FDA Authorizes Reduced-Risk Claims for Cigarettes With Very Low Nicotine

December 30, 2021

On December 23, the Food and Drug Administration (FDA) authorized two combustible cigarettes with low nicotine levels to be marketed as “modified risk tobacco products” (MRTPs). The designation allows 22nd Century Group, which describes itself as “a leading agricultural biotechnology company focused on tobacco reduction,” to advertise its VLN King and VLN Menthol cigarettes under reduced exposure claims.

The company can state each of these products has “95 percent less nicotine,” “helps reduce your nicotine consumption” and “greatly reduces your nicotine.”

To a layman, the MRTP process is almost indistinguishable from the premarket tobacco product application (PMTA) process that e-cigarette manufacturers have had to go through over the past year. The latter has dominated the news—since late summer, the FDA has denied the PMTAs for many small- to medium-size vape producers, some of which have sued the agency to put their submissions back under review.

With a PMTA, a company has to prove that its product would be “appropriate for the protection of public health”—a threshold that has come to be understood as the likelihood of a given vape helping an adult smoker to switch to the safer alternative, rather than introducing a new generation to nicotine.

So far, the FDA has authorized only a single e-cigarette and two tobacco-flavored e-liquid cartridges—and has yet to weigh in on the market’s largest players.

All of which is to say, an authorized PMTA does not grant a manufacturer permission to make reduced risk claims, even though the standard basically implies it. An MRTP does. As Clive Bates, a tobacco control expert and the former director of Action on Smoking and Health (UK), has stated, an MRTP is about “communication.”

“Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers,” Mitch Zeller, the director of the FDA’s Center for Tobacco Products (CTP), said in a press statement. “If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”

Will the world ever accept that nicotine might not be the issue?

Still, who exactly would enjoy smoking cigarettes with very low nicotine levels? Or, put another way: Will the world ever accept that nicotine might not be the issue?

There’s an open debate in tobacco control about the efficacy of reducing nicotine in cigarettes, which the FDA has embraced but not enacted. Some believe that by removing as much nicotine as possible from cigarettes, fewer and fewer people will have a reason to smoke, because they’ll have options that won’t perpetuate their dependence. (By law, the agency cannot require that nicotine levels in cigarettes be lowered literally to zero, but it can demand that they come as close as possible.)

“We believe [the] announcement by the FDA is a clear indication that the FDA is moving forward with its plan to address the incredible harms caused by smoking,” James Mish, the chief executive officer of 22nd Century Group, said in a press release. “This plan includes the authorization of less toxic tobacco products such as e-cigarettes and other non-combustible products along with a nicotine cap of 0.5 mg of nicotine per gram of tobacco in combustible tobacco products. This level of nicotine content, which the FDA has described as being ‘minimally or non-addictive,’ has already been achieved by 22nd Century in its VLN products.”

This has been a global urge: Many observers are now watching New Zealand, an ocean-locked nation that may not have the same black market concerns as countries with neighbors at their borders, as something of a test case. In early December, the government announced that it would gradually raise every year until it covered the whole population, effectively banning the sale of combustible cigarettes over time.

But New Zealand has a much more holistic perspective on tobacco harm reduction, and has accepted and promoted vaping products as safer nicotine alternatives. The US, on the other hand, has been lagging with this view, despite the fact that countless public health authorities and experts have asserted that vaping is far less harmful than smoking and youth vaping rates continue to decline.

As Bates also noted, the FDA’s recent decision only further confuses the problem—people die from burning tobacco, not from nicotine—and there are evidently thousands of vaping products that are more appealing to adult smokers, who could benefit from using them to quit if the agency would only give the green light.



Photograph by Castio T. Lauren via WordPress/Flickr

Alex Norcia

Alex was formerly Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in the New York Times Magazine, the Columbia Journalism Review, the Los Angeles Times and the New Republic, among other outlets. He was also previously a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received grants from the Foundation for a Smoke-Free World. He is currently based in Los Angeles.

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