The United States Food and Drug Administration (FDA) has approved the marketing of ZYN nicotine pouch products after an extensive review certifies that the products meet public health standards.
The products that received FDA marketing orders are ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen.
The FDA said these ZYN products met the public health standard required by the 2009 Family Smoking Prevention and Tobacco Control Act, which considers the risks and benefits of products to the population.
In a statement published on its website, the FDA said this is the first time it has authorized products commonly referred to as nicotine pouches, adding, “These are small synthetic fibre pouches containing nicotine designed to be placed between a person’s gum and lip”.
FDA said its evaluation “showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose a lower risk of cancer and other serious health conditions than such products.
According to the FDA, there is “evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products”
The approval was granted in the face of overwhelming evidence, which showed that these nicotine pouch products have the potential to provide a benefit that outweighs the risk to adult smokers and users of other smokeless tobacco products that is sufficient to outweigh the risks of products.
However, the FDA assured that it will closely monitor the marketing and use of these products.
Reacting to the approval, Matthew Farrelly, PhD, director of the Office of Science in the FDA’s Center for Tobacco Products, said, “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.”
He said, “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.”