In December 2019, FDA authorized the sale of 22nd Century Group’s proprietary Moonlight® and Moonlight® Menthol cigarettes.
As a part of its authorization, FDA determined that commercial availability of 22nd Century Group’s proprietary Moonlight® and Moonlight® Menthol brand of reduced nicotine content cigarettes is “appropriate for the protection of the public health.” This FDA authorization follows the FDA’s review of the Premarket Tobacco Product Applications (PMTA) submitted by 22nd Century Group.
22nd Century joins just two other companies (Philip Morris International and Swedish Match) in having marketing orders granted under the FDA’s PMTA regulatory pathway.
Mitch Zeller, J.D., the Director of the FDA’s Center for Tobacco Products, explained in an agency news release why the FDA authorized the sale of Moonlight®:
Conventional cigarettes are designed to create and sustain addiction to nicotine. In announcing the FDA’s comprehensive plan to regulate tobacco and nicotine in July 2017, we noted our commitment to taking actions that will allow more addicted smokers to reduce their dependence and decrease the likelihood that future generations will become addicted to cigarettes… 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.
The FDA news release further provides that:
On average, conventional cigarettes made in the U.S. contain tobacco with a nicotine content of 10 to 14 milligrams (mg) per cigarette. Cigarettes with reduced nicotine content, which at the low end may range from 0.4 to 7.4 mg per cigarette, have existed for decades, primarily for research use. Moonlight® and Moonlight® Menthol have nicotine content between 0.2 to 0.7 mg per cigarette. As part of the FDA’s scientific review, the agency considered whether smokers who switch to reduced nicotine cigarettes would either smoke more cigarettes or change the way they smoked, such as taking a bigger puff, in order to get the same level of nicotine they would have from smoking conventional cigarettes. Generally, the FDA determined that smokers of reduced nicotine cigarettes tend to actually decrease the number of cigarettes smoked per day and that they do not change the intensity of their puff or inhalation. In addition, though data is limited, the agency expects that non-smokers, including youth, are unlikely to start using the authorized products, and those that do experiment with the authorized products are unlikely to develop nicotine dependence.
While the FDA’s authorization does allow the Company to make Moonlight® available to adult smokers, this authorization does not allow the Company to describe in its labeling or advertising the product’s unique attributes or the benefits smokers could potentially derive from using the product. Nevertheless, many smokers and retailers have asked us to bring Moonlight® to market. 22nd Century is currently completing the state and federal regulatory filings necessary to bring Moonlight® to market in the U.S. The Company expects to launch Moonlight® in limited distribution in 2020.