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FDA's Plan to Lower Nicotine in Cigarettes to Non-Addictive Levels Shines Spotlight on 22nd Century Group

XXII | July 31, 2017

FDA's Plan to Lower Nicotine in Cigarettes to Non-Addictive Levels Shines Spotlight on 22nd Century Group

22nd Century is the only company in the world capable of growing tobacco with non-addictive levels of nicotine.

22nd Century Group, Inc. (NYSE American:XXII), a plant biotechnology company that is focused on tobacco harm reduction, stated today that the Company welcomes the announcement by the United States Food and Drug Administration (FDA) that the Agency is exercising its authority under the Family Smoking Prevention and Tobacco Control Act to mandate lower nicotine – at non-addictive levels – in combustible cigarettes sold in the United States.

22nd Century is already capable of achieving the FDA’s ambitious new product standard. As previously reported, 22nd Century is the only company in the world capable of growing tobacco with non-addictive levels of nicotine. The Company’s proprietary Very Low Nicotine tobacco is grown on independently-owned farms in the United States – without any artificial extraction or chemical processes.

22nd Century uses its proprietary and patent-protected Very Low Nicotine tobacco to produce the world’s lowest nicotine tobacco cigarettes. 22nd Century’s Very Low Nicotine cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette. In each case, this represents a reduction of at least 95% less nicotine relative to “Big Tobacco” cigarette brands, including Marlboro®, Camel®, Newport®, and American Spirit®. 22nd Century’s Very Low Nicotine cigarettes have the taste and sensory characteristics of conventional cigarettes, but contain only trace amounts of nicotine so that smokers’ exposure to nicotine is reduced drastically.

In the FDA announcement on July 28, 2017, FDA Commissioner Scott Gottlieb, M.D., stated that “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users. Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it's vital that we pursue this common ground."

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.” Shortly thereafter, in a Washington Post newspaper article, Dr. Kessler said that the amount of nicotine in a cigarette should drop from about 10 milligrams to less than 1 milligram. By producing cigarettes that contain less than 0.6 mg of nicotine per cigarette, 22nd Century has already met Dr. Kessler’s standard and has simultaneously demonstrated that the FDA’s targets are both technically achievable and realistic.

In order to provide public health officials, tobacco industry competitors, and the general public with compelling scientific data in support of Very Low Nicotine cigarettes, 22nd Century has partnered with independent researchers and officials from the FDA, the National Institute of Drug Abuse (NIDA), the National Cancer Institute (NCI), and the Centers for Disease Control and Prevention (CDC), to develop SPECTRUM® brand research cigarettes.

22nd Century has already delivered more than 22 million SPECTRUM cigarettes and recently received a new purchase order for 2.4 million additional government research cigarettes. Utilized by dozens of independent scientists and researchers over the past several years, the SPECTRUM product line consists of a series of cigarette styles that vary nicotine yields over a 50-fold range – from very low (97% less nicotine than conventional brands) to relatively high nicotine yields. 22nd Century is the only company in the world capable of producing the Very Low Nicotine SPECTRUM brand styles. Separate from the SPECTRUM research cigarettes program, 22nd Century was also chosen to supply the Company’s proprietary Very Low Nicotine fine cut tobacco to the FDA for additional research.

Agencies of the U.S. federal government have invested more than $100 million on independent clinical research with SPECTRUM cigarettes that supports the conclusion that lowering nicotine levels in combustible tobacco cigarettes would drastically improve public health. Public health policy reform advocates, Drs. Michael Fiore and Timothy Baker wrote in The New England Journal of Medicine: “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.”

Building on the large and growing body of clinical research in support of Very Low Nicotine cigarettes, the World Health Organization (WHO) cited 22nd Century’s proprietary tobacco cigarettes in its recommendation that all WHO-member countries mandate reductions in nicotine in combustible tobacco cigarettes to non-addictive levels.

A landmark clinical study cited by WHO in its recommendation – and likely influential in FDA’s stated intention to reduce nicotine levels – was published in The New England Journal of Medicine in 2015. The authors of the study, led by the Center for the Evaluation of Nicotine in Cigarettes, concluded that 22nd Century’s proprietary Very Low Nicotine SPECTRUM cigarettes were “associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.” Links and a brief summary of 17 completed clinical trials using the 22nd Century’s Very Low Nicotine cigarettes are provided at the Company’s website. Today there are at least 25 ongoing clinical trials using 22nd Century’s proprietary Very Low Nicotine cigarettes.

“We are thrilled that FDA is now moving to lower nicotine in combustible cigarettes to non-addictive levels; this is a technically achievable standard whose time has come,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “With a mountain of science and evidence supporting our Very Low Nicotine products, 22nd Century stands ready to partner with the FDA – and with any Big Tobacco companies that are truly committed to improving the health of American smokers.”

Mr. Sicignano concluded, “Lowering nicotine in cigarettes to non-addictive levels will save millions of lives and billions in healthcare costs; 22nd Century is proud to have such an important role in this public policy imperative.”

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.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, 2016, filed on March 8, 2017, 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.