One product, one panel, one record.
VSL#3® Probiotic Capsules (112.5 Billion CFU, 60 capsules) — label audit
Eight organisms, not one strain designator between them — sold by a company that publishes five of five designators plus the licensor on its women's vaginal-health supplement. And the complete label for this product exists only as a picture: the Product Information Sheet is 3.4 MB, one page, and yields zero extractable characters to two independent parsers.
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
- 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. It sits outside every D27 denominator this site publishes and changes none of them.
- 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 The check this audit normally runs before it prints a panel — matching the government label record's UPC to the barcode on the bottle now being sold — failed on this product. The live storefront barcode is 860009487314 and the brand's own insert agrees with it; both government records carry 7 45749 01781 9, an earlier GS1 prefix from an earlier manufacturer. Everything drawn from those records is therefore labelled prior-generation packaging rather than the panel in today's bottle, and where the insert and the records disagree, the insert governs. Two further things are not quotable from this page. First, no formulation-level efficacy conclusion: a federal injunction bars this product's sellers from citing clinical studies performed on the pre-2016 formulation as applicable to it, and the one study the brand does cite by name never states which formulation it used. Second, nothing about kosher or halal status: the halal certifier is not named anywhere, and Star-K's register returns identical responses to different queries, so the search of it cannot be shown to be exhaustive.
The Label Verifiability Score for this product
36.0 out of 100
Rank 109 of the 154 products in this audit the rubric can score. This rank is shared with 1 other product — 2 products sit on 36.0 and are tied. They hold the position jointly; no tiebreaker is applied, because every tiebreaker available here would be a number the rubric deliberately refused to weigh, smuggled back in to make a list look tidier.
The score measures one thing: how much of what you are buying this company tells you, and how much of that survives being checked against a source that is not the company. It does not measure whether the product works — this site holds no efficacy data of its own, and 0 of 294 organism slots in the founding cohort carry a strain with a human randomised trial for any male-specific outcome, so nobody in this category has evidence that would support a ranking by effect.
Computed over the whole rubric: this record answers all five questions below, so nothing is renormalised away and the divisor is the full 1.00. That share travels with every score on this site and is never dropped — a score over part of the rubric’s weight and the same score over all of it are different claims.
| Component | Weight | What was counted, and where | Fraction | Weight × fraction |
|---|---|---|---|---|
| Strain identity printed on the panel | 0.24 | 0 of 8 organism slots carry a printed strain designator. | 0 / 8 = 0.0000 | 0.0000 |
| Per-organism amount printed | 0.20 | 0 of 8 organism slots have an amount of its own; the rest are inside a blend total. | 0 / 8 = 0.0000 | 0.0000 |
| What the CFU count is measured against | 0.22 | Potency basis "through-expiry": CFU figure printed yes, single basis stated yes, basis reaches expiry yes — 3 of 3. | 3 / 3 = 1.0000 | 0.2200 |
| Printed designators that lead to a human trial | 0.20 | 0 of 8 checked organism slots resolve to at least one human randomised trial under the designator exactly as printed. This counts whether the identity leads to a trial, never what the trial found. | 0 / 8 = 0.0000 | 0.0000 |
| 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 | 0.1400 |
0.3600 — the last column added up — divided by 1.00, the weight this record could answer, is 0.3600. Multiplied by 100 and rounded to one decimal, that is the 36.0 above.
See this product’s row in the full ranking, alongside the other 153 scored products, or read what each of the five components asks and how to check it .
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 | 112.5 billion CFU per capsule — the insert's wording is "at least 112.5 billion lyophilized probiotic bacteria" |
| What that count is measured against | Through expiry |
| Strain designators | None — species only |
| Organism slots transcribed here | 8 — the full panel |
| Marketed as | Unisex |
Product Information Sheet, read from the rendered image because the PDF yields no text: "VSL#3® products if unopened and stored under refrigeration (36-46°F or 2-8°C), are guaranteed through the 'Best if used by' date." Page copy: "Unlike many probiotics that only promise potency at the time of manufacture, VSL#3® guarantees potency through expiration when stored as directed." And the insert's quantity wording: "Each capsule contains at least 112.5 billion lyophilized probiotic bacteria" — "at least" is the honest construction. Storage: refrigerate at 36-46°F, stable at room temperature up to two weeks, may be stored frozen until needed but must not be refrozen after thawing.
