One product, one panel, one record.

Visbiome (ExeGi Pharma, LLC) Extra Strength GI Care Packets, 30 packets (formerly Visbiome Extra Strength Packets) — medical food — label audit

The 900-billion SKU is byte-identical to the 450-billion one on every axis except dose — same eight strains, same designators, same excipient, same undisclosed split — and it is labelled for advanced ulcerative colitis and ileal pouch management, which makes its best-in-batch price per CFU the wrong reason to buy it and its worst-case $10.67 a day among the two highest ongoing costs in this corpus, alongside Xymogen ProbioMax Complete 350B at $10.47.

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 a medical food, one regulatory lane above every SKU in D₂₇. It sits outside every D₂₇ denominator this site publishes and exists here as part of the control group 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 This SKU shares its label document, and therefore its caveats, with Visbiome Advanced GI Care. Four bounded items. 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 the mapping of those accessions to La-14, Bl-04 and Bi-07 is a supported inference from accession identity, not a brand-stated fact; Bi-07 at moderate confidence only. Second, the Monash Low FODMAP and Kosher claims are unverified rather than absent. Third, the DSM accessions could not be confirmed at DSMZ. Fourth, the statement that the two packet SKUs share the same ratios rests on identical extracted panel text, not on a disclosed split — the split is undisclosed for both, so ratio identity cannot be asserted. What did survive in full: all eight strain designators, the Clean Label Project certification confirmed at the issuer under this SKU's own name, the absence of any potency-basis language in the 12-page insert, the price ladder arithmetic, 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.

How the 50.3 is arrived at: the five components of the Label Verifiability Score, each with the weight it carries and the fraction this label actually earned.
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
The five weights sum to 1.00. This record answers all five, so the divisor below is that full 1.00 and nothing has been renormalised away. Fractions are shown to four decimals and the weighted values to six, which is the precision at which adding the last column by hand, dividing, and rounding to one decimal reproduces the published score on every product in this audit. The site's own arithmetic uses the exact fractions and rounds once at the end, so the printed total can differ from the column's own sum in the sixth decimal and never in the score. Recomputed from this product's own record on every build. A stored score that no longer follows from the record it summarises fails the build.

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.

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.

What Visbiome (ExeGi Pharma, LLC) Extra Strength GI Care Packets, 30 packets (formerly Visbiome Extra Strength Packets) — medical food discloses, as recorded from its label and label record.
Disclosure As recorded
CFU as printed 900 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 — the same document that governs this SKU and the Advanced GI Care packet — 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.

Every organism named on the panel of Visbiome (ExeGi Pharma, LLC) Extra Strength GI Care Packets, 30 packets (formerly Visbiome Extra Strength Packets) — medical food, in panel order, with what its designator resolves to.
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
The query column is the exact search string, so that a reader can re-run it and get our result or a different one.

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 pagevisbiome-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 this SKU — 12 pages, June 2026 revision, fetched directly and extracted in full. The same insert governs both packet SKUs. Source for the eight strains and their DSM/SD accessions (§3.2), the reclassification footnotes, the maltose excipient and 14-row allergen table (§5), storage and the Product Code table (§12) including 69355-0516-01 for Extra Strength, and the certification claims (§13). This is the document in which the potency-through-expiry guarantee is absent.
  • Dated capture of the brand’s own pagevisbiome-extra-strength-pdp-2026-07-31https://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits. captured Live product page, HTTP 200. Source for price and subscription terms, the 900B per-packet figure, the advanced-UC and ileal-pouch dosing, the ingredients tab whose extracted text is character-for- character identical to the Advanced GI Care page, and the "1 Studies" rendering of the antibiotic-associated-diarrhoea substantiation block.

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

$5.33 a day at the dose the label itself instructs.

Price
$160.00 USD
What that buys
30-packet box (30 servings at the Advanced UC dose of 1 packet daily). $144.00/delivery on Subscribe & Save.
Price checked
the source we read it fromhttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

For context, the median verified cost across the frozen founding cohort is $1.52 a day — about $553 a year. The two figures come off one median: 24 priced products give an even count, so the median is the mean of the two middle ones, $1.515 a day. The daily figure is that rounded to the cent; the annual figure is $1.515 × 365 = $ 552.975, rounded to the dollar. Annualising the rounded $1.52 instead gives $ 554.80, which is why the rule is printed rather than left for you to guess at.

That median runs over 24 products, not 27: three of the founding teardowns have no verifiable US price at all, and are excluded rather than estimated. It is not a median over every teardown on this site.

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.

