What does the FDA marketing authorization for Zyn nicotine pouches mean? : NPR

Federal health officials have authorized the marketing and sale of Zyn nicotine pouches, marking the first time the Food and Drug Administration has authorized these popular products that sit between a user’s gum and upper lip.

After “extensive scientific review,” the FDA said, these products were found to have lower risks of cancer and other serious health problems than cigarettes and smokeless tobacco products.

“To receive marketing authorization, the FDA must have sufficient evidence that new products offer more benefits than risks to the health of the population,” said Matthew Farrelly, director of the Office of Science of the Center for Products. of tobacco from the FDA, in a press release. “In this case, the data shows that these nicotine pouches meet this bar by benefiting adults who use cigarettes and/or smokeless tobacco products and switch to these products completely.”

The FDA’s decision covers 3- and 6-milligram Zyn products with cinnamon, citrus, coffee, fresh mint and menthol flavors.

Although the agency’s action allows their legal marketing in the United States to adults 21 and older, it does not mean that these products, which contain nicotine, are considered safe or “FDA approved.” “. The agency said, “There is no safe tobacco product” and people under 21 should not use it.

Zyn has gained popularity, and so have its critics

Zyn’s popularity exploded last year, with fans online inspiring others to use the products. Zyn pouches have been on the market for about a decade. But it wasn’t until last summer that popularity reached such a level that it contributed to a shortage.

The products contain powdered nicotine and when placed in the user’s mouth along their upper gums, they dissolve and enter the bloodstream.

Zyn, which is owned by tobacco giant Philip Morris, was originally created to help existing nicotine users kick their habit. But even though Zyn doesn’t contain harmful tobacco, it’s still addictive: Zyn notes that the FDA requires it to carry the following warning: “This product contains nicotine. Nicotine is an addictive chemical.”

As interest in the product exploded thanks to users on TikTok and other social media sites, younger people were attracted to the products. Philip Morris previously told NPR that its research indicated that the average age of Zyn users was 39 and that the company had not paid any “Zynfluencers” to advertise its products online.

Contributing to last summer’s national shortage was a subpoena from the Washington, D.C., attorney general to Philip Morris, alleging its online sales violated the District’s ban on flavored nicotine. The company suspended all online sales in response, and in December, the attorney general said Zyn’s makers would pay $1.2 million to resolve the investigation.

The FDA said it will continue to monitor product advertising and use to ensure that ads are specifically targeted to adults 21 and older.