FDA allows ZYN nicotine pouches to be marketed as less harmful than cigarettes

The Food and Drug Administration said the maker of the ZYN nicotine pouches can market its products as safer than cigarettes.

On Tuesday, the FDA authorized Phillip-Morris International to market 20 of its ZYN products as a "lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis" than cigarettes. ZYN pouches contain nicotine but not tobacco and are placed between one's gum and lip.

The decision by the FDA does not mean that ZYN products are safe. The FDA was careful to note that there is "no safe tobacco product."

"There is no safe tobacco product, and those who do not use tobacco products should not start," the FDA said in Tuesday's press release. "For adults who currently smoke cigarettes, fully quitting the use of all forms of tobacco products would most benefit their health. However, switching completely from cigarettes to FDA-authorized nicotine pouches may reduce exposure to many harmful chemicals found in cigarettes."

“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, Ph.D., J.D., acting director of the FDA’s Center for Tobacco Products. “Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”

ZYN products were authorized for sale in the U.S. in January 2025. The flavors approved by the "modified risk" order do not include fruity flavors, which are usually popular among young teens.

Along with the modified risk order, the FDA asked Swedish Match USA to study how its customers perceive risks and to understand information about risks. The agency also requires the company to monitor upticks in use for youth as the FDA may withdraw orders.