Certification claims for Visbiome (ExeGi Pharma, LLC) Extra Strength GI Care Packets, 30 packets (formerly Visbiome Extra Strength Packets) — medical food, each checked at the issuer’s own register.
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 Extra Strength" by name, together with Visbiome Advanced GI Care, GI Care, GI Care Kids, Unflavored Sachets (Canada) and four Visbiome Vet SKUs, all dated 2026-05-26. Scope limit: Clean Label Project tests for contaminants — heavy metals, pesticides, residues. It says nothing about CFU count, strain identity, potency at expiry or clinical efficacy. A purity mark, not a potency mark.

The register we queried (opens in a new tab)

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; /certified-products/ and /fodmap-certified-products/ both return HTTP 404, the public partner page does not contain the string "Visbiome", and the site has no working search parameter. Not a statement that they lack it — it could not be checked.

The register we queried https://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.

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." No agency is named anywhere in the insert or on the product pages, so no register exists to query. For contrast, the DSLD transcription of the VSL#3 label names 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" rather than "Halal certified" — a weaker phrase that appears deliberately chosen, with no certifier named. Recorded because the wording is the finding.

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 worst-case-ongoing-cost-of-use-in-the-corpus

At $160 a box and up to 2 packets a day for ileal pouch management, worst-case cost of use is $10.67 a day, roughly $324 a month. That is level with the highest ongoing per-day cost in this corpus by a wide margin — justifiable for the indicated population, a very expensive mistake for anyone self-selecting into it.

The record: visbiome.com Extra Strength PDP, $160.00 / 30 packets, ileal-pouch dosing 1–2 packets/day, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 2 cost-per-cfu-is-the-wrong-optimisation-target-for-this-sku

Across the line, cost per 100 billion CFU falls monotonically — $1.11 (Kids, 225B) → $1.04 (capsules, 112.5B) → $0.79 (Advanced, 450B) → $0.59 (Extra Strength, 900B) — so doubling 450B to 900B costs 50% more, not 100%. The ladder is priced coherently and there is no penalty on the high-dose SKU. But this SKU is labelled for advanced ulcerative colitis and ileal pouch management: post-surgical and severe-disease populations under physician supervision. Buying it to save money per CFU for general wellness is a category error.

The record: visbiome.com price ladder across four SKUs, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 3 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 §12. Identity of all eight strains is disclosed; the per-strain CFU split is not. 900 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 4 potency-at-expiry-guarantee-exists-only-in-website-copy

"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-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 5 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 VSL#3 has it in the controlled document.

The record: DSLD 315338 (VSL#3 Unflavored, 30 packets, Alfasigma USA) — open it (opens in a new tab)

Finding 6 one-hundred-plus-clinical-studies-is-unenumerated

The page claims "100+ Clinical Studies" while its own substantiation block enumerates 23 — and the Extra Strength page renders the antibiotic-associated-diarrhoea block as "1 Studies" where the Advanced GI Care page renders "1 Study". The quoted PubMed count for "De Simone Formulation" is 22; the only route to 100+ runs through the VSL#3 trademark literature, including the post-2016 reformulation the brand's own litigation page argues is a different product.

The record: visbiome.com Extra Strength substantiation block, 2026-07-31; PubMed "De Simone Formulation" (quoted) = 22 — open ithttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 7 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 subsections 11.1 IBS, 11.2 UC, 11.3 AAD and 11.4 Ileal Pouch, and no HE subsection. A bibliography reference is not an intended use.

The record: visbiome.com FAQ versus Visbiome Package/Product Insert, June 2026, INTENDED USE and §11 — open ithttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 8 dshea-supplement-disclaimer-under-medical-food-disease-claims

The site footer on the same page as the disease claims carries the dietary-supplement disclaimer — "This product is not intended to diagnose, treat, cure or prevent any disease" — directly contradicting a page whose headline function is the dietary management of named diseases.

The record: visbiome.com product page footer, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 9 kosher-certifier-not-named-and-monash-register-app-gated

Two of the four certification claims cannot be checked at any register: the Kosher claim names no agency, and the Monash Low FODMAP register lives in a mobile app. "Halal suitable" is not a Halal certification.

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 10 aad-indication-rests-on-a-single-cited-trial

Antibiotic-associated diarrhoea is claimed as an indication on the strength of one cited study (Selinger et al., J Hosp Infect 2013;84(2):159-65). 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-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 11 ndc-format-product-codes-in-a-medical-food-insert

Insert §12 lists product codes in 5-4-2 NDC format, 69355-0516-01 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 — 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 12 clinically-effective-badge-and-proving-its-efficacy

A "Clinically Effective" badge sits next to the price and the page says the formulation has had "numerous clinical studies proving its efficacy". "Proving" is absolute; 23 enumerated trials of varying size and quality in specific populations are not proof.

