This article is more than 5 years old. Information may no longer be current.
FDA OKs two reduced-nicotine cigarettes
The FDA announced that it would allow the sale and marketing of Moonlight and Moonlight Menthol, two new reduced-nicotine cigarettes produced by 22nd Century Group Inc.
“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, JD, director of the FDA’s Center for Tobacco Products, said in a press release. “Still, we must remain vigilant to ensure that the products authorized today actually deliver on that promise for consumers.”
Conventional cigarettes contain 10 mg to 14 mg of nicotine each, and although other reduced-nicotine cigarettes (0.4 mg to 7.4 mg each) are already on the market, the new products have less nicotine than most, with 0.2 mg to 0.7 mg of nicotine per cigarette, according to the release.
The products were authorized after the agency determined they could be used to protect public health due to their potential to reduce adult smokers’ nicotine dependence.
During their review of Moonlight and Moonlight Menthol in the premarket tobacco product application pathway, the FDA determined that smokers who switched to reduced-nicotine products typically decreased the number of cigarettes per day and did not take larger puffs of the cigarettes to get the same level of nicotine as conventional cigarettes.
The agency also found that nonsmokers are unlikely to start using the new products, and that people experimenting with them are less likely to become addicted than if they tried conventional cigarettes.
The FDA noted that it is continuing to review the company’s modified-risk tobacco product applications, which would allow the company to market the products as less harmful than conventional products.
“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 nonsmokers, including youth, using these products,” Zeller said. – by Erin Michael
Disclosure: Zeller reports no relevant financial disclosures.