National Conference on “Tobacco Regulatory Science” to Address FDA’s New Comprehensive Plan for Nicotine Regulation

22nd Century’s Very Low Nicotine cigarettes will be featured in key panel discussions.

CLARENCE, N.Y.--()--22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today that the Vermont Center on Behavior and Health’s 5th Annual Conference will focus on Tobacco Regulatory Science and will include the prodigious science surrounding 22nd Century’s Very Low Nicotine tobacco cigarettes. This national conference will take place on October 5-6, 2017 in Burlington, Vermont and will feature, as its keynote speaker, Mitch Zeller, J.D., Director of the U.S. Food and Drug Administration Center for Tobacco Products. Director Zeller’s address comes on the heels of FDA Commissioner Dr. Scott Gottlieb’s July 28th announcement that the FDA is planning to reduce nicotine content in cigarettes to non-addictive levels. In his address to open the conference, Director Zeller will expand upon “FDA’s New Comprehensive Plan for Nicotine Regulation.”

This Tobacco Regulatory Science conference gathers together many of the world’s foremost scientific experts on the important behavioral impacts of Very Low Nicotine tobacco cigarettes. Chairing the panel on Very Low Nicotine Content Cigarettes is Neal Benowitz, M.D., Core Director and Investigator, University of California, San Francisco (UCSF) Tobacco Center of Regulatory Science. Dr. Benowitz recently authored a paper: “Comprehensive Nicotine Regulation to End the Combustible Tobacco Epidemic” where he states that an FDA-mandated 95% reduction in nicotine content would “make it impossible to compensate by smoking cigarettes more intensively or smoking more per day.”

Eric C. Donny, Ph.D., Co-Director, Center for the Evaluation of Nicotine in Cigarettes; Professor of Physiology & Pharmacology, Baptist Cancer Center, Wake Forest, will address the “Main Effects and Moderators of the Impact of Nicotine Content on Smoking Rate and Nicotine Dependence.” Dr. Donny’s landmark 840-patient, Phase III study, Randomized Trial of Reduced-Nicotine Standards for Cigarettes, was published in the New England Journal of Medicine and used exclusively 22nd Century’s SPECTRUM® research cigarettes.

Dorothy K. Hatsukami, Ph.D., Co-Director, Center for the Evaluation of Nicotine in Cigarettes, Professor of Psychiatry and Director of the Tobacco Research Programs, University of Minnesota, will address “Approaches to Reducing Nicotine in Cigarettes” at this conference. Together, Dr. Hatsukami and Dr. Donny are leading the Phase III study, Strategies for Reducing Nicotine Content in Cigarettes, which features 1,250 participants and uses 22nd Century’s SPECTRUM research cigarettes. This important study compares two different approaches to help smokers lose their addiction to nicotine: (A) an immediate reduction in nicotine content in cigarettes to non-addictive levels, or (B) a gradual reduction in nicotine content in cigarettes to non-addictive levels. The results of this study are expected imminently; whatever the outcome, 22nd Century will be the “winner” since the various research cigarettes used in both arms of this study were provided by 22nd Century.

Stephen T. Higgins, Ph.D., Director, University of Vermont Tobacco Center of Regulatory Science, will discuss the results of his recently published study “Addiction Potential of Cigarettes with Reduced Nicotine Content in Populations with Psychiatric Disorders and Other Vulnerabilities to Tobacco Addiction.” As a part of this study, Professor Higgins, et al. provided participants with 22nd Century’s SPECTRUM research cigarettes. The lowest nicotine level (0.4mg/g) represents a 95% reduction in nicotine as compared to the nicotine level in conventional cigarettes. Professor Higgins, et al. note that “the 0.4mg/g dose most consistently and robustly differed from the [conventional nicotine] control dose.” Only 22nd Century is capable of growing tobacco with a 95% reduction in nicotine.

“We are proud that 22nd Century’s proprietary Very Low Nicotine cigarettes can help all smokers – even vulnerable population groups,” explained Henry Sicignano III, President and CEO of 22nd Century Group. “By mandating that all cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine, the FDA will be taking a giant step in preventing a future generation from becoming addicted to combustible cigarettes. This is a massively important initiative.”

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.

About the Vermont Center on Behavior and Health

The Vermont Center on Behavior and Health (VCBH) is an interdisciplinary research center committed to investigating relationships between lifestyle patterns and the risk for chronic disease. VCBH is a part of the University of Vermont and The Robert Larner, M.D. College of Medicine.

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
James Vail, 716-270-1523
Director of Communications
jvail@xxiicentury.com

Release Summary

“Tobacco Regulatory Science” Conference to Address FDA’s Nicotine Plan; 22nd Century’s Very Low Nicotine Cigarettes will be Discussed in Key Panels

Contacts

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