One product, one panel, one record.
Visbiome (ExeGi Pharma, LLC) Advanced GI Care Packets, 30 packets (formerly Visbiome Unflavored Packets) — medical food — label audit
Eight organisms, eight unique strain designators, two depositary accessions each — one of 99 labels in this audit that designate every organism they contain, and the same eight accessions appear on both sibling Visbiome SKUs — and the potency-through-expiry guarantee exists only in website copy, not in the twelve-page package insert, while the competitor it sued for false advertising prints that same guarantee on its physical label.
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 at all — it is a medical food, one regulatory lane above every SKU in D₂₇. It sits outside every D₂₇ denominator this site publishes and exists on the site as a control group: 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 Four things on this page are bounded and must not be quoted loosely. First, the two human RCTs found under printed accessions SD5219 and SD5220 are trials of single strains or small pairs, at their own doses, for allergic rhinitis and antibiotic-associated microbiota disturbance — outcomes this product does not claim. They establish provenance, not efficacy for this eight-strain consortium, and mapping those accessions to the commercial strains La-14, Bl-04 and Bi-07 is a supported inference from accession identity, not a brand-stated fact. Bi-07 is recorded at moderate confidence only. Second, the Monash Low FODMAP and Kosher claims are unverified, not absent — the first register is app-gated, the second names no agency. Third, the DSM accessions themselves could not be confirmed at DSMZ. Fourth, the claim that FDA has ruled IBS ineligible as a medical-food indication was checked against the primary guidance, was not found there, and is published in neither direction. What did survive in full: all eight strain designators, the Clean Label Project certification confirmed at the issuer, the absence of any potency-basis language in the 12-page insert, the 23-study enumeration against the "100+" claim, the FAQ/insert mismatch on hepatic encephalopathy, and the zero counts for every gendered term across the product pages and the catalogue.
The Label Verifiability Score for this product
50.3 out of 100
Rank 93 of the 154 products in this audit the rubric can score. This rank is shared with 1 other product — 2 products sit on 50.3 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 | 8 of 8 organism slots carry a printed strain designator. | 8 / 8 = 1.0000 | 0.2400 |
| 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-off-label-only": CFU figure printed yes, single basis stated no, basis reaches expiry no — 1 of 3. | 1 / 3 = 0.3333 | 0.073333 |
| Printed designators that lead to a human trial | 0.20 | 2 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. | 2 / 8 = 0.2500 | 0.0500 |
| 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 |
0.503333 — the last column added up — divided by 1.00, the weight this record could answer, is 0.5033. Multiplied by 100 and rounded to one decimal, that is the 50.3 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 | 450 billion CFU per packet (single aggregate across all eight organisms; no per-strain split) |
| What that count is measured against | Through expiry — off-label only |
| Strain designators | All organisms coded |
| Organism slots transcribed here | 8 — the full panel |
| Marketed as | Unisex |
Website, product page "Storage" tab: "Guaranteed Potency Through Best-By Date — If unopened and stored under refrigeration". The 12-page June 2026 package insert says nothing of the kind — the extracted insert text was searched for "best", "expir", "guarante" and "shelf" and returned zero matches. Insert §12 states only: "VISBIOME is shipped and stored cold to ensure maximum potency (36-46° F / +2 - +8° C). Do not freeze. VISBIOME can be stored at room temperature for up to one week without adversely impacting potency." That is a handling instruction, not a potency guarantee.
The panel’s own words on potency, verbatim.
The brand page promises a through-expiry count. The printed panel does not. Only the panel is a label claim.
Every organism on the panel carries a printed strain designator. Whether those designators lead anywhere is a separate question, answered below.
