One product, one panel, one record.
Nestlé Health Science (developed by Seres Therapeutics; distributed by Aimmune Therapeutics) VOWST (fecal microbiota spores, live-brpk), 12-capsule course — FDA-approved oral live biotherapeutic, BLA 125757 — label audit
VOWST discloses no strain, no species and no genus — its composition is specified at phylum level, "Firmicutes spores" — and it is one of two products in this corpus whose efficacy was reviewed by a regulator before sale, alongside REBYOTA (BLA 125739, approved 30 November 2022). It is the extreme point of the disclosure axis and the top of the evidence axis at the same time, which is why counting named strains cannot be a ranking method.
This page is an audit of a label. It records what this product’s panel discloses, what of that could be checked against a primary record, and what could not. The score below ranks this product on that disclosure and on nothing else.
The record this page rests on
- NIH label record
- No NIH Dietary Supplement Label Database record is on file for this product in this teardown.
- Label read on
- The most recent dated artefact behind this page. Labels change; this is how old our reading of it is.
- Cohort
- Addendum — outside the founding denominators Torn down 2026-07-31, after the founding cohort of 27 was frozen, and it is not a dietary supplement — it is an FDA-approved prescription biologic, two regulatory lanes above every SKU in D₂₇. It sits outside every D₂₇ denominator this site publishes and exists here as the ceiling: the thing the supplement lane gets measured against.
- How deep this went
- Full forensic teardown Panel transcribed, every strain designator queried, every certification chased to its issuer’s own register, and the literature behind each marketing claim opened and read.
- What did not survive verification
- Part of this page was refuted or could not be reproduced Three things on this page are bounded. First, the ~$17,500 per-course price is trade-press sourced and UNVERIFIED at the manufacturer — all three of the company's own domains return HTTP 403 — so it is recorded in a price note and not as a price, and no cost-per-day figure derived from it should be quoted as fact. Second, the headline figure for the Seres-to-Nestlé asset sale was not resolved: coverage reports $155 million and $175 million with a separate $50 million milestone, and no single number should be published without the Seres 8-K. Third, no sex-subgroup efficacy finding is asserted in either direction, because FDA's clinical review memo was not retrieved. One further item is a finding rather than a gap and must travel with the "0 strains" number: VOWST discloses no strains, so the strain count here is 0 of 0, not 0 of N — categorically different from a supplement that had fifteen organisms it could have named and did not. What did survive verification in full: the biologics licence and every identifier attached to it, confirmed at three independent government registers; the phylum-level composition and the 30-fold CFU range; the absence of any potency-basis statement on the approved label; the ECOSPOR III efficacy numbers at 8, 12 and 24 weeks; and the reconciliation of the consumer site's recurrence-free percentages to the label's recurrence rates.
The Label Verifiability Score for this product
No score and no rank
No Label Verifiability Score is published for this product, and none is estimated. A score must rest on at least 50% of the rubric by weight; this record answers 36%, so a number here would present an average of one or two components as a summary of five.
The product stays in the audit and stays on this site. It is listed, unranked, on the label audit, and it is absent from the ranking rather than placed at the bottom of it: an unanswered question is not a bad answer, and ranking it as though it were would be a number about our reach dressed up as a fact about the product.
| Component | Weight | What was counted, and where | Fraction |
|---|---|---|---|
| Strain identity printed on the panel | 0.24 | No organism slot has been transcribed from this panel, so there is nothing to count. | Not answered |
| Per-organism amount printed | 0.20 | No organism slot has been transcribed from this panel, so there is nothing to count. | Not answered |
| What the CFU count is measured against | 0.22 | Potency basis "none-stated": CFU figure printed yes, single basis stated no, basis reaches expiry no — 1 of 3. | 1 / 3 = 0.3333 |
| Printed designators that lead to a human trial | 0.20 | No organism slot has been transcribed from this panel, so there is nothing to count. | Not answered |
| Certification confirmed at the issuer’s own register | 0.14 | 1 claimed certification found on the issuer’s own public register. Read the scope before reading the mark: most certify one narrow property. | 1 / 1 = 1.0000 |
This record answers 36% of the rubric by weight, below the 50% floor a published score requires. Scoring it would present an average of one or two components as a summary of five. Listed, unranked, and the components it did answer are shown above.
The ranking of the 154 products that can be scored is on the home page, with what the score measures and what it does not.