The panel’s own words on potency, verbatim.
The panel guarantees the count through the expiration or best-by date. This is the only basis that is falsifiable by a reader holding the bottle.
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.
| Organism as printed | Designator as printed | Quantity as printed | What the designator resolves to | The query we ran |
|---|---|---|---|---|
| Streptococcus thermophilus | — none printed | — not stated separately | No designator printed | — |
| Bifidobacterium breve | — none printed | — not stated separately | No designator printed | — |
| Bifidobacterium lactis (previously classified as B. longum) | — none printed | — not stated separately | No designator printed | — |
| Bifidobacterium lactis (previously classified as B. infantis) | — none printed | — not stated separately | No designator printed | — |
| Lactobacillus acidophilus | — none printed | — not stated separately | No designator printed | — |
| Lactobacillus plantarum (correct name: Lactiplantibacillus plantarum) | — none printed | — not stated separately | No designator printed | — |
| Lactobacillus paracasei (correct name: Lacticaseibacillus paracasei) | — none printed | — not stated separately | No designator printed | — |
| Lactobacillus helveticus (previously classified as L. delbrueckii subsp. bulgaricus) | — none printed | — not stated separately | No designator printed | — |
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 — vsl3-product-information-sheet-2026-07-31https://cdn.shopify.com/s/files/1/0222/7614/5232/files/ProductInsert.pdf — Address given, not linked: this site does not link out to the products it audits. captured The brand's Product Information Sheet — the only complete label this product has, and the primary artefact behind this page. It is 3,437,587 bytes, one page, and yields zero extractable characters to both pypdf and pdfminer.six. It was read by rendering it at 1717x3400 px and reading the image. Source for the through-expiry guarantee, the "at least 112.5 billion" wording, Table 1 "Adult Recommended Daily Intake", the storage conditions, the allergen declaration and the "How Supplied" UPC table, which confirms the live barcode 860009487314.
- Dated capture of the brand’s own page — vsl3-probiotic-capsules-2026-07-31https://www.vsl3.com/products/probiotic-capsules — Address given, not linked: this site does not link out to the products it audits. captured The live product page, HTTP 200 to a plain automated fetch, plus products.json. Source for the price, the strain list as the brand prints it, the dosing sentence that contradicts the insert, the claim set, the 2002 "Data on file" survey and the ProVoice footnote.
- NIH Dietary Supplement Label Database record — DSLD 315337 (opens in a new tab) captured Government label record, brand "Alfasigma USA", on-market, UPC 7 45749 01781 9, FDA Statement of Identity "Probiotic Medical Food". Recorded as prior-generation packaging: its UPC does not match the SKU now on sale (860009487314), so the UPC cross-check this audit normally requires FAILED here. Where this record and the current insert disagree, the insert wins. The 2017 predecessor record, DSLD 73496 (VSL Pharmaceuticals, off-market, "Product of USA"), carries the identical UPC.
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
$4.40 a day at the dose the label itself instructs.
- Price
- $65.95 USD
- What that buys
- 60-capsule bottle at $1.0992 per capsule — 7.5 to 15 days at the insert's labeled adult dose
- Price checked
- — the source we read it fromhttps://www.vsl3.com/products/probiotic-capsules — Address given, not linked: this site does not link out to the products it audits.
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 |
|---|---|---|
| FODMAP Friendly Certified | Confirmed at issuer | 31 July 2026 |
| Kosher (Star-K, per the government label record) | Brand-asserted, unverified | 31 July 2026 |
| Halal Certified | Brand-asserted, unverified | 31 July 2026 |
| "Produced under GMP-certified conditions" | Brand-asserted, unverified | 31 July 2026 |
| Third-party contaminant or potency laboratory | Not checked | 31 July 2026 |
FODMAP Friendly Certified
Found on the certifier’s own public register.
