Philip Morris International Inc. (PMI) announced that the U.S. Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders ever granted for nicotine pouches, enabling PMI to market the claim that using ZYN instead of cigarettes reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.
FDA Approval Marks a Milestone for Nicotine Pouches
Stacey Kennedy, PMI U.S. CEO, stated, "FDA's decision is an important moment for the more than 45 million legal-age nicotine consumers in America. 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 that the decision reinforces the agency's science-based approach to evaluating products across the continuum of risk.
List of Authorized ZYN Products
The MRTP orders cover 20 ZYN variants: ZYN Cool Mint 3 mg and 6 mg, ZYN Peppermint 3 mg and 6 mg, ZYN Spearmint 3 mg and 6 mg, ZYN Wintergreen 3 mg and 6 mg, ZYN Citrus 3 mg and 6 mg, ZYN Coffee 3 mg and 6 mg, ZYN Cinnamon 3 mg and 6 mg, ZYN Smooth 3 mg and 6 mg, ZYN Chill 3 mg and 6 mg, and ZYN Menthol 3 mg and 6 mg.
ZYN's Regulatory Journey and Scientific Basis
In January 2025, ZYN became the first nicotine pouch authorized for sale in the United States after a rigorous scientific review through the premarket tobacco product application (PMTA) pathway. The FDA noted that ZYN products contain substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, posing a lower risk of cancer and other serious health conditions. A study showed that a substantial proportion of adults who used cigarettes or smokeless tobacco completely switched to ZYN.
Impact on Smoking Cessation
FDA review considered extensive data indicating that some adults who smoke and have started using ZYN reduced their cigarette use over time. Over half of those surveyed reported no cigarette consumption in the past 30 days. Among those who continued to smoke, the majority (80.7%) reduced their cigarette consumption, and more than half (57.2%) reduced their cigarettes per day by more than 50%.
Contrast with Global Regulatory Approaches
The FDA's action highlights a stark contrast: in the U.S., nicotine products undergo detailed scientific review before authorization, while many countries opt for bans rather than careful evaluation. PMI now holds MRTP authorizations for ZYN, versions of IQOS devices and consumables, and eight General snus products, underscoring its position as an industry leader in reduced-risk products.
