22nd Century Delivers 3.6 Million Variable Nicotine Content Research Cigarettes for Independent Scientific Studies - Seite 2

In addition to growing public support, recent reports indicate that the Biden Administration is actively considering moving forward the FDA’s Advanced Notice of Proposed Rulemaking (ANPRM) that will require Big Tobacco to reduce the amount of nicotine in all combustible cigarettes sold in the U.S. Considering these reports, 22nd Century is confident that the new Administration is placing a high focus on public health, particularly respiratory health, as a critical initiative. In addition, David Kessler, who was the first FDA commissioner to call for a cap on the amount of nicotine allowed in combustible cigarettes, is now a senior adviser to the Biden administration on scientific matters. That fact, along with the appointment of Xavier Becerra as Secretary of the U.S. Department of Health and Human Services, a long-time proponent of tougher regulation for the tobacco industry, are additional favorable signs.

“The lowest nicotine level style of our variable nicotine content research cigarettes accounted for a sizable portion of our recent order and were selected for a very specific reason. This style contains as little as 0.5 milligrams of nicotine per gram of tobacco, the same level in our VLN cigarettes, and a level that the FDA has identified as ‘minimally or non-addictive’. The science has already established that people who use these products reduce the number of cigarettes they consume without increasing the intensity of smoking, as well as increase their smoke-free days and double their quit attempts,” said Michael Zercher, chief operating officer at 22nd Century. “Fulfilling orders of this size demonstrate 22nd Century’s ability to deliver mass quantities of our reduced nicotine content cigarettes and the technical feasibility of a product standard for all products in the U.S. to be ‘minimally or non-addictive’.”

Made from proprietary tobacco engineered to contain 95% less nicotine than conventional cigarette tobacco, 22nd Century’s RNC cigarettes already meet 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. Numerous independent scientific studies have demonstrated that using RNC 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 with minimal or no evidence of nicotine withdrawal or compensatory smoking.