Two new reduced nicotine cigarettes permitted through premarket application

Posted at 10:37 AM, Dec 18, 2019

Two combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes were announced by the U.S. Food and Drug Administration on Tuesday.

The USDA said it authorized the marketing of two new tobacco products manufactured by 22nd Century Group Inc. –  Moonlight and Moonlight Menthol.

The U.S. Food and Drug Administration said, “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.”

The FDA added that the UDSA’s action allows for the new tobacco products to be legally sold or distributed in the U.S., but it does not mean they are “FDA-approved.”

The FDA said, “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.”

On Tuesday Governor Northam also announced his budget proposal will include a call to increase the cigarette tax in Virginia, currently the second-lowest in the nation, by 30 cents a pack.

Click here to read the entire announcement and comments from the FDA.