What this label discloses
Everything in this table is what the product itself states — on the printed panel, on the brand’s own page, or in the label record the manufacturer filed. Nothing in it is checked yet; checking is the next section.
| Disclosure | As recorded |
|---|---|
| CFU as printed | Each capsule contains between 1×10⁶ and 3×10⁷ Firmicutes spore colony forming units in 92 ± 4% (w/w) glycerol in saline |
| What that count is measured against | No basis stated |
| Strain designators | None — species only |
| Organism slots transcribed here | 0 — the full panel |
| Marketed as | Unisex |
A CFU number appears with no temporal basis of any kind. A count with no basis is not a quantity; there is no date at which it is claimed to be true.
The panel names species only, with no strain designator anywhere. A species name is not a claim: the trials in this field are of strains, and a species can contain thousands.
What of that is verifiable
A disclosure is verifiable when a reader can open a record that neither we nor the brand controls and see the same thing. Below is every dated artefact this page rests on. What is absent from this list is not verified, however reasonable it sounds.
- Dated capture of the brand’s own page — dailymed-spl-99e5a37a-930c-4641-bcdd-7013ec1c15fe (opens in a new tab) captured This is not a brand page — it is the current FDA/NLM Structured Product Label, Revised 2/2025, Initial U.S. Approval 2023, US license number 2109, © 2025 Nestlé. The type field's nearest available value is brand-page-capture, and this note says what the artefact actually is rather than letting the enum imply something weaker. Every composition, efficacy, safety and storage figure on this page comes from this document, because the FDA-hosted package-insert PDF is an unfinalised template. Source for §11 DESCRIPTION (the phylum-level composition and the 1×10⁶–3×10⁷ CFU range), §12.1 (mechanism not established), §13.1 (no carcinogenicity, genotoxicity, mutagenicity or fertility evaluation), §5.1–§5.2 (transmissible agents, food allergens), §14 (ECOSPOR III efficacy at 8, 12 and 24 weeks) and §16 (NDC 71881-400-12, storage 2–25 °C).
- Internet Archive capture — 20251006132817 (opens in a new tab) captured Internet Archive snapshot of the consumer site, used because vowst.com returns HTTP 403 to automated fetch. Source for the consumer marketing claims quoted verbatim on this page — the recurrence-free framing at two and six months, the "1-2 GUT PUNCH" line, the "only FDA-approved microbiome treatment in oral capsules" claim, and the footer codes VOW-PM-USA-0207 07/25 and © 2025 Nestlé.
How many of its strains have a human trial for what it is sold for
Across the frozen founding cohort, 0 of 294 organism slots (0.0%) carry an organism with a human randomised controlled trial for any male-specific outcome. Not for this product — for all 27 of the founding teardowns, taken together. That is the number to hold against any men’s probiotic, including this one.
Two further founding-cohort figures for context: only 43 of 294 organism slots carry a strain with any human RCT at all under the exact code printed on the label, and only 2 of 27 products have a published human trial of the finished formula — the thing actually in the bottle. All three figures divide by the frozen cohort of 27 teardowns and 294 organism slots, never by every teardown on this site.
For this product specifically, 0 organism slots carry a strain with a human RCT under the exact designator printed on the label.
A word on what a designator has to clear before it counts here. The organism must be named with the exact strain code that appears in the trial, the trial must be in humans, and the code must return that trial when a reader searches it. A species name does not qualify: the trials in this field are of strains, and a species contains thousands of them.
What it costs per day
What certification it holds, checked at the issuer’s own register
A badge on a bottle is a claim like any other. Every row below was checked — or not checked — at the certifier’s own public register, never at the badge. Across the frozen founding cohort, 2 of 27 products hold a certification we could confirm at the issuer — a founding-cohort figure, not a count over every teardown on this site.
| Programme | Status at the issuer | Checked |
|---|---|---|
| FDA Biologics License Application — BLA 125757, US license number 2109 | Confirmed at issuer | 31 July 2026 |
FDA Biologics License Application — BLA 125757, US license number 2109
Found on the certifier’s own public register.
Not a certification in the NSF or USP sense — a biologics licence, approved 26 April 2023 under the Public Health Service Act, and verified at three independent government endpoints. FDA CBER posts STN 125757 with the approval letter, the Summary Basis for Regulatory Action and the clinical review memo. openFDA's NDC directory returns exactly one record for product_ndc 71881-400 — marketing category BLA, application number BLA125757, marketing start 2023-04-26, active ingredient "DONOR HUMAN STOOL SPORES (ETHANOL TREATED)", strength 30000000 [CFU]/1, UNII 9K7X6R5BMW, listing expiration 2027-12-31. DailyMed carries the current Structured Product Label, setid 99e5a37a-930c-4641-bcdd-7013ec1c15fe, Revised 2/2025. A negative control was run and mattered: the same openFDA endpoint returns 404 for labeler_name "Seres", because the listing is held by Aimmune Therapeutics after the asset transfer. A single-query conclusion would have been wrong.
