FDA Nicotine Pouch PMTA Tracker
Live status of FDA marketing authorization for every nicotine pouch SKU we track. PMTA — the Premarket Tobacco Product Application — is the FDA pathway every nicotine pouch product must clear to be legally marketed in the US.
Brand-level PMTA rollup
| Brand | SKUs Tracked | FDA Authorized | Status |
|---|---|---|---|
| ZYN | 20 | 20 | ✅ Full lineup authorized |
| on! PLUS | 7 | 7 | ✅ Full lineup authorized |
| FRE | 4 | 0 | PMTA pending / not submitted |
| Lucy | 6 | 0 | PMTA pending / not submitted |
| Rogue | 6 | 0 | PMTA pending / not submitted |
| VELO | 5 | 0 | PMTA pending / not submitted |
Per-SKU PMTA status
| SKU | Brand | Strength | Status |
|---|---|---|---|
| on! PLUS Mint 3mg | on! PLUS | 3 mg | PMTA Submitted (Not Authorized; only 6mg/9mg variants are FDA authorized as of May 2026) |
| on! PLUS Mint 6mg | on! PLUS | 6 mg | FDA Authorized (Dec 2025, PMTA Pilot) |
| on! PLUS Mint 9mg | on! PLUS | 9 mg | FDA Authorized (Dec 2025, PMTA Pilot) |
| on! PLUS Tobacco 6mg | on! PLUS | 6 mg | FDA Authorized (Dec 2025, PMTA Pilot) |
| on! PLUS Tobacco 9mg | on! PLUS | 9 mg | FDA Authorized (Dec 2025, PMTA Pilot) |
| on! PLUS Wintergreen 6mg | on! PLUS | 6 mg | FDA Authorized (Dec 2025, PMTA Pilot) |
| on! PLUS Wintergreen 9mg | on! PLUS | 9 mg | FDA Authorized (Dec 2025, PMTA Pilot) |
| ZYN Chill 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Chill 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Cinnamon 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Cinnamon 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Citrus 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Citrus 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Coffee 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Coffee 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Cool Mint 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Cool Mint 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Menthol 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Menthol 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Peppermint 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Peppermint 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Smooth 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Smooth 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Spearmint 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Spearmint 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Wintergreen 3mg | ZYN | 3 mg | FDA Authorized (Jan 2025, PMTA) |
| ZYN Wintergreen 6mg | ZYN | 6 mg | FDA Authorized (Jan 2025, PMTA) |
| FRE Mint 3mg | FRE | 3 mg | PMTA Submitted (Not Authorized as of May 2026) |
| FRE Mint 9mg | FRE | 9 mg | PMTA Submitted (Not Authorized as of May 2026) |
| FRE Watermelon 12mg | FRE | 12 mg | PMTA Submitted (Not Authorized as of May 2026) |
| FRE Wintergreen 15mg | FRE | 15 mg | PMTA Submitted (Not Authorized as of May 2026) |
| Lucy Berry Citrus 4mg | Lucy | 4 mg | PMTA Submitted May 2022 (Not Authorized; under FDA review as of May 2026) |
| Lucy Berry Citrus 8mg | Lucy | 8 mg | PMTA Submitted May 2022 (Not Authorized as of May 2026) |
| Lucy Cinnamon 8mg | Lucy | 8 mg | PMTA Submitted May 2022 (Not Authorized as of May 2026) |
| Lucy Cool Mint 8mg | Lucy | 8 mg | PMTA Submitted May 2022 (Not Authorized as of May 2026) |
| Lucy Mango 4mg | Lucy | 4 mg | PMTA Submitted May 2022 (Not Authorized as of May 2026) |
| Lucy Pomegranate 12mg | Lucy | 12 mg | PMTA Submitted May 2022 (Not Authorized as of May 2026) |
| Rogue Honey Lemon 3mg | Rogue | 3 mg | PMTA Submitted (Not Authorized as of May 2026) |
| Rogue Honey Lemon 6mg | Rogue | 6 mg | PMTA Submitted (Not Authorized as of May 2026) |
| Rogue Mango 6mg | Rogue | 6 mg | PMTA Submitted (Not Authorized as of May 2026) |
| Rogue Peppermint 6mg | Rogue | 6 mg | PMTA Submitted (Not Authorized as of May 2026) |
| Rogue Wintergreen 3mg | Rogue | 3 mg | PMTA Submitted (Not Authorized as of May 2026) |
| Rogue Wintergreen 6mg | Rogue | 6 mg | PMTA Submitted (Not Authorized as of May 2026) |
| VELO Bahia Breeze 4mg | VELO | 4 mg | PMTA Submitted (Not Authorized; under FDA review as of May 2026) |
| VELO Citrus 4mg | VELO | 4 mg | PMTA Submitted (Not Authorized as of May 2026) |
| VELO Dryft Spearmint 7mg | VELO | 7 mg | PMTA Submitted (Not Authorized; under FDA review as of May 2026) |
| VELO Ice Cool 4mg | VELO | 4 mg | PMTA Submitted (Not Authorized as of May 2026) |
| VELO Ice Cool 7mg | VELO | 7 mg | PMTA Submitted (Not Authorized as of May 2026) |
How we track this
We maintain an internal Brand Facts database of every nicotine pouch SKU sold or in PMTA review in the US. For each SKU, we record the exact FDA status string from public FDA dockets and manufacturer communications. This page is regenerated from that database on every site deploy.
FDA Authorized means the FDA has issued a Marketing Granted Order (MGO) under section 910(c)(1)(A)(i) of the FD&C Act. This is the only pathway by which a nicotine pouch product is legally marketed post-Premarket Tobacco Product Application (PMTA) review.
PMTA Pending means the manufacturer has filed an application and the FDA has it under active review. Denied means the FDA issued a Marketing Denial Order. Not submitted means no PMTA application has been filed for that SKU as of our last review.
FDA marketing authorization is not the same as “FDA approved” or “safe.” No tobacco or nicotine product is safe. Authorization means the FDA determined that marketing of the product meets the public health standard required by the Family Smoking Prevention and Tobacco Control Act.
Where we get the data
- FDA Center for Tobacco Products — Oral Nicotine Products
- Regulations.gov FDA dockets (search by manufacturer)
- Manufacturer press releases on PMTA decisions
- Our own SKU-level verification via product packaging and retailer listings
Journalists, researchers, and harm-reduction sites: this page is freely citable. Suggested citation format:
Clean Nicotine Pouch. (2026). FDA Nicotine Pouch PMTA Tracker. https://cleannicotinepouch.com/fda-pmta-trackerMore on FDA + nicotine pouches
- Which nicotine pouches have FDA marketing authorization?
- Browse coverage by brand — ZYN, VELO, Rogue, on! PLUS, Lucy
- State-by-state legality (50 states)