| Organism as printed | Designator as printed | Quantity as printed | What the designator resolves to | The query we ran |
|---|---|---|---|---|
| Lactobacillus acidophilus | DSM24735 / SD5212 | — not stated separately | Animal or in-vitro only | DSM24735 · DSM 24735 · SD5212 · SD-5212 |
| Lactobacillus plantarum | DSM24730 / SD5209 | — not stated separately | Animal or in-vitro only | DSM24730 · DSM 24730 · SD5209 · SD-5209 |
| Lactobacillus paracasei | DSM24733 / SD5218 | — not stated separately | No records | DSM24733 · DSM 24733 · SD5218 · SD-5218 |
| Lactobacillus delbrueckii subsp. bulgaricus | DSM24734 / SD5210 | — not stated separately | No records | DSM24734 · DSM 24734 · SD5210 · SD-5210 |
| Streptococcus thermophilus | DSM24731 / SD5207 | — not stated separately | No records | DSM24731 · DSM 24731 · SD5207 · SD-5207 |
| Bifidobacterium longum (correct name: Bifidobacterium lactis) | DSM24736 / SD5219 | — not stated separately | Human RCT | DSM24736 · DSM 24736 · SD5219 |
| Bifidobacterium breve | DSM24732 / SD5206 | — not stated separately | Animal or in-vitro only | DSM24732 · SD5206 · SD-5206 |
| Bifidobacterium infantis (correct name: Bifidobacterium lactis) | DSM24737 / SD5220 | — not stated separately | Human RCT | DSM24737 · DSM 24737 · SD5220 |
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 — visbiome-package-product-insert-june-2026https://cdn.shopify.com/s/files/1/0736/3645/files/Visbiome_Package_Product_Insert_June2026.pdf — Address given, not linked: this site does not link out to the products it audits. captured The authoritative label document for both packet SKUs — 12 pages, June 2026 revision, fetched directly and extracted in full. Source for the eight strains and their DSM/SD accessions (§3.2), the two reclassification footnotes, the maltose excipient and the 14-row allergen table (§5), the storage instruction and Product Code table (§12), the certification claims (§13) and a 65-item bibliography. This is where the potency-through-expiry guarantee is absent.
- Dated capture of the brand’s own page — visbiome-advanced-gi-care-pdp-2026-07-31https://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits. captured Live product page, HTTP 200 — the URL slug still reads visbiome-unflavored but the page now serves the renamed SKU, confirmed by the insert §12 heading "VISBIOME ADVANCED GI CARE PACKETS (Formerly Visbiome Unflavored Packets)". Source for price and subscription terms, the "Guaranteed Potency Through Best-By Date" storage claim, the "100+ Clinical Studies" claim and the 23-study substantiation block, the hepatic-encephalopathy FAQ answer, the "Clinically Effective" badge and the DSHEA footer disclaimer. The ingredient panel is present as text, not trapped in a JPEG.
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, 2 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
$3.57 a day at the dose the label itself instructs.
- Price
- $106.95 USD
- What that buys
- 30-packet box (30 servings at the Advanced IBS dose of 1 packet daily). $96.26/delivery on Subscribe & Save.
- Price checked
- — the source we read it fromhttps://www.visbiome.com/products/visbiome-unflavored — 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 |
|---|---|---|
| Clean Label Project Certified | Confirmed at issuer | 31 July 2026 |
| Low FODMAP Certified by Monash University | Brand-asserted, unverified | 31 July 2026 |
| Kosher certified (certifying agency not named) | Brand-asserted, unverified | 31 July 2026 |
| Halal suitable (self-assessment, not a certification claim) | Brand-asserted, unverified | 31 July 2026 |
Clean Label Project Certified
Found on the certifier’s own public register.
The certifier's own server-rendered search results list "Visbiome Advanced GI Care" and "Visbiome Extra Strength" (plus GI Care, GI Care Kids, Unflavored Sachets (Canada) and four Visbiome Vet SKUs), all dated 2026-05-26. Scope limit, stated plainly: Clean Label Project tests for contaminants — heavy metals, pesticides, residues. It says nothing about CFU count, strain identity, potency at expiry or clinical efficacy. It is a purity mark, not a potency mark. Access note — cleanlabelproject.org/wp-json/wp/v2/clp-product returns HTTP 403 and the individual product pages render via JavaScript, so this verification rests on the issuer's own results page.
Low FODMAP Certified by Monash University
The badge is displayed, but the register could not be reached to confirm it. We call this unverified, not false.
Asserted in insert §13. Monash's certified-product list lives inside their mobile app, not on the public web; /certified-products/ and /fodmap-certified-products/ both return HTTP 404, the public "Low FODMAP Certified partners" page does not contain the string "Visbiome", and the site has no working search parameter. This is not a statement that they lack the certification. It could not be checked.
Kosher certified (certifying agency not named)
The badge is displayed, but the register could not be reached to confirm it. We call this unverified, not false.
Insert §13, verbatim - "VISBIOME is Kosher certified." The certifying agency is not named anywhere in the insert or on the product pages, so no register exists to query. Unverifiable by construction. For contrast, the DSLD transcription of the competitor VSL#3 label names its agency, Star-K, and declares the seal.