How it differs from the same brand’s women’s version
Across the fourteen same-brand men’s-versus-women’s label diffs run inside the frozen founding cohort, zero men’s or default formulas contain a probiotic strain, identified by designator, that was selected on male-specific evidence. In eight of the fourteen the sex-specific differentiator is a botanical or a mineral, and in five of the fourteen the women’s SKU is better-specified, cheaper, or both — “better-specified” meaning the panel that discloses more, never the panel with more in it. The rule behind each of those counts, and all fourteen pairs classified against it , are published in full. Diffs run on teardowns added since sit outside this fourteen, and outside the sentence above.
This brand sells no women’s counterpart to this product, so there is no diff to run.
Every finding on this page, with the record behind it
Finding 1 no-strain-species-or-genus-disclosure-phylum-level-only
SPL §11 specifies the product as a spore suspension "manufactured from human fecal matter sourced from qualified donors", ethanol-treated and filtered, containing "between 1×10⁶ and 3×10⁷ Firmicutes spore colony forming units" per capsule. There is no strain list, no species list and no genus list. This is the most extreme case of undisclosed composition in the corpus, and it is FDA-approved.
The record: VOWST current SPL §11 DESCRIPTION, DailyMed setid 99e5a37a-930c-4641-bcdd-7013ec1c15fe, Revised 2/2025 — open it (opens in a new tab)
Finding 2 cfu-basis-unstated-on-an-approved-label
The label states a content range and never says whether it holds at manufacture or through the expiry date. Neither phrase appears anywhere in the approved labelling. On the test applied to every supplement in this project, VOWST fails it.
The record: VOWST current SPL, searched in full; openFDA strength field records the upper bound only, 30000000 [CFU]/1 — open it (opens in a new tab)
Finding 3 thirty-fold-potency-range-with-unknown-dose-response
1×10⁶ to 3×10⁷ CFU per capsule is a 30-fold window — 4×10⁶ to 1.2×10⁸ per four-capsule dose, 1.2×10⁷ to 3.6×10⁸ per twelve-capsule course. A patient at the bottom of the range receives one thirtieth of the organisms of a patient at the top, at the same price, and the label makes no claim that outcome is independent of where in the range the lot fell. The mechanism is unestablished, so dose–response is unknown.
The record: VOWST current SPL §11 and §16; openFDA NDC record for 71881-400-12 — open it (opens in a new tab)
Finding 4 mechanism-of-action-not-established
SPL §12.1, verbatim - "The mechanism of action of VOWST has not been established." This is on the FDA-approved label.
The record: VOWST current SPL §12.1 — open it (opens in a new tab)
Finding 5 not-evaluated-for-carcinogenicity-genotoxicity-or-fertility
SPL §13.1, verbatim - "VOWST has not been evaluated for carcinogenicity, genotoxicity, mutagenic potential, or impairment of male or female fertility in animals."
The record: VOWST current SPL §13.1 — open it (opens in a new tab)
Finding 6 donor-derived-transmissible-agent-and-food-allergen-warnings
This is processed human stool in a capsule. SPL §5.1 carries a transmissible-infectious-agents warning; §5.2 warns of the "Potential presence of food allergens" because donors have no dietary restrictions.
The record: VOWST current SPL §5.1 and §5.2 — open it (opens in a new tab)
Finding 7 manufacturer-price-not-publicly-retrievable
The ~$17,500 per course figure rests on trade press. All three of the company's own domains return HTTP 403 to automated fetch and the archived consumer site publishes no price.
The record: Healio Gastroenterology, October 2023; vowst.com, vowsthcp.com and nestlehealthscience.us all HTTP 403, 2026-07-31 — open ithttps://www.healio.com/news/gastroenterology — Address given, not linked: this site does not link out to the products it audits.
Finding 8 undisclosed-adjunct-burden-in-the-dosing-protocol
Before the first dose the patient must complete antibacterial treatment 2–4 days prior, drink 296 mL of magnesium citrate the day before and at least 8 hours pre-dose — or, with impaired kidney function, 250 mL of a polyethylene glycol electrolyte solution the label explicitly flags as "not approved for this use" — then fast for at least 8 hours. A bowel prep is part of the protocol and is not in the sticker price.
