US FDA grants reduced-risk marketing claim to 20 ZYN nicotine pouches

The US Food and Drug Administration (FDA) has granted modified-risk orders for 20 ZYN nicotine pouch products, allowing their manufacturer to market a specific claim that the products pose lower risks than cigarettes.

The orders, issued on 30 June 2026, mark the FDA’s first modified-risk authorization for nicotine pouches. The 20 products, manufactured by Swedish Match USA Inc., cover 10 ZYN variants in 3-milligram and 6-milligram strengths.

Under the orders, the products may carry the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The FDA said its decision followed a scientific review that considered the relative health risks of the products, consumer understanding of the claim, potential youth use and the impact on the population. The agency concluded that the specific claim was scientifically accurate for the authorized products and that marketing them with the claim would benefit the population as a whole.

“FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products.

The authorization is valid for five years and requires Swedish Match USA to conduct postmarket surveillance and studies. The FDA may withdraw the orders if continued marketing no longer benefits public health, including if there is a significant increase in youth uptake.

The FDA first authorized the marketing of the 20 ZYN products in January 2025 through its premarket tobacco product application pathway. That authorization allowed their sale but did not permit reduced-risk claims.

The agency stressed that there is no safe tobacco product and that people who do not use tobacco should not start. It said adults who smoke would benefit most from completely quitting all tobacco products, while those who switch completely from cigarettes to FDA-authorized nicotine pouches may reduce their exposure to many harmful chemicals found in cigarettes.

The FDA has since authorized additional nicotine pouch products, including 11 ZYN ULTRA products in August 2026, but those products are not covered by the June 30 modified-risk orders.