FDA Approves Two New Tobacco Products
Both contain less nicotine than regular smokes.
Dec 19, 2019
WASHINGTON—This week, the U.S. Food and Drug Administration authorized the marketing of two new tobacco products, according an agency news release. Manufactured by 22nd Century Group Inc., Moonlight and Moonlight Menthol are combusted, filtered cigarettes that contain a reduced amount of nicotine as compared to typical commercial cigarettes.
22nd Century Group Inc. submitted science-based reviews of the premarket tobacco product applications to the FDA, which judges the cigarettes appropriate for sale in the United States because they have the potential to reduce nicotine dependence in adult smokers. The agency determined that non-smokers, including youth, are unlikely to start using the products, and those who experiment are less likely to become addicted than people who experiment with conventional cigarettes.
Allowing the new tobacco products to be legally sold in the U.S does not mean they are safe or “FDA-approved.” The FDA noted that Moonlight and Moonlight Menthol cigarette products differ from traditional cigarettes in nicotine content only and that they share similar health risks as conventional cigarettes.
“Conventional cigarettes are designed to create and sustain addiction to nicotine,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “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. [This authorization] represents the first product to successfully demonstrate the potential for these types of tobacco products to help reduce nicotine dependence among addicted smokers.”
On average, traditional cigarettes made in the U.S. contain tobacco with a nicotine content of 10 to 14 milligrams per cigarette. Cigarettes with reduced nicotine content may range from 0.4 to 7.4 mg per cigarette and 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 decrease the number of cigarettes smoked per day and that they do not change the intensity of their puff or inhalation.
Because Moonlight and Moonlight Menthol meet the definition of a cigarette, the company must adhere to existing FDA restrictions for cigarettes and other federal laws. 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.
Compliance and regulations Tobacco
