress.
“If this could be implemented, it could be a tremendous boon for public health,” Waxman said.
Gottlieb, a physician, called for a public debate on what maximum nicotine level would best protect the public’s health and whether a new limit should be implemented gradually or all at once. He also sought opinions on whether addicted smokers would compensate by smoking more, or create a black market for high-nicotine cigarettes.
James Figlar, executive vice president of research and development for R.J. Reynolds Tobacco, said he hopes to work with the FDA to establish “a regulatory framework that is based on tobacco-harm reduction and recognizes the continuum of risk.”
Reduced-nicotine cigarettes — such as Marlboro UItra Lights, which contain 0.5 milligrams of nicotine apiece — have been on the U.S. market for years, but they aren’t popular and smoking-cessation groups have been reluctant to endorse them.