Philip Morris International Inc. (PMI) (NYSE: PM) has 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 authorised 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-authorised 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 authorised, while in many countries policymakers opt for bans rather than careful evaluation.