On the documents, on! PLUS Wintergreen 9 mg wins, and it wins on the fact that documents exist. FDA has published its portion mass, dimensions, pouch count, nicotine source and clinical abuse-liability data. FRE’s entire published specification is three lines, its ingredient list reads “salt and other food-grade ingredients”, and it is not among the 43 pouches FDA says may lawfully be sold in the United States. Both are prohibited in California.
First look, based on manufacturer specifications and regulatory filings. Nobody here has used either product, so there are no scores on this page and no tasting notes — only what primary documents establish. For one of these two that is a great deal; for the other, almost nothing. That asymmetry is the most informative thing about the comparison.
What each company and each regulator has actually published
Every cell below is sourced or marked as not published. I have not estimated anything.
| on! PLUS Wintergreen 9 mg | FRE Wintergreen 12 mg | |
|---|---|---|
| Manufacturer | Helix Innovations LLC (applicant); product manufacturer U.S. Smokeless Tobacco Company LLC | National Tobacco Company, L.P. (Turning Point Brands) |
| FDA authorisation | Yes — marketing granted order 19 December 2025, STN PM0009121.PD17 | None. Not on FDA’s authorised list |
| Nicotine per pouch | 9 mg (“Nicotine Concentration: 9 mg/pouch”) | 12 mg (label strength) |
| Pouches per can | 14 (“Portion Count: 14 pouches”) | 20, in rolls of 5 tins |
| Portion mass | 0.714 g | Not published anywhere, by anyone |
| Portion size | 27.5 × 10.5 mm (no thickness published) | Not published |
| mg per gram | ≈12.6 mg/g — my arithmetic from FDA’s two figures | Cannot be computed |
| Nicotine source | Tobacco, free-base (FDA) | Not stated by FRE; measured as racemic in an independent study |
| pH | Not published | Not published (brand-level: FRĒ 15 mg measured at pH 9.0) |
| Moisture | Not published — applicant said it is not a routine design parameter | Not published |
| Ingredient list | Described by FDA as flavour ingredients, artificial sweeteners, stabilizers, fillers and pH adjusters | “Contains: salt and other food-grade ingredients.” |
| Can material | “white CR plastic can and flat lid assembly” | “tin” / 20 ct can |
| Published price | None — the brand site is a registration gate | $5.29 single tin, $24.99 five-can roll |
| California Unflavored Tobacco List | Not listed | Not listed |
One number in that table needs flagging. FDA gives 14 pouches at 0.714 g against a declared can quantity of 9 g — and 14 × 0.714 is 9.996. FDA’s own footnotes to the appendix say that it interprets “Product Quantity to mean quantity within the container closure system, unless otherwise identified” and that attributes “may display converted values”. I am reporting both figures and leaving them unreconciled, because FDA does.
FRE’s column is short for a reason I checked rather than assumed. Its product page’s PRODUCT SPECS heading carries exactly three lines: “Available in: 3mg, 6mg, 9mg, 12mg and 15mg strengths”, “Size: 20 Nicotine white pouches/tin. 5 tins/roll.”, and “Contains: salt and other food-grade ingredients.” There is no ingredient list on the site, and the ingredients page returns a 404. The California register independently confirms the strengths, the 20-count can and the five-pack roll, so the format facts are solid — the composition facts simply do not exist publicly.
And what I did not do: the store lists shipping weights, and they are internally impossible — a single tin and a five-can roll both appear at 114 g. Those are carrier placeholders, so there is no arithmetic route to FRE’s mg/g and I have not built one. For why that quotient matters, see pouch weight vs nicotine content: the maths.
The one measured chemical difference, and it is a real one
FDA states on the order itself that on! PLUS’s nicotine source is “Tobacco”, and in the technical review that “The new products are pouched oral tobacco products containing tobacco-derived nicotine”, and that they “contain free-base nicotine and are available in three flavors (Mint, Tobacco, Wintergreen) with each flavor available in two nicotine levels (6 mg and 9 mg).”
FRE never says. Its site offers “pharmaceutical-grade nicotine salts” and calls the product “tobacco-free” and “zero-tobacco” — claims about leaf, not about where the nicotine came from.
The question was answered anyway, by a lab rather than a company. A National Cancer Institute-funded study at Roswell Park measured the optical isomers of nicotine across 50 pouches and reported that “only BRIDGE and FRĒ pouches contained racemic nicotine”, with “The remaining ONPs and all OTPs contained 100% S-nicotine.” The paper’s own interpretive rule is stated plainly: “Equal amounts of R- and S-isomers (R,S-racemic) were a potential indicator of synthetic nicotine.”
