FDA Authorizes Low-Nic Cigarettes

    The U.S. Food and Drug Administration (FDA) has issued marketing orders to permit the sale in the U.S. of 22nd Century Group’s proprietary low-nicotine Moonlight and Moonlight Menthol cigarettes.

    After reviewing the premarket tobacco product applications (PMTA) submitted by 22nd Century Group in December 2018, the FDA concluded that the marketing of Moonlight and Moonlight Menthol cigarettes is “appropriate for the protection of the public health.”

    Among other things, the agency determined that nonsmokers, including youth are unlikely to start smoking Moonlight and Moonlight Menthol cigarettes, and those who experiment are less likely to become addicted than people who experiment with conventional cigarettes.

    According to the FDA, conventional cigarettes made in the U.S. on average contain tobacco with a nicotine content of 10 to 14 milligrams per cigarette. Moonlight and Moonlight Menthol have nicotine content between 0.2 to 0.7 mg per cigarette.

    “Conventional cigarettes are designed to create and sustain addiction to nicotine,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products in a statement announcing the authorization.

    “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.”

    “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.”