Verified at the issuer's own certified-product listing, SKU by SKU. The register returns "VSL#3 112.5B Capsules", "VSL#3 450B Unflavoured Powder Packets", "VSL#3 900B Double Strength Powder Packets" and "VSL4 Gut Capsules" as certified products. This is a real, issuer-side confirmation — and note what it covers: FODMAP content, a dietary attribute. It says nothing about potency, identity or contaminants.
Kosher (Star-K, per the government label record)
The badge is displayed, but the register could not be reached to confirm it. We call this unverified, not false.
Star-K's own product listing (1.14 MB, A-Z filtered) and company listing were searched and no VSL, Alfasigma or Actial entry was found — but the register ignores search parameters server-side (identical byte counts are returned for different queries) and the company page is JavaScript-driven at 21 KB, so the listing read cannot be established as exhaustive. Brand-asserted and unverified, which is not the same as "does not hold it".
Halal Certified
The badge is displayed, but the register could not be reached to confirm it. We call this unverified, not false.
The certifier is not named anywhere — not on the site, not on the insert, not in the government label record. There is no register to query, which makes the claim unverifiable by construction rather than merely unverified.
"Produced under GMP-certified conditions"
The badge is displayed, but the register could not be reached to confirm it. We call this unverified, not false.
No certifying body is named, so there is no issuer at which to check it.
Third-party contaminant or potency laboratory
We have not queried this register for this product. It does not mean the product holds nothing.
None is named, so none could be checked. No laboratory, no certificate of analysis, no heavy-metal panel and no identity-testing statement appears anywhere on the site or in the insert. Note the asymmetry this creates: the one certification that could be verified at an issuer covers a dietary attribute, and nothing at all covers potency, identity or contaminants on a $65.95 refrigerated medical food.
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.
Compared against VSL4® Vaginal Health (sold by the same company on the same website). Diffed .
What the two panels differ by
- Five of five organisms carry full designators on the women's product — L. plantarum ROSELLA, L. rhamnosus Rosell-11, B. bifidum HA-132, L. crispatus Rosell-470 and L. gasseri HA-275 — against zero of eight here. vsl3.com/products/vsl4-vaginal-health panel versus vsl3.com/products/probiotic-capsules, both fetched 2026-07-31
- The women's product names its licensor and its deposit lineage in a footnote: "L. plantarum ROSELLA is L. plantarum P17630 (Proge P17630®), licensed from PROGE FARM®, Italy." Nothing equivalent appears on this product. vsl4-vaginal-health panel footnote, 2026-07-31
- Different regulatory classes. This SKU is a medical food, with the government label record carrying the FDA Statement of Identity "Probiotic Medical Food". VSL4 is a dietary supplement. DSLD 315337 FDA Statement of Identity versus the VSL4 product page, 2026-07-31
- $65.95 for 60 refrigerated capsules at 112.5 billion CFU each, against $28.97 for 30 shelf-stable capsules at 10 billion CFU, with cranberry extract, acacia fibre, vitamin D3, riboflavin and folate alongside the organisms. vsl3.com/products.json?limit=250, full 5-product catalogue, 2026-07-31
What is identical across the pair
- Both are sold by the same company, on the same website, under the same brand family.
- Both print a total CFU figure and neither prints a per-organism allocation.
Every finding on this page, with the record behind it
Finding 1 the-complete-label-yields-zero-extractable-characters
VSL#3's only detailed product document is 3,437,587 bytes, one page, and contains no text at all. Two independent parsers agree: pypdf reports fonts None, a zero-byte content stream, zero /Font objects and zero /Image objects; pdfminer.six extract_text() returns nothing but a form feed. Everything a patient needs — dosing by indication and age, the CFU-basis statement, the allergen list, the UPC table — exists only as rasterised artwork. A screen reader cannot read it. Neither can a search engine, a price-comparison tool or a pharmacist's parser. The direct contrast is in the same category and on the same shelf: the competing eight-species medical food publishes a 12-page, fully extractable insert in FDA prescribing-information format, 39,402 characters of it.
The record: cdn.shopify.com/s/files/1/0222/7614/5232/files/ProductInsert.pdf, 3,437,587 bytes, parsed with pypdf and pdfminer.six on 2026-07-31, both returning zero characters — open ithttps://cdn.shopify.com/s/files/1/0222/7614/5232/files/ProductInsert.pdf — Address given, not linked: this site does not link out to the products it audits.
