On June 30, 2026, the FDA issued modified risk granted orders to Swedish Match USA, Inc., a wholly owned subsidiary of Philip Morris International Inc., covering 20 ZYN nicotine pouch products.
The authorisation permits Swedish Match USA to market ZYN 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.”
The orders cover ten ZYN varieties, including Cool Mint, Menthol, Peppermint, Cinnamon, Citrus, Coffee, Chill, Smooth, Spearmint, and Wintergreen, each available in 3 mg and 6 mg nicotine strengths.
The authorisation falls under the modified risk tobacco product pathway, known as MRTP, which Congress created in Section 911 of the Federal Food, Drug, and Cosmetic Act as part of the 2009 Tobacco Control Act.
FDA determined that the products satisfied the statutory standard for a risk modification order, meaning the products will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.
The ZYN MRTP orders represent the first such authorisation for nicotine pouches, extending FDA’s precedent to a fast-growing category of oral nicotine products that do not involve combustion and contain no leaf tobacco.
This authorisation is distinct from the PMTA marketing authorisation FDA issued for the same 20 ZYN products in January 2025, which allowed the products to be legally marketed but did not permit any reduced-risk or reduced-exposure claims.
The MRTP pathway is deliberately demanding, requiring applicants to demonstrate not only scientific accuracy but also that consumers will understand claims appropriately and that marketing will benefit population health as a whole.
For ZYN specifically, FDA opened a public comment docket in June 2025, the comment period closed in March 2026, and the Tobacco Products Scientific Advisory Committee held a public meeting on the applications in January 2026.
The authorisation is subject to important limitations, including postmarket surveillance and study obligations, and the orders are effective for a period of five years only.
FDA made clear that the orders do not mean ZYN has been “approved,” that ZYN is safe, or that ZYN may be marketed as a smoking cessation treatment.
Before the ZYN orders, FDA had issued MRTP authorisations for Swedish Match General snus products, Philip Morris’s IQOS heated tobacco system, 22nd Century Group’s VLN reduced-nicotine cigarettes, and U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff.
FDA has acknowledged that many tobacco users hold misperceptions about the varying risks of tobacco products, and that adults who fully switch from cigarettes to lower-risk alternatives can generally reduce their health risks.
The ZYN authorisation reinforces a central principle of modern tobacco harm reduction policy: while complete cessation remains the best outcome, not all tobacco products present the same level of risk.