FDA issues modified risk tobacco product orders for Philip Morris International’s nicotine pouches

The U.S. Food and Drug Administration (FDA) has issued modified risk tobacco product (MRTP) orders on June 30 for 20 variants of Philip Morris International’s ZYN nicotine pouch.

These are the first MRTP orders to be granted for nicotine pouches and mean the products may be marketed with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

“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.

“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 action highlights a stark contrast: In the U.S., nicotine products undergo detailed scientific review before being authorized, while in many countries, policymakers instead choose bans over careful evaluation.

In January 2025, ZYN was the first nicotine pouch authorized for sale in the United States following rigorous scientific review. With this week’s decision, PMI holds modified risk tobacco product 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.