The Food and Drug Administration issued marketing granted orders to 20 Zyn nicotine pouch products. The announcement on Thursday marks the first nicotine pouch product to be authorized by the FDA.
The products, each with two nicotine strengths (3 milligram and 6 milligram), include Zyn Chill, Zyn Cinnamon, Zyn Citrus, Zyn Coffee, Zyn Cool Mint, Zyn Menthol, Zyn Peppermint, Zyn Smooth, Zyn Spearmint and Zyn Wintergreen.
Tobacco company Philip Morris International (PMI) bought Zyn maker Swedish Match North America (SMNA) in 2022.
“Today’s actions are specific to these products only; the authorizations do not apply to any other nicotine pouch or other Zyn products,” the FDA said.
The authorization does not allow the company to make reduced risk claims about the authorized products, which would require a modified risk tobacco product application, the agency said.
“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 (CTP). “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 said it determined that the specific products receiving marketing authorization met the public health standard, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
“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 FDA said.
The agency said 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.
As part of its evaluation, the FDA said it reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. 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 CTP. “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.”
The FDA said it has placed “stringent” marketing restrictions on the new products to prevent youth access and exposure. The agency will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any requirements.
The move allows the products to be legally sold in the United States; however, it does not mean the products are safe or FDA approved, the agency said.
To date, the FDA has received applications for nearly 27 million products and has made determinations on more than 26 million of those applications. This includes authorization of other flavored oral tobacco products, including nicotine mints and chews in 2021 and mint smokeless tobacco in 2015.
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