Six Years After the PMTA Deadline: Who Is Authorized (2026)
All 43 FDA-authorized nicotine pouch products belong to PMI or Altria. Every independent brand still has zero. The numbers by brand, strength and date.
TL;DR
Six years after the September 9, 2020 PMTA submission deadline, FDA has authorized 43 nicotine pouch products. Every one of them belongs to a brand owned by Philip Morris International or Altria. Independent brands, and BAT's VELO, hold zero. This scorecard lays out the numbers by company, brand, strength and date, using FDA's authorized-products list current through August 21, 2026, and each brand's official US product lineup.
In one sentence: 43 authorized products, 2 companies, 0 independents: FDA authorization in nicotine pouches has so far tracked market share, not the number of brands applying.
The authorizations, by date
| Date | Products | Brand | Company | Strengths |
|---|---|---|---|---|
| January 16, 2025 | 20 | ZYN | Swedish Match (PMI) | 3mg, 6mg (10 flavors) |
| December 19, 2025 | 6 | on! PLUS | Helix Innovations (Altria) | 6mg, 9mg (Mint, Tobacco, Wintergreen) |
| On FDA's list as of 2026 | 6 | on! (original line) | Helix Innovations (Altria) | 2mg, 4mg (Autumn Spice, Cappuccino, Rich Berry) |
| August 21, 2026 | 11 | ZYN Ultra | Swedish Match (PMI) | 9mg (10 flavors), 11mg (Smooth only) |
| Total | 43 |
Source: FDA, Nicotine Pouch Products Authorized by FDA, current through August 21, 2026. The full product-level list is on our FDA-authorized nicotine pouches page.
By company
| Company | Brands | Authorized products | Share of authorizations |
|---|---|---|---|
| Philip Morris International (Swedish Match) | ZYN, ZYN Ultra | 31 | 72% |
| Altria (Helix Innovations) | on!, on! PLUS | 12 | 28% |
| Everyone else | VELO, Rogue, Lucy, FRE, zone, ALP, Juice Head, Sesh+, others | 0 | 0% |
The two companies that hold every authorization are also the two that lead the category commercially. Altria reported on! at a 14.4% retail share of the nicotine pouch category in Q2 2026. PMI's investor materials have put ZYN at roughly two-thirds of US category volume in 2025. Together that is around three-quarters of the market holding 100% of authorizations, and the brands making up the remaining quarter holding none.
By strength
Authorized products cluster at 3mg, 6mg and 9mg. Above 9mg there is exactly one.
| Strength | Authorized products | Brands |
|---|---|---|
| 2mg | 3 | on! |
| 3mg | 10 | ZYN |
| 4mg | 3 | on! |
| 6mg | 13 | ZYN (10), on! PLUS (3) |
| 9mg | 13 | ZYN Ultra (10), on! PLUS (3) |
| 11mg | 1 | ZYN Ultra Smooth |
Before August 21, 2026, the authorized ceiling was 9mg. Meanwhile unauthorized brands sell well above it: FRE lists 12mg and 15mg on frepouch.com, Lucy lists 12mg on lucy.co, and ZYN's own site sells every Ultra flavor at 11mg even though FDA authorized only Smooth at that strength.
What is on shelves but not on the list
Counting only what each brand's official US website lists as for sale in September 2026:
- Rogue (Swisher): 7 flavors at 3mg and 6mg, 14 SKUs. Authorized: 0.
- Lucy: Pouches line, 6 flavors at 4/8/12mg (18 SKUs), plus the Breakers line, 6 flavors at 4/8mg (12 SKUs). Authorized: 0.
- FRE (Turning Point Brands): 7 flavors at 3/6/9/12/15mg, up to 35 SKUs. Authorized: 0.
- VELO (BAT): 10 original-line flavors at 2/4/7mg plus the VELO Plus line at 3/6/9mg. VELO does not publish a full SKU matrix. Authorized: 0.
- ZYN Ultra (PMI): 8 retail varieties, each sold at 9mg and 11mg (16 SKUs). Authorized: 11, and only one at 11mg.
That is at least 79 SKUs from Rogue, Lucy and FRE alone, none authorized, against 43 authorized products in total. Adding VELO, zone, ALP, Juice Head, Sesh+, Black Buffalo, ZEO and the Swedish imports, the unauthorized side of the market is several times larger than the authorized side by SKU count.
Why the gap matters
- Enforcement discretion is not authorization. Products with PMTAs submitted by the September 9, 2020 deadline (or the May 14, 2022 deadline for synthetic nicotine) can stay on the market while FDA reviews them, but FDA can issue a marketing denial order at any time.
- "FDA authorized" is a brand-level claim consumers cannot verify at the shelf. The ZYN Ultra 11mg case shows why: the brand is authorized, most of the 11mg cans are not.
- Independent brands have had six years without a decision. Lucy filed in May 2022; Rogue, FRE and VELO filed by the 2020 deadline. None has received either an authorization or a public denial.
For adults 21 and older, none of this is a safety ranking. FDA's tobacco products overview states there is no safe tobacco product, and a marketing granted order is not approval for smoking cessation or any therapeutic use.
Methodology and reuse
Authorization counts come from FDA's authorized-products list (current through August 21, 2026). Retail lineups come from each brand's official US website (roguenicotine.com, lucy.co, frepouch.com, velo.com/us, us.zyn.com), checked September 2026. Market-share figures are as reported by Altria and PMI in their own earnings materials. The underlying SKU-level table is our FDA PMTA Tracker, published as an open dataset under CC BY 4.0; journalists and researchers may reuse it with attribution.