Following a thorough scientific examination, the U.S. Food and Drug Administration authorized the commercialization of Zyn nicotine pouch products on Thursday.
The decision left the American Lung Association “extremely disappointed.”
The FDA has authorized the commercialization of nicotine pouches for the first time; these are “small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip.”
According to FDA authorities, the 20 Zyn nicotine pouch products satisfied the public health criteria that considers the products’ manufacturing processes, facilities, and controls, as well as the risks and benefits of their present and potential consumer usage.
“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 stated.
“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 stated.
It is also possible that nicotine pouches could be beneficial to adults who smoke cigarettes or use smokeless tobacco products, as there is a low likelihood that young people will use nicotine pouches.
According to the results of the National Youth Tobacco Survey conducted in 2024, 1.8% of students in middle school and high school use nicotine pouches.
By the year 2021, the Food and Drug Administration (FDA) has devised assessment guidelines that would be used to analyze and either permit or refuse the marketing of tobacco products in the United States.
“It’s critical that the manufacturer market these products responsibly to prevent youth use,” Brian King, director of the FDA’s Center for Tobacco Products, stated.
“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.
Zyn nicotine pouch products may be marketed to adults 21 years of age and older through print, broadcast, and internet marketing appeals thanks to FDA marketing authority.
Manufacturer Zyn has expressed its intention to limit juvenile access to the items and lessen their potential attraction among those under the age of 21, and it must also monitor the demographics of audiences exposed to the marketing appeals.
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Examples include avoiding the use of characters, images, or topics that might appeal to young people, as well as not using actors or models younger than 35 to sell the nicotine pouches.
The American Lung Association is against the move, despite the FDA and Zyn officials stating that the advantages of marketing the nicotine pouch devices to adults outweigh the hazards.
“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.
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“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 stated.
“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 added. “This shows an alarming rate of people younger than 21 using this product.”
Zyn nicotine pouches are tobacco products, according to the association, and “no tobacco product is safe.”
