One product, one panel, one record.
BioGaia Osfortis® Probiotic Capsules (60 capsules) — label audit
The strain in this bottle was tested in men, for testosterone, in a randomised placebo-controlled trial with a BioGaia employee among its authors — and it did nothing. "The supplementation had no effect on testosterone levels, neither using high- or low dose, nor placebo." The brand published the null and sells this strain to women for bone health instead, where its own larger and longer trial of the identical formulation was also null.
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.
The Label Verifiability Score for this product
82.9 out of 100
Rank 29 of the 154 products in this audit the rubric can score. This rank is shared with 6 other products — 7 products sit on 82.9 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 86% of the rubric by weight — the share of the five questions below this record could answer. The remaining question is unanswered, and unanswered is not nought: it leaves the divisor rather than dragging the score down. That share travels with the number and is never dropped — this score over 86% of the 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 | 1 of 1 organism slot carries a printed strain designator. | 1 / 1 = 1.0000 | 0.2400 |
| Per-organism amount printed | 0.20 | 1 of 1 organism slot has an amount of its own; the rest are inside a blend total. | 1 / 1 = 1.0000 | 0.2000 |
| What the CFU count is measured against | 0.22 | Potency basis "none-stated": CFU figure printed yes, single basis stated no, basis reaches expiry no — 1 of 3. | 1 / 3 = 0.3333 | 0.073333 |
| Printed designators that lead to a human trial | 0.20 | 1 of 1 checked organism slot resolves 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. | 1 / 1 = 1.0000 | 0.2000 |
| Certification confirmed at the issuer’s own register | 0.14 | Every certification on this record is brand-asserted with the register unreachable, or not yet queried. An unreachable register is a fact about the verification infrastructure, not about this brand, so it may not move its position. | Not answered | — excluded from the divisor, not counted as nought |
0.713333 — the last column added up — divided by 0.86, the weight this record could answer, is 0.8295. Multiplied by 100 and rounded to one decimal, that is the 82.9 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 | 10 billion CFU per 2-capsule serving |
| What that count is measured against | No basis stated |
| Strain designators | All organisms coded |
| Organism slots transcribed here | 1 — the full panel |
| Marketed as | Marketed to women |
A CFU number appears with no temporal basis of any kind. A count with no basis is not a quantity; there is no date at which it is claimed to be true.
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 |
|---|---|---|---|---|
| L. reuteri | ATCC PTA 6475 (L. reuteri Osfortis®) | 10 billion CFU | Human RCT | ("ATCC PTA 6475" OR "ATCC-PTA-6475" OR "reuteri 6475" OR "ATCC PTA6475") AND (bone OR osteoporosis OR BMD) AND randomized controlled trial[pt] |
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.
- NIH Dietary Supplement Label Database record — DSLD 311009 (opens in a new tab) captured NIH's transcription of the physical label, on-market, version code 110877-002, country of origin Spain. UPC cross-check passed digit for digit: the Shopify barcode 602359460254 equals the DSLD upcSku 6 02359 46025 4. Source for the "Vitamin D contributes to the maintenance of normal bones" statement, the "Clinically proven" statement, and the absence of a gluten-free statement that the two sibling SKUs carry.
- Photograph of the printed panel — Osfortis_B_supp_facts_1-25.pnghttps://cdn.shopify.com/s/files/1/0763/5261/8780/files/Osfortis_B_supp_facts_1-25.png — Address given, not linked: this site does not link out to the products it audits. captured The brand's own Supplement Facts image, transcribed by reading it, and independently confirmed against DSLD 311009 — the two agree exactly. Recorded as its own artefact because it is the only place on any BioGaia property where this product's CFU figure appears at all: the panel is published as a PNG and nowhere as text, which makes it unreadable to a screen reader and to any price-comparison or safety tool.
- Dated capture of the brand’s own page — biogaia-osfortis-2026-07-31https://www.biogaia.com/products/osfortis — Address given, not linked: this site does not link out to the products it audits. captured The live brand page, HTTP 200 to a plain request, plus its Shopify product JSON (SKU 46025, barcode 602359460254). Source for the price, the claim set, the free-from line that omits gluten, and the women's positioning — the Shopify description field reads "A women's probiotic for daily use / Designed for women before, during / Promote strong bones, immune balance & GI wellness*", and the brand-authored image alt text describes "a daily women's probiotic" and "women's health before during and after menopause".
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, 1 organism slot carries 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
$1.63 a day at the dose the label itself instructs.
