22nd Century Meets With FDA On Modified Risk Tobacco Product Application For World’s Lowest Nicotine Tobacco Cigarettes

Source from:  Business Wire 06/20/2017

22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that the Company and its wholly-owned subsidiary, Goodrich Tobacco Company, held yesterday a very encouraging and productive meeting with the Office of Science of the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA). Based on written feedback received ahead of the meeting, and on the positive exchange between Goodrich and the FDA at the meeting itself, the Company will now move forward with a significantly expanded Modified Risk Tobacco Product (MRTP) application with the CTP/FDA for the Company’s BRAND A Very Low Nicotine (VLN) cigarettes.

The World’s Lowest Nicotine Tobacco Cigarettes

BRAND A VLN cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05mg nicotine yield per cigarette. In each case, this represents a reduction of at least 95% less nicotine relative to “Big Tobacco” cigarette brands, including Marlboro?, Camel?, Newport?, and American Spirit?. The Company’s MRTP application to the CTP/FDA will request that BRAND A packaging and marketing be allowed to disclose to consumers that the Company’s proprietary Very Low Nicotine cigarettes reduce smokers’ exposure to nicotine.

22nd Century is the only company in the world capable of growing virtually nicotine-free tobacco. Without any artificial extraction or chemical processes, 22nd Century’s BRAND A cigarettes are made with the Company’s proprietary VLN tobacco that is grown on independently-owned farms in the United States. 22nd Century’s finished Very Low Nicotine cigarettes have the taste and sensory characteristics of conventional cigarettes, but contain only trace amounts of nicotine so smokers’ exposure to nicotine is drastically reduced.

“We are extremely pleased with the frank and collaborative dialogue that occurred in yesterday’s meeting,” explained Gregg M. Gellman, 22nd Century’s Director of Regulatory Affairs. “FDA’s written and in-person feedback – combined with the ongoing discussions we plan to have with the FDA in the coming weeks and months – will help 22nd Century prepare and submit comprehensive and robust MRTP application for BRAND A Very Low Nicotine cigarettes.”

“The World Health Organization has recommended ‘mandated reductions in nicotine to minimally addictive levels.’ Unfortunately, at present, smokers in the United States do not have a Very Low Nicotine cigarette option,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We believe BRAND A VLN cigarettes will prove invaluable in drastically reducing smokers’ exposure to nicotine. To this end, 22nd Century looks forward to continuing to work closely with the FDA on this very important public health matter.” Enditem