FDA Authorizes Marketing of 22nd Century Group’s Proprietary Moonlight and Moonlight Menthol Cigarettes

FDA determines that sale of product in the U.S. is ‘appropriate for the protection of the public health’

Williamsville, NY, Dec. 17, 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 plant research, announced today that the U.S. Food and Drug Administration (FDA) has found that the marketing of 22nd Century Group’s proprietary Moonlight and Moonlight Menthol brand cigarettes are “appropriate for the protection of the public health,” and the FDA has issued marketing orders to permit the sale of these products in the U.S. This FDA authorization follows the FDA’s review of the Premarket Tobacco Product Applications (PMTA) previously submitted by 22nd Century Group.

“FDA authorization of 22nd Century’s proprietary Moonlight and Moonlight Menthol brand cigarettes is a major milestone in our efforts to drive meaningful change in the tobacco industry,” said Michael Zercher, President and Chief Operating Officer of 22nd Century Group. “22nd Century joins just two other companies in having marketing orders granted under the FDA’s PMTA regulatory pathway.  Those other companies, Philip Morris International and Swedish Match, are very large, global tobacco companies with significant financial, scientific and regulatory affairs resources, so we are extremely proud of the world-class work done by our regulatory team to successfully secure this marketing authorization from the FDA.”

The FDA also issued a news release today explaining why Moonlight and Moonlight Menthol brand cigarettes received authorization for marketing and sales of the products in the U.S. market. In that news release, Mitch Zeller, J.D., the Director of the FDA’s Center for Tobacco Products, stated, “Conventional cigarettes are designed to create and sustain addiction to nicotine. In announcing the FDA’s comprehensive plan to regulate tobacco and nicotine in July 2017, we noted our commitment to taking actions that will allow more addicted smokers to reduce their dependence and decrease the likelihood that future generations will become addicted to cigarettes… Today’s authorization represents the first product to successfully demonstrate the potential for these types of tobacco products to help reduce nicotine dependence among addicted smokers.”  The FDA news release further provides that, “The agency determined that non-smokers, including youth, are also unlikely to start using the products, and those who experiment are less likely to become addicted than people who experiment with conventional cigarettes.”