on! is Altria’s nicotine pouch brand, made by Helix Innovations and manufactured in the United States by U.S. Smokeless Tobacco Company. The interesting thing about it is the gap between what FDA has authorised — twelve products — and what sits on shelves, which is most of the range plus a strength no regulator has ruled on. on! and on! PLUS are also chemically different products, not two sizes of one.
on! is unusually well documented for a pouch brand, because its owner is a listed company and its applications have generated hundreds of pages of FDA review. Almost everything below comes from a filing, a review or a court docket rather than from marketing.
Who owns it
The brand began in Switzerland. In July 2019 Altria announced “an agreement with Burger Söhne Holding AG (Burger Group) to acquire 80% ownership of certain companies of the Burger Group that will commercialize on! oral nicotine pouches”, expecting to invest $372 million. It closed through a vehicle and for less: Altria’s FY2021 annual report records that “In 2019, Helix acquired Burger Söhne Holding and its subsidiaries… At closing, Altria owned an 80% interest in Helix, for which Altria paid $353 million.” Full ownership followed in two steps on two separate entities — “At December 31, 2021, Altria owned 100% of the global on! business as a result of transactions in December 2020 and April 2021 to purchase the remaining 20% interest in (i) Helix ROW and (ii) Helix, respectively”, for about $250 million in total.
The international arm was never a Swiss AG, despite the brand’s Swiss origin: the FY2021 report names it “Helix Innovations GmbH and its subsidiaries (“Helix ROW”)”, with Helix Innovations LLC covering the United States and Canada. By FY2025 the label is “Helix Innovations LLC (“Helix”) and its foreign affiliates (“Helix International”)”, parked in an “all other” category with no product-level disclosure.
Who actually makes the pouches is answered by FDA rather than Altria. Both technical reviews name, on their cover pages, the applicant as Helix Innovations LLC and the “Product manufacturer” as U.S. Smokeless Tobacco Company LLC — Altria’s moist-snuff subsidiary — and Helix’s regulatory correspondence address is Altria’s own Richmond, Virginia offices. For the brands either side of it, see our guides to ZYN and VELO.
The authorised range: twelve products, and I can list all of them
FDA’s authorised-list page states that “There are 43 nicotine pouch products authorized by the FDA” and that “These are the only nicotine pouch products that may be lawfully sold in the United States”. Twelve of the 43 are Helix’s — I pulled FDA’s database export and counted: 12 Helix plus 31 Swedish Match.
| Authorised | Product | Line | STN |
|---|---|---|---|
| 19 Dec 2025 | Mint 6 mg · Mint 9 mg | on! PLUS | PM0009121.PD10 / PD11 |
| 19 Dec 2025 | Tobacco 6 mg · Tobacco 9 mg | on! PLUS | PM0009121.PD13 / PD14 |
| 19 Dec 2025 | Wintergreen 6 mg · Wintergreen 9 mg | on! PLUS | PM0009121.PD16 / PD17 |
| 4 Aug 2026 | Rich Berry 2 mg · Cappuccino 2 mg · Cappuccino 4 mg · Autumn Spice 2 mg | on! | PM0008766.PD1 / PD4 / PD5 / PD7 |
| 19 Aug 2026 | Rich Berry 4 mg · Autumn Spice 4 mg | on! | PM0008766.PD2 / PD8 |
Two things worth noticing. The December 2025 on! PLUS authorisation was the first decision out of FDA’s nicotine pouch review pilot, so on! has a genuine first to its name. And the authorised flavour sets do not overlap: on! PLUS is Mint, Tobacco and Wintergreen only, on! is Rich Berry, Cappuccino and Autumn Spice only — and “Cappuccino” was filed with FDA as Cafe Latte.
…and the range on the shelf, which is mostly not in that list
This is the part a brand guide usually skips. Helix set out its own application history in a complaint filed against FDA on 2 September 2026: “Helix submitted 45 PMTAs for its original on! pouch products. All those applications have been pending for more than 2,270 days and remain pending to this day.” Those 45 cover the flavours most people actually buy — FDA’s review of the newer products footnotes the older set as having included on! 4 mg in “Original, Wintergreen, Cinnamon, Citrus, Berry, Coffee flavors” and on! Mint at 1, 2, 3, 4 and 8 mg.
Nine more were filed in September 2024 in 2, 4 and 8 mg across three flavours, of which the 2 and 4 mg sets were granted and “The remaining PMTAs remain pending”; and at the top of the range, Helix told the court FDA “has still failed… to issue an order granting or denying the 12-mg strength products”. These are Helix’s own allegations in an adversarial pleading, stayed on 8 October 2026 and unadjudicated — but a primary record of what Helix says about its own filings.