Halal suitable (self-assessment, not a certification claim)
The badge is displayed, but the register could not be reached to confirm it. We call this unverified, not false.
The insert says "VISBIOME is Halal suitable" — a materially weaker phrase than "Halal certified", and one that appears deliberately chosen. No certifier is named. Recorded here because the wording choice is the finding, not because a certification was claimed.
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 proprietary-blend-by-the-manufacturers-own-word
The insert calls the De Simone Formulation "a proprietary blend of the following live, lyophilized probiotic bacteria" in §3.2 and repeats it in §12. Identity of all eight strains is disclosed; the per-strain CFU split is not. 450 billion is an aggregate.
The record: Visbiome Package/Product Insert, June 2026 revision, §3.2 and §12 — open ithttps://cdn.shopify.com/s/files/1/0736/3645/files/Visbiome_Package_Product_Insert_June2026.pdf — Address given, not linked: this site does not link out to the products it audits.
Finding 2 potency-at-expiry-guarantee-exists-only-in-website-copy
The strongest form of the potency claim — "Guaranteed Potency Through Best-By Date" — appears in the product page's Storage tab and nowhere in the 12-page package insert, which returns zero matches for "best", "expir", "guarante" and "shelf". Website copy can be changed silently; a package insert generally cannot.
The record: visbiome.com Storage tab versus Visbiome Package/Product Insert, June 2026, searched in full — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
Finding 3 the-product-it-sued-prints-the-same-guarantee-on-the-label
The government's own transcription of the VSL#3 label reads "If stored under refrigeration, the product is guaranteed through 'Best if used by' date." Both products claim at-expiry potency. Only one has it in the controlled document, and it is not this one.
The record: DSLD 315338 (VSL#3 Unflavored, 30 packets, Alfasigma USA) — open it (opens in a new tab)
Finding 4 one-hundred-plus-clinical-studies-is-unenumerated
The page claims "100+ Clinical Studies" and "25+ Years of continuous research". Its own substantiation block directly beneath enumerates 23 — IBS 10, UC 8, AAD 1, Ileal Pouch 4. The quoted PubMed count for "De Simone Formulation" is 22. The only route to 100+ runs through the VSL#3 trademark literature, which includes reviews, letters, editorials, animal work and the post-2016 reformulated VSL#3 that Visbiome's own litigation page argues is a different product.
The record: visbiome.com product page substantiation block, 2026-07-31; PubMed "De Simone Formulation" (quoted) = 22 — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
Finding 5 website-asserts-an-indication-the-package-insert-does-not
The product-page FAQ lists hepatic encephalopathy as an intended use. The June 2026 package insert's INTENDED USE section lists four conditions and does not include it; §11 has clinical subsections 11.1 IBS, 11.2 UC, 11.3 AAD and 11.4 Ileal Pouch, and no HE subsection. The insert's bibliography cites HE literature, but a reference is not an intended use.
The record: visbiome.com product-page FAQ versus Visbiome Package/Product Insert, June 2026, INTENDED USE and §11 — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
Finding 6 dshea-supplement-disclaimer-under-medical-food-disease-claims
The site footer on the same page as the disease claims reads "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." That is the dietary-supplement disclaimer, and it directly contradicts the page's own headline function — the dietary management of two named diseases.
The record: visbiome.com product page footer, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
Finding 7 kosher-certifier-not-named-and-monash-register-app-gated
Two of the four certification claims cannot be checked. The Kosher claim names no agency; the Monash Low FODMAP register lives in a mobile app. "Halal suitable" is not a Halal certification and reads as a deliberately chosen weaker phrase.
The record: Visbiome Package/Product Insert, June 2026, §13; monashfodmap.com public partner list, 2026-07-31 — open ithttps://www.monashfodmap.com/product-and-recipe-certification-program/our-certified-partners/ — Address given, not linked: this site does not link out to the products it audits.
Finding 8 aad-indication-rests-on-a-single-cited-trial
The page claims antibiotic-associated diarrhoea as an indication supported by one study (Selinger et al., J Hosp Infect 2013;84(2):159-65) and banners the outcome as "Reduction in antibiotic side effect." One trial is a thin basis for a labelled intended use.
