Application will be ‘robust’

| June 21, 2018

The 22nd Century Group says it has initiated three short-term studies ‘investigating the behavioral and biochemical responses’ to its proprietary ‘Very Low Nicotine Content’ tobacco.

The company said in a press note that its scientists would submit to the US Food and Drug Administration the data collected from these studies as part of its ‘revised and enhanced Modified Risk Tobacco Product (MRTP) application for “BRAND A” Very Low Nicotine Content cigarettes’.

In announcing in April/May last year that the FDA had granted it authorization to conduct a clinical trial on its Brand B low tar-to-nicotine ratio cigarettes, the company said it intended to submit an MRTP application to the FDA for Brand B.

‘Slated for submission this year, 22nd Century’s MRTP application will request a marketing order from the US Food and Drug Administration (FDA) to allow 22nd Century to disclose to consumers that the VLN™ tobacco of “BRAND A” cigarettes contains at least 95 percent less nicotine than the tobacco in conventional cigarettes,’ the company said in its most recent press note.

’22nd Century is the only company in the world that has grown commercial crops of proprietary VLN™ tobacco with nicotine levels of just 0.4 mg per gram of tobacco – a level that has been recognized by many public health officials as only “minimally or non-addictive”. Independent clinical trials using 22nd Century’s proprietary SPECTRUM® research cigarettes have shown that Very Low Nicotine Content cigarettes “reduce cravings, reduce consumption of cigarettes, and increase quit attempts”.

‘As announced by the FDA in July 2017, the FDA is seeking to dramatically reduce the nicotine levels in all cigarettes for precisely the same reasons 22nd Century is developing “BRAND A” as a Modified Risk Tobacco Product. Accordingly, 22nd Century may be the first company in the world to win FDA approval to market a combustible cigarette as a “Modified Risk Tobacco Product”.

‘22nd Century’s clinical studies are designed to confirm and substantiate further data previously collected by independent researchers. 22nd Century’s short-term studies will expand the demographic reach of the independent trials, thus demonstrating the suitability of the Company’s Very Low Nicotine tobacco for a wide range of smokers.

‘Summaries for two of the studies, “Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes” and “Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes,” are already posted at www.clinicaltrials.gov.

‘The third study, “A Longitudinal Ambulatory Study to Assess Changes in Cigarette Consumption Behavior and Biomarkers of Exposure during a 6-Week Switch to Very Low Nicotine Cigarettes”, will be added soon.

‘While the FDA is engaged in the rule-making process to limit nicotine in all cigarettes to minimally or non-addictive levels, 22nd Century’s MRTP application for “BRAND A” Very Low Nicotine Content cigarettes pursues a complementary and potentially faster pathway for regulatory approval.’

“22nd Century’s team of scientists, regulatory experts, and specialist consultants are meticulously assembling our revised MRTP application for “BRAND A” Very Low Nicotine Content cigarettes,” president and CEO Henry Sicignano, III was quoted as saying.

“Later this year, we will submit a robust MRTP application that answers many of the questions the FDA is asking with regard to the agency’s planned national nicotine reduction mandate. The public deserves – and desperately needs – a minimally or non-addictive cigarette … sooner, rather than later.”

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