Anticipating FDA’s “Reduced Nicotine Mandate,” 22nd Century Will Discontinue U.S. Sales of RED SUN Brand
CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE:XXII), a plant biotechnology company focused on tobacco harm reduction and hemp/cannabis research, announced today that, in preparation for the planned mandate by the U.S. Food and Drug Administration (FDA) that all cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine, the Company will discontinue U.S. sales of RED SUN brand cigarettes.
Over the last 6 years, agencies of the U.S. federal government have invested more than $100 million in independent clinical research with 22nd Century’s proprietary SPECTRUM cigarettes. The results of numerous independent studies strongly support the conclusion that lowering nicotine levels in combustible tobacco cigarettes will drastically improve public health.
Because RED SUN cigarettes do not contain the Company’s proprietary Very Low Nicotine tobacco, 22nd Century believes that the continued marketing of the brand is inconsistent with the FDA’s plan to drastically reduce nicotine in all combustible cigarettes that are sold in the United States.
“22nd Century stands ready to cooperate fully and enthusiastically with the FDA to drastically reduce nicotine content in cigarettes. In this spirit, we have decided to retire the RED SUN brand in the U.S.,” explained Henry Sicignano, III, President and CEO of 22nd Century Group. “On the other hand, for the vast majority of American smokers who wish to quit smoking – or to significantly reduce the number of cigarettes they smoke – it is clear that 22nd Century’s Very Low Nicotine cigarettes will be a revolutionary product.”
As previously reported, 22nd Century is remarkable for its ability to grow tobacco with minimally or non-addictive levels of nicotine – without any artificial extraction or chemical processes. 22nd Century’s Very Low Nicotine cigarette brand styles contains as little as 0.4 mg nicotine per cigarette – a reduction of at least 95% less nicotine relative to leading cigarette brands in the U.S. market.
“The Tobacco Control Act explicitly and unambiguously gives the FDA the authority to regulate nicotine levels in cigarettes,” explained James E. Swauger, PhD, Senior Vice President of Science and Regulatory Affairs for 22nd Century Group. “22nd Century stands ready to partner with the FDA and with any company that is committed to improving the health of American smokers.”
For smokers outside of the United States who refuse to quit, who accept the health risks associated with smoking, and who also seek a potentially reduced exposure product, 22nd Century remains committed to the development of relatively high nicotine cigarettes that satisfy smokers’ craving for nicotine while delivering far less tar. Accordingly, for international markets, the Company is investing in the patents and the research necessary to create a reduced exposure cigarette with relatively higher levels of nicotine.
Underlining 22nd Century’s commitment to this effort, in the second quarter of 2017, the FDA granted 22nd Century authorization to conduct an exposure study on the Company’s BRAND B, low tar-to-nicotine ratio cigarettes. BRAND B has been developed to show that as smokers make the adjustment to higher nicotine cigarettes, they take in less smoke per unit of nicotine inhaled.
On November 14, 2017, the United States Patent and Trademark Office awarded 22nd Century a patent that describes the means to produce cigarettes that expose smokers to reduced amounts of harmful constituents. This new patent covers tobacco with increased nicotine levels and cigarettes with reduced tar-to-nicotine ratios. This patent also includes methods for reducing harmful tobacco-specific nitrosamines (TSNAs), which are known carcinogens.
“22nd Century’s patent portfolio continues to grow and demonstrates clearly our commitment to disruptive technology that will dramatically improve public health,” explained Mr. Sicignano. “Looking forward, we expect to substantially increase Company sales again in 2018, we are excited about the FDA’s bold plan to mandate minimally or non-addictive levels of nicotine in cigarettes, and we are already taking steps to produce enough of our proprietary Very Low Nicotine tobacco seed to supply the entire U.S. industry.”
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 cannabis/hemp plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis 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, 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.