FDA Modified Risk Tobacco Product (MRTP) Orders for ZYN

The U.S. Food and Drug Administration issued Modified Risk Tobacco Product (MRTP) orders covering twenty variants of PMI’s ZYN nicotine pouch line, marking the first MRTP authorizations for nicotine pouches. The authorized claim 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 products listed in the order are:

  • 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
  • ZYN Menthol 3 mg and 6 mg

PMI U.S. CEO Stacey Kennedy highlighted that the decision benefits more than 45 million legal‑age nicotine consumers in America and provides “accurate, science‑based information” about reduced‑risk switching from cigarettes to ZYN. She added that the FDA’s approach underscores a science‑based evaluation across the risk continuum.

The FDA’s order notes that the products, as actually used, would significantly reduce harm and disease risk for individual users and benefit public health overall, satisfying the requirements of section 911(g)(1)(A) and (B). The agency’s review found that nicotine pouches deliver nicotine via oral absorption without combustion, markedly lowering exposure to harmful chemicals compared with combustible tobacco.

In January 2025, ZYN became the first nicotine pouch authorized for sale in the United States through the pre‑market tobacco product application (PMTA) pathway. The FDA’s evaluation then concluded that ZYN contains substantially lower amounts of harmful constituents than cigarettes and most smokeless products, resulting in a lower risk of cancer and serious health conditions. Evidence from a study showed a substantial proportion of adults who previously used cigarettes or smokeless tobacco completely switched to the authorized nicotine pouch products.

Further FDA data indicated that among surveyed ZYN users, over half reported no cigarette consumption in the prior 30 days. Of those who continued smoking, 80.7% reduced their cigarette consumption, and 57.2% cut their daily cigarettes by more than 50%.

PMI now holds MRTP authorizations for ZYN, versions of its IQOS heat‑not‑burn devices and consumables, and eight General snus products, reinforcing its position as an industry leader. The company’s smoke‑free portfolio, which includes cigarettes, heat‑not‑burn, nicotine pouch, and e‑vapor products, is sold in over 105 markets and was used by more than 43 million legal‑age consumers worldwide as of 31 December 2025. The smoke‑free segment contributed 43% of PMI’s total net revenues in the first quarter of 2026.

Since 2008, PMI has invested over $16 billion in developing, scientifically substantiating, and commercializing innovative smoke‑free products, building capabilities in pre‑clinical toxicology, clinical and behavioral research, and post‑market studies. PMI’s U.S. operations employ more than 3,000 people and operate manufacturing facilities in Aurora, Colorado; Owensboro, Kentucky; and Wilson, North Carolina.