Our primary mission in tobacco is to reduce the harm caused by smoking by bringing our VLN® reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes – to adult smokers in the U.S. and international markets.
Nicotine has long been known as the primary addictive chemical in cigarettes. Utilizing genetic engineering, gene-editing, and modern plant breeding, 22nd Century has successfully manipulated the tobacco plant and developed a cigarette with 95% less nicotine than all other leading brands. VLN® contains just 0.5 mg of nicotine per gram of tobacco and is the only combustible tobacco product that meets the nicotine levels proposed in the FDA’s Advance Notice of Proposed Rulemaking (ANPRM) for a tobacco product standard that requires all combustible cigarettes to contain “minimally or non-addictive” levels of nicotine.
Projections show that when the FDA implements its nicotine cap as part of its Comprehensive Plan for Tobacco and Nicotine Regulation, it would help five million adult smokers to quit within one year, help 33 million people to avoid becoming regular smokers, and save more than eight million American lives by the end of the century. Numerous independent scientific studies, funded largely by the FDA, the National Institutes of Health, and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, increase their number of smoke-free days, and double their quit attempts – all with minimal or no evidence of nicotine withdrawal or compensatory smoking.
In December 2019, the FDA authorized the commercial sale of 22nd Century’s reduced nicotine content cigarettes. Following a rigorous science-based review of the Company’s premarket tobacco product application (PMTA), the Agency determined that authorizing these reduced nicotine products for sale in the U.S. is “appropriate for the protection of the public health”.
22nd Century’s Modified Risk Tobacco Product (MRTP) application is currently under review by the FDA, requesting authorization to market the Company’s reduced nicotine cigarettes under the brand name VLN®. The Company is highly confident that its MRTP application for VLN® is in the final stages of the FDA’s review process. This important designation will allow 22nd Century to communicate key features of VLN® King and VLN® Menthol King, including the headline claim of “95% less nicotine.” VLN® tastes, smells, and smokes like a conventional cigarette. This disruptive product is an innovative alternative to addictive, conventional cigarettes and will help adult smokers reduce their exposure to nicotine.
22nd Century is fully prepared and eager to launch its VLN® cigarettes within 90 days of receiving authorization from the FDA. Adult smokers deserve a choice and 22nd Century is committed to bringing VLN® to market.