The FDA goes ahead with a “historic” plan to reduce nicotine in cigarettes

Scott Gottlieb, commissioner of the Food and Drug Administration, wants to reduce nicotine levels in cigarettes to make them less addictive. (J. Scott Applewhite / AP)

This publication has been updated.

The Food and Drug Administration took the first concrete action on Thursday to reduce nicotine in cigarettes to make them much less addictive, opening a regulatory process described as a "first historic step" by the agency's top official.

Commissioner Scott Gottlieb unveiled a "prior notice of regulatory proposal," the first step in what promises to be a long and complicated regulatory effort to reduce nicotine levels. minimally addictive or non-addictive.

Today #FDA took a historic first step to advance our regulatory process to produce minimally combustible or non-addictive cigarettes through the regulation of nicotine levels under the tobacco product standard of the FDA https: //

– Scott Gottlieb, MD (@SGottliebFDA) March 15, 2018

The notice, to be published on Friday in the Federal Register, includes new published data in the New England Journal of Medicine on Thursday based on a possible policy scenario. The badysis funded by the FDA found that cutting back on nicotine levels could bring the smoking rate to 1.4 percent from the current 15 percent of adults. That in turn would result in 8 million fewer deaths caused by tobacco until the end of the century, which Gottlieb called "an undeniable benefit to public health."

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. Breaking the nicotine level would not only help them succeed, but could also prevent young people who are experimenting with cigarettes from becoming addicted.

The nicotine notice will be open for public comment for 90 days. FDA officials are seeking opinions on what the maximum level of nicotine in cigarettes should be and whether that limit should be implemented once or gradually. Nicotine levels can be manipulated by mixing leaves, chemical extraction and genetic engineering.

Other critical issues to be addressed, according to officials, include the potential for the illicit trade in nicotine-containing cigarettes and whether addicted smokers would compensate for reducing nicotine levels by smoking more. After the comment period ends, officials will decide if they 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 prevent millions of tobacco. related deaths. Smoking is already at its lowest point in the United States, and tobacco use among young people also has historically low rates. Still, smoking causes 480,000 deaths annually in this country.

The Tobacco Control Act of 2009 gave the FDA the power to regulate tobacco, but not to prohibit it.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, an anti-smoking group, said Thursday's action will be "enormously important" as long as it is followed by fast action from the FDA to develop and adopt a final rule .

"It would be the most important public health proposal we've seen from the US government in the last 20 years," he 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 the first time we have a government agency that says it is feasible, feasible and can be implemented in a way that does not cause serious negative consequences," Myers said. [19659016] Robin Koval, executive director and president of the Truth Initiative, another non-profit anti-smoking organization, also praised the effort, describing it as "a serious and strong response". But it will be important for the FDA to also advance on other fronts, Gottlieb said about the new rules for electronic cigarettes that Gottlieb delayed last summer.

Speaking about his comprehensive tobacco strategy on Thursday, Gottlieb said he sees "a historic opportunity" to use nicotine reduction as a way from conventional cigarettes to nicotine-free products without the serious risks to nicotine. health that poses the burning of tobacco. These alternative nicotine delivery products include electronic cigarettes or nicotine replacement therapies.

A spokesman for Philip Morris International said the company was still reviewing the agency's prior notice. The firm had previously expressed support for Gottlieb's nicotine regulation plan, which it 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 of R.J. Reynolds Tobacco Company said in a statement that it hopes to "work with the FDA in its scientific review of nicotine levels in cigarettes and take advantage of the opportunity to establish a regulatory framework based on reducing harm to tobacco and recognizing the continuum of risk. "

The FDA also said on Thursday it plans to issue two other early announcements soon: one on the role of flavors, including menthol, in the use and cessation of tobacco products and the other on the regulation of raw cigars.

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