The record: visbiome.com product page, badge adjacent to price, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 14 two-cent-discount-rendering-inconsistency-across-both-packet-skus

The headline renders the discounted price as $143.98 while the subscription block on the same page renders $144.00/delivery and states the saving as $16.00 ($160.00 × 0.90 = $144.00). The same 2-cent class of gap reproduces on the Advanced GI Care SKU — systematic, i.e. a rounding bug in the theme's discount renderer rather than a typo.

The record: visbiome.com product pages for both packet SKUs, 2026-07-31 — open ithttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

Finding 15 cold-chain-with-a-seven-day-room-temperature-tolerance

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-extra-strength — 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; /certified-products/ and /fodmap-certified-products/ both return HTTP 404, the public partner page does not contain the string "Visbiome", and the site has no working search parameter. Not a statement that they lack it — it could not be checked.
Kosher certified (certifying agency not named) status
Insert §13, verbatim - "VISBIOME is Kosher certified." No agency is named anywhere in the insert or on the product pages, so no register exists to query. For contrast, the DSLD transcription of the VSL#3 label names Star-K and declares the seal.
Halal suitable (self-assessment, not a certification claim) status
The insert says "VISBIOME is Halal suitable" rather than "Halal certified" — a weaker phrase that appears deliberately chosen, with no certifier named. Recorded because the wording is the finding.
The per-strain CFU split
900 billion is a single aggregate across eight organisms, and the manufacturer's own insert calls the formulation "a proprietary blend". Same organisms and, as far as anyone can tell, same ratios as the 450-billion packet — but the split is undisclosed for both, so "as far as anyone can tell" is the honest limit of that statement.
Monash University Low FODMAP certification
The issuer's register is inside a mobile app; the public partner list does not contain "Visbiome"; two plausible register URLs return 404. 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.
The DSMZ deposit numbers DSM24730–DSM24737 at the depositary itself
dsmz.de returns a JavaScript search shell containing none of the queried accession numbers to an automated fetch. Three of the eight are independently corroborated through the paired ATCC "SD" accessions instead, which is a stronger result — but the DSMZ records themselves were not confirmed.
The physical carton copy
The product page's image gallery loads via JavaScript and the raw HTML carries a single CDN image URL, so the carton — where a potency-basis statement would legally live — is not retrievable as text.
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 Medical Foods FAQ, Third Edition was fetched in full and does not mention IBS, ulcerative colitis, pouchitis or probiotics anywhere. A web-search summary asserted otherwise; that assertion was not reproduced from the primary document and is published in neither direction.
The downstream consequences of the VSL#3 litigation asserted on visbiome.com
The brand's undated "Note to Healthcare Professionals" page recounts delistings, halted university trials and a Canadian withdrawal in the present tense about 2018–2019 events. The jury verdict and the Fourth Circuit affirmance are verified; the 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

Primary product record: https://www.visbiome.com/products/visbiome-extra-strengthhttps://www.visbiome.com/products/visbiome-extra-strength — Address given, not linked: this site does not link out to the products it audits.

This is the same product as Visbiome Advanced GI Care with twice the CFU in the packet. Not similar — the same. The extracted ingredient-tab text from the two pages is character-for-character identical: same eight organisms, same DSM and ATCC accessions, same two reclassification footnotes, same single maltose excipient. The only difference between the two SKUs is 450 billion versus 900 billion per packet, and, as far as anyone can tell, the same ratios — which is as far as anyone can tell, because the split is undisclosed on both.

So everything true of the 450-billion packet is true here: full strain identity, no per-strain dose, a potency-through-expiry guarantee that lives on a web page and not in the twelve-page package insert, Clean Label Project certification confirmed at the issuer, an unnamed Kosher agency, an app-gated Monash register, a “100+ clinical studies” claim the page’s own block enumerates at 23, a hepatic-encephalopathy indication that appears in the FAQ and not in the insert, and a DSHEA supplement disclaimer sitting under two named disease claims.

Two things are specific to this SKU, and they pull in opposite directions.

The dose ladder is priced coherently, which is rare enough to say out loud. Cost per 100 billion CFU falls monotonically across the line: $1.11 for the Kids packet, $1.04 for the capsules, $0.79 for Advanced GI Care, $0.59 here. Doubling the dose costs 50% more, not 100%. There is no penalty pricing on the high-dose SKU — which is what you would want, given that the high-dose SKU is the one labelled for the sickest patients.

And that is exactly why cost per CFU is the wrong reason to buy this one. The 900-billion packet is labelled for advanced ulcerative colitis and ileal pouch management — post-surgical and severe-disease populations, under physician supervision. At two packets a day it costs $10.67 a day, about $324 a month, level with the highest ongoing cost in this corpus — Xymogen ProbioMax Complete 350B is recorded at $10.47 a day. Defensible for the indicated population. A very expensive mistake for anyone optimising a wellness purchase on a price-per-billion spreadsheet.