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FDA Authorizes Marketing of 22nd Century Group’s VLN® as a Modified Risk Tobacco Product
VLN® Is World’s First and Only Combustible Cigarette to Receive FDA MRTP DesignationFDA Adds Evidence-Based, Headline Claim “Helps You Smoke Less” to
About this update from 22nd Century Group, Inc
[{"type":"text","content":"VLN® Is World’s First and Only Combustible Cigarette to Receive FDA MRTP DesignationFDA Adds Evidence-Based, Headline Claim “Helps You Smoke Less” to Company’s Requested Claims VLN® 95% Reduced Nicotine Content Cigarettes to Launch in the U.S. Within 90 DaysVLN® to Launch Outside the U.S. in First Quarter 2022 BUFFALO, N.Y., Dec. 23, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science, announced today that the U.S. Food and Drug Administration (FDA) has authorized the marketing of the Company’s VLN® King and VLN® Menthol King reduced nicotine content cigarettes as modified risk tobacco products (MRTPs). In doing so, the Agency found that VLN® – which smokes, tastes, and smells like a conventional cigarette but contains 95% less nicotine than conventional, highly addictive cigarettes – “help reduce exposure to, and consumption of, nicotine for smokers who use them.” “Today’s decision to authorize VLN®’s MRTP application places the FDA and 22nd Century together at the vanguard of transforming the tobacco industry. 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 – the addictive chemical found in all tobacco products. This is the first, and most likely will be the only, combustible cigarette to ever carry the FDA’s MRTP designation. The FDA’s decision to require the additional headline claim ‘Helps You Smoke Less’ alongside our requested headline claim of '95% Less Nicotine' gives adult smokers a crystal-clear reason to replace their conventional and highly addictive cigarettes with VLN®,” said James A. Mish, chief executive officer at 22nd Century Group. “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,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Having options like these products authorized today, which contain...