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Phase III Study using 22nd Century’s SPECTRUM® Research Cigarettes Demonstrates Immediate Reduction to Very Low Nicotine is Most Likely to Lead to Less Harm

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22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today that Dr. Dorothy Hatsukami, at the Vermont Center on Behavior and Health’s 5th Annual Conference on Tobacco Regulatory Science, revealed the fundamental findings of a highly anticipated 1,250-patient, 20-week study that compared smokers who were assigned to: i) an immediate reduction to Very Low Nicotine cigarettes; ii) gradual reduction in reduced nicotine content cigarettes; or iii) normal nicotine content cigarettes. Designed to determine which approach produces the most optimal outcomes for smokers, the announcement of the results of the seminal phase III study comes only weeks after the United States Food and Drug Administration (FDA) announced that the Agency is exercising its authority under the Family Smoking Prevention and Tobacco Control Act to mandate lower nicotine – at non-addictive levels – in all combustible cigarettes sold in the United States.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171006005223/en/

22nd Century’s proprietary SPECTRUM® research cigarettes facilitate independent studies on nicotine  ...

22nd Century’s proprietary SPECTRUM® research cigarettes facilitate independent studies on nicotine reduction strategies. The FDA plans to mandate lower nicotine – at non-addictive levels – in all cigarettes sold in the United States. (Photo: Business Wire)

Dr. Hatsukami, who is the Co-Director of the Center for the Evaluation of Nicotine in Cigarettes and Professor of Psychiatry and Director of the Tobacco Research Programs at the University of Minnesota, led the ground-breaking phase III study that was conducted in 10 cities across the United States and included participants from all demographics.

22nd Century was the exclusive provider of the Very Low Nicotine and other SPECTRUM research cigarettes that were used in Dr. Hatsukami’s 1,250-participant trial and in more than 16 other clinical trials. In fact, 22nd Century is the only company in the world capable of growing tobacco with nicotine levels of just 0.4mg per gram of tobacco, which is more than a 95% reduction in nicotine as compared to tobacco in conventional cigarettes. Many scientists around the world believe that tobacco with this very low level of nicotine is minimally or non-addictive.

Though the details of Dr. Hatsukami’s phase III study are still under peer review, Dr. Hatsukami divulged the answer to the study’s core question of whether an immediate or a gradual reduction in nicotine is the best approach. Dr. Hatsukami clearly and confidently declared in her panel presentation at the Vermont Conference that “an immediate approach [to nicotine reduction] is most likely to lead to less harm.” Further, Dr. Hatsukami pointed out that the study data indicates compensatory smoking is less likely to occur with an immediate reduction in nicotine, and that the there was a “greater likelihood of more rapid smoking cessation” with the immediate approach to nicotine reduction.

Following Dr. Hatsukami’s discussion, Dr. Stephen T. Higgins, Director of the University of Vermont Tobacco Center of Regulatory Science took the podium and announced to the conference attendees: “I will present evidence that reducing nicotine content lowers the addiction potential of smoking among those with psychiatric conditions or socioeconomic disadvantage consistent with prior evidence in samples from the general adult smoker population.” In addition to finding reduced evidence of addiction in smokers of 22nd Century’s Very Low Nicotine Content (VLNC) cigarettes, Dr. Higgins found that: “VLNCs did not produce evidence of compensatory smoking.” [emphasis added]

Dr. Jonathan Foulds of Penn State College of Medicine also delivered a powerful call to action at the conference, challenging the attending scientists to deny the tobacco industry any diversions or strategies that could be used to delay the FDA’s planned mandate to reduce nicotine in cigarettes to very low, non-addictive levels. Dr. Foulds then pointed out the stakes involved: “Such a move [by FDA to reduce nicotine content of cigarettes] could result in one of the largest single improvements in public health ever [seen] in this country.”

“Considering the results of numerous phase II and phase III studies that have been conducted with VLN cigarettes, there is now compelling and conclusive evidence that Very Low Nicotine cigarettes decrease cigarette dependence, reduce the number of cigarettes smoked per day, and increase smokers’ quit attempts,” explained Henry Sicignano III, President and CEO of 22nd Century Group. “With the power to save millions of lives and to prevent a new generation of young people from becoming dependent on tobacco, minimally or non-addictive Very Low Nicotine cigarettes are the ultimate harm reduction strategy.”

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.

Contact information

22nd Century Group
James Vail, 716-270-1523
Director of Communications
jvail@xxiicentury.com

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