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Philip Morris International Announces Landmark FDA Decision for ZYN

A landmark achievement was announced for Philip Morris International and our industry-leading nicotine pouch product, ZYN—one that represents a significant step forward in supporting adults who would otherwise continue smoking and advancing our shared vision of a smoke-free America.

After more than five years of rigorous scientific review resulting in FDA marketing authorization for ZYN products, followed by an additional two years of review under the FDA’s Modified Risk Tobacco Product (MRTP) pathway, ZYN has achieved a truly historic milestone. The FDA has issued MRTP orders for 20 ZYN nicotine pouch products, covering all ten flagship flavors in both 3mg and 6mg strengths.

For those less familiar with FDA regulation, this achievement is exceptionally significant. The MRTP pathway represents one of the most demanding scientific and regulatory standards in the tobacco and nicotine category. To obtain an MRTP order, a company must demonstrate through extensive scientific evidence that communicating reduced-risk information to consumers is appropriate and benefits public health as a whole. In many ways, receiving an MRTP order is comparable to earning a gold-standard regulatory designation.

Most importantly, ZYN is now the first nicotine pouch product authorized by the FDA to communicate reduced-risk information to legal-age adults who smoke, including the

FDA-authorized claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” – FDA Official Release: FDA Authorizes 20 ZYN Nicotine Pouches to Be Marketed with Specific Modified Risk Claim | FDA

 This authorization is a major scientific and regulatory validation of tobacco harm reduction and reinforces a principle many public health experts, researchers, and harm reduction advocates have long supported: not all nicotine products present the same level of risk.