Finding 2 the-product-page-contradicts-the-brands-own-insert-on-dosing-by-four-times
The page says "Typical adult dosage is 1-2 capsules up to 4 times daily, or as directed by a physician" — a range that starts at one. The brand's own Product Information Sheet, Table 1 "Adult Recommended Daily Intake", gives 4-8 capsules (450-900 billion CFU) for irritable bowel syndrome and 4-8 capsules for ulcerative colitis maintenance, and marks the capsules N/A for pouchitis and for active flaring ulcerative colitis. A patient following the page's low end takes one quarter of the brand's own minimum. On a product sold for the dietary management of a diagnosed condition, a fourfold gap between the sales page and the clinical insert is a real defect. The page also states the capsules are "Formulated for the dietary management of IBS and ulcerative colitis" without the insert's N/A qualifications, and site-wide copy claims the family is "specially designed for the dietary management of irritable bowel syndrome (IBS), ulcerative colitis (UC), and pouchitis."
The record: vsl3.com/products/probiotic-capsules dosing sentence against the Product Information Sheet Table 1, read from the rendered image, both 2026-07-31 — open ithttps://www.vsl3.com/products/probiotic-capsules — Address given, not linked: this site does not link out to the products it audits.
Finding 3 the-real-cost-is-four-to-eight-dollars-a-day-and-is-never-stated
At the insert's minimum labeled adult dose of four capsules, this bottle costs $4.40 a day and lasts fifteen days. At the insert's maximum of eight, it costs $8.79 a day and lasts 7.5 days. A single bottle does not qualify for free shipping, which requires a multipack, a powder, or an order over $101. The page shows $65.95 and a dosing sentence, and states no cost per day at any dose. The arithmetic is entirely the brand's own price divided by the brand's own dosing table.
The record: $65.95 for 60 capsules (vsl3.com, 2026-07-31) against Table 1 of the brand's Product Information Sheet
Finding 4 zero-strain-designators-across-eight-organisms
No DSM, ATCC, CNCM, NCIMB or CECT designator appears anywhere — not on the page, not on the insert, not in any of the three government label records. And no per-organism CFU is disclosed either: one aggregate figure of 112.5 billion across eight organisms, which is functionally identical to a proprietary blend. The aggravating comparison is internal. The same company, on the same website, sells VSL4 Vaginal Health, whose panel names L. plantarum ROSELLA, L. rhamnosus Rosell-11, B. bifidum HA-132, L. crispatus Rosell-470 and L. gasseri HA-275, and adds a footnote identifying ROSELLA as P17630 licensed from PROGE FARM. Five of five, plus the licensor. The capability and the house style exist; they are simply not applied to the flagship medical food.
The record: vsl3.com/products/probiotic-capsules strain list against the VSL4 Vaginal Health panel on the same site, plus DSLD 315337, 315338 and 73496, all 2026-07-31 — open ithttps://www.vsl3.com/products/vsl4-vaginal-health — Address given, not linked: this site does not link out to the products it audits.
Finding 5 the-headline-clinical-citation-does-not-support-what-it-is-cited-for
The page says "In a 2021 clinical study, VSL#3® showed outcomes comparable to those achieved with a low FODMAP diet" and footnotes it to "Ankerson L, et al. J Med Internet Res. 2021; 23(12): e30291." That is Ankersen DV et al. (the brand misspells the first author and gets the initial wrong). Six problems with the citation as deployed. One: the trial dosed VSL#3 sachets at 2 x 450 billion CFU a day — 900 billion, the top of the insert's range, which on this SKU is eight capsules a day at $8.79 — and the claim is printed on the capsules page. Two: it was open-label with no placebo, registry masking "NONE", and the comparator was a diet. Three: enrolment was estimated at 124; 34 IBS patients and 6 healthy controls were actually enrolled, and the reported comparison rests on 21 patients, with the authors writing "Although this study was underpowered, findings from this study warrant further research in a larger sample." Four: the result was an IBS-SSS reduction of -130.00 against -126.50 with P > .99, and a non-significant difference in an underpowered open-label crossover is an absence of evidence, not equivalence. Five: which VSL#3 the trial used is not stated anywhere. Six: the author list includes an affiliation at Ferring International Center SA, and Ferring is a listed industry collaborator on the registry record.
