The U.S. Food and Drug Administration (FDA) on Thursday announced that they have authorized the marketing of a wide array of ZYN nicotine pouch products to adults 21 and older as a less harmful alternative to cigarettes or smokeless tobacco products.
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This marks the first time the FDA has granted marketing authorization to nicotine pouch products, which are small pouches made of synthetic fiber that contain nicotine, and are designed to be placed between a person’s gum and lip.
The FDA said Thursday that they found the ZYN nicotine pouches met certain public health standards imposed by the 2009 Family Smoking Prevention and Tobacco Control Act, which relate to the potential harms and benefits of the products to the general population.
The FDA found 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 agency stated.
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“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Dr. 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,” Dr. Farrelly said.
Additionally, the FDA found that youth use of nicotine pouches remains low despite the product’s growing sales in recent years.
The 2024 National Youth Tobacco Survey found that 1.8 percent of U.S. middle and high school students reported currently using nicotine pouches, compared with 5.9 percent that reported use of e-cigarettes.
“It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Dr. 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.”
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The ZYN products for which the FDA is allowing marketing are the following, each with two nicotine strengths (3 milligram and 6 milligram): ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen.
The FDA appended a disclaimer to their announcement, stating that while the authorization permits ZYN products to be legally marketed in the U.S. to adults 21 and older, “it does not mean these tobacco products are safe, nor are they ‘FDA approved.'”
