UNITED STATES
FDA permits new reduced-nicotine cigarettes

The US Food and Drug Administration (FDA) has authorised the sale and marketing of two new reduced-nicotine tobacco products manufactured by 22nd Century Group Inc., it announced in a press release.

According to the press release, the products, called Moonlight and Moonlight Menthol, are combusted, filtered cigarettes with a reduced amount of nicotine compared to regular commercial cigarettes. 22nd Century Group Inc. had submitted the premarket tobacco product applications (PMTA) in December 2018 and, following a rigorous science-based review, the FDA has determined the products are “appropriate for the protection of the public health.”
The agency states that the products have the potential to reduce nicotine dependence in addicted adult smokers, while non-smokers, including youths, are unlikely to start using the products. The press release goes on to say, that while the new tobacco products may be legally sold and distributed in the US, it does not mean they are safe or “FDA-approved”.
Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products said, “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. We’ll be closely monitoring how Moonlight and Moonlight Menthol are marketed and will take action as necessary if the company fails to comply with any applicable statutory or regulatory requirements or if there is a notable increase in the number of non-smokers, including youth, using these products.”

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