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22nd Century Receives Order for 3.6 Million New SPECTRUM® Variable Nicotine Cigarettes for U.S. Government-Supported Research
The Company’s Research Cigarettes Continue to Fuel Studies Adding to the Vast Body of Research Supporting a National Nicotine Standard for Combustible
About this update from 22nd Century Group, Inc
[{"type":"text","content":"The Company’s Research Cigarettes Continue to Fuel Studies Adding to the Vast Body of Research Supporting a National Nicotine Standard for Combustible Cigarettes\nWILLIAMSVILLE, N.Y., Dec. 08, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, announced today that the U.S. Food and Drug Administration (FDA) in coordination with the National Institute on Drug Abuse (NIDA) and others, has submitted an order to 22nd Century for 3.6 million variable nicotine research cigarettes. The Company’s research cigarettes will continue to fuel numerous independent, scientific studies to validate the enormous public health benefits identified by the FDA and others of implementing a national standard requiring all cigarettes to contain minimally or non-addictive levels of nicotine. The selection of SPECTRUM® cigarettes for use in ongoing research is not connected to 22nd Century’s Modified Risk Tobacco (MRTP) application for the Company’s reduced nicotine content VLN® cigarettes. 22nd Century believes that authorization of the Company’s MRTP application is imminent, and it plans to launch VLN® cigarettes within just 90 days of authorization. 22nd Century continues to maintain a dialogue with the FDA, and the Company believes the agency is in the final stage of review. At this time, the Company has no outstanding requests for information from the FDA, and the Company is confident it has satisfied every FDA requirement for the agency to make a final decision about our application. “Mitch Zeller, director of the CTP at the FDA recently presented at the Food and Drug Law Institute’s Tobacco and Nicotine Products Conference and was asked whether the FDA is still considering moving ahead with the agency’s plan to reduce nicotine content in cigarettes to non-addictive levels,” said James A. Mish, chief executive officer of 22nd Century Group. “Zeller confirmed that the FDA remains ‘absolutely committed to everything that was in that plan.’ The continuation of studies to validate the role of reduced nicotine content cigarettes in public health and their potential to reduce and even eliminate tobacco-related diseases and death demonstrate the FDA’s continued commitment to tobacco harm reduction.” Mish added, “We are proud to partner with public ...