The record: VOWST current SPL §2, dosing and administration — open it (opens in a new tab)
Finding 9 pivotal-trial-is-93-percent-white-at-n-182-itt
ECOSPOR III's ITT population was 182 (VOWST 89, placebo 93), mean age 65.5, 93.4% white, 59.9% female, 73.1% previously treated with vancomycin. A narrow evidence base for a very expensive product.
The record: VOWST current SPL §14, Study 1; PMID 35045228 (N Engl J Med 2022;386(3):220-229), NCT03183128 — open it (opens in a new tab)
Finding 10 fourteen-of-twenty-two-pivotal-trial-authors-are-sponsor-employees
Of the 22 authors on PMID 35045228, 14 list "Seres Therapeutics, Cambridge, MA" as their affiliation. That is normal for a registrational phase 3 and does not invalidate the trial — the data were independently reviewed by FDA in the BLA, which is the check no supplement trial receives — but it should be disclosed rather than smoothed over.
The record: PubMed author-affiliation block, PMID 35045228 — open it (opens in a new tab)
Finding 11 manufacturer-domains-hard-block-automated-access
vowst.com returns HTTP 403 to automated fetch, so the manufacturer's consumer claims are auditable only through the Internet Archive.
The record: vowst.com HTTP 403, 2026-07-31; Wayback snapshot 20251006132817 used instead — open it (opens in a new tab)
Finding 12 fdas-own-hosted-package-insert-is-an-unfinalised-template
The package-insert PDF hosted at fda.gov/media/167579 reads "Initial U.S. Approval: YYYY", "Revised: M/YYYY", "U.S. license number: XXXXX" and "© 20XX". Anyone quoting figures from it without cross-checking DailyMed is quoting a draft. Every figure on this page was taken from the current DailyMed SPL instead.
The record: fda.gov/media/167579/download, 7 pp., template placeholders present, 2026-07-31 — open it (opens in a new tab)
Finding 13 common-adverse-reactions-are-not-trivial
Abdominal distension 31.1%, fatigue 22.2%, constipation 14.4%, chills 11.1%, diarrhoea 10.0%.
The record: VOWST current SPL §6, adverse reactions — open it (opens in a new tab)
Finding 14 consumer-marketing-frames-recurrence-free-rates-and-calls-the-comparator-antibiotics-alone
The consumer site reports "88% RECURRENCE FREE" at two months and "79%" at six, against 60% and 53%. The arithmetic reconciles exactly to the label's recurrence rates and both timepoints are shown — no inflation, no cherry-picking. But the survival framing understates the effect (12.4% versus 39.8% recurrence, RR 0.32, reads as a two-thirds reduction), the page calls the comparator arm "antibiotics alone" when it was a placebo-controlled design, and "1-2 GUT PUNCH" implies a mechanistic combination on a product whose label says the mechanism has not been established.
The record: Archived vowst.com, Wayback snapshot 20251006132817, versus VOWST current SPL §14 — open it (opens in a new tab)
What we could not verify
Every gap below is published rather than deleted. Most are derived automatically from the empty fields in this page’s own record, so a gap cannot be hidden by leaving a box blank.
- A US retail price, and therefore the cost per day
- No manufacturer-published US price could be retrieved. vowst.com, vowsthcp.com and nestlehealthscience.us all return HTTP 403 to automated fetch, and the archived vowst.com snapshot carries a "SAVINGS & SUPPORT" section with no price in it. The figure in circulation is trade-press sourced — Healio Gastroenterology, October 2023, verbatim: "The price per course of Vowst therapy is approximately $17,500" (same article: "Rebyota is nearly $9,500"; FMT "has a sticker price of $1,500, according to ACG"). At that figure the arithmetic is ~$5,833 per dosing day across three days and ~$1,458 per capsule, but the underlying number is UNVERIFIED at the manufacturer and is not recorded here as a price. Cost per day is in any case not a meaningful metric for this product: it is one three-day course, not a daily supplement. The honest framing is $17,500 once versus $18–$160 a month forever, and the relevant question is not price per CFU but whether a randomised trial exists for the outcome you want. There is also an undisclosed adjunct burden that is not in any sticker price — a mandatory magnesium citrate bowel prep, or, for renally impaired patients, a polyethylene glycol electrolyte solution the label itself flags as "not approved for this use".