Meanwhile Altria’s second-quarter 2026 results report that “Helix resumed shipments of 12-milligram on! PLUS in Florida, North Carolina and Texas in Mint, Wintergreen and Tobacco, with a national expansion planned for the third quarter”, with Blueberry Mint and Mango Pineapple to follow across 6, 9 and 12 mg. So: a 12 mg pouch is shipping and expanding in a market where the highest authorised strength is 11 mg, held by a single ZYN product.
How is that lawful? Enforcement discretion. Products first regulated in 2016 that were on the market then and filed by the September 2020 deadline may remain on sale during review, and in May 2026 FDA published guidance saying it “does not intend to prioritize” enforcement against pouch products with pending, accepted applications — while noting that falling within the policy “in no way has a bearing on whether the tobacco product is likely to receive premarket authorization”. Absence from the list is not rejection: FDA does not publish pending applications, and no marketing denial order to Helix appears anywhere I looked.
on! and on! PLUS are not two sizes of one product
They use different nicotine chemistry, and FDA’s reviews say so plainly. The on! products “contain nicotine bitartrate dihydrate” — a salt — while the on! PLUS products “contain free-base nicotine”. That is the salt-versus-freebase distinction doing real work inside one brand.
| on! | on! PLUS | |
|---|---|---|
| Nicotine form | Nicotine bitartrate dihydrate (salt) | Free-base nicotine |
| Portion weight | 0.263 g target (0.260 g in the order letter) | 0.714 g target |
| Portion size | 24 × 14 mm | 27.5 × 10.5 mm |
| Pouches per can | 20 | 14 |
| Declared can quantity | 5.26 g | 9 g |
| Opening | Press in and push up a tab; the rim is blocked to remove a pick point | Break a perforated label, twist the lid to align top and bottom arrows |
| Authorised strengths | 2 mg, 4 mg | 6 mg, 9 mg |
One oddity, flagged rather than smoothed over: 14 pouches at 0.714 g is 9.996 g, against a declared can quantity of 9 g. Both figures are reported as FDA states them. Neither can carries a moisture specification — Helix told FDA it “did not provide target specifications and lower range limit for moisture content and particle size distribution for the new products” because these “are not routine design parameters for product characterization”.
What the strengths actually deliver
Altria published a pharmacokinetic study of its own product, which is to its credit even though it is not independent: “This study was funded by Altria Client Services LLC, and all authors are employees of Altria Client Services LLC.” Across five on! strengths, “The mean nicotine Cmax for NPs increased with nicotine level, ranging from 3.5 ng/mL (1.5 mg NP) to 15.4 ng/mL (8 mg NP), compared with 12.2 ng/mL for OBCs and 9.8 ng/mL for OBMST” — that is, the 8 mg pouch peaked higher than the participants’ own cigarettes and their own moist snuff. On the paper’s baseline-adjusted figures the 8 mg pouch reached 137.4% of own-brand cigarettes (95% CI 113.5–166.2). 8 mg is not an authorised strength.
Independently, a Tobacco Control study with a CDC corresponding author and no declared grant measured legacy on! bought in 2020 and found a high-pH, high-freebase product: 2 mg at pH 8.72 with 83.2% freebase nicotine, 4 mg at pH 8.75 and 79.9%, and 8 mg at pH 7.98 and just 48.0% — “exhibiting approximately a 50% reduction”. The strongest pouch in the range had its free nicotine fraction halved. Those samples pre-date on! PLUS, so date the figures when you use them; pH is what makes a milligram figure misleading.
FDA’s own conclusion on on! PLUS is narrower than either: the products “are expected to have a lower abuse liability than the high abuse liability comparison product”, that comparison being usual-brand moist smokeless tobacco. They were never compared against cigarettes, and three of the six were not clinically tested at all — their data were bridged from measured nicotine content, including from a product FDA calls “on! GEN 1 PLUS Mint 9 mg”. FDA also recorded that on! PLUS had “Higher free and total nicotine compared to General Snus comparison products”, and that of the eleven harmful constituents analysed, the products “do not contain measurable quantities of carcinogenic TSNAs, including NNN and NNK”.
Where it is legal
The United States is the business. Altria’s corporate page adds only that on! PLUS “is also in limited distribution in Sweden and the UK”, and that sentence is the entire public record of on! outside North America — the FY2025 report says Altria generates substantially all revenue from domestic customers, and there is no published European strength ladder or flavour list for on!. I am not going to infer one from ZYN’s.
Where pouches are banned, on! is banned with everything else — Germany, the Netherlands, Belgium and Australia among them. Norway deserves a correction we have owed for a while: it is not a flat statutory ban but a prior-approval regime. Under tobakksskadeloven § 34 d a maker must apply to the Directorate of Health before a new nicotine product may be imported or sold, and “Frem til eventuell godkjenning er gitt er produktet forbudt å innføre eller selge på det norske markedet”. The Directorate refused every pouch application in 2021–22 on the ground of appeal to young people, the Ministry upheld three refusals in 2023, and the Directorate now states flatly that “Nikotinsnus er ikke tillatt å innføre eller selge i Norge”. Same outcome as a ban, different mechanism — and the difference matters when reading a tobacco company’s Norwegian revenue line. Where sale is prohibited we name no sellers and describe no routes around it.
