Public Health Leaders Urge FDA to Issue Final Rule for Reducing Nicotine in Cigarettes by March 2019

22nd Century’s VLNTM tobacco makes possible the FDA’s plan to render all cigarettes sold in the US minimally or non-addictive.

CLARENCE, N.Y.--(BUSINESS WIRE)-- 22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction and Very Low Nicotine tobacco, announced today that 41 public health and medical organizations wrote an open letter to Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration (FDA), urging the FDA to quickly implement its plan to reduce nicotine in cigarettes to minimally or non-addictive levels.

22nd Century is the only company in the world that has grown commercial crops of proprietary tobacco with nicotine levels of just 0.4mg per gram of tobacco – a 95% reduction in nicotine as compared to tobacco used in conventional cigarettes. 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. The independent research conducted with 22nd Century’s SPECTRUM cigarettes provided the foundation for the FDA’s plan to mandate that all cigarettes sold in the United States contain only “minimally or non-addictive” levels of nicotine.

In their May 21, 2018 letter to Dr. Gottlieb, the American Heart Association, the American Cancer Association, the American Medical Association and dozens of other public health and medical organizations described the “massive public health benefits” that will result from the adoption of the FDA’s vital plan to dramatically reduce nicotine in cigarettes:

“Every day that passes means more kids moving from experimentation to addiction and more adults who want to quit and try to quit, but remain addicted to a lethal product. We urge FDA to issue a proposed rule within six months of its ANPRM (by September 16, 2018) and a final rule six months later (by March 16, 2019). We also urge that implementation of the rule be no later than the one-year period provided for in Section 907 of the Family Smoking Prevention and Tobacco Control Act, which would allow the rule to be implemented by March of 2020.” (emphasis added)

The letter also points to the FDA's estimates that a new cigarette product standard could enable an additional 5 million adult smokers to quit within just one year of implementation. And, by the end of the century, the FDA’s nicotine reduction policy could prevent more than 33 million people, mostly youth and young adults, from becoming regular smokers; further, there would be 8 million fewer smoking-related deaths within that time.

The authors call for the FDA to act with a “sense of urgency commensurate with the [lifesaving] potential” of reducing nicotine to minimally or non-addictive levels. Citing independent clinical studies made possible through the use of 22nd Century’s proprietary SPECTRUM research cigarettes, the authors remind the FDA that “very low nicotine cigarettes [show] the absence of compensatory smoking, as well as demonstrable reductions in cigarettes smoked per day and [reductions] in exposure to harmful smoking constituents.”

“Noting that the major tobacco companies have a long history of manipulating nicotine levels in cigarettes to make them more addictive, in their open letter to Dr. Gottlieb, dozens of highly respected public health leaders urge the FDA to issue – in less than one year’s time – its final rule on mandating very low levels of nicotine in cigarettes,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “22nd Century’s Very Low Nicotine (VLNTM) tobacco makes possible the FDA’s plan to render all cigarettes sold in the U.S. minimally or non-addictive. We urge the FDA to move forward, aggressively, to issue its final rule in this public health imperative so that millions of lives might be saved.”

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 hemp/cannabis plants through genetic engineering and plant breeding. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in hemp/cannabis is to develop proprietary hemp 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, 2017, filed on March 7, 2018, 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.

22nd Century Group
James Vail, 716-270-1523
Director of Communications
jvail@xxiicentury.com

Source: 22nd Century Group, Inc.