20 ZYN nicotine pouch products have received Modified Risk Tobacco Product (MRTP) orders from the U.S. Food and Drug Administration (FDA), with 20 variants covered by the authorization. This marks the first time the FDA has granted MRTP orders for nicotine pouches. For the authorized ZYN products, Philip Morris International Inc. (PMI U.S.) can now market the following modified-risk claim in the United States: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The FDA’s decision comes as PMI continues its transformation toward what it describes as a smoke-free future, with the company developing and scientifically assessing alternatives to conventional cigarettes for adults who would otherwise smoke.
What the FDA Authorization Says
The FDA’s Modified Risk Granted Order states:
“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.”
The agency therefore authorized the products for marketing as modified risk tobacco products with the approved 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.”
The authorization applies to the specific ZYN products identified in the FDA orders and permits PMI U.S. to use the approved modified-risk information when marketing those products in the United States.
The Data Behind the Decision
In reviewing the ZYN applications, the FDA considered data showing that some adults who smoke and had started using ZYN products reduced their cigarette consumption over time. More than half of those surveyed reported no cigarette consumption in the previous 30 days.
Among those who continued to smoke after starting to use ZYN, 80.7% reduced their cigarette consumption, while 57.2% reduced the number of cigarettes they smoked per day by more than 50%.
The data formed part of the evidence submitted by PMI in support of its MRTP applications.
How ZYN Works Differently
Unlike cigarettes, which burn tobacco and produce smoke that is inhaled, ZYN nicotine pouches deliver nicotine through absorption in the oral mucosa.
PMI says this results in substantially lower exposure to harmful and potentially harmful chemicals compared with smoking cigarettes. The company describes the distinction as central to its broader shift toward smoke-free alternatives.
The FDA authorization represents a significant regulatory milestone for the nicotine pouch category, while also underscoring the distinction between modified-risk authorization and a finding that the products are risk-free. The authorization specifically concerns the relative risk of the authorized products compared with cigarettes.
For PMI, the decision marks another step in its ongoing transformation toward a smoke-free future, backed by what the company describes as rigorous scientific assessment and transparent risk evaluation.
