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Zyn nicotine pouches can be marketed in the U.S., the FDA says. What does this mean?
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Federal health officials have authorized the marketing and sale of Zyn nicotine pouches, marking the first time the Food and Drug Administration authorized these popular products that go between a user's gum and upper lip.
After "an extensive scientific review," the FDA said, the products were found to pose lower risks of cancer and other serious health conditions compared to cigarettes and smokeless tobacco products.
"To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks," Matthew Farrelly, director of the Office of Science in the FDA's Center for Tobacco Products, said in a statement. "In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products."
The FDA's decision covers 3- and 6-milligram Zyn products in flavors including cinnamon, citrus, coffee, cool mint and menthol.
While the agency's action allows them to be legally marketed in the U.S. to adults 21 and older, it doesn't mean 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 grown in popularity and so have its critics
Zyn's popularity exploded in the last year, with fans online influencing others to use the products. Zyn pouches have been on the market for about a decade. But only this past summer did popularity grow to such a level that it contributed to a shortage.
The products contain powdered nicotine and when placed in a user's mouth along their upper gums it dissolves and enters the bloodstream.
Zyn, which is owned by tobacco giant Philip Morris, was originally created to help existing nicotine users kick their habit. But while Zyn doesn't contain harmful tobacco, it's still addictive: Zyn notes that the FDA requires it to have the 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 have been drawn to the products. Philip Morris previously told NPR that its research indicates the average age of Zyn users is 39 and that the company has not paid any so-called "Zynfluencers" to advertise their products online.
Contributing to the nationwide shortage last summer was a subpoena from Washington, D.C.'s attorney general to Philip Morris, alleging that 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 will pay $1.2 million to resolve the investigation.
The FDA said it will continue monitoring the advertising and use of the products to ensure ads are specifically targeted to adults 21 and up.
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