22nd Century’s Very Low Nicotine Cigarettes Significantly Reduce Withdrawal and Craving Symptoms in Vulnerable Population Groups

“When nicotine content is set very low… dependence decreases, smoking rates decrease, and people are better able to quit if they choose to do so.” Dr. Stephen T. Higgins, University of Vermont Center on Tobacco Regulatory Science

CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco harm reduction, announced today that scientists from the University of Vermont Center on Tobacco Regulatory Science, Brown University, Johns Hopkins University, and Southern Illinois University published online in the October 2016 issue of Psychopharmacology a new independent clinical study which concluded that, even among vulnerable populations, 22nd Century’s Very Low Nicotine tobacco cigarettes significantly reduce nicotine withdrawal and craving symptoms. Dr. Stephen T. Higgins, et al., conducted the study, which examined the effects of Very Low Nicotine cigarettes on economically disadvantaged women, opioid-dependent individuals, and individuals with affective disorders.

The FDA Center for Tobacco Products (CTP) partners with other public health agencies to conduct research that drives tobacco regulatory action based on the best available science. At the onset of his clinical study, Dr. Higgins discussed the objectives for his trial in an FDA sponsored Tobacco Regulatory Science in Action video. In the video, Dr. Higgins explains that “when nicotine content is set very low… dependence decreases, smoking rates decrease, and people are better able to quit if they choose to do so.” Characterizing the results of previous trials with Very Low Nicotine cigarettes as “promising,” Dr. Higgins states clearly: “we have to make cigarettes less addictive.”

The Higgins study, which exclusively used 22nd Century’s SPECTRUM® research cigarettes as provided by the National institute on Drug Abuse (NIDA), examined the potential impacts of enacting a national policy to lower the nicotine content of cigarettes to a level not capable of sustaining addiction. The study scientists note that “there is now an abundance of evidence that very low nicotine content cigarettes provide smokers with significant relief [from withdrawal symptoms].”

Fifteen scientific papers from independent clinical studies have already demonstrated a host of desirable outcomes for the broader U.S. smoking population, including: reduced smoking, reduced nicotine exposure, reduced nicotine dependence, increased abstinence, reduced exposure to toxicants and few adverse events with little evidence of withdrawal-related discomfort or safety concerns. Independent scientists widely agree that 22nd Century’s proprietary Very Low Nicotine cigarettes drastically reduce smokers’ exposure to nicotine and do not result in compensatory smoking. In contrast, “light” cigarettes (as previously labeled and marketed by “Big Tobacco” companies like Altria Group, Inc. (NYSE: MO) and Reynolds American, Inc. (NYSE: RAI)), merely reduce machine-smoking nicotine yields by diluting the smoke rather than by reducing the nicotine content of the tobacco itself. Accordingly, “light” cigarettes made by Big Tobacco companies can result in compensatory smoking and actually lead to increased exposure to toxicants.

The paper by Dr. Higgins, et al. adds to the substantial number of previous clinical trials that support the use of 22nd Century’s Very Low Nicotine cigarettes with a nicotine content of 0.4mg/g. Dr. Higgins reports that this 95-97% reduction in nicotine versus conventional tobacco has “the greatest likelihood” of falling below a nicotine dependence threshold. Only 22nd Century can grow tobacco plants with such minute nicotine content.

“22nd Century’s Very Low Nicotine cigarettes have proven beneficial for every examined smoker population, from the broad U.S. smoking population to subsets that include smokers suffering from schizophrenia, heavy consumers of alcohol, and now even the most vulnerable groups among us,” noted Henry Sicignano, III, President and Chief Executive Officer at 22nd Century Group. “Under the Tobacco Control Act of 2009, the FDA has the regulatory authority to mandate that all U.S. cigarette manufacturers offer Very Low Nicotine brand styles so that smokers can have a non-addictive choice. I understand why Altria might be hesitant to embrace the idea of Very Low Nicotine Marlboro® cigarettes… but I can no longer imagine why public health officials would hesitate.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. Visit www.xxiicentury.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, 2015, filed on February 18, 2016, 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.

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Source: 22nd Century Group, Inc.