The record: PMID 34904950 (J Med Internet Res 2021;23(12):e30291) and ClinicalTrials.gov NCT03586622, retrieved 2026-07-31, against the citation as printed on vsl3.com — open it (opens in a new tab)
Finding 6 ninety-three-percent-of-gastroenterologists-rests-on-a-2002-survey-marked-data-on-file
Verbatim from the page: "In a 2002 survey of gastroenterologists, 93% reported that IBS patients were satisfied with VSL#3.¹", where footnote 1 reads "Data on file". A 2002 survey necessarily concerns the pre-2016 product. It is unpublished, unverifiable by anyone outside the company, and twenty-four years old. It is not a clinical study, so it likely falls outside the literal wording of the injunction described elsewhere on this page — but it is doing continuity work in the reader's mind that the injunction exists to prevent. The neighbouring claim, "The #1 gastroenterologist-recommended multi-strain probiotics brand", footnotes to "ProVoice® Surveys" with no date, sample size or methodology given.
The record: vsl3.com/products/probiotic-capsules body copy and footnotes, fetched 2026-07-31 — open ithttps://www.vsl3.com/products/probiotic-capsules — Address given, not linked: this site does not link out to the products it audits.
Finding 7 the-same-retail-barcode-survived-a-change-of-manufacturer-and-country
DSLD 73496 is the 2017 VSL Pharmaceuticals label, marked "Product of USA" and "Made in the USA". DSLD 315337 is the 2024 Alfasigma USA label, marked "Product of Italy". Both carry the identical UPC 7 45749 01781 9. The same retail barcode persisted across a change of manufacturer, a change of country of manufacture, and — per the litigation record — a change of formulation. A shopper scanning the barcode could not have detected any of it. Separately, neither record matches the SKU now on sale, whose barcode is 860009487314 under a different GS1 prefix.
The record: DSLD 73496 (entry 2017-05-24, off-market) and DSLD 315337 (entry 2024-10-24, on-market), both UPC 7 45749 01781 9, against the live storefront barcode 860009487314 — open it (opens in a new tab)
Finding 8 a-federal-injunction-governs-what-this-brand-may-claim-and-the-page-does-not-mention-it
Verified at the issuing court's own published opinion — De Simone; ExeGi Pharma, LLC v. VSL Pharmaceuticals, Inc.; Alfasigma USA, Inc., Nos. 20-1846 and 20-1869, US Court of Appeals for the Fourth Circuit, argued 2022-01-27, decided 2022-06-07, published, affirmed. A jury found Leadiant and Alfasigma liable for false advertising under the Lanham Act, awarding ExeGi $15 million, and found VSL liable for breaching its licence with De Simone, awarding him $967,435. The district court's permanent injunction, quoted verbatim in the opinion, bars them from "(1) stating or suggesting in VSL#3 promotional materials directed at or readily accessible to United States consumers that the present version of VSL#3 produced in Italy ("Italian VSL#3") continues to contain the same formulation found in the versions of VSL#3 produced before January 31, 2016 ("the De Simone Formulation")... and (2) citing to or referring to any clinical studies performed on the De Simone Formulation or earlier versions of VSL#3 as relevant or applicable to Italian VSL#3." The practical consequence for any comparison table: the roughly 410 PubMed records indexed under "VSL#3" are not transferable to the product now sold under that name, and a US court has said so in terms. None of this is disclosed on the consumer product page.
The record: US Court of Appeals for the Fourth Circuit, No. 20-1846, published opinion, 29 pages, text extracted 2026-07-31 — open ithttps://www.ca4.uscourts.gov/opinions/201846.P.pdf — Address given, not linked: this site does not link out to the products it audits.
