FDA's decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes
STAMFORD, CT, June 30, 2026--(BUSINESS WIRE)--Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: "Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."
"FDA's decision is an important moment for the more than 45 million legal-age nicotine consumers in America," said Stacey Kennedy, PMI U.S. CEO. "Today's news 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," she added. "More broadly, it reinforces the agency's science-based approach to evaluating products across the continuum of risk and communicating those findings transparently."
The FDA's action highlights a stark contrast: in the U.S., nicotine products undergo detailed scientific review before being authorized, while in many countries policymakers opt for bans rather than careful evaluation.
Products covered by the FDA's MRTP orders include:
ZYN Cool Mint 3 mg
ZYN Cool Mint 6 mg
ZYN Peppermint 3 mg
ZYN Peppermint 6 mg
ZYN Spearmint 3 mg
ZYN Spearmint 6 mg
ZYN Wintergreen 3 mg
ZYN Wintergreen 6 mg
ZYN Citrus 3 mg
ZYN Citrus 6 mg
ZYN Coffee 3 mg
ZYN Coffee 6 mg
ZYN Cinnamon 3 mg
ZYN Cinnamon 6 mg
ZYN Smooth 3 mg
ZYN Smooth 6 mg
ZYN Chill 3 mg
ZYN Chill 6 mg
ZYN Menthol 3 mg
ZYN Menthol 6 mg
In January 2025, ZYN was the first nicotine pouch authorized for sale in the United States following rigorous scientific review. With today's decision, PMI holds MRTP authorizations for ZYN, the first nicotine pouch authorized by the FDA, versions of IQOS devices and consumables and eight General snus products, underscoring the company's position as an industry leader and innovator.
EDITOR'S NOTE
FDA has authorized the ZYN MRTP claim, effective immediately.
From the FDA Modified Risk Granted Order: "Based on our review of your MRTPAs, we determined that the proposed modified risk tobacco products, as described in your applications and specified in Appendix A, have satisfied the requirements of section 911(g)(1)(A) and (B), including that they, as actually used by consumers, would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products. Therefore, we authorize marketing of the tobacco products as modified risk tobacco products with the following modified risk information: 'Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.'"