First Nicotine Pouches Receive FDA Market Authorization
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) has given the greenlight for Zyn to be marketed in the United States. It is the first time the agency has authorized the marketing of a nicotine pouch product.
On Jan. 16, the agency announced the authorization of 20 ZYN products through the premarket tobacco product application (PMTA) pathway following a scientific review.
The FDA determined that the specific products met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard considers the risks and benefits of products to the population as a whole, according to the agency.
ZYN is part of the Swedish Match portfolio. Swedish Match NA LLC is a subsidiary of Philip Morris International Inc.
"An estimated 45 million Americans regularly consume nicotine and about 30 million of them smoke, the most harmful form of nicotine consumption," said Tom Hayes, president of Swedish Match North America LLC. "The FDA's decision recognizes the role that ZYN can play in the protection of the public health by helping people switch from cigarettes and other traditional tobacco products."
Specifically, the FDA issued marketing granted orders for the following products, each with two nicotine strengths, 3 milligrams and 6 milligrams: ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen. The FDA's actions are specific to these products only; the authorizations do not apply to any other nicotine pouch or other ZYN products.
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Among several key considerations, the FDA's evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products — such as moist snuff and snus — the authorized products pose lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products, the FDA stated.
"To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks," said Matthew Farrelly, director of the Office of Science in the FDA's Center for Tobacco Products. "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."
Additionally, the FDA found that the applicant showed these nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth.
As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. For example, the 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported currently using nicotine pouches.
"It's critical that the manufacturer market these products responsibly to prevent youth use," said Brian King, director of the FDA's Center for Tobacco Products. "While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health."