$XXII FDA Provides Positive and Encouraging Feedback for Very Low MRTPA Filings


FDA Provides Positive and Encouraging Feedback for 22nd Century’s Very Low Nicotine MRTPA Filings

22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is focused on reducing the harm caused by smoking, today announced that the U.S. Food and Drug Administration (FDA) has provided the Company with helpful and positive feedback on the Company’s combined Modified Risk Tobacco Product Applications (MRTPAs) and Premarket Tobacco Product Applications (PMTAs) for 22nd Century’s “BRAND A” Very Low Nicotine tobacco cigarettes.

On December 31, 2015, the Company’s wholly owned subsidiary, Goodrich Tobacco Company, submitted MRTPAs and PMTAs to the FDA seeking a reduced exposure order for 22nd Century’s “BRAND A” Very Low Nicotine cigarettes. More specifically, the Company requested in its MRTPAs permission from the FDA to be able to state, as truthful and accurate in BRAND A packaging and marketing, that the Company’s proprietary Very Low Nicotine cigarettes reduce smokers’ exposure to nicotine.

With less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette, BRAND A cigarettes are the world’s lowest nicotine tobacco cigarettes. Relative to “Big Tobacco” cigarette brands, including Marlboro®, Camel®, Newport®, and American Spirit®, BRAND A contains 95% less nicotine. Unlike so-called “light” or “ultra-light” cigarettes (which terms are now banned by the FDA from labeling and marketing in the United States), 22nd Century’s proprietary BRAND A cigarettes are designed to deliver greatly reduced ratios of nicotine to other smoke components.

The Company is very pleased with the productive and encouraging communication it received from the FDA. Though the Company is only requesting an MRTP marketing order that will allow 22nd Century to disclose that BRAND A reduces smokers’ exposure to nicotine, the FDA has requested more information related to the independent clinical studies on the Company’s Very Low Nicotine tobacco that focused on smoking cessation and harm reduction objectives.

Further, though the Company’s MRTPAs and PMTAs for BRAND A included a comprehensive overview of many independent clinical trials that have found that smoking 22nd Century’s Very Low Nicotine cigarettes delivers the sensory and behavioral experience associated with conventional cigarettes while providing only minimal exposure to the most addictive component of tobacco, the FDA expressed interest in receiving additional documents pertaining to research findings and statistical analyses related to the focus group studies that were conducted in support of the Company’s BRAND A applications.

In response to the FDA’s requests, and in conjunction with additional clarifying guidance, the Company has withdrawn its existing filings in order to file even more expansive and robust MRTPAs and PMTAs for BRAND A that will include additional scientific data and information from already completed clinical studies on the Company’s Very Low Nicotine tobacco cigarettes, in addition to smoking cessation research. In order to help further expedite the FDA review process, the Company also intends to bifurcate its application into separate PMTAs and MRTPAs for BRAND A to enjoy the benefit of the FDA’s shorter review timing for PMTAs as compared to MRTPAs.

As 22nd Century expands upon its discussion and interactions with the FDA’s Center for Tobacco Products (CTP) on the Company’s MRTPAs and PMTAs for its BRAND A Very Low Nicotine over-the-counter product, the Company is also continuing to separately work with the FDA’s Center for Drug Evaluation and Research (CDER) with respect to the Company’s previously-filed New Drug Application (NDA) for 22nd Century’s proposed “X-22” prescription-based smoking cessation product. Thus, 22nd Century is advancing two distinct products – one a proposed reduced exposure combustible cigarette, the other a proposed pharmaceutical smoking cessation aid – with different parts of the FDA.

“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. “To address this critically important issue, we look forward to collaborating with the FDA in 2017 on both BRAND A and on X-22 in order to provide consumers access to 22nd Century’s remarkable Very Low Nicotine products.”


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