Philip Morris International Inc. announced on August 21, 2026, that 11 ZYN ULTRA nicotine pouch products from its affiliate, Swedish Match USA, Inc., had been authorized by the U.S. Food and Drug Administration (FDA) through the Premarket Tobacco Product Application (PMTA) pathway.
The authorized products include 11 ZYN ULTRA nicotine pouches, including 10 with 9mg nicotine strength and 1 ZYN ULTRA Smooth product with 11mg. This authorization brings the total number of FDA-authorized nicotine pouch products in the U.S. to 43, including 23 reviewed as part of the agency’s nicotine pouch PMTA pilot program.
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FDA ZYN Nicotine Pouch Authorization Timeline
Following the FDA’s authorization of four new On! nicotine pouch products on August 4, 2026, the agency authorized 11 additional ZYN ULTRA products on August 21. This latest authorization is another major development in the FDA regulatory history. The following are the key milestones:
| Date | Key Milestones |
| January 16, 2025 | FDA authorized the first 20 ZYN nicotine pouch products for marketing through the PMTA pathway. |
| June 30, 2026 | FDA issued Modified Risk Granted Orders (MRTP orders) for the 20 previously PMTA-authorized ZYN nicotine pouch products, which allow them to be marketed with a modified-risk claim under FDA requirements. |
| August 21, 2026 | FDA authorized 11 new ZYN ULTRA nicotine pouch products for marketing through the PMTA pathway, bringing the total number of FDA-authorized nicotine pouch products in the U.S. to 43. |
It’s worth noting that the June 30 MRTP orders and the August 21 PMTA authorizations served different purposes. The MRTP orders applied to 20 ZYN products that had already received FDA marketing authorization, allowing them to be marketed with specific modified-risk claims under FDA requirements. The August 21 authorization approved the marketing of 11 new ZYN ULTRA products through the PMTA pathway. This expands ZYN’s FDA-authorized nicotine pouch lineup beyond its previously authorized 3mg and 6mg products, bringing the total number of FDA-authorized nicotine pouch products in the U.S. to 43.
What Was Authorized by the FDA
On August 21, 2026, the FDA authorized the marketing of 11 ZYN ULTRA nicotine pouches through the Premarket Tobacco Product Application (PMTA) pathway. The products are manufactured by Swedish Match USA, a U.S. affiliate of Philip Morris International (PMI).
The authorized ZYN ultra pouches include:
- ZYN ULTRA Chill — 9mg
- ZYN ULTRA Citrus — 9mg
- ZYN ULTRA Cool Mint — 9mg
- ZYN ULTRA Deep Freeze — 9mg
- ZYN ULTRA Menthol — 9mg
- ZYN ULTRA Peppermint — 9mg
- ZYN ULTRA Smooth — 9mg
- ZYN ULTRA Spearmint — 9mg
- ZYN ULTRA Wintergreen Chill — 9mg
- ZYN ULTRA Wintergreen — 9mg
- ZYN ULTRA Smooth — 11mg
One detail that stands out in this authorization is the nicotine strength. According to the FDA, nicotine exposure is not assessed based solely on the product’s labeled nicotine content. The agency also considers its design, formulation, materials, and other characteristics that can affect the amount and rate of nicotine delivered to the user.
The FDA’s evaluation also showed that the newly authorized nicotine pouch products contained lower levels of most harmful and potentially harmful constituents (HPHCs) than other oral and smokeless tobacco products, with many constituents at levels too low to be quantified. The evaluation result does not mean the products are risk-free or that nicotine itself is harmless.
What Does the FDA Authorization Mean for U.S. Nicotine Pouch Users
For adult nicotine pouch users in the U.S., the latest FDA authorization brings some practical impacts:
(1) A Wide Selection of FDA-Authorized Nicotine Pouch Products
With 11 new ZYN ULTRA nicotine pouches authorized, the total number of nicotine pouches authorized by the FDA in the U.S. has reached 43, giving adult users more federally authorized nicotine pouch products to choose from.
(2) More Nicotine Strength Options
The latest authorization adds 9mg and 11mg ZYN ULTRA nicotine pouch products to the FDA-authorized lineup. Along with the previously authorized 3mg and 6mg nicotine strengths, this gives adult users more options across the ZYN nicotine strength range.
For adults who currently smoke cigarettes or use electronic cigarettes, the higher-strength options may offer more choices when switching to alternative nicotine products. The FDA said the newly authorized products may deliver enough nicotine to reduce cravings and withdrawal symptoms to a degree that could support switching from more harmful tobacco products.
Conclusion
The latest FDA Authorization of 11 new ZYN ULTRA nicotine pouches further strengthens ZYN’s position in the nicotine pouch market. Meanwhile, many additional 11mg ZYN ULTRA products remain under FDA review. With more nicotine pouch products receiving FDA authorization, nicotine pouches are playing a more important role in the U.S. nicotine market.
