For Immediate Release: December 17, 2019

The U.S. Food and Drug Administration today 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 rigorous science-based 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.

While today’s action permits the new tobacco products to be legally sold or distributed in the U.S., it does not mean these products are safe or “FDA-approved.” In its decision, the agency notes that the Moonlight and Moonlight Menthol cigarette products differ from conventional cigarettes in nicotine content only – the products share similar adverse health risks as conventional cigarettes. There are no safe tobacco products and those who do not use tobacco products should not start.

“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. Importantly, this includes 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.

Since 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. The agency has previously issued a document providing its rationale for these types of postmarket requirements, which highlight important considerations for reviewing the company’s applications.

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.

Additionally, today’s action is not a decision on the separate modified risk tobacco product (MRTP) applications that the company submitted to market these products with specific modified risk information. The FDA is continuing its substantive review of the company’s MRTP applications, which includes, among other things, evaluating whether the modified risk advertising or labeling enables the public to comprehend the modified risk information and to understand its relative significance in the context of total health. The company would need to receive an MRTP order from the FDA before they could market a tobacco product with any implicit or explicit claims that, among other things, a product reduces exposure to a substance or that use of the product is less harmful or would reduce harm or the risk of disease associated with other commercially marketed tobacco products. If a company markets a tobacco product as an MRTP without authorization, the company would be in violation of the law and may face FDA advisory or enforcement actions.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

Inquiries Media: Stephanie Caccomo 301-348-1956 Consumer: 888-INFO-FDA

Related Information