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

Williamsville, NY, Nov. 21, 2019 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: ), 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 ‘.’  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Rulemaking (NPRM) for the reduced nicotine product standard, which was expected in October, was listed as being “Withdrawn” as of October 23, 2019, on the White House Office of Information and Regulatory Affairs . 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) 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 and , 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 for more information.

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