FDA Allows Label Saying Zyn Nicotine Pouches Less Harmful Than Cigarettes

Authored by Zachary Stieber via The Epoch Times,

The Food and Drug Administration is letting Philip Morris International market its Zyn nicotine pouches as being safer than cigarettes.

The FDA said on June 30 that the pouches can now feature the statement, “Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The authorization of the modified risk statement followed an extensive scientific review, regulators said.

That process concluded that Philip Morris subsidiary Swedish Match demonstrated the claim was scientifically accurate, that consumers understand the claim, and that marketing the products with the claim would benefit the population.

“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,” Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said in a statement.

“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.”

The FDA initially cleared Zyn pouches in 2025. Officials at the time said that the benefits to adult cigarette smokers outweighed the risks to adults and youth, based in part on the finding that the pouches contain fewer harmful chemicals than cigarettes.

An FDA advisory panel in January said the proposed statement was likely accurate.

The Campaign for Tobacco Free Kids opposed the proposal at the time. The nonprofit said that Swedish Match did not meet the standard for authorization, in part because there was no demonstrated benefit.

The authorization of the new claim includes the requirement that the pouch manufacturer carry out studies and surveillance, including assessing how people interact with the updated products and understand the updated risk-related information.

The authorization lasts for five years and can be extended.

If the FDA determines that the marketing under the adjusted statement no longer benefits the population, such as a scenario that involved a spike in uptake among young people, the agency may withdraw the authorization, officials said.

Philip Morris CEO Stacey Kennedy hailed the development. Kennedy said in a statement it “ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to Zyn reduces the risk of smoking-related diseases like heart disease and lung cancer.”

“More broadly, it reinforces the agency’s science-based approach to evaluating products across the continuum of risk and communicating those findings transparently,” she said.