In First, FDA Allows Low-Nicotine Cigarette to Be Marketed as a ‘Modified Risk Tobacco Product’ | Troutman pepper


Some cigarette pack labels may soon feature the phrases “95% less nicotine”, “helps reduce your nicotine intake” and “…significantly reduces your nicotine intake”. On December 23, 2021, the Food and Drug Administration (FDA) released Orders granted with modified risk to VLN King and VLN Menthol King cigarettes from 22nd Century Group, Inc., allowing the company to market the low nicotine cigarettes with these proposed reduced exposure claims if the company adds the phrase “Helps you smoke less “. Of course, the company’s products will continue to be required to carry one of four The Surgeon General’s Warnings for cigarettes.

This decision marks the first time the FDA has allowed a combustible cigarette to be marketed under the “modified risk tobacco product” (MRTP) pathway (Philip Morris Products SA owns the first MRTP cigarette relating to its system of tobacco products heated IQOS/HeatSticks). Under the Food, Drug, and Cosmetic Act, a company cannot sell a new tobacco product “to reduce harm or risk of tobacco-related disease” without FDA clearance. 21 USC § 387k. Prior to 22nd Century Group, Inc.’s low nicotine cigarettes, the only other products to successfully obtain FDA marketing clearance under the “modified risk” pathway involved no burning tobacco. These include Swedish Match USA, Inc.’s General Snus products – a moist, smokeless tobacco pouch placed under the upper lip – and Philip Morris Products SA’s IQOS/Marlboro Heatsticks system, which “heats the tobacco but does not don’t burn it.” In fact, the FDA permit commercialization of the latter because, among other things, “the process used to heat tobacco in the IQOS system significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke”.

The clearance of low-nicotine cigarettes suggests that the FDA is willing to consider a variety of alternatives bearing an MRTP claim to conventional cigarettes. Mitch Zeller, director of the FDA’s Center for Tobacco Products, explained the agency’s decision in a Press release. “Our mission is to find ways to stop tobacco-related disease and death. We know three out of four adult smokers want to quit, and data on these products show they can help addicted adult smokers move away from highly addictive burnt cigarettes,” he said. “Having options like these products allowed today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less dependent on burnt cigarettes, they would likely smoke less and could be exposed to fewer harmful chemicals that cause tobacco-related illness and death.

22nd Century Group, Inc. said the products could arrive in pilot markets in the United States within the next 90 days and in the first global market by the end of the first quarter of this year.

At least three other new tobacco products wait for FDA clearance MRTP claims – two smokeless tobacco products and an e-cigarette – but no other combustible cigarettes. For now, 22nd Century Group, Inc. alone holds this distinction.


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