22nd Century Group Moonlight Brand PMTA Approved by FDA

Categories: fda, News, Top Tobacco NewsBy Published On: December 17th, 2019179 words

The U.S. Food and Drug Administration (FDA) has authorized 22nd Century Group, Inc. to market and sell two new tobacco products that went through the agency’s premarket tobacco product application process.

Moonlight and Moonlight Menthol are two new combusted, filtered cigarettes that contain a reduced amount of nicotine compared to the typical commercial cigarettes. The FDA reviewed the premarket tobacco product applications (PMTAs) submitted by 22nd Century Group and reviewed all of the scientific data also submitted by the company. After what was described as a rigorous review, the FDA determined that authorizing these reduced nicotine products for sale in the U.S. was appropriate for the protection of public health, mostly due to the potential of these products to reduce nicotine dependence in addicted adult smokers who may benefit from reduced exposure to nicotine and cigarette consumption. The FDA also determined that non-smokers, including youth, would unlikely start using these products and those who do use these products are less likely to become addicted than those who use traditional cigarettes.

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