Finding 9 the-current-seller-of-record-is-not-the-company-most-sources-name
vsl3.com's Terms of Service state verbatim that "The Site is owned and operated by Actial Nutrition, Inc.", and the Product Information Sheet reads "Manufactured for Actial Nutrition, Inc. Lafayette, CO 80026 ©2023." Alfasigma is not the current US seller. A residual trace of the prior owner remains in plain sight: the storefront's Shopify handle is still alfasigmausa.myshopify.com.
The record: vsl3.com/policies/terms-of-service and the Product Information Sheet, both read 2026-07-31 — open ithttps://www.vsl3.com/policies/terms-of-service — Address given, not linked: this site does not link out to the products it audits.
Finding 10 the-dietary-supplement-disclaimer-sits-on-a-medical-food-page
This product openly names diseases — IBS, ulcerative colitis, pouchitis. For a dietary supplement that would be a straightforward illegal disease claim. It is not a dietary supplement: medical foods are a distinct FDA category under the Orphan Drug Act and are defined by being for the dietary management of a specific disease, so naming the disease is the category working as intended. Do not report this product for making disease claims. What is incoherent is the footer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease" is the dietary-supplement disclaimer, sitting under a page that says the product is formulated for the dietary management of ulcerative colitis. The brand is running both regulatory postures at once. The government label record adds a third oddity: it carries the FDA Statement of Identity "Probiotic Medical Food" while sitting in the Dietary Supplement Label Database.
The record: vsl3.com/products/probiotic-capsules footer against its own indication copy, plus the FDA Statement of Identity field in DSLD 315337 — open it (opens in a new tab)
Finding 11 no-mens-outcome-evidence-and-no-mens-product-in-a-five-product-catalogue
The complete VSL catalogue is five products: VSL#3 Capsules, VSL#3 Powder, VSL#3 DS Powder, VSL4 Gut Capsules and VSL4 Vaginal Health. Exactly one is sex-targeted, and it is the women's one. No men's claim, no men's SKU, no male-specific ingredient. And the query VSL#3 AND (men[Title] OR male[Title] OR mens[Title]) returns three records, all of them animal — mouse bone loss, rat neurotoxicity, mouse cognition. There is a genuine men's-urological literature attached to the De Simone Formulation, and it is recorded on the Visbiome page in this batch rather than here, because the court record bars treating pre-2016 trials as applicable to this product.
The record: vsl3.com/products.json?limit=250 (5 products, all enumerated) plus PubMed E-utilities, run 2026-07-31
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.
- Kosher (Star-K, per the government label record) status
- Star-K's own product listing (1.14 MB, A-Z filtered) and company listing were searched and no VSL, Alfasigma or Actial entry was found — but the register ignores search parameters server-side (identical byte counts are returned for different queries) and the company page is JavaScript-driven at 21 KB, so the listing read cannot be established as exhaustive. Brand-asserted and unverified, which is not the same as "does not hold it".
- Halal Certified status
- The certifier is not named anywhere — not on the site, not on the insert, not in the government label record. There is no register to query, which makes the claim unverifiable by construction rather than merely unverified.
- "Produced under GMP-certified conditions" status
- No certifying body is named, so there is no issuer at which to check it.
- Third-party contaminant or potency laboratory status
- None is named, so none could be checked. No laboratory, no certificate of analysis, no heavy-metal panel and no identity-testing statement appears anywhere on the site or in the insert. Note the asymmetry this creates: the one certification that could be verified at an issuer covers a dietary attribute, and nothing at all covers potency, identity or contaminants on a $65.95 refrigerated medical food.
- Whether the government label records describe the product now on sale
- They do not appear to. The live storefront barcode is 860009487314 and the insert's "How Supplied" table agrees with it, but DSLD 315337 (brand "Alfasigma USA", entry 2024-10-24) and DSLD 73496 (brand "VSL Pharmaceuticals", entry 2017-05-24, off-market) both carry UPC 7 45749 01781 9. The UPC cross-check therefore failed, and everything taken from DSLD on this page is labelled as prior-generation packaging rather than as the panel now in the bottle. Where the current insert and DSLD disagree, the insert wins.