Scope that carefully, because it is easy to overstate. The finding is that FRĒ’s nicotine measured as racemic, which the authors treat as an indicator of synthetic origin — not that FRE uses synthetic nicotine. The authors say so themselves: purified synthetic S-nicotine is possible but more expensive, and carbon isotope work would be needed to confirm. The samples were a convenience batch bought between March 2021 and April 2023, and the paper does not state which FRĒ flavour or strength was tested. The distinction itself is covered in tobacco-free vs synthetic nicotine, and the free-base-versus-salt question in nicotine salts vs freebase nicotine.
Two further figures from the same study are worth having, both brand-level rather than SKU-level. Nicotine content across the sample ranged up to “16.3 ± 0.7 mg/pouch (FRĒ 15 mg)” — the highest in the set, and above its own label. And “Average pH of ONP brands ranged from 7.0 (VELO 4 mg) to 9.0 (FRĒ 15 mg), which correspondingly ranged from 0.9% to 89.7% freebase nicotine.” That is the 15 mg, not the 12 mg, and the flavour is unstated — so treat it as what the brand does at its top strength, not as a specification for this can. Why it matters at all is pouch pH and why it changes the hit.
What FDA measured, for the one product it reviewed
The on! PLUS review contains findings no FRE document can match, and also less than you might hope.
On harmful constituents, FDA analysed eleven and concluded that “Of the 11 HPHCs analyzed in the new products, the majority of HPHCs were too low to be quantified in the new products. In fact, the new products do not contain measurable quantities of carcinogenic tobacco-specific nitrosamines (TSNAs), including NNN and NNK, or the carcinogenic polycyclic aromatic hydrocarbon, B[a]P.” The reason that matters is in FDA’s next sentence: NNN “is the predominant driver of excess oral cancer risk among adult smokeless tobacco users”. For the broader picture there is TSNAs in snus: what the numbers actually mean.
Note what is absent: FDA published no quantified constituent figure at all — no mg/g, no ng/g, nothing. The entire constituent section is directional. And the products’ pH and moisture are not in the record either; on moisture, FDA writes that “The applicant did not provide target specifications and lower range limit for moisture content and particle size distribution for the new products and indicated that these are not routine design parameters for product characterization.” That is more interesting than a redaction. The applicant said moisture was not a routine design parameter, and FDA accepted it.
On abuse liability, this specific product was clinically tested rather than inferred from another: FDA’s review describes a randomised crossover study of the “on! PLUS Wintergreen 6 mg … and 9 mg … and on! PLUS Tobacco 9 mg … and usual brand moist smokeless tobacco among adults who use smokeless tobacco.” The conclusion is that abuse liability “is likely lower than moist smokeless tobacco”, with the important balancing sentence FDA includes itself: the products “still delivered sufficient nicotine to users and alleviated symptoms of craving and withdrawal from baseline.”
The comparator is worth pinning down, because it is set per application and people generalise about it wrongly. Here the abuse-liability comparator was usual-brand moist smokeless tobacco, and the constituent comparators were four General snus products plus three from the literature. It was not cigarettes. A different pouch application used different comparators, so “FDA compares pouches to moist snuff” is not a statement that holds across the category.
Regulatory status in the United States
This is the axis on which the two products are least alike, and it needs stating precisely in both directions.
on! PLUS Wintergreen 9 mg is authorised. It appears on FDA’s list of nicotine pouch products authorised by the FDA, a page that states: “There are 43 nicotine pouch products authorized by the FDA. These are the only nicotine pouch products that may be lawfully sold in the United States.” The same page carries FDA’s standing caution: “While these products are authorized to be sold in the United States, it does not mean these products are safe, nor are they ‘FDA approved.’ All tobacco products are harmful and potentially addictive.” The order letter puts it in FDA’s own legal terms — permitting marketing “does not mean FDA has ‘approved’ the new tobacco products specified in Appendix A”. It also carries no modified-risk order: “Helix” appears nowhere on FDA’s list of modified risk granted orders, and the order letter notes that “modified risk claims (either explicit or implicit) cannot be made without an MRTP order granted.”
FRE Wintergreen 12 mg has no FDA authorisation. That is not the same as having been rejected, and the difference is worth getting right:
- No FRE product, and no National Tobacco Company or Turning Point Brands entry, appears on the authorised list.
- No marketing denial order, warning letter or import alert against the brand could be found. FDA’s warning-letter database returns nothing for “National Tobacco Company” or “frepouch”; the two hits for “Turning Point Brands” are vape retail entities and concern no pouch. The relevant import alert names neither company.
