US: FDA''s Nicotine Mandate To Create A Very Low Nicotine Cigarette

Source from:  Chasing Markets 08/22/2018

22nd Century Group, Inc. [NYSE: XXII], a plant biotechnology company focused on tobacco harm reduction and Very Low Nicotine tobacco, announced today 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.

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.

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.

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 [NYSE: XXII] 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.

"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 (NYSE: XXII) [NYSE: XXII] 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.  Enditem