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

CLARENCE, N.Y.--()--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.

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, 2015, filed on February 18, 2016, 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.

Contacts

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399

Release Summary

Nicotine Reduction Strategy is Championed by Growing Number of Scientists and Public Health Experts Non-addictive Cigarettes Could Save Millions of Lives

Contacts

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399