22nd Century Highlights Public Comments to the FDA’s Nicotine Reduction Plan

WILLIAMSVILLE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a leader in tobacco harm reduction and Very Low Nicotine tobacco, today called attention to comments submitted to the U.S. Food and Drug Administration (FDA) in response to the FDA’s Advance Notice of Proposed Rulemaking (ANPRM) to develop a nicotine product standard in cigarettes that will lower nicotine to minimally or non-addictive levels. The open comment period on the FDA’s ANPRM ends July 16, 2018. To date, major medical associations, government agencies, tobacco insiders, and the public at large have submitted nearly 3,000 public comments to the FDA. Although some companies in the tobacco industry have requested a 90-day extension of the comment period and have facilitated hundreds of “form letter” comments, the responses from scientists and regulators have been overwhelmingly in favor of the FDA’s plan to dramatically reduce the nicotine content of cigarettes. As the only company in the world growing multiple varieties of Very Low Nicotine flue-cured and burley tobacco varieties, 22nd Century makes possible the FDA’s vital new plan.

Below is a summary of some of the most important comments that the FDA has received to date in response to the ANPRM:

“Given the immense public health benefits predicted by the FDA, the ACC strongly supports the implementation of a nicotine product standard in cigarettes to a minimally addictive or non-addictive level.”
“The FDA should move quickly to develop and issue a final regulation to maximize the number of lives saved.”

American College of Cardiology, June 5, 2018

“American Society of Addiction Medicine urges the FDA to move forward with a proposed rule within six months after release of its ANPRM and final rule six months after. In addition, we urge the FDA to establish the tobacco product standard no later than one year after publication, as provided in Section 907 of the Family Smoking Prevention and Tobacco Control Act.”

American Society of Addiction Medicine, June 14 2018

“I am encouraged by the strong actions that the FDA is pursuing to improve the health of our nation, facilitate quitting among smokers who are currently struggling with their addiction, and prevent a future generation from becoming addicted to a highly toxic tobacco product.”

Dorothy K. Hatsukami, PhD, Professor of Psychiatry, University of Minnesota, June 11, 2018

“Immediate nicotine reduction is likely to have the largest public health benefit.”

American Psychological Association, College on Problems of Drug Dependence, Society for Research on Nicotine and Tobacco June 12, 2018

“Our results support a conclusion that a national regulatory policy reducing the nicotine content of cigarettes would reduce the addiction potential of cigarette smoking and that those effects would extend to populations that are highly vulnerable to tobacco addiction.”

Stephen T. Higgins Ph.D., Director, Vermont Center on Behavior and Health, April 26, 2018

“Consistent with the aims of this ANPRM, the 2014 Surgeon General's Report identified reduction of the nicotine content of tobacco products to make them less addictive as a tobacco "end game" strategy to accomplish the U.S. overall goal of a society free of tobacco-related death and disease.”
“This action would contribute to a significant reduction in the lives lost and medical costs associated with the burden of smoking-related morbidity and mortality.”

California Department of Public Health, May 4, 2018

“This proposed rule is a necessary step towards protecting youth and adults from the dangers of nicotine dependence.”

Washington County, Oregon Department of Health and Human Services, June 14th, 2018

“…the Montana Department of Public Health and Human Services strongly supports the FDA's pursuit to lower the nicotine level of cigarettes to minimally or non-addictive levels…”

Montana Department of Public Health and Human Services, June 14, 2018

“Although we will likely see many more comments to the FDA’s plan to require the reduction of the nicotine content of cigarettes to minimally or non-addictive levels, already there is strong scientific, regulatory, and public support for the plan,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “What’s more, very soon, 22nd Century will submit our Company’s extensive comments regarding a drastically reduced nicotine content standard… and we will address, specifically, questions of commercial feasibility.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering and plant breeding. 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 strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for 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, 2017, filed on March 7, 2018, 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.

 

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