FDA Issues First MRTP for Reduced-Nicotine Cigarettes

22nd Century Group plans to launch VLN King, VLN Menthol King cigarettes in U.S. in early 2022
VLN King and VLN Menthol King cigarettes
Photograph courtesy of 22nd Century Group Inc.

BUFFALO, N.Y. — 22nd Century Group Inc. can market its reduced-nicotine cigarettes as modified risk tobacco products (MRTPs) after authorization from the U.S. Food and Drug Administration (FDA).

The FDA on Dec. 23 authorized the marketing of VLN King and VLN Menthol King combusted, filtered cigarettes as MRTPs, which help reduce exposure to, and consumption of, nicotine for smokers who use them.

These are the first combusted cigarettes to be designated as MRTPs and the second tobacco products overall to receive exposure modification orders, which allows them to be marketed as have a reduced level of a substance.

The exposure modification orders for VLN King and VLN Menthol King allow 22nd Century to market them with claims including: “95% less nicotine,” “helps reduce your nicotine consumption” and “greatly reduces your nicotine consumption,” the FDA said.

22nd Century said it is prepared to launch VLN cigarettes in the United States over the next 90 days and outside of the United States by the end of 2022.

“Today’s decision to authorize VLN’s MRTP application places the FDA and 22nd Century together at the vanguard of transforming the tobacco industry,” James A. Mish, CEO at 22nd Century, said. “With 60% of adult smokers in our U.S. market research telling us they are likely to try VLN, this is a complete game-changer for 22nd Century, the tobacco industry, public health, and adult smokers looking to change their relationship with nicotine.”

VLN cigarettes smoke, taste and smell like a conventional cigarette, but with 95% less nicotine than conventional cigarettes, according to 22nd Century.

In the review of 22nd Century’s MRTP applications, the FDA found that nicotine levels in tobacco and mainstream smoke of VLN cigarettes are at least 96% lower than the majority of marketed and market-leading conventional cigarette brands. The FDA’s behavioral and clinical pharmacology review found that by exclusively smoking cigarettes with the same or similarly reduced nicotine content as VLN cigarettes, consumers could reduce their nicotine exposure by about 95%.

“Our mission is to find ways to stop tobacco-related disease and death,” the FDA’s Center for Tobacco Products (CTP) Director Mitch Zeller said. “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.”

Despite the MRTP and exposure modification orders, these products are not considered safe for “FDA approved,” the agency said, adding that there are no safe tobacco products and people who do not currently use tobacco products should not start.

The initial exposure modification orders expire in five years, and the FDA may withdraw the initial orders if the agency determines, among other things, the orders are no longer expected to benefit the health of the population.

FDA commits to menthol ban 

Despite authorizing a menthol cigarette product, the FDA said it is still committed to moving forward with the rulemaking process to ban menthol as a characterizing flavor in cigarettes and cigars.

“In reaching today’s determination, the FDA considered both the current legal status of menthol cigarettes and the available science demonstrating that these particular products could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day,” the FDA said.

22nd Century expects its VLN Menthol cigarettes to be able to stay on the market regardless of whether the FDA bans menthol.

“As the FDA also looks to ban menthol in highly addictive cigarettes, we fully expect the FDA will allow our VLN Menthol cigarettes, which offer little appeal for youth and former smokers because of their reduced nicotine content, to be allowed by the FDA to remain on the market to provide an off-ramp for adult smokers of menthol cigarettes,” Mish said.

22nd Century, Buffalo, N.Y., is a plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing and modern plant breeding, the company said.

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