In a First, FDA Authorizes Marketing of Low-Nicotine Cigarette as “Modified Risk Tobacco Product”

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Some cigarette pack labels may soon feature the phrases “95% less nicotine,” “helps reduce your nicotine consumption,” and “… greatly reduces your nicotine consumption.” On December 23, 2021, the Food and Drug Administration (FDA) issued modified risk granted orders to 22nd Century Group, Inc.’s VLN King and VLN Menthol King cigarettes, 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 bear one of four Surgeon General’s warnings for cigarettes.

The move marks the first time the FDA has authorized the marketing of a combustible cigarette in the “modified risk tobacco product” (MRTP) pathway (Philip Morris Products S.A. holds the first cigarette MRTP relating to its IQOS/HeatSticks heated tobacco product system). Under the Food, Drug, and Cosmetic Act, a company cannot sell a new tobacco product “for use to reduce harm or the risk of tobacco-related disease” without FDA authorization. 21 U.S.C. § 387k. Prior to 22nd Century Group, Inc.’s low-nicotine cigarettes, the only other products to successfully obtain FDA marketing authorization under the “modified risk” pathway did not involve burning tobacco. Those include Swedish Match USA, Inc.’s General Snus products — a smokeless, moist tobacco pouch placed under the upper lip — and Philip Morris Products S.A.’s IQOS/Marlboro Heatsticks system, which “heats tobacco but does not burn it.” Indeed, the FDA permitted marketing 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.”

Authorization of the low-nicotine cigarettes suggests the FDA is willing to consider a variety of MRTP-claim-bearing alternatives to conventional cigarettes. Mitch Zeller, director of 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 that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” he said. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. 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.”

22nd Century Group, Inc. has indicated that the products could hit shelves in pilot markets in the U.S. within the next 90 days and the first global market by the end of the first quarter this year.

At least three other new tobacco products await FDA authorization of MRTP claims — two smokeless tobacco products and an e-cigarette — but no other combustible cigarette. For now, 22nd Century Group, Inc. alone holds that distinction.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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