The US Food and Drug Administration (FDA) has authorized 20 ZYN nicotine pouch products to carry a specific modified risk claim. The orders mark the first modified risk authorizations granted to nicotine pouches.
The FDA issued the orders to Swedish Match USA on June 30 after an extensive scientific review. It examined relative health risks, consumer understanding, youth-use data and the possible impact on the wider population. The authorization applies only in the United States and only to products named in the orders.
Exact FDA-Authorized Risk Claim
The products may now carry this 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 decision covers ZYN Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen. Each variety received orders in 3 mg and 6 mg nicotine strengths.
The FDA first authorized these products for US sale through the Premarket Tobacco Product Application pathway in January 2025. That decision allowed marketing but did not permit modified risk claims.
Bret Koplow, acting director of the FDA’s Center for Tobacco Products, explained the agency’s approach.
“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,” he said.
He added that the “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.”
Strict Conditions and Public-Health Monitoring
The FDA said Swedish Match proved that the authorized claim was scientifically accurate for the 20 products. It also found that consumers understood the statement and that its use would benefit the population as a whole.
However, the orders do not mean the products are safe or “FDA approved.” Nicotine is addictive, and people who do not use tobacco or nicotine products should not start. The FDA says completely quitting tobacco provides the greatest health benefit for adults who smoke.
Swedish Match must conduct post-market surveillance and studies on consumer behaviour and understanding of the risk information. The orders expire after five years, although the company may apply for renewed authorization.
The FDA may withdraw them earlier if continued marketing no longer benefits public health. A significant increase in youth use could trigger such action.
First MRTP Orders for Nicotine Pouches
The ruling makes ZYN the first nicotine pouch product to secure FDA Modified Risk Tobacco Product orders. PMI said the claim took effect immediately, but the authorization has no legal force outside the United States.
Philip Morris International said its smoke-free products were available in more than 105 markets at the end of 2025. The company estimated that over 43 million legal-age consumers used them worldwide.
Its smoke-free business generated 43% of total net revenue during the first quarter of 2026. PMI says it has invested more than $16 billion in smoke-free product development and research since 2008.
Its portfolio includes cigarettes, heated-tobacco products, nicotine pouches and e-vapour products.
