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World Health Organization Recommends “Mandated Reductions in Nicotine to Minimally Addictive Levels”

XXII | July 11, 2016

World Health Organization Recommends “Mandated Reductions in Nicotine to Minimally Addictive Levels”

22nd Century’s Very Low Nicotine Cigarettes Could Facilitate Global Nicotine Reduction Strategy

22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that the World Health Organization (WHO) Study Group on Tobacco Product Regulation (TobReg) has recommended “a policy of limiting the sale of cigarettes to brands with a nicotine content that is not sufficient to lead to the development and/or maintenance of addiction.” (WHO Global Nicotine Reduction Strategy)

The WHO report states: “No specific amount of nicotine has yet been identified as the absolute threshold for addiction; however, it is likely to be equal to or possibly less than 0.4 mg/g of dry cigarette tobacco filler.” 22nd Century is the only company in the world capable of producing combustible tobacco cigarettes at this very low level of nicotine – without any artificial extraction or chemical processes.

Reflecting on independent clinical studies, the WHO report explains that government-mandated nicotine reduction strategies utilizing Very Low Nicotine cigarettes could “decrease the acquisition of smoking and progression to addiction among experimenters, limit the number of cigarettes smoked by some proportion of addicted smokers and both increase the number of addicted smokers who stop smoking and reduce the number of those who relapse.”

22nd Century’s proprietary Very Low Nicotine SPECTRUM®, MAGIC®, and BRAND A cigarettes have the taste and sensory characteristics of conventional cigarettes, but contain approximately 95% less nicotine than conventional cigarettes made by Altria Group, Inc. (NYSE: MO) and Reynolds American, Inc. (NYSE: RAI), including Marlboro®, Newport®, Camel®, and American Spirit®.

Reduced nicotine “yield” cigarettes first developed and marketed by “Big Tobacco” companies in the 1970’s as “light,” and “low tar” (terms now banned by the FDA from labeling and marketing in the United States), deliver doses of nicotine that are actually comparable to full-flavored conventional cigarettes and, in fact, extend the prevalence of addiction. In stark comparison, 22nd Century’s Very Low Nicotine cigarettes drastically reduce smokers’ exposure to nicotine. A growing body of scientific evidence – including the ground breaking clinical trial by Donny et al. that was funded by the FDA and published in The New England Journal of Medicine – demonstrates that 22nd Century’s proprietary Very Low Nicotine cigarettes do not sustain addiction. Further, the use of 22nd Century’s Very Low Nicotine cigarettes has been shown to decrease daily cigarette consumption, as well as nicotine and toxicant exposure.

As demonstrated by the WHO report, many public health officials believe it is a critically important health need to provide consumers with a product that reduces exposure to nicotine. This point echoes former U.S. FDA Commissioner Dr. David Kessler’s recommendation that “the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate harm reduction strategy.”

"22nd Century is the only company in the world that can make cigarettes containing naturally grown tobacco with nicotine at the non-addictive levels recommended by the WHO and former U.S. FDA Commissioner Dr. David Kessler," explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. "We welcome the opportunity to collaborate with public health officials and scientists around the world to test and implement the important recommendations made by the World Health Organization Study Group on Tobacco Product Regulation."

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 and www.magiccigarettes.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.