Home Health FDA clears 22nd Century’s Moonlight and Menthol Moonlight low-nicotine cigarettes

FDA clears 22nd Century’s Moonlight and Menthol Moonlight low-nicotine cigarettes


The Food and Drug Administration on Tuesday authorized two new low-nicotine cigarettes for sale to the public.

The agency cleared applications from 22nd Century Group for its Moonlight and Moonlight Menthol cigarettes. Both products contain less nicotine than their peers, which the FDA hopes will help reduce the number of people addicted to nicotine. Still, the cigarettes present similar health risks as conventional cigarettes, the FDA said in a press release Tuesday.

“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,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement. “Still, we must remain vigilant to ensure that the products authorized today actually deliver on that promise for consumers.”

Nicotine is incredibly addictive. The FDA in July 2017 announced a sweeping plan to reduce the amount of nicotine in cigarettes to minimally or nonaddictive levels. Those plans appear to have stalled amid intense lobbying of the Trump administration.

22nd Century filed its application with the FDA just over a year ago. The company also filed a separate application with the FDA to advertise its cigarettes as less harmful than conventional ones, which is still under review.

Shares of 22nd Century surged more than 30% to $1.08 a share on Tuesday. The company’s stock has dropped 58% this year.

Correction: 22nd Century’s low-nicotine cigarettes are the first to get cleared through a new regulatory process put in place by the FDA in 2009. Other low-nicotine cigarettes that were available on the U.S. market before then were allowed to stay on the market without additional review.

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