In a bid to drive down the almost half a million US deaths attributed to smoking each year, the Food and Drug Administration on Thursday unveiled a plan to regulate tobacco that is notable for its breadth and simplicity: strip cigarettes of their power over users by reducing their nicotine content to nonaddictive levels. The FDA is seeking outside comment on a number of issues, including what nicotine levels should be permitted and whether the change should be implemented gradually or all at once.
Gottlieb, the commissioner of the FDA, said the announcement was "a significant step in our efforts to confront nicotine addiction in combustible cigarettes". But FDA's regulatory efforts have been hampered for years by legal challenges by Big Tobacco companies. The smokers were broken up into groups, and given cigarettes with different amounts of nicotine; the control group smoked normal cigarettes (with 15.8 mg of nicotine each), and each group had progressively less potent cigarettes, with the lowest group smoking cigarettes with just 0.4 mg of nicotine each.
The FDA hasn't yet decided exactly how much it will cut nicotine or how quickly.
It also promised to 'begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.' Today's announcement is official opening of that dialogue. And although a potential nicotine product standard for cigarettes is the cornerstone of our approach, we also continue to push forward on additional pieces of the FDA's multi-year plan created to work in concert to better protect kids and significantly reduce tobacco-related disease and death.
He said regulators should consider cutting nicotine by 95% to 97% per cigarette to really see an effect.
Public comments about a proposed standard can be made for the next 90 days. Those products must either have the same characteristics as those marketed on/before February 15, 2007, or have different characteristics but do not raise different questions of public health.
It's the boldest move yet against cigarette makers by the FDA, which only got permission to regulate tobacco products in 2009. The hopes are that this could reduce the rate of tobacco-related deaths by over 8 million by the end of the century.
The agency is considering limiting the amount of nicotine it will allow in cigarettes to 0.3, 0.4, or 0.5 milligrams of nicotine per gram of tobacco filler.
Gottlieb said answers will be sought on questions such as, "What potential maximum nicotine level would be appropriate for the protection of public health?" According to the Centers for Disease Control and Prevention, 15 percent of USA adults still smoke.
Part of FDA Commissioner Scott Gottlieb's road map, introduced July 28, involves supporting a continuum of risk strategy to tobacco products that may have a role for electronic cigarettes, heat-not-burn traditional cigarettes and other innovative products.
Young people would benefit hugely from the proposed move, one lung health expert said. "This is a clinical and public health action that will help them".