In a bid to drastically reduce the number of U.S. deaths attributed to smoking each year, the Food and Drug Administration 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% 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 just one year, and the smoking rate would in turn plunge to 1.4% from its current level of 15%. 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.
Although the effort announced Thursday is an advance notice of proposed rule making — the first step in the creation of a new regulation — it represents the FDA’s first effort to dictate what can and cannot be included in a cigarette, according to former Rep. Henry A. Waxman (D-Beverly Hills), who championed antismoking policies during his decades in Congress.
“If this could be implemented, it could be a tremendous boon for public health,” Waxman said. “It is clear nicotine is what keeps people smoking. It’s a drug that is delivered when cigarettes are inhaled and the reason why so many people find it impossible or difficult to give them up.”
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.
“It’s critical that our policies reflect the latest science and is informed by the input we receive” from groups and individuals with a stake in the outcome, he added.
The FDA action won praise from public health advocates, who lament the loss of 480,000 American lives each year due to smoking.
"The benefits the FDA cites for this proposal are extraordinary," said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. He added that for the proposal to have maximum impact, the FDA should reduce nicotine levels in all combustible tobacco products, not just cigarettes.
The FDA appears to recognize this concern. “If a standard were to apply to cigarettes only, it could be substantially less effective,” the agency wrote in its regulatory notice.
Tobacco industry representatives, many of whom are seeking FDA approval for new “modified risk” tobacco products, cautiously applauded the focus on making smoking less dangerous.
James Figlar, executive vice president of research and development for R.J. Reynolds Tobacco Co., 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.”
The proposal harks back to 1976, when tobacco researcher Michael Russell observed that “people smoke for the nicotine. But they die from the tar.”
In the years since, public health campaigns have relied heavily on nicotine-replacement products such as lozenges and patches to help wean smokers off cigarettes.
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 very popular and smoking-cessation groups have been reluctant to endorse them, citing the harmful chemicals generated by any combustible product.
But a growing body of research argues in favor of reducing cigarettes’ nicotine content. In trials, people instructed to exclusively smoke very low nicotine cigarettes smoked fewer per day, showed less evidence of the kinds of physiological harms produced by cigarette smoking, and were more likely to try to quit after the trial was over. They did not appear to smoke more cigarettes at a sitting, or to inhale more deeply, in an effort to compensate for the lower levels of nicotine they were getting.
“The faster you get to those lower levels, the more likely people will benefit and reduce their harm quickly,” Donny said. “If you do it over time, you run the risk of people smoking more and exposing themselves to more harmful chemicals.”
Gottlieb made clear that no decisions had been made about how quickly nicotine levels would be reduced in American cigarettes. The 90-day comment period that precedes the start of federal rule making opens in mid-June. After that, Gottlieb said, “we’re not going to prejudge how long this will take.”
Donny said a lengthy regulatory process would be reasonable given the sweep of the FDA’s initiative and the prospect of a rapid reduction in smokers’ exposure to nicotine.
“This is a very bold move by the FDA, and unlike many policies, it could dramatically affect public health,” he said.
The burgeoning market for electronic cigarettes has refocused the health debate on the role of nicotine in keeping smokers hooked. These vaping devices deliver nicotine with fewer toxic chemicals than traditional cigarettes produce, but they also introduce potential smokers to nicotine’s addictive buzz.
“We see a historic opportunity here to potentially more rapidly migrate cigarette users into products that are modified-risk,” Gottlieb said, adding that “the jury’s still out” on whether e-cigarettes present a net gain to public health.
Mitch Zeller, director of the FDA’s Center for Tobacco Products, suggested that this round of tobacco regulation would focus primarily on combustible tobacco products, which he called the most dangerous mechanism for the delivery of nicotine.
In the coming weeks, Zeller and Gottlieb said, the FDA will launch two additional regulatory initiatives related to tobacco — one on the use of menthol and other flavorings, and another related to premium cigars.
Dr. Michael Fiore, a tobacco researcher at the University of Wisconsin, called the FDA’s new approach “a potential game-changer.”
Asked whether smokers would rise up in protest, Fiore said they were likely to welcome a chance to be free of their addiction.
“When we talk to smokers, almost all rue the day they ever began smoking and became addicted,” he said. “They dread the cost, the health impacts, what they’re modeling for their children. And 50% to 60% try to quit every year.
“They’re letting us know they don’t want to smoke,” Fiore added. “This is a clinical and public health action that will help them.”