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Nicotine Reduction Strategy is Championed by Growing Number of Scientists and Public Health Experts

XXII | July 14, 2016

Nicotine Reduction Strategy is Championed by Growing Number of Scientists and Public Health Experts

22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that in this month’s issue of Tobacco Control, Drs. Dorothy Hatsukami, Ghazi Zaatari and Eric Donny state that failure to act on the World Health Organization (WHO) recommendation of mandating nicotine reductions in cigarettes to non-addictive levels could lead to the loss of millions of lives. Scientists and public health experts around the world are increasingly calling for countries to implement nicotine reduction policies following the seminal WHO Study Group recommendation (WHO Global Nicotine Reduction Strategy).

Cigarette smoking currently leads to more than 480,000 deaths each year in the United States and approximately 6 million deaths each year on a world-wide basis. The tobacco control community has known for decades that the harm associated with smoking is exacerbated and perpetuated by its addictiveness. The WHO recommendation that calls for “mandated reductions in nicotine” underscores the important assertions that have been made for several years by public health experts advocating for non-addictive cigarettes:

“The FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate harm reduction strategy.”

Former U.S. FDA Commissioner Dr. David Kessler (2010)

“If I was head of the FDA, the meeting (to solve the tobacco problem by reducing nicotine from 7 milligrams to harmless levels found in say, a tomato – 0.3 milligrams) would take about an hour.”

Prof. Gregory Connolly of the Harvard School of Public Health (2011)

“Reducing the nicotine content of combustible tobacco to levels that will not sustain dependence seems to us to be the most promising regulatory policy option for preventing [at least] 20 million premature deaths.”

Drs. Michael Fiore and Timothy Baker (2015)

“A nicotine reduction strategy could decrease the acquisition of smoking and progression to addiction among experimenters, limit the number of cigarettes smoked by some proportion of addicted smokers and both increase the number of addicted smokers who stop smoking and reduce the number of those who relapse.”

WHO Study Group on Tobacco Product Regulation (2015)

“Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA can establish standards for tobacco products to protect public health, including the reduction, but not complete elimination, of nicotine. It is time for the FDA to exercise this authority that has the potential to save so many lives.”

Matthew L. Myers, President, Campaign for Tobacco-Free Kids (2015)

“Allowing this idea [of mandating nicotine reductions in cigarettes to non-addictive levels] to sit on the shelf when it has the potential to save millions of lives would be a travesty.”

Drs. Dorothy Hatsukami, Ghazi Zaatari and Eric Donny (2016)

22nd Century Group is the only company in the world capable of producing combustible cigarettes containing naturally-grown tobacco with non-addictive levels of nicotine.

On December 31, 2015, 22nd Century’s wholly owned subsidiary, Goodrich Tobacco Company, submitted a Modified Risk Tobacco Product (MRTP) application to the FDA seeking a reduced exposure order so that 22nd Century’s BRAND A Very Low Nicotine cigarettes may be introduced into commerce in the United States.

BRAND A cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette – in each case, a reduction in nicotine of at least 95% relative to conventional cigarettes. 22nd Century believes that if smokers are offered a choice of 22nd Century’s Very Low Nicotine cigarettes versus traditional cigarettes, then millions of smokers will ultimately choose the world’s lowest nicotine tobacco cigarette as made by 22nd Century.

"Independent studies have shown that smoking 22nd Century’s Very Low Nicotine cigarettes generally leads to a reduction in the number of cigarettes smoked… and often to an increase in quit attempts compared to continued use of traditional nicotine content cigarettes,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We are pleased that the WHO has recommended the mandating of nicotine reductions in cigarettes to non-addictive levels and that the FDA continues to fund independent clinical studies that utilize 22nd Century’s VLN cigarettes; we eagerly anticipate introducing these extraordinary cigarettes to smokers around the world."

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 cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. Visit www.xxiicentury.com and www.magiccigarettes.com for more information.

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