The Food and Drug Administration (FDA) has announced the authorization of 20 ZYN nicotine pouch products through the PMTA pathway. This is the first time the agency has authorized a nicotine pouch product.
“The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act,” the agency noted in a statement. “This standard considers the risks and benefits of products to the population as a whole.”
Among several key considerations, the agency’s evaluation showed that the authorized products “pose lower risk of cancer and other serious health conditions” than cigarettes and most smokeless tobacco products.
The company also provided scientific evidence from a study showing that a substantial portion of adults who use cigarettes or smokeless tobacco products switched to the newly authorized nicotine pouches.
“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. “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.”
Additionally, the FDA found that the ZYN nicotine pouches have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products. As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years.
“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. “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 products for which the FDA issued marketing granted orders 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’s actions are specific to these products only; the authorizations do not apply to any other nicotine pouch or other ZYN products. Additionally, 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.
