22nd Century Files MRTP with FDA

Applies to advertise very low nicotine content cigarettes as containing 95% less nicotine.

22nd Century Group Inc., a plant biotechnology company focused on tobacco harm reduction and Very Low Nicotine tobacco, has submitted a Modified Risk Tobacco Product (MRTP) application with the U.S. Food and Drug Administration (FDA) for the Company’s Very Low Nicotine Content cigarettes.

22nd Century’s proposed Very Low Nicotine (VLN) cigarettes, the subject of the MRTP application, are made with the Company’s proprietary VLN tobacco and, as a result, contain very low levels of nicotine.

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There are almost 38 million smokers in the United States. In a Special Report published in the May 2018 issue of the New England Journal of Medicine, a statistical model funded by the FDA predicted that, if all cigarettes in the United States were required to have very low nicotine content, approximately 5 million smokers would quit smoking within a year and that number would increase to a total of 13.0 million within five years. By the year 2100, the model estimates that approximately 33 million people would either quit smoking or not start smoking. The model further predicts that 8.5 million deaths will be averted and 134.4 million life years will be gained by the year 2100.

22nd Century’s MRTP application joins the Company’s previously filed Premarket Tobacco Application (PMTA). Together, these important applications seek the FDA’s authorization to commercialize the Company’s VLN cigarettes and to advertise that the VLN cigarettes contain 95% less nicotine as compared to the 100 leading cigarette brands in the United States.

22nd Century’s proposed VLN cigarettes are the same as the lowest nicotine content style of the Company’s SPECTRUM research cigarettes. 22nd Century’s SPECTRUM research cigarettes were developed in collaboration with the FDA and other U.S. federal government agencies to provide independent scientists with the products necessary to investigate the public health benefits of reduced-nicotine content cigarettes. Since 2011, 22nd Century has produced and delivered tens of millions of the Company’s Very Low Nicotine Content (VLNC) SPECTRUM research cigarettes for use in dozens of clinical studies funded by more than $100 million from agencies of the United States federal government.

22nd Century’s MRTP application references more than 50 independent studies that utilized SPECTRUM research cigarettes. Of particular note, the six-week 840-participant study by Donny, et al. published in the New England Journal of Medicine in October 2015 found that VLNC cigarettes were: “associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.” A 20-week 1,250-participant study by Hatsukami, et al. published in the Journal of the American Medical Association (JAMA) in September 2018 concluded that an immediate reduction in nicotine to very low levels was associated with:

Lower toxicant exposure across time;

Fewer cigarettes smoked per day;

Greater reduction in nicotine dependence; and

More days in which participants smoked no cigarettes (cigarette-free days).

Reducing the nicotine content of cigarettes to non-addictive levels has long been part of the FDA’s vision to reduce the harm caused by smoking. In a June 16, 2010 press release, Dr. David Kessler, the former FDA Commissioner, recommended that “[t]he FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels. If we reduce the level of the stimulus, we reduce the craving. It is the ultimate harm reduction strategy.” (emphasis added)

On July 28, 2017, in introducing the FDA’s comprehensive plan for tobacco and nicotine regulation, Dr. Scott Gottlieb, the current FDA Commissioner, declared in a public announcement that “looking at ways to reduce nicotine levels in cigarettes so that they are minimally or non-addictive …. is a cornerstone of our new and more comprehensive approach to effective tobacco regulation.”

And, this Fall, during an FDA webcast, Dr. Lynn Hull, Lead Pharmacologist at the Division of Individual Health Science within the FDA’s Center for Tobacco Products, reviewed the science behind the FDA’s intention to issue a proposed rule that, when finalized and effective, would limit the amount of nicotine in all cigarettes sold in the United States (and perhaps in all other combusted tobacco products as well) to minimally-addictive or non-addictive levels. In the webcast, Dr. Hull indicated a minimally-addictive or non-addictive level of nicotine in cigarettes could be between approximately 0.2 to 0.7mg nicotine per gram of tobacco.

22nd Century’s proposed VLN cigarettes – with just 0.5mg nicotine per gram tobacco (~0.3 mg per cigarette) – fall squarely within the nicotine range anticipated by the FDA’s Dr. Hull.

“22nd Century’s proprietary VLN cigarettes have at least 95% less nicotine than each of the 100 leading cigarette brands in the United States. We concur with former FDA Commissioner Dr. David Kessler: Cigarettes with non-addictive levels of nicotine represent ‘the ultimate harm reduction strategy,’” explained Henry Sicignano III, president and CEO of 22nd Century Group. “We believe that the public health implications of very low nicotine content cigarettes are enormous; 22nd Century is tremendously excited about introducing our proprietary VLN cigarettes into the U.S. market.”