US FDA Approves Sale of ZYN Nicotine Pouch Products
The United States Food and Drug Administration (FDA) has given its approval for the marketing of ZYN nicotine pouch products after a thorough review confirmed that they meet public health standards. This marks the first time the FDA has authorized products commonly referred to as nicotine pouches.
The products that received FDA marketing orders include ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint, and ZYN Wintergreen.
According to the FDA, these ZYN products meet the public health standard outlined in the 2009 Family Smoking Prevention and Tobacco Control Act, which evaluates the risks and benefits of tobacco-related products to the general population.
The FDA’s assessment found that the nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip, pose a lower risk of cancer and other serious health issues compared to traditional cigarettes and most smokeless tobacco products, including moist snuff and snus. The pouches contain significantly fewer harmful substances than these other products, making them a less harmful alternative.
The FDA also pointed to evidence from studies showing that a significant proportion of adults who use cigarettes or smokeless tobacco have completely switched to the newly authorized nicotine pouch products. This switch has been seen as a potential public health benefit, as it reduces the health risks associated with traditional tobacco products.
Matthew Farrelly, PhD, director of the Office of Science in the FDA’s Center for Tobacco Products, commented on the approval, stating, “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.” He added, “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.”
However, the FDA has made it clear that it will continue to closely monitor the marketing and usage of these nicotine pouch products to ensure that they continue to meet safety standards.
This approval marks a significant milestone in the regulation of tobacco-related products and offers a new, potentially less harmful alternative for adults looking to quit smoking or using smokeless tobacco products.