- Price
- $48.99 USD
- What that buys
- 60-capsule bottle (30 servings at two capsules daily)
- Price checked
- — the source we read it fromhttps://www.biogaia.com/products/osfortis — 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 |
|---|---|---|
| No third-party certification claimed | Not checked | 31 July 2026 |
| EvidenceBiotics® | Not checked | 31 July 2026 |
No third-party certification claimed
We have not queried this register for this product. It does not mean the product holds nothing.
The product pages and the FAQ were scanned for NSF, USP Verified, Informed, ConsumerLab, BSCG, Non-GMO Project, cGMP, ISO and third-party, and no genuine hit was returned. The brand claims no certification, which is a different statement from not holding one. Both registers that would settle it are hard-blocked to automation — nsf.org Cloudflare 403 with an empty Angular shell at listings.nsf.org, and Akamai 403 at both quality-supplements.org and usp.org, two attempts each. Record this as "none claimed, unverified either way", never as "does not hold certification".
EvidenceBiotics®
We have not queried this register for this product. It does not mean the product holds nothing.
A BioGaia trademark, not a certification — the brand's own page defines it as "a category of premium probiotics held to the highest scientific and quality standards", with no issuer, no register and no audit behind it. "Clinically proven" is likewise a label statement rather than a mark.
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 the-lead-claim-is-contradicted-by-a-larger-longer-trial-of-the-identical-regimen
The page's lead claim is "Clinically shown to improve bone health in adults with low bone density." It rests on PMID 29926979 — 90 women aged 75-80 with low bone mineral density, 10^10 CFU/day, twelve months, 70 completers, primary endpoint met with an intention-to-treat mean difference of 1.02% (95% CI 0.02 to 2.03). Then read PMID 38865129, published in JAMA Network Open in 2024: 239 early-postmenopausal women aged 50-60, two years, capsules at 5 x 10^8 or 5 x 10^9 CFU twice daily, each also containing cholecalciferol 200 IU. The high-dose arm is 1 x 10^10 CFU/day plus 400 IU vitamin D/day — the Osfortis regimen, capsule for capsule. Its result, verbatim: "Tibia vBMD (primary outcome), hip and spine vBMD, and tibia cortical area and BMD decreased significantly in all groups, with no group-to-group differences" and "There were no significant treatment effects on any other predefined outcomes." Conclusion: "supplementation with L reuteri had no effect on bone loss or bone turnover over 2 years." The exact formulation was tested at twice the duration and 2.7 times the sample size of the trial the claim rests on, and it failed on every predefined endpoint.
The record: PMID 38865129 (JAMA Netw Open 2024, n=239, 2 years, null) against PMID 29926979 (J Intern Med 2019, n=90, MD 1.02%, 95% CI 0.02-2.03) — open it (opens in a new tab)
Finding 2 improve-bone-health-is-not-what-the-positive-trial-showed
The positive trial showed reduced loss, not improvement. Bone density fell in both arms; it fell 1.02 percentage points less in the probiotic arm, with a 95% confidence interval whose lower bound is 0.02% — it cleared significance by a hair, in 70 completers, at a single Gothenburg centre, and it did not replicate. The authors' own conclusion is appropriately modest: the strain "should be further explored as a novel approach". "Improve" is the brand's word, not theirs.
The record: PMID 29926979 (J Intern Med 2019), effect size and authors' conclusion quoted from the abstract — open it (opens in a new tab)
Finding 3 the-claim-says-adults-and-no-man-has-ever-been-enrolled-in-a-bone-trial-of-this-strain
"Clinically shown to improve bone health in adults with low bone density" — and both bone RCTs of this strain enrolled women only, one aged 75-80 and the other 50-60. The page goes further elsewhere: the strain "promotes and supports strong and healthy bones throughout every stage of life." Neither "adults" nor "every stage of life" is supported by anything in the trial population.
The record: PMID 29926979 (women 75-80) and PMID 38865129 (women 50-60) — the complete bone RCT literature for this strain, confirmed by two query formulations returning 2 and 3 records
Finding 4 the-strain-was-tested-in-men-for-testosterone-and-it-did-nothing
PMID 38770015 (Contemporary Clinical Trials Communications, 2024) is a twelve-week double-blind placebo-controlled RCT in healthy men aged 55-65, comparing high dose and low dose of L. reuteri ATCC PTA 6475 against placebo. Verbatim: "The supplementation had no effect on testosterone levels, neither using high- or low dose, nor placebo", and "The present study does not support the hypothesis that a probiotic supplementation can increase testosterone levels in ageing men." Triglycerides fell in the high-dose arm; nothing else moved. The conflict-of-interest statement reads "Jakob Axelsson is an employee of Biogaia AB." The only other men's record is PMID 41492377, a single-arm open-label study in ten men aged 50-69 which reports that "although remarkable changes in sex hormones were not observed", body fat percentage, blood pressure and some inflammation markers fell — no control group. Publish this: BioGaia co-authored the study that tested its own strain for the most-marketed men's supplement outcome there is, reported a clean null, and does not sell a testosterone product. Any "L. reuteri 6475 for men's testosterone" content elsewhere on the internet is contradicted by the strain owner's own trial.