- Whether an application is pending can be neither confirmed nor denied, and that is a matter of law rather than of my research. Under 21 CFR 1114.47(b), “FDA will not publicly disclose the existence of an application” unless the applicant has itself disclosed it or authorised FDA to. Turning Point Brands’ own quarterly filings state that the company “has only two product lines currently subject to the PMTA process” — and never name FRE as one of them. So FDA may not say and the company has not said.
Two things sit in tension here, both from primary documents, and I am not going to adjudicate between them. Turning Point Brands’ filings describe the PMTA regime as one “with continued sales permitted during the pendency of the applications”. FDA’s May 2026 enforcement guidance states the legal position as: “all new tobacco products on the market without authorization are illegally marketed products” — while conceding that “FDA lacks the resources to pursue enforcement against every product that has not received authorization” and setting out a priority order in which a pending, accepted and filed application counts in a product’s favour. The same guidance names “high nicotine content” among the factors that raise a product’s enforcement priority. A 12 mg pouch in a market whose highest authorised strength is 11 mg sits inside that criterion. That is FDA’s stated test, not my prediction.
Wintergreen means methyl salicylate
This is the one axis where the flavour itself is the interesting variable, and it applies to both products equally.
Wintergreen flavour is methyl salicylate, a salicylate ester. WHO’s Joint FAO/WHO Expert Committee on Food Additives set an acceptable daily intake of 0–0.5 mg per kg of body weight and concluded there is no safety concern at current levels of intake when it is used as a flavouring agent. The underlying 1967 monograph is franker about the compound in bulk: “The adult human oral LD50 is estimated at 0.5 g/kg body-weight … The ester is potentially the most toxic salicylate for infants and children, as 4 ml can be fatal.”
Measured amounts in pouches exist — for other brands. The Roswell Park survey found that “methyl salicylate, which gives a characteristic wintergreen taste, was identified in all ONP and OTP wintergreen flavors”, and its highest pouch figure was “methyl salicylate (wintergreen) (Rogue Wintergreen: 14.9 ± 0.5 mg/pouch)”. In traditional moist snuff the loads are larger still, up to 26.8 mg per pouch in one product.
No published measurement exists for either product on this page. And three mismatches mean the ADI cannot be turned into a pouch count: it is a swallowed-diet figure in milligrams per kilogram of body weight per day, the route differs for something held under a lip, and nobody has measured how much methyl salicylate a user actually absorbs from a pouch. I am leaving that arithmetic undone rather than smuggling in an absorption assumption. For a wintergreen pouch whose chemistry has been measured, there is the Rogue Wintergreen 6mg review, and a same-flavour head-to-head at ZYN Wintergreen 6mg vs Rogue Wintergreen 6mg.
Both of these are prohibited in California, and in Massachusetts
The flavour-ban outcome is the same for both, and I verified it rather than inferring it.
California’s Department of Justice publishes an Unflavored Tobacco List, which states: “To be sold legally in California, a covered tobacco product must be included on this list; otherwise, it is classified as a prohibited flavored tobacco product under Health & Safety Code §§ 104559.1(g) and 104559.5(a)(6).” Its scope reaches nicotine-only products explicitly — “Any product containing or derived from tobacco or nicotine (including synthetic nicotine, nicotinic alkaloids, and nicotine analogs)” — so FRE’s nicotine source, whatever it is, changes nothing.
Searching that register on 29 October 2026: “Wintergreen” returns no products at all, while a control search for “Menthol” returns rows, so the search works and the absence is real. The Helix entries are on! Original at five strengths and on! PLUS Tobacco 6 and 9 mg only — no Wintergreen, no Mint. The FRE entries are Original, Smooth and Sweet only. Neither product in this comparison is listed, so both are prohibited flavoured tobacco products there. Notably, FDA authorisation does not get a product onto California’s list: the 9 mg Wintergreen has the federal order and is still absent. FRE concedes the point in its own words, telling subscribers that “due to new state restrictions, we cannot ship Mint, Wintergreen, Watermelon or Lush to your region.”
Massachusetts reaches both as well, and more broadly. M.G.L. c. 270 § 28 names wintergreen in its definition of a characterising flavour — “menthol, mint, wintergreen, herb or spice” — and defines a tobacco product as “a product containing or made or derived from tobacco or nicotine that is intended for human consumption … regardless of nicotine content in the product”. The prohibition binds manufacturers and online sales: “No person, retailer or manufacturer shall sell, distribute, cause to be sold or distributed, offer for sale any flavored tobacco product … in any retail establishment, online or through any other means to any consumer in the commonwealth.” And the statute’s evidentiary provision does the rest automatically, since a public claim of a characterising flavour “shall constitute presumptive evidence that the tobacco product is a flavored tobacco product” — both companies call their product Wintergreen, and FDA’s own order records Wintergreen as the characterising flavour of the authorised one. The only carve-out is for products FDA has approved as cessation products, and a marketing granted order is expressly not an approval, so it does not apply. The out-of-state delivery carve-out in that section covers electronic nicotine delivery systems only.