The record: visbiome.com substantiation block, ref 19, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
Finding 9 ndc-format-product-codes-in-a-medical-food-insert
Insert §12 lists product codes in 5-4-2 NDC format, including 69355-0412-02 for this SKU. FDA's medical-food guidance Q17 states that medical-food labelling "should not include NDC numbers" and that their presence "misbrands the product under section 403(a)(1)". openFDA returns no match for labeler_name 69355, labeler_name ExeGi or product_ndc 69355-0412 — so these are NDC-formatted identifiers that are not registered NDCs.
The record: Insert §12 Product Code table; FDA Medical Foods FAQ 3rd Ed. Q17; openFDA NDC directory, three null lookups — open it (opens in a new tab)
Finding 10 clinically-effective-badge-and-proving-its-efficacy
A "Clinically Effective" badge sits next to the price, and the page says its formulation has had "numerous clinical studies proving its efficacy". "Proving" is absolute. The underlying literature is 23 enumerated trials of varying size and quality in specific populations.
The record: visbiome.com product page, badge adjacent to price, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
Finding 11 label-gallery-is-javascript-only
The ten-image label gallery loads via JavaScript and the raw HTML carries exactly one CDN image URL, so the carton copy is not machine-readable from the brand's own site. The ingredient panel itself is text — this is a partial version of the category-wide problem, in a better-behaved brand.
The record: visbiome.com product page HTML, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
Finding 12 two-cent-discount-rendering-inconsistency-across-both-packet-skus
The page headline renders the discounted price as $96.24 while the subscription block on the same page renders $96.26/delivery and states the saving as $10.69 ($106.95 − $10.69 = $96.26; $106.95 × 0.90 = $96.255). The same 2-cent gap reproduces on the Extra Strength SKU. Trivial in dollars, notable because it is systematic — a rounding bug in the theme's discount renderer, not a typo.
The record: visbiome.com product pages for both packet SKUs, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
Finding 13 cold-chain-with-a-seven-day-room-temperature-tolerance
The product requires refrigeration, is not shipped to AK, HI, PR or USVI, and tolerates room temperature for seven days. A delayed summer delivery can plausibly land a degraded product. The brand ships a temperature sensor card, which is an honest acknowledgement that the risk is real.
The record: visbiome.com shipping and storage statements; Insert §12 storage instruction — open ithttps://www.visbiome.com/products/visbiome-unflavored — Address given, not linked: this site does not link out to the products it audits.
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.
- Low FODMAP Certified by Monash University status
- Asserted in insert §13. Monash's certified-product list lives inside their mobile app, not on the public web; /certified-products/ and /fodmap-certified-products/ both return HTTP 404, the public "Low FODMAP Certified partners" page does not contain the string "Visbiome", and the site has no working search parameter. This is not a statement that they lack the certification. It could not be checked.
- Kosher certified (certifying agency not named) status
- Insert §13, verbatim - "VISBIOME is Kosher certified." The certifying agency is not named anywhere in the insert or on the product pages, so no register exists to query. Unverifiable by construction. For contrast, the DSLD transcription of the competitor VSL#3 label names its agency, Star-K, and declares the seal.
- Halal suitable (self-assessment, not a certification claim) status
- The insert says "VISBIOME is Halal suitable" — a materially weaker phrase than "Halal certified", and one that appears deliberately chosen. No certifier is named. Recorded here because the wording choice is the finding, not because a certification was claimed.
- The per-strain CFU split
- 450 billion is a single aggregate across eight organisms. Any one of the eight could be a token fraction of it. The manufacturer's own insert calls it "a proprietary blend" in §3.2 and §12, so this is the brand's word, not an inference. Visbiome is fully transparent on identity and opaque on proportion — the exact inverse of the usual failure mode in this category.
- Monash University Low FODMAP certification
- The issuer's register is inside a mobile app. The public partner list does not contain "Visbiome", the two plausible register URLs return 404, and the site has no working search. Brand-asserted, unverified — not absent.
- The Kosher certifying agency
- The insert claims Kosher certification and names no agency, so there is no register to check. A certification whose issuer is unnamed cannot be verified by anyone.
- The DSMZ deposit numbers DSM24730–DSM24737 at the depositary itself
- dsmz.de/collection/catalogue/details/culture/DSM-##### returns a JavaScript search shell containing none of the queried accession numbers to an automated fetch. The deposits are independently corroborated for three of the eight strains through the paired ATCC "SD" accessions, which is a stronger result than the DSMZ page would have given — but the DSMZ records themselves were not confirmed.
