August 22, 2018
22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company focused on tobacco harm reduction and Very Low Nicotine tobacco, announced that the National Institute on Drug Abuse (NIDA), the U.S. Food and Drug Administration (FDA), and public health researchers have requested a new, significant quantity of 22nd Century’s proprietary SPECTRUM® research cigarettes. In coordination with NIDA, FDA, and others, RTI International has submitted an order to 22nd Century for 3.6 million SPECTRUM® research cigarettes.
RTI’s newest SPECTRUM® order comes on the heels of the close of the FDA’s public comment period for the FDA’s Advanced Notice of Proposed Rulemaking (ANPRM) to establish a rule that will require that all cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine. While the FDA is pressing ahead with its rule-making process, 22nd Century is simultaneously advancing its historic Modified Risk Tobacco Product (MRTP) application for the Company’s proprietary “BRAND A” Very Low Nicotine Content (VLNC) cigarettes. 22nd Century will file its MRTP application before the end of this year.
Progress on the FDA’s planned reduced nicotine mandate mirrors the work 22nd Century has undertaken to create a Very Low Nicotine Cigarette product standard that will forever change the U.S. tobacco industry. Very Low Nicotine Content will eliminate all cigarettes’ ability to create and sustain addiction.
With 95% less nicotine than the tobacco contained in the conventional cigarettes sold by Altria (MO), Reynolds American, a subsidiary of British American Tobacco (BATS.L), and the other “Big Tobacco” companies, 22nd Century’s VLNC cigarettes may become the first combustible cigarettes authorized by the FDA as Modified Risk Tobacco Products.
Independent scientists are currently leading more than two dozen active clinical studies using 22nd Century’s proprietary SPECTRUM® research cigarettes. Following the completion of numerous clinical studies that have examined the broad application of VLNC cigarettes to smokers (Donny, et al., Hatsukami, et al., Mercincavage, et al.), researchers are investigating the application and effect of VLNC cigarettes on more narrow, vulnerable groups in society, including adolescents, those diagnosed with ADHD, patients with mood and anxiety disorders, smokers with schizophrenia, and others. The data collected from these independent studies will add to the deep body of knowledge gained from already completed clinical studies on the impact of VLNC cigarettes on public health.
“22nd Century’s proprietary SPECTRUM® research cigarettes have been, and continue to be, the linchpin of the scientific support for both the FDA’s efforts to dramatically reduce nicotine in cigarettes and for 22nd Century’s own MRTP application for VLNC cigarettes,” explained Henry Sicignano III, President and Chief Executive Officer of 22nd Century Group. “VLN™ SPECTRUM® cigarettes are now widely recognized by public health advocates as the archetype of all cigarettes to come… And 22nd Century’s offer to license our proprietary tobacco technology to all interested companies means VLN™ cigarettes may soon be available – worldwide – to smokers who wish to sever their addiction to cigarettes.”
22nd Century developed SPECTRUM® in partnership with independent researchers and officials from the National Institute on Drug Abuse (NIDA), the U.S. Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Centers for Disease Control and Prevention (CDC). The main SPECTRUM® product line, uniquely produced by 22nd Century, consists of a series of cigarette styles that vary nicotine yields over a 50-fold range – from very low (97% less nicotine than tobacco contained in conventional cigarette brands) to relatively high nicotine yields. SPECTRUM® features 24 styles, in both regular and menthol versions, with 8 different levels of nicotine.
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.