22nd Century Announces the Immediate Feasibility of the FDA’s Nicotine Reduction Plan

22nd Century Group, Inc. (NYSE American:XXII), a plant biotechnology company that is a leader in tobacco harm reduction and Very Low Nicotine tobacco, yesterday responded to the Advance Notice of Proposed Rulemaking (ANPRM) by the U.S. Food and Drug Administration (FDA) to develop a rule that will require all cigarettes sold in the United States to contain only minimally or non-addictive levels of nicotine. When the Company’s response is posted online by the FDA at www.regulations.gov, the corresponding tracking number will be: 1k2-94b8-wdcp. 22nd Century’s complete response to the FDA’s ANPRM is currently available at: www.xxiicentury.com/ANPRM.

22nd Century’s public comments to the FDA’s ANPRM describe how the FDA’s proposed rule to require that all cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine is supported by rigorous independent science. The Company also demonstrates that the planned mandate is exceedingly practical and urgently needed in the interests of public health.

The FDA’s stated goal to render cigarettes minimally or non-addictive is immediately feasible. 22nd Century has produced and delivered tens of millions of the Company’s Very Low Nicotine Content (VLNC) SPECTRUM® research cigarettes since 2011 for use in numerous independent clinical studies funded by more than $100 million from agencies of the United States federal government. The results of these independent clinical studies show that upon switching to 22nd Century’s VLNC SPECTRUM® cigarettes, smokers: (1) reduce their cigarette consumption, (2) experience lessened withdrawal symptoms, and (3) increase their attempts to quit smoking. These peer-reviewed and published studies provide a solid scientific foundation for the FDA’s proposed nicotine reduction mandate. VLNC cigarettes are so promising that independent researchers estimate that in the first year after implementation of the FDA’s rule to limit cigarettes to minimally or non-addictive levels of nicotine, approximately 5 million people would stop smoking and, in as few as five years after implementation of the FDA’s plan, more than 13 million people would stop smoking.