The Food and Drug Administration (FDA) announced it has authorized the marketing of two new tobacco products manufactured by 22nd Century Group Inc. — Moonlight and Moonlight Menthol, which are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.
Following a review of the premarket tobacco product applications (PMTAs) submitted by the company, the agency determined that authorizing these reduced nicotine products for sale in the U.S. is appropriate for the protection of the public health because of, among several key considerations, the potential to reduce nicotine dependence in addicted adult smokers, who may also benefit from decreasing nicotine exposure and cigarette consumption.
The agency determined that non-smokers, including youth, are also unlikely to start using the products, and those who experiment are less likely to become addicted than people who experiment with conventional cigarettes.
“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,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “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. Still, we must remain vigilant to ensure that the products authorized today actually deliver on that promise for consumers. 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 non-smokers, including youth, using these products.”
Under the PMTA pathway, manufacturers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health.
That standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products, including youth. The agency’s evaluation includes reviewing a tobacco product’s components, ingredients, additives and health risks, as well as how the product is manufactured, packaged and labeled.
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.
Because Moonlight and Moonlight Menthol meet the definition of a cigarette under the Federal Food, Drug and Cosmetic Act, the company must adhere to existing restrictions for cigarettes under FDA regulations, as well as other federal laws that, among other things, prohibit television and radio advertising.
In addition, to further limit youth access to the products and exposure to their advertising and promotion, the FDA is placing stringent restrictions on how the products are marketed — particularly via websites and through social media platforms — by including restrictions that prevent advertising from being targeted to youth.
With the authorization of these products, the FDA will evaluate new available data regarding real-world use of these products through postmarketing records and reports as required in the marketing order.
The company is required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.
The FDA may withdraw this marketing order if, among other reasons, it determines that the continued marketing of a product is no longer appropriate for the protection of the public health, such as if there is an uptake of the product by youth, the agency said.