FDA allows lower-risk claims for some ZYN nicotine pouches
The agency said Swedish Match may market 20 ZYN products as lower risk than cigarettes, while requiring five years of follow-up research.
By Tom Brennan · Health & Medicine Correspondent
3 min read
The Food and Drug Administration said Swedish Match USA may tell consumers that some ZYN nicotine pouches pose lower health risks than cigarettes. The decision matters because ZYN is the leading nicotine pouch brand among middle and high school students who report using the products, according to the FDA’s youth tobacco survey.
The FDA said Tuesday that it authorized modified-risk marketing claims for 20 ZYN products made by Swedish Match USA, a Philip Morris International company. Under the decision, the company may say the covered products put users at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis than cigarettes.
The authorization applies to certain ZYN flavors, including Cool Mint, Citrus, Coffee and Cinnamon, in 3-milligram and 6-milligram strengths, according to NBC News. Flavors such as Black Cherry and Peach, which NBC News described as fruity varieties known to appeal to children, are not part of the FDA action.
Nicotine pouches are used by placing them between the lip and gum, then throwing them away after use, according to NBC News. The products can contain up to 6 milligrams of nicotine, but the FDA has not approved them as nicotine replacement therapies for quitting smoking, NBC News reported.
The FDA’s decision does not describe nicotine pouches as risk-free. NBC News reported that cigarette smoke from burning tobacco has long been known to cause cancer, heart disease and other illnesses, while nicotine is the substance that makes cigarettes addictive.
Youth use remains a concern
The FDA’s latest National Youth Tobacco Survey, released last week, found that 1.7% of middle and high school students said they used nicotine pouches in 2025. Among those students, more than one in six reported daily use, and ZYN was the most frequently named nicotine pouch brand, according to the survey.
Mike Seilback, assistant vice president of nationwide advocacy and state public policy at the American Lung Association, criticized the FDA decision. In an emailed statement reported by NBC News, Seilback called the move “appalling” and said the Lung Association wants the agency to reverse it.
“We must protect our children from a lifelong addition to nicotine,” Seilback said in the statement, according to NBC News.
The FDA placed conditions on the authorization. The agency said Swedish Match USA must study for five years how customers understand the risks tied to its products, NBC News reported.
The agency also said it could withdraw the authorization if it finds evidence of a significant rise in youth use of the products, according to NBC News. That condition makes youth uptake a central test for whether the lower-risk claims remain available to the company.
This story draws on original reporting from NBC News.