FDA Proposes Reduced Nicotine Content in Cigarettes, Boosting 22nd Century Group's Harm Reduction Efforts

Thursday, Dec 12, 2024 11:34 am ET1min read

22nd Century Group applauds FDA's proposal to mandate reduced nicotine content in cigarettes, a policy that originated during the Trump administration and continued under the Biden administration. The company, which has provided reduced nicotine content cigarettes for research, sees this as a significant step towards reducing smoking-related deaths. VLN reduced nicotine content cigarettes from 22nd Century have shown potential in reducing nicotine intake, and the company plans to launch additional products to expand distribution.

The U.S. Food and Drug Administration (FDA) has authorized the marketing of 22nd Century Group Inc.'s VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products (MRTPs) [1]. These cigarettes, which contain 95% less nicotine than traditional cigarettes, mark the first combusted cigarettes to receive such authorization and the second tobacco product overall to receive an "exposure modification" order.

The FDA's decision to approve these low-nicotine cigarettes is a significant step forward in reducing smoking-related deaths, as three out of four adult smokers express a desire to quit [1]. According to Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products, "Our mission is to find ways to stop tobacco-related disease and death. These products have the potential to help addicted adult smokers transition away from highly addictive combusted cigarettes" [1].

The exposure modification orders allow the manufacturer to market these cigarettes with specific reduced exposure claims regarding nicotine, such as "helps reduce your nicotine consumption" and "greatly reduces your nicotine consumption" [1]. However, the FDA recommends that the labeling and advertising include the statement, "Nicotine is addictive. Less nicotine does not mean safer. All cigarettes can cause disease and death" [1].

The FDA's decision to authorize these low-nicotine cigarettes comes after years of research and development by 22nd Century Group. The company has been providing reduced nicototine content cigarettes for research purposes and plans to launch additional products to expand distribution [2].

In conclusion, the FDA's authorization of 22nd Century Group's low-nicotine cigarettes marks a significant step forward in reducing smoking-related deaths. With three out of four adult smokers expressing a desire to quit and the potential to help addicted smokers transition away from highly addictive combusted cigarettes, these cigarettes have the potential to make a meaningful impact on public health.

References:
[1] FDA. (2023, February 2). FDA authorizes marketing of 22nd Century Group Inc.’s VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-tobacco-products-help-reduce-exposure-and-consumption-nicotine-smokers-who
[2] 22nd Century Group. (n.d.). About Us. Retrieved from https://www.xxiicentury.com/about/

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