Counterfeits: what nobody has documented
I went looking for primary evidence of counterfeit on! and found none, which is itself the answer. FDA’s warning-letter database returns no rows for Helix Innovations, while the same search interface returns eleven rows for “nicotine pouch” — all to small online retailers, none about counterfeiting. FDA’s Import Alert 98-06, the detention list for unauthorised tobacco products, contains the word “counterfeit” nowhere at all, and no Helix Innovations or on! entry.
One trap worth printing, because it would be easy to fall into. That import alert does carry an entry for “HELIX SWEDEN AB” of Helsingborg, published 13 August 2026, for FUMI brand nicotine pouches. That is a different company in a different country with a different brand, and it has nothing to do with Helix Innovations LLC of Richmond, Virginia.
What Helix actually does is police the name. The USPTO’s trademark trial records show three oppositions it has brought, all against marks that look or sound like ON!: against ONI (filed March 2026) and against ONDO twice (December 2024 and September 2024). Its oldest asserted registrations issue from Madrid Protocol serials, consistent with a mark that began outside the United States with the Burger Group. Altria’s annual report discusses illicit trade and counterfeiting as a portfolio-wide risk — “Counterfeit versions of our operating companies’ products can negatively affect adult nicotine consumer experiences” — but names no brand and asserts no on!-specific problem.
Since the brand publishes no lot-code lookup, seal verification or authorised-retailer list, the most concrete authentication detail is in FDA’s own paperwork: an on! PLUS can has a perforated label that must be broken on first opening, plus alignment arrows top and bottom; an on! can opens by pressing in and pushing up a tab, with a blocked rim.
Verdict
on! is a serious, well-capitalised brand with an unusually candid paper trail — Altria published a study showing its 8 mg pouch out-peaking its users’ own cigarettes, which not every owner would have done. The measured picture is of a high-pH product that delivers briskly for a pouch, with the top of the old range formulated to pull its freebase fraction back down.
What I would want a buyer to know is the regulatory shape. Twelve SKUs are authorised; most of what you see is on sale under enforcement discretion, on applications pending in the original case for over six years; and a 12 mg product is expanding nationally with no FDA decision either way. None of that makes the pouches unsafe, and authorisation would not make them safe either — as FDA says in terms, a marketing order “does not mean FDA has ‘approved'” the product, and the orders are “subject to withdrawal or temporary suspension”. It does mean the stability of what is on the shelf depends on an agency timetable rather than on the brand. On the question people most often bring to a pouch brand, FDA’s own review is the thing to quote: summarising a 2025 systematic review, it records that the authors “were uncertain if oral nicotine pouches help people quit smoking relative to conditions in which adults were assigned to continue smoking as usual or to quit using no support”. Nothing here is a quitting aid, and nobody including the regulator claims otherwise.
If you want the products rather than the company, our on! PLUS Mint 6 mg write-up is the closest look we have, and the master ranking places it against the field.
Sources
- FDA, Nicotine Pouch Products Authorized by the FDA (content current 21 August 2026), and the Searchable Tobacco Products Database CSV export (data as of 29 September 2026), from which the twelve-product table was built.
- FDA, Technical Project Lead review, Helix Innovations on! PLUS, and the corresponding review and marketing granted order letter for the on! line (19 August 2026).
- FDA, guidance on enforcement priorities for unauthorized ENDS and nicotine pouch products (May 2026); Import Alert 98-06 (published 22 October 2026); and FDA’s warning letter database, searched for Helix Innovations and for nicotine pouch on 27 October 2026.
- Altria Group SEC filings: Q2 2019 earnings release, FY2021 Form 10-K, FY2025 Form 10-K and Q2 2026 earnings release. Altria’s own Helix Innovations corporate page is a commercial source and is cited as such.
- Helix Innovations LLC et al. v. United States Food and Drug Administration et al., No. 5:26-cv-00199 (N.D. Tex.), complaint filed 2 September 2026, paragraphs 64 and 96–100. Stayed 8 October 2026; allegations unadjudicated.
- Altria-funded pharmacokinetics: Psychopharmacology (2022) — PMC9385814. Funded by Altria Client Services LLC, all authors employees of the funder.
- Independent chemistry: “Total and unprotonated (freebase) nicotine content in new types of oral ‘tobacco-free’ nicotine products”, Tobacco Control 35:127 — PMC12075619. No specific grant declared; samples bought in 2020.
- Helsedirektoratet, guidance to the Norwegian Tobacco Harm Act, section on tobacco products, citing tobakksskadeloven § 34 d and tobakksforskriften chapter 8.
- USPTO, TTABVUE proceedings for Helix Innovations — oppositions 91306008, 91295661 and 91294037.
Last verified 27 October 2026.
