Home CannaBusiness 22nd Century Meets with FDA on Modified Risk Tobacco Product Application for World’s Lowest Nicotine Tobacco Cigarettes

22nd Century Meets with FDA on Modified Risk Tobacco Product Application for World’s Lowest Nicotine Tobacco Cigarettes

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CLARENCE, N.Y.–(BUSINESS WIRE)–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.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 8, 2017, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

Contacts

22nd Century Group
Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com

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