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FDA Approves Sale of Low-Nicotine Cigarettes
  • Robert Preidt
  • Posted December 17, 2019

FDA Approves Sale of Low-Nicotine Cigarettes

The U.S. Food and Drug Administration on Tuesday approved the sale of two reduced nicotine cigarettes.

Moonlight and Moonlight Menthol cigarettes were given the green light because they contain much less nicotine than traditional cigarettes and they could help adult smokers kick the habit, the FDA said.

"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," said Mitch Zeller, director of the FDA's Center for Tobacco Products.

"Still, we must remain vigilant to ensure that the products authorized today actually deliver on that promise for consumers," he added in an agency news release.

"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 nonsmokers, including youth, using these products," Zeller said.

But the agency noted that its review of the reduced nicotine cigarettes concluded that nonsmokers, including youth, are unlikely to start using these cigarettes. People who experiment with them are also less likely to become addicted than people who experiment with conventional cigarettes.

On average, conventional cigarettes made in the United States have a nicotine content of 10 to 14 milligrams (mg) per cigarette, compared with between 0.2 to 0.7 mg per cigarette in the two newly approved cigarettes. Both are marketed by 22nd Century Group.

But the approval to sell the cigarettes in the United States does not mean they are safe or "FDA-approved," the FDA noted. The new cigarettes differ from conventional cigarettes in nicotine content only and pose the same health risks as conventional cigarettes.

One smoking cessation expert agreed with that assessment.

"Although the FDA determined that smokers who used the reduced nicotine cigarettes did not smoke more and in some cases decreased the number of cigarettes smoked, my experience with smokers has been that when they try to reduce their nicotine/cigarette intake without using cessation medications, they are generally uncomfortable, experience withdrawal and often return to their normal pattern of smoking or increase the number of cigarettes smoked," said Patricia Folan, director of the Center for Tobacco Control at Northwell Health, in Great Neck, N.Y.

"It will be interesting to see how other smokers who try these reduced nicotine cigarettes react among the general public," she added. "Even though the nicotine levels in these cigarettes are lower, it does not appear that the other thousands of hazardous chemicals in these cigarettes have been reduced."

The FDA move came as the Trump administration weighs a possible ban on flavored e-cigarettes, though Trump has reportedly been backing away from that idea in recent weeks. E-cigarette use among teens has skyrocketed in recent years.

In its announcement Tuesday, the FDA emphasized that, despite this approval, there are no safe tobacco products and people who do not use tobacco products should not start.

"Conventional cigarettes are designed to create and sustain addiction to nicotine," Zeller said.

"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," he added.

More information

The American Cancer Society has more on the health risks of smoking.

SOURCES: Patricia Folan, DNP, director, Center for Tobacco Control, Northwell Health, Great Neck, N.Y.; U.S. Food and Drug Administration, news release, Dec. 17, 2019
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