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Press Release

FDA Remains Firmly Committed to Nicotine Reduction in Cigarettes

22nd Century Group,Inc.
Posted on: 31 Jan 18

22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company focused on tobacco harm reduction, reports recent activity relevant to the nicotine reduction mandate planned by the US Food and Drug Administration (FDA) .

In July 2017, FDA Commissioner Scott Gottlieb, M.D., announced the FDA’s plan to limit nicotine in cigarettes to minimally or non-addictive levels. In his announcement, Dr. Gottlieb explained that if nicotine – long known as the primary addictive component of cigarettes – were reduced, smokers would lose their addiction to cigarettes and would then be free to choose when and how often to smoke. An equally important component in FDA’s announced plan is to provide current smokers who are unable or unwilling to quit using nicotine with other, less harmful means to obtain it.

Prominent health advocacy associations have endorsed FDA’s plan to dramatically reduce nicotine in cigarettes to minimally addictive or non-addictive levels and to provide “demonstrably less hazardous” (non-combustible) products for the subset of smokers who are unable or unwilling to quit. On October 13, 2017, the heads of the Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and the Truth Initiative co-authored a letter to Dr. Gottlieb and the FDA urging the agency to enact a nicotine mandate as promptly as possible: “We support the objective of reducing the level of nicotine in cigarettes to render them minimally or non-addictive… It is critical that FDA begin action promptly, and set a firm deadline for completing, a Final Rule to reduce the levels of nicotine in cigarettes.”

On January 23, 2018, The National Academies of Sciences, Engineering, and Medicine (NASEM) published an independent report evaluating the available scientific evidence addressing the short- and long-term health effects related to the use of electronic nicotine delivery systems (ENDS), such as e-cigarettes. While the NASEM report raised some concerns, the authors found conclusive evidence that switching exclusively to e-cigarettes “reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.” The report also found substantial evidence that “nicotine intake from e-cigarette devices among experienced adult users can be comparable to that from combustible tobacco cigarettes.” These two conclusions strengthen support for the FDA’s proposed standard to: 1) reduce the nicotine content in cigarettes, and 2) provide current cigarette smokers who will not quit nicotine, with less harmful means to obtain it.

In a statement on the FDA’s website, Dr. Gottlieb said, “the report finds that current smokers who completely switch to e-cigarettes may see improved short-term health outcomes.” Responding to comments on the NASEM report that were posted on Twitter, Dr. Gottlieb made it clear that approved ENDS products are only part of the FDA plan, “We are pursuing a market where we use the product standard to render combustible cigs minimally or non-addictive.”

On January 25, 2018, Dr. Gottlieb continued to trumpet the FDA’s plan in a speech at the World Economic Conference in Davos, Switzerland. Stating that the smoking rate in the United States is too high, Dr. Gottlieb explained “we wish to reduce it greatly through our proposal to reduce nicotine in combustible cigarettes to minimally/non-addictive levels.”

“22nd Century’s Very Low Nicotine tobacco technology demonstrates that the FDA’s plan to dramatically reduce nicotine in cigarettes is technologically feasible,” explained James E. Swauger, PhD, Senior Vice President of Science and Regulatory Affairs for 22nd Century Group. “The letter to the FDA from public health associations, together with the NASEM report on e-cigarettes, highlight the growing public and scientific consensus that the FDA’s planned nicotine reduction mandate is timely, practical, and urgently needed.”

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 hemp/cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in hemp/cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.comfor 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20180131006193/en/

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Last updated on: 31/01/2018

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