WILLIAMSVILLE, N.Y.–(BUSINESS WIRE)–22nd Century Group, Inc. (NYSE American: XXII) — a plant biotechnology company that is a leader in reduced nicotine tobacco and hemp/cannabis plant research — met on Friday, February 14, 2020 with the U.S. Food and Drug Administration’s Tobacco Product Scientific Advisory Committee (TPSAC) to present the Company’s Modified Risk Tobacco Product (MRTP) application for its proprietary, reduced nicotine content cigarettes. This meeting was the first time that TPSAC considered an MRTP application for a modified exposure claim and also TPSAC’s first discussion of an application for a combustible tobacco product.

“Our team was extremely well-prepared for the meeting and performed exceptionally well,” said Mike Zercher, President of 22nd Century Group. “We believe that all adult smokers have the right to know that our VLN^® products contain 95% less nicotine than conventional cigarettes, and we believe TPSAC agreed with us. Our research shows VLN^® strongly appeals to adult smokers, while importantly former and never-smokers have little interest in the product.

“22nd Century is poised to significantly disrupt the $100 billion U.S. tobacco industry,” Zercher continued. “Based on the success of the meeting, the FDA’s public statements at the meeting and in its briefing document published ahead of the meeting, as well as the FDA’s previous guidance about the timing of its reviews of MRTP applications in general, we believe the FDA is likely to reach a decision on our MRTP application sometime in the second quarter of this year. The FDA’s potential authorization of our MRTP application would be the culmination of years of effort and the investment of millions of dollars by the Company and could lead to the launch of VLN^® as soon as this year,” Zercher concluded.

“With this TPSAC meeting, 22nd Century has now passed one of the final regulatory milestones in seeking FDA authorization of our MRTP application,” commented John Pritchard, Vice President of Regulatory Science at 22nd Century Group. “Our comprehensive, science-based MRTP applications are supported by well over $100 million of independent clinical research conducted at leading institutions and major universities in the United States and elsewhere. Furthermore, we already have secured an FDA authorization for our Moonlight^® and Moonlight^® Menthol brand of reduced nicotine content cigarettes by meeting the PMTA regulatory requirements,” continued Pritchard. “We believe that receiving an FDA authorization for our MRTP products will also further advance the FDA’s stated goal of achieving a reduced nicotine product standard for all cigarettes sold in the United States. We expect the FDA to close the public comment period on our MRTP application soon, and for the FDA to then finalize its review of our MRTP application,” Pritchard concluded.

22nd Century’s MRTP application seeks a reduced exposure marketing authorization from the FDA to allow its reduced nicotine content cigarettes to be marketed under the brand name “VLN^®,” with pack and advertising claims stating that the product contains 95% less nicotine than conventional tobacco cigarettes, as well as related claims regarding nicotine exposure.

In the FDA’s briefing document prepared by the FDA for the members of TPSAC and posted to the FDA’s website prior to the meeting, the FDA stated: “FDA’s preliminary scientific review of the application found that the … proposed claims are substantiated: there is about a 95% reduction in nicotine in the tobacco itself, the smoke it yields, and the nicotine that is absorbed when the product is smoked exclusively. When the product is dual used with normal nicotine content cigarettes, nicotine exposure is still significantly reduced. In studies of smokers who do not intend to quit, compared to smokers assigned to a control condition where they continue smoking usual brand cigarettes, smokers assigned to use the product reduce total number of cigarettes per day (CPD) by about 30% at 6 weeks and 50% at 20 weeks.”

The FDA’s TPSAC briefing document further states: “The applicant’s study and the peer-reviewed literature indicate that the abuse liability of VLN^® cigarettes is similar to nicotine replacement therapy (NRT) gum. Using [reduced nicotine content] cigarettes can reduce nicotine dependence. In clinical studies, where smokers are told to switch completely to [reduced nicotine content] cigarettes, CPD and nicotine dependence scores decrease even among smokers who continue to dual use the product with their usual brand cigarettes. Reducing cigarette consumption can increase the likelihood that some smokers will quit. Using [reduced nicotine content] cigarettes is associated with increased quit attempts, even among smokers not interested in quitting. Among smokers interested in quitting, switching to [reduced nicotine content] cigarettes in combination with using NRT may also facilitate quitting.”

The Company’s reduced nicotine content cigarettes enable adult smokers to experience the same taste and smell as conventional cigarettes but with minimal exposure to nicotine. The FDA’s own assessment of its proposed plan to limit the nicotine content of all combustible cigarettes to levels already achieved in VLN^® – just 0.5 milligrams of nicotine per gram of tobacco – states that such a reduced nicotine product standard would lead to five million adult smokers quitting one year after implementation, with over eight million American lives saved by the end of this century.

The public Tobacco Product Scientific Advisory Committee meeting took place at the FDA White Oak Campus in Silver Spring, MD. The meeting transcripts and a video recording of the webcast are expected to be posted on the FDA’s website here.

About 22nd Century Group, Inc.

22nd Century Group is a plant biotechnology company focused on technologies that allow it to regulate the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering and modern plant breeding. The Company’s primary mission in tobacco is to reduce the harm caused by smoking by bringing to market reduced nicotine content cigarettes with 95% less nicotine than conventional cigarettes. The Company’s primary mission in hemp/cannabis is to develop proprietary hemp/cannabis plants with unique cannabinoid profiles and desirable agronomic traits. Visit https://xxiicentury.com for more information.