- Which VSL#3 formulation was used in the one clinical study the brand cites by name
- It is not stated in the paper, the abstract or the trial registry. Ankersen 2021 (PMID 34904950, NCT03586622) is a single-centre Danish trial that started 2018-09-23 — after the January 2016 formulation change — with Ferring Pharmaceuticals listed as an industry collaborator, and neither the manufacturer nor the origin of the sachets is recorded anywhere. This is material rather than pedantic, and nothing is asserted either way.
- The Star-K kosher certification
- Star-K's product and company registers were searched and no entry was found, but the register's search is non-functional server-side — different queries return identical byte counts — and the company page is JavaScript-driven, so the listing read cannot be shown to be exhaustive. Recorded as brand-asserted and unverified rather than absent.
- The halal certification
- The certifier is not named on the site, on the insert, or in the government label record. There is nothing to look up.
- A machine-readable version of the product's own label
- There is none. The Product Information Sheet is 3,437,587 bytes, one page, and yields zero extractable characters — verified two independent ways: pypdf reports fonts None, a zero-byte content stream, a /Font count of 0 and an /Image count of 0; pdfminer.six extract_text() returns a single form-feed character. The dosing tables, the CFU-basis statement, the allergen list and the UPC table were read by rendering the PDF at 1717x3400 px and reading the image.
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.
Two eight-organism probiotic medical foods sit on the same shelf at almost the same price. One publishes a twelve-page insert in FDA prescribing-information format with 39,402 characters of extractable text and a deposit designator for every organism it contains. The other publishes a picture.
VSL#3’s Product Information Sheet is its only complete label. It is 3.4 MB, one page, and yields zero extractable characters — confirmed two independent ways, with pypdf reporting no fonts and a zero-byte content stream, and pdfminer.six returning nothing but a form feed. The dosing tables, the potency guarantee, the allergen list and the UPC table exist only as rasterised artwork. It was read here by rendering the file at 1717×3400 pixels and looking at it. A screen reader cannot do that. Neither can a search engine, a comparison tool, or a pharmacist’s parser.
Inside that picture is the dosing table, and the dosing table does not agree with the shop. The page says “Typical adult dosage is 1–2 capsules up to 4 times daily.” Table 1 of the insert says 4–8 capsules for irritable bowel syndrome and 4–8 for ulcerative colitis maintenance, and marks the capsules N/A for pouchitis and for active flaring UC. A patient who follows the page’s low end takes a quarter of the brand’s own minimum.
Run the brand’s own price through the brand’s own table and the shelf-price intuition collapses. Not $1.10 a capsule — $4.40 a day at the labeled minimum, with the bottle gone in fifteen days; $8.79 a day at the labeled maximum, gone in 7.5. A single bottle does not even qualify for free shipping. No cost per day appears anywhere on the page, at any dose.
Then the panel. Eight organisms, zero designators — no DSM, no ATCC, no CNCM, no CECT, on the page, on the insert, or in any of the three government records — and one aggregate CFU figure across all eight, which is a proprietary blend in everything but name. The comparison that makes this damning is not with a competitor. It is with the same company’s own website, where VSL4 Vaginal Health names five of five organisms with full designators and footnotes the licensor. The house style exists. It is applied to the $28.97 women’s supplement and withheld from the $65.95 physician-supervised medical food.
Credit where it is due, and there is real credit here: the potency guarantee is the strong form — “guaranteed through the ‘Best if used by’ date”, with the quantity stated as “at least” 112.5 billion — the cold chain is genuine, the FODMAP Friendly certification was confirmed at the certifier’s own register SKU by SKU, the physician testimonials are named and attributed, and a dosing table by indication and by age is more than almost any consumer probiotic attempts. Naming IBS and ulcerative colitis is legal and appropriate for a medical food; this product is not making illegal disease claims and should not be reported as though it were.
What it is doing is resting a lot of weight on very little. The one clinical study it cites by name was open-label, had no placebo, was declared underpowered by its own authors, was analysed on 21 patients, was dosed in sachets at 900 billion CFU a day, is printed on the capsules page, and never states which formulation it used. The “93% of gastroenterologists” figure is a 2002 survey sourced to “Data on file”. And a federal appellate court has affirmed an injunction barring this product’s sellers from citing the pre-2016 clinical literature as applicable to it — a fact that appears nowhere on the page.