For the state-level picture around this, see where to buy nicotine pouches in California.
Who should pick which
With no scores to offer, the honest version of this section is about what each product lets you know.
on! PLUS Wintergreen 9 mg is the one with a record. If you want to know what you are putting in your mouth — how much it weighs, how big it is, where the nicotine came from, what a regulator found when it looked — that information exists only for this product. It also sits in the 9–11 mg tier, which is not a beginner’s strength; at roughly 12.6 mg/g by my arithmetic it is mid-range by concentration despite the high per-pouch number, because the pouch is relatively heavy. Fourteen pouches a can is among the lowest counts on the market, which is worth factoring into cost — see how many pouches are in a can.
FRE Wintergreen 12 mg is cheaper per pouch and that is the whole of its documented case. Twenty pouches at $5.29 a tin is roughly 26 cents each at the manufacturer’s own list price, against a competitor that publishes no price at all because its site is a registration gate. Against that: a 12 mg label that the brand’s top strength has been measured exceeding, no pouch weight, no pH, no ingredient list beyond “salt and other food-grade ingredients”, no authorisation, and a strength that sits above anything FDA has authorised in a market where FDA names high nicotine content as an enforcement factor. If you are stepping up, the tier above this one is worth reading first.
And if you are in California or Massachusetts, neither is lawfully for sale, which settles the question differently.
Frequently asked questions
Is FRE illegal? It has no FDA marketing authorisation, and FDA’s position is that “all new tobacco products on the market without authorization are illegally marketed products”. No denial order or warning letter against the brand could be found, and whether an application is pending cannot lawfully be disclosed by FDA or has not been disclosed by the company.
Is 12 mg stronger than 9 mg? Per pouch, on the labels, yes. Per gram, unknown, because FRE’s pouch weight is unpublished — and the one independent measurement of FRE’s top strength came in above its label. A bigger number on a heavier pouch is not the same product as a bigger number on a lighter one.
Which has more pouches? FRE, by a wide margin: 20 against 14.
Does FRE use synthetic nicotine? The company does not say. An independent lab measured FRĒ’s nicotine as racemic, which the researchers describe as a potential indicator of synthetic nicotine; confirming it would need isotope work nobody has published.
Why are there no scores on this page? Because scores on this site come from products actually used, and neither of these has been. When that changes, this page gets rewritten.
Sources
- US Food and Drug Administration. “Marketing Granted Orders”, letter to Helix Innovations LLC, 19 December 2025, Appendix A (STN PM0009121.PD17). PDF.
- US Food and Drug Administration. “Technical Project Lead (TPL) Review of Nicotine Pouch PMTAs”, Helix Innovations LLC. PDF.
- US Food and Drug Administration. “Nicotine Pouch Products Authorized by the FDA”. Content current as of 21 August 2026; read 29 October 2026.
- US Food and Drug Administration. “Modified Risk Granted Orders”. Content current as of 15 July 2026.
- US Food and Drug Administration. Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization, May 2026. PDF. Marked “Contains Nonbinding Recommendations”.
- 21 CFR § 1114.47 (Confidentiality), as promulgated in Federal Register 86(190), 5 October 2021, document 2021-21011. Full text at govinfo.
- Page MK, Leigh NJ, Block AC, et al. “Comparison of nicotine and selected flavoring contents between tobacco-free and tobacco-containing oral pouches.” Nicotine Tob Res 2026. PMC12824957. Funded by the National Cancer Institute; one author declares grants and advisory roles outside the work.
- Joint FAO/WHO Expert Committee on Food Additives. “Methyl salicylate”, FAO Nutrition Meetings Report Series No. 44A / WHO Food Add./68.33, eleventh meeting, Geneva, 21–28 August 1967. Monograph via IPCS INCHEM. ADI 0–0.5 mg/kg bw, maintained at the fifty-seventh meeting in 2001.
- California Department of Justice. Unflavored Tobacco List. Searched 29 October 2026 for Wintergreen, Helix, FRE and Turning Point, with Menthol as a control.
- Massachusetts General Laws c. 270 § 28. malegislature.gov. Read 29 October 2026.
- FRE. Wintergreen nicotine pouches product page and flavour-ban subscription notice. Commercial sources, read 29 October 2026.
- Turning Point Brands. Second quarter 2026 results, 4 August 2026, and first quarter 2026 results, 7 May 2026. Commercial sources; the PMTA footnote is quoted from the company’s own release.
Last verified 29 October 2026.
