FDA Grants Modified Risk Authorization to 22nd Century Group’s VLN

FDA Grants Modified Risk Authorization to 22nd Century Group's VLN

22nd Century Group, Inc., a leading agricultural biotechnology company that is focused on tobacco harm reduction and reduced nicotine tobacco products, has announced 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). This comes after the FDA found that VLN meets the criteria to be viewed as helping to “reduce exposure to, and consumption of, nicotine for smokers who use them.”

VLN smokes, tastes and smells like a conventional cigarette but contains 95 percent less nicotine than conventional, highly addictive cigarettes.

In commenting on the recent authorization, Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, commented: “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. 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.”

In a press release, James A. Mish, chief executive officer at 22nd Century Group, commented: “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 percent 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.”

Mish continued: “Having secured this FDA marketing order, we are fully prepared to launch VLN with select retail and marketing partners in our pilot markets in the U.S. within the next 90 days and in the first of several global markets by the end of the first quarter of 2022. We are also in discussions with additional retail trade, marketing, and strategic partners to scale VLN sales in the U.S. and internationally, including through potential licensing of our technology to facilitate the broader industry transition to RNC products. We will provide additional details on strategic partners and the rollout of VLN in the coming months.”