USA – FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway

The U.S. Food and Drug Administration today announced it has authorized the marketing of two new tobacco products manufactured by 22nd Century Group Inc. –  Moonlight and Moonlight Menthol, which are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.

Following a rigorous science-based review of the premarket tobacco product applications (PMTAs) submitted by the company, the agency determined that authorizing these reduced nicotine products for sale in the U.S. is appropriate for the protection of the public health because of, among several key considerations, the potential to reduce nicotine dependence in addicted adult smokers, who may also benefit from decreasing nicotine exposure and cigarette consumption. 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.

While today’s action permits the new tobacco products to be legally sold or distributed in the U.S., it does not mean these products are safe or “FDA-approved.” In its decision, the agency notes that the Moonlight and Moonlight Menthol cigarette products differ from conventional cigarettes in nicotine content only – the products share similar adverse health risks as conventional cigarettes. There are no safe tobacco products and those who do not use tobacco products should not start…