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22nd Century Group Comments on Delay of Reduced Nicotine Rule for Cigarettes

Modified Risk Tobacco Product application for Very Low Nicotine Content cigarettes becoming increasingly important to people who smoke

Williamsville, NY, Nov. 21, 2019 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, Very Low Nicotine Content (VLNC) tobacco and hemp/cannabis research, responded today to the FDA’s recent removal of the Tobacco Product Standard for Nicotine Level of Certain Tobacco Products from the Trump administration’s ‘unified agenda.’  The much anticipated Notice of Proposed Rulemaking (NPRM) for the reduced nicotine product standard, which was expected in October, was listed as being “Withdrawn” as of October 23, 2019, on the White House Office of Information and Regulatory Affairs website. The unified agenda was updated with the new information on Wednesday, November 20, 2019, as part of a semiannual review.

“22nd Century Group is disappointed that FDA appears to have delayed its efforts to enact a product standard rule to lower the amount of nicotine in all cigarettes sold in the United States to non-addictive levels,” said Cliff Fleet, CEO of 22nd Century Group.  “We believe such a rule, when enacted, will dramatically reduce the death and disease caused by cigarette smoking.

“We are encouraged, however, that FDA publicly stated that the Agency continues to work on the nicotine-reduction rule. Furthermore, we remain optimistic about the approval of our Modified Risk Tobacco Product (MRTP) application for very-low nicotine content cigarettes. We believe this application is moving quickly through the Agency’s scientific review process, and we plan to launch this product in the U.S. after we receive an MRTP marketing order for this application.”

As publicly reported yesterday by both Barron’s and CNBC, FDA officials said the omission from the unified agenda does not mean the FDA will stop working on it. FDA representatives Stephanie Caccomo and Michael Felberbaum both said the agency is reviewing comments it received in response to the proposal to cap nicotine levels in cigarettes.

22nd Century Group’s response echoed reactions by various public health advocates and organizations. The American Heart Association issued a statement saying they were “deeply disappointed” that the rule had been delayed.  “We urge the FDA and the administration to ensure that protecting public health, particularly the health of our nation’s kids, tops its priority list.” They added that the rule “would have an enormous impact on the millions of cigarette smokers who are currently addicted to products that kill when used as intended.”

“22nd Century continues to believe an industry-wide, national nicotine reduction mandate is the best way to reduce the harm caused by smoking,” said John Pritchard, Vice President of Regulatory Science for 22nd Century Group.  “We will continue to vigorously pursue approval of our MRTP application for our VLNC cigarettes, which is unaffected by the timing of the national nicotine reduction rule. Our MRTP application is an opportunity for FDA to make minimally or non-addictive cigarettes available to adult smokers who want them.”

 

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to decrease the level of nicotine in tobacco plants and to modify the level of cannabinoids in hemp/cannabis plants through genetic engineering and modern 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/cannabis plants for important new medicines and agricultural crops. Visit www.xxiicentury.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, 2018, filed on March 6, 2019, 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.

James Vail
22nd Century Group, Inc.
7162701523
jvail@xxiicentury.com