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

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

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

10/03/2017

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.

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.”

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