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Washington Examiner Publishes Public Policy Article by 22nd Century’s James Vail and Juan Sanchez Tamburrino, Ph.D.

July 31, 2018

CLARENCE, N.Y.--(BUSINESS WIRE)--Jul 31, 2018--22nd Century Group, Inc. (NYSE American: XXII ), a plant biotechnology company focused on tobacco harm reduction and Very Low Nicotine tobacco, announced today that The Washington Examiner published an op-ed article by James Vail, Director of Communications, and Juan Sanchez Tamburrino, Ph.D. Vice President of Research and Development, at 22nd Century.

The article calls for the U.S. Congress, tobacco control advocates, and the American people “to ensure that the FDA’s nicotine reduction plan quickly becomes reality.” Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Association (FDA), has stated that the FDA’s efforts to lower nicotine in cigarettes will be based on science. Since 2011 the National Institutes of Health (NIH), in cooperation with the FDA, has funded dozens of important clinical studies employing 22nd Century’s Very Low Nicotine Content (VLNC) cigarettes. The results of these numerous clinical studies provide independent scientific support for the FDA’s planned rule to require that all cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine. Citing the many completed clinical studies using VLNC cigarettes, the article succinctly and concisely summarizes the important results:

that VLNC cigarettes reduce cravings, reduce consumption of cigarettes, and increase quit attempts. Further, the benefits of VLNC cigarettes appear to , , and , including those with psychiatric disorders and opioid dependence.”

An often-repeated but erroneous objection to the FDA’s planned nicotine reduction mandate is that VLNC cigarettes will lead to “compensation” – i.e. cigarettes with minimally or non-addictive levels of nicotine will drive smokers to consume more cigarettes. Vail and Tamburrino conclusively address this misconception by citing the work of preeminent independent tobacco scientists:

, et al. recently coauthored a letter to the FDA that emphatically closed the door on the myth that smokers might smoke more if cigarettes were minimally or non-addictive: ‘ Effectively compensating to maintain nicotine exposure is virtually impossible when switching to cigarettes with minimally addictive nicotine content.’” (emphasis added)

In responding to the FDA’s Advanced Notice of Proposed Rulemaking (ANPRM) for a mandate that will require that all cigarettes sold in the United States contain only minimally or non-addictive levels of nicotine, twelve prominent United States Senators urged the FDA to set an aggressive deadline for rulemaking and implementation of a reduced nicotine standard, proclaiming “the FDA can help save millions of lives and positively impact public health for generations to come.”

Separately, in an article published in Tobacco Asia on July 26, 2018, author Thomas Schmid gives voice to the likely fears of many tobacco insiders when he writes:

“The question on many tobacco firm executives’ minds around the world also is whether the FDA rule is going to have a domino effect. Historically, many countries – particularly in Europe – have regularly felt compelled to follow suit with their own corresponding rules whenever FDA had enacted an important new regulation.”

Indeed, conventional tobacco control methods may have reached their limits. Australian smokers endure the world’s most aggressive tobacco control laws, including a ban on all marketing, mandated plain white packaging, a prohibition on store displays, and the highest taxes in the world. A pack of cigarettes in Australia costs more than USD $20. Yet, from the years 2013 to 2016, the smoking rate in Australia remained virtually unchanged.

“The FDA’s plan to limit nicotine in cigarettes is moving forward rapidly in the United States; at the same time, the World Health Organization is advocating for equally bold nicotine reduction measures around the world,” explained Henry Sicignano III, President and Chief Executive Officer of 22nd Century Group. “With continued pressure from lawmakers, the FDA, public health advocates, and the public at large, smokers everywhere may soon be free from the addictive power of nicotine.”

About the Washington Examiner

The Washington Examiner provides news, investigative reporting, commentary and analysis focused on Washington, D.C. with a monthly circulation of 40,000 print and 4 million unique online viewers.

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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20180731005782/en/

CONTACT: 22nd Century Group

James Vail, 716-270-1523

Director of Communications

jvail@xxiicentury.com

KEYWORD: UNITED STATES NORTH AMERICA NEW YORK

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY RETAIL COMMUNICATIONS PUBLISHING TOBACCO FDA

SOURCE: 22nd Century Group, Inc.

Copyright Business Wire 2018.

PUB: 07/31/2018 12:55 PM/DISC: 07/31/2018 12:55 PM

http://www.businesswire.com/news/home/20180731005782/en

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