Officials with the U..S. Food and Drug Administration on Thursday OK’d the marketing of Zyn nicotine pouches to adults. Photo courtesy of the Food and Drug Administration
Jan. 16 (UPI) — The U.S. Food and Drug Administration on Thursday approved the marketing of Zyn nicotine pouch products after undertaking an extensive scientific review of them.
The American Lung Association said it was “extremely disappointed” in the decision.
It’s the first time the FDA has approved marketing of nicotine pouches, which it describes as “small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip.”
FDA officials said the 20 Zyn nicotine pouch products met the public health standard that weighs risks and benefits; current and potential use by consumers; and the methods, facilities and controls used to manufacture the 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 press release.
“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,” Farrelly said.
The nicotine pouches also could benefit adults who smoke cigarettes or use smokeless tobacco products with a low risk of youth using nicotine pouches.
A 2024 National Youth Tobacco Survey showed 1.8% of middle school and high school students use nicotine pouches.
The FDA in 2021 established assessment rules for reviewing and allowing or denying the marketing of tobacco products in the United States.
“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, said.
“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,” King added.
The FDA marketing authorization allows the marketing of Zyn nicotine pouch products to adults age 21 and over by using digital, broadcast and print marketing appeals.
Manufacturer Zyn also must track the demographics of audiences exposed to the marketing appeals and has stated its intent to restrict youth access to the products and reduce their potential appeal those under age 21.
Examples include not using actors or models under age 35 to promote the nicotine pouches and avoiding the use of characters, images or themes that might appeal to youth.
While the FDA and Zyn officials said the benefits of marketing the nicotine pouch products to adults outweigh the risks, the American Lung Association opposes the decision.
“We are extremely disappointed that the FDA authorized these Zyn nicotine pouches — especially since the product has been on the market illegally up until now,” ALA officials said Thursday in a news release.
“While it has not been sold in the U.S. for long, we are already seeing very concerning levels of youth use and troubling use of influencers and celebrities to promote the product,” the ALA officials said.
“One study found there has been a 641% increase in sales of the products between 2019 and 2022, but just 2.9% of U.S. adults had ever used a nicotine pouch,” the ALA continued. “This shows an alarming rate of people younger than 21 using this product.”
The association said Zyn nicotine pouches are tobacco products and “no tobacco product is safe.”