Health officials authorize low-nicotine cigarettes for public sale

Health officials authorize low-nicotine cigarettes for public sale

Federal health officials on Tuesday said they will allow the sale of two new cigarettes with extremely reduced levels of nicotine.

The Food and Drug Administration said it will allow 22nd Century Group to begin selling two new cigarettes, called Moonlight and Moonlight Menthol, that contain significantly less nicotine than standard cigarettes.

FDA officials said the new products have the potential to reduce nicotine dependence in addicted adult smokers. The agency said it determined that non-smokers, including youth, are also unlikely to start using the new cigarettes, because of the low nicotine levels.

The cigarettes are the first to be approved for marketing through a strict tobacco-focused regulatory process put in place by the FDA in 2009. Other low-nicotine cigarettes that were available before 2009 have been allowed to stay on the market without additional review.

The agency said that just because the company is getting marketing approval, it does not mean the new cigarettes are “FDA approved.”

The products differ from conventional cigarettes in nicotine content only, FDA said. Cigarettes can still cause cancer, lung disease and a number of other health problems. The agency emphasized that there are no safe tobacco products, and those who do not use tobacco products should not start.

Traditional cigarettes usually have between 10 to 14 milligrams of nicotine per cigarette. The new products have nicotine content between 0.2 to 0.7 milligrams per cigarette.

Mitch Zeller, the FDA’s tobacco chief, said the new cigarettes are the first to “successfully demonstrate the potential ... to help reduce nicotine dependence among addicted smokers.”

Zeller said the agency will 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.”

When the Trump administration took over in 2017, then-FDA Commissioner Scott Gottlieb enacted a plan to reduce nicotine levels in traditional cigarettes, but the agency has not outlined what, if any, restrictions it will place on tobacco companies. 

Cigarette smoking among adults has hit an all-time low, as just under 14 percent of adults smoked cigarettes in 2018, according to a recent federal study. But cigarette smoking is the leading cause of preventable death in the U.S., causing more than 480,000 deaths per year.