Commissioner Scott Gottlieb unveiled an “advance notice of proposed rulemaking,” the earliest step in what promises to be a long, complicated regulatory effort to lower nicotine levels to be minimally addictive or nonaddictive.
The notice, to be published Friday in the Federal Register, includes new data published in the New England Journal of Medicine on Thursday based on a possible policy scenario. That FDA-funded analysis found that slashing nicotine levels could push the smoking rate down to 1.4 percent from the current 15 percent of adults. That in turn would result in 8 million fewer tobacco-related deaths through the end of the century — which Gottlieb termed “an undeniable public health benefit.”
The evaluation was based on reducing nicotine levels to 0.4 milligrams per gram of tobacco filler, FDA officials told reporters during a teleconference.
Many adults try to quit smoking each year but fail because nicotine is such an addictive substance, said Mitch Zeller, director of the FDA's Center for Tobacco Products. Cutting the nicotine level would not only help them succeed, but it also could keep young people who may be experimenting with cigarettes from becoming addicted, he said.
The nicotine notice will be open for public comment for 90 days. FDA officials are seeking input on what the maximum nicotine level in cigarettes should be and whether such a limit should be implemented all at once or gradually. Nicotine levels can be manipulated by leaf blending, chemical extraction and genetic engineering.
Other critical issues that will need to be addressed, according to officials, include the potential for illicit trade in high-nicotine cigarettes and whether addicted smokers would compensate for lower nicotine levels by smoking more. After the comment period ends, officials will decide whether to move forward with a formal proposal.
Thursday's action follows Gottlieb's announcement last summer that the agency would pursue a comprehensive plan on tobacco and nicotine regulation in an effort to avert millions of tobacco-related deaths. Smoking is at an all-time low in the United States, and tobacco use among young people is also at historically low rates. Still, smoking causes 480,000 deaths annually in this country.
The 2009 Tobacco Control Act gave the FDA the power to regulate tobacco, though not to ban it.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, an antismoking group, said that Thursday's action will have “enormous significance” — provided it is followed by quick FDA action to develop and adopt 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,” Myers said. No regulatory agency in the world has seriously proposed reducing nicotine in cigarettes, he said.
“While this issue has been discussed conceptually for years, 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,” Myers said.
Robin Koval, chief executive and president of Truth Initiative, another anti-tobacco group, also praised the effort, calling it a “a serious, strong response.” But it will be important for the FDA also to move forward on other fronts, she said, including on new e-cigarette rules that were delayed last summer by Gottlieb.
In discussing his comprehensive tobacco strategy on Thursday, Gottlieb said he sees “a historic opportunity” to use nicotine reduction as a way to move smokers from conventional cigarettes to products that provide nicotine without the serious health hazards posed by burning tobacco. Those alternative nicotine-delivery products include e-cigarettes or nicotine replacement therapies.
A spokesman for Philip Morris International said the company was still reviewing the agency's advance notice. The firm previously had expressed support for Gottlieb’s nicotine regulation plan, which he said “encourages the development of innovative new tobacco products that may be less harmful than cigarettes.”
James Figlar, executive vice president of research and development for R.J. Reynolds Tobacco, said in a statement that he looks forward “to working with FDA on its science-based review of nicotine levels in cigarettes and to build on the opportunity of establishing a regulatory framework that is based on tobacco harm reduction and recognizes the continuum of risk.”
The FDA also said Thursday that it plans to soon issue two other advance notices: one on the role that flavors, including menthol, play in the use and cessation of use of tobacco products; and the other on the regulation of premium cigars.