- The manufacturer's own price
- vowst.com, vowsthcp.com and nestlehealthscience.us all return HTTP 403 to automated fetch, and the archived consumer site has a savings-and-support section with no price. The ~$17,500 per course figure is trade-press sourced (Healio Gastroenterology, October 2023) and is marked UNVERIFIED at the manufacturer wherever it appears.
- The headline figure for the Seres-to-Nestlé asset sale
- Trade coverage and Seres IR releases report $155–175 million with a separate $50 million milestone payment; investing.com reports $155 million and PRNewswire/Nasdaq coverage references $175 million. The exact figure was not resolved. Do not publish a single number without pulling the Seres 8-K.
- Sex-subgroup efficacy analysis
- FDA's product page points to Section 1.1 of the clinical review memo for demographic subgroups. That document was not retrieved. No sex-specific efficacy finding is asserted in either direction.
- The manufacturer's own consumer claims, at first hand
- vowst.com hard-blocks automated access with HTTP 403, so the consumer marketing quoted on this page is auditable only through an Internet Archive snapshot dated 2025-10-06.
How to check every line of this page yourself
Nothing on this page requires trusting us. Every claim above resolves to a record you can open:
- Open the NIH Dietary Supplement Label Database record linked at the top of this page. It is the label the manufacturer filed, not our transcription of it.
- Compare the CFU line and the suggested-use line against the disclosure table above. If they disagree with us, we are wrong and we want to know.
- Take any strain designator from the panel and run the query printed beside it. The query is published precisely so you can get a different answer than we did.
- Divide the price by the number of days the label’s own dose instructions make the container last. That arithmetic is the whole of the cost-per-day row.
- Search the certifier’s own register for this product, not for the brand. A company can participate in a programme without this product being on its list.
Every other product on this site is asked the same four questions: what organisms are in it, what basis its CFU number has, who verified its certification, and what makes it a men’s product. VOWST answers them in a way that breaks the scoring method, and that is precisely why it is here.
What organisms are in it: unknown, by design, at phylum level. The approved label describes a spore suspension “manufactured from human fecal matter sourced from qualified donors”, treated with ethanol to kill everything that is not a spore, filtered, and specified as “between 1×10⁶ and 3×10⁷ Firmicutes spore colony forming units” per capsule. No strain. No species. No genus. This is the most extreme undisclosed composition in the corpus — and it is not a defect. A donor-derived consortium cannot have a fixed roster. What substitutes for compositional disclosure is a defined process, a release specification, donor screening, lot release under 21 CFR 610, and a pre-market efficacy review.
What basis the CFU figure has: none stated. Neither “at manufacture” nor “at expiry” appears anywhere on the label. If a supplement did that, it would go straight into the red-flag column. Here the omission means something close to the opposite: potency within specification through the labelled dating period is a licence condition FDA enforces, not a promise the manufacturer volunteered. A supplement’s silence on CFU basis means nobody checked. VOWST’s silence means FDA checked. Same missing sentence, opposite meaning — and the criticism that survives that context is the 30-fold range itself, on a product whose mechanism the label says has not been established.
Who verified the certification: a regulator, at its own register, with no intermediary. BLA 125757, approved 26 April 2023, US license 2109, confirmed at FDA CBER, in openFDA’s NDC directory and on DailyMed. Every certification on this site is read at the issuing body — that is the standing rule, not this product’s distinction. What is unusual here is the issuer: a drug regulator granting a licence, rather than a private certifier attesting to a supplement. One other product in this audit sits in the same position, REBYOTA, under BLA 125739.
What makes it a men’s product: nothing. One regimen for all adults 18 and over, no sex-based subsection in Specific Populations, and a pivotal trial that was 59.9% female.
Which leaves the lesson this SKU exists to teach. Two products in this corpus disclose nothing about which organisms are inside: VOWST, and a supermarket “50 billion CFU, 15 strains” proprietary blend. One has a New England Journal of Medicine phase 3 trial and an FDA licence; the other has neither. Strain disclosure is a proxy for rigour, not rigour itself. The proxy is excellent inside the supplement lane, where nothing else is verifiable, and it breaks completely at the lane boundary. Any ranking that counts named strains will put VOWST below a gummy.
And because “microbiome therapy” marketing obscures it: this is processed human stool in a capsule, with a transmissible-agents warning, an unrestricted-donor food-allergen warning, no carcinogenicity or fertility evaluation, and an unestablished mechanism — all of it printed on the approved label. An approved drug is allowed to say “we don’t know how it works.” A supplement making a comparable admission would be unusual enough to be newsworthy.