The decision allows ZYN nicotine pouches to be legally marketed in the U.S. to adults aged 21 and older, the FDA said in a news release on Thursday, Jan. 6. The small natural fiber pouches are designed to be placed between the gum and lip.
The FDA said the pouches contain substantially lower levels of harmful chemicals compared to cigarettes and most smokeless tobacco products, reducing risks of cancer and other serious health conditions.
"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," said Matthew Farrelly, director of the Office of Science in the FDA's Center for Tobacco Products.
ZYN submitted a study showing a significant number of adults who smoke cigarettes or smokeless tobacco products switched entirely to the nicotine pouches, according to the FDA. The federal agency also said ZYN showed that the pouches can help adults who use more dangerous forms of tobacco.
The FDA's review also focused on children's exposure to ZYN, given the growing sales of nicotine pouches in recent years. The products have been seen in some social media trends, raising concerns about teen use.
The 2024 National Youth Tobacco Survey reported that just 1.8 percent of U.S. middle and high school students currently use nicotine pouches.
"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."
The FDA's authorization includes strict restrictions for digital, TV, and radio advertisements. These measures aim to ensure ads target adults 21 and older.
ZYN agreed to not mass-market advertise on TV and radio. The company will also use actors or models 35 or older in ads, along with avoiding content, themes, or imagery designed to appeal to children.
The FDA authorized marketing for the following ZYN products in two nicotine strengths (3 and 6 milligrams):
- ZYN Chill
- ZYN Cinnamon
- ZYN Citrus
- ZYN Coffee
- ZYN Cool Mint
- ZYN Menthol
- ZYN Peppermint
- ZYN Smooth
- ZYN Spearmint
- ZYN Wintergreen
The decision applies only to these specific products and does not permit ZYN to make reduced-risk claims without separate approval.
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