- The physical carton copy
- The product page's ten-image gallery loads via JavaScript; the raw HTML contains exactly one CDN image URL. The carton — which is where a potency-basis statement would legally live — is not retrievable as text from the brand's own site.
- Funding and author affiliation for the 23 De Simone Formulation studies listed on the page
- Full text was not pulled. Do not characterise their sponsorship in either direction.
- Whether FDA has ruled IBS ineligible as a medical-food indication
- FDA's "Frequently Asked Questions About Medical Foods; Third Edition" was fetched in full (12 pp.). It addresses pregnancy (Q22–Q23) and diabetes mellitus (Q25–Q26) explicitly and does not mention irritable bowel syndrome, ulcerative colitis, pouchitis or probiotics anywhere. A web-search summary asserted otherwise; that assertion was not reproduced from the primary document and is not published here. Unverified either way.
- The downstream consequences of the VSL#3 litigation asserted on visbiome.com
- The brand's "Note to Healthcare Professionals" page recounts wholesalers delisting VSL#3, six universities halting trials and a Canadian withdrawal dated 15 November 2018. The page is undated and written in the present tense about 2018–2019 events. The jury verdict and the Fourth Circuit affirmance are verified; this consequences list is brand-asserted and was not checked item by item.
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.
Give this product what it has earned, because on the axis this project cares about most it is among the best labels in the corpus — its GI Care sibling names the same eight organisms with the same designators.
It names every organism it contains, twice. Eight strains, eight unique DSM accessions, eight paired ATCC special-deposit accessions — L. acidophilus DSM24735/SD5212, L. plantarum DSM24730/SD5209, L. paracasei DSM24733/SD5218, L. delbrueckii subsp. bulgaricus DSM24734/SD5210, S. thermophilus DSM24731/SD5207, B. longum DSM24736/SD5219, B. breve DSM24732/SD5206, B. infantis DSM24737/SD5220 — with the label printing its own reclassification footnotes rather than hiding behind stale taxonomy. One excipient. A 14-row allergen table. An ingredient panel that exists as text.
And a certification, Clean Label Project, that was confirmed on the certifier’s own website — one of very few in this project that survived a trip to the issuer.
Now the three findings that matter.
The potency guarantee is in the marketing, not in the label document. The website promises “Guaranteed Potency Through Best-By Date.” The twelve-page package insert — searched in full for best, expir, guarante and shelf — says nothing of the kind. Its only relevant sentence is a handling instruction. The sharp version of this finding is the comparison: VSL#3, the product Visbiome successfully sued for false advertising, prints that guarantee on its physical label, per the US government’s own transcription. Both claim at-expiry potency; only one put it somewhere it cannot be quietly edited.
“100+ clinical studies” is not enumerated anywhere. The page’s own substantiation block, directly beneath the claim, lists 23. The quoted PubMed count for the formulation is 22. The only path to 100+ runs through the VSL#3 trademark literature — which includes the post-2016 reformulation that Visbiome’s own litigation page argues is a different product. The 23 are the honest number, and on their own they are a stronger evidence base than any dietary supplement in this corpus.
The identity is complete; the proportion is not. 450 billion is one aggregate across eight organisms, and the manufacturer’s own insert calls it “a proprietary blend.” Fully transparent on identity, opaque on proportion — the exact inverse of the usual failure mode, and a better trade if you have to pick one. It is still a proprietary blend, by the brand’s own word.
Then there is the thing this SKU is on the site to demonstrate. There is no men’s Visbiome and no women’s Visbiome. Every gendered term across both product pages and the full catalogue returns zero. The line segments on condition and dose — IBS, advanced IBS, UC, AAD, ileal pouch, paediatric; 112.5B, 225B, 450B, 900B — and nothing else. The one product family with 23 enumerated human trials behind it does not think sex is a variable in its dosing table. Everything a “men’s probiotic” implies is absent from the product line built by the people who ran the trials.
One more thing a reader is owed, because the category invites the mistake: “medical food” does not mean FDA-reviewed. It is a labelling permission to name diseases, granted with exactly as much efficacy review as a gummy receives — none. Visbiome says so itself, in its own FAQ: “Visbiome® is a medical food as defined by the Orphan Drug Act and additional FDA regulations. Visbiome is not an FDA approved Drug.” Credit for that. Then read the footer on the same page, which carries the dietary supplement disclaimer telling you the product is “not intended to diagnose, treat, cure or prevent any disease” — directly under two named disease claims.