The record: PMID 38770015, conclusion and COI statement quoted verbatim; PMID 41492377 as the only other record, confirmed by two query formulations both returning the identical 2 hits — open it (opens in a new tab)
Finding 5 a-secondary-analysis-of-the-same-ninety-women-is-indexed-as-a-second-trial
PMID 36261538 (npj Biofilms and Microbiomes, 2022) is a secondary microbiome analysis of 20 selected responders and non-responders drawn from the 90 women in PMID 29926979. It is not an independent trial and it is not replication, but it is separately indexed and will be counted as a second positive study by anyone who does not read the abstract. Recorded here so that the count stays at one positive trial and one null one.
The record: PMID 36261538, identified in its own abstract as a sub-analysis of the PMID 29926979 cohort — open it (opens in a new tab)
Finding 6 no-potency-basis-and-no-cfu-figure-anywhere-on-the-product-page
The panel says "10 billion CFU" with no temporal basis of any kind — not at manufacture, not through expiration, not guaranteed until anything. And the number appears nowhere in the page body: not in the description, not in the bullets, not in the meta description. It exists only inside a PNG. A shopper comparing this product against a competitor on the product page alone has no potency figure to compare, and no date at which any figure is claimed to be true.
The record: DSLD 311009 and the brand's own panel image Osfortis_B_supp_facts_1-25.png, against the full text of biogaia.com/products/osfortis, 2026-07-31 — open ithttps://www.biogaia.com/products/osfortis — Address given, not linked: this site does not link out to the products it audits.
Finding 7 the-one-biogaia-product-that-is-not-gluten-free-does-not-say-so-on-its-own-page
The FAQ states it plainly: "All of our products except for Osfortis are also free from gluten." The government record agrees — Gastrus and Protectis both carry a "Gluten free" statement and Osfortis does not. The product page does not carry it. Its free-from line reads only "Vegan capsules, Non-GMO ingredients, no artificial colors, flavors, dairy or soy". A coeliac buyer reading the product page would not learn this, and would have to find it in a general FAQ.
The record: biogaia.com/pages/faq against biogaia.com/products/osfortis and DSLD 311009, all 2026-07-31 — open ithttps://www.biogaia.com/pages/faq — Address given, not linked: this site does not link out to the products it audits.
Finding 8 an-eu-authorised-claim-printed-verbatim-on-a-us-label
The label carries "Vitamin D contributes to the maintenance of normal bones." That is an EU Regulation 1924/2006 Article 13(1) authorised claim, word for word. It is not a US authorised health claim and it is printed on a US label. This is a paperwork tell rather than a fraud, but it is a tell.
The record: DSLD 311009 label statement, transcribed from the physical label — open it (opens in a new tab)
Finding 9 naming-the-diagnosed-population-is-the-most-exposed-wording-in-this-batch
"Clinically shown to improve bone health in adults with low bone density" names a population defined by a diagnosis — low bone density is osteopenia or osteoporosis. Under 21 CFR 101.93(g) a statement that implicitly identifies a disease state, including by naming the population that has it, moves from structure/function language toward an implied disease claim. The safe version of this sentence is "supports bone health". The version on the page is not it. Two smaller overreaches sit beside it: "proven to reach the gut alive", where survival is not efficacy and "proven" does heavy lifting, and "immune balance", claimed with no immune endpoint in either bone trial.
The record: biogaia.com/products/osfortis claim text, 2026-07-31, read against 21 CFR 101.93(g) — open ithttps://www.biogaia.com/products/osfortis — Address given, not linked: this site does not link out to the products it audits.
Finding 10 the-most-expensive-sku-in-its-batch-for-the-weakest-net-evidence-position
$1.633 a day, single pack size, no multipack discount — against $0.700 to $0.966 for Gastrus and $0.616 to $0.900 for the paediatric SKU. It is the only one of the three whose on-dose trial is null. That is a statement about the evidence position, not about whether the product works.
The record: biogaia.com Shopify product JSON for all three SKUs, prices and pack sizes captured 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.
- No third-party certification claimed status
- The product pages and the FAQ were scanned for NSF, USP Verified, Informed, ConsumerLab, BSCG, Non-GMO Project, cGMP, ISO and third-party, and no genuine hit was returned. The brand claims no certification, which is a different statement from not holding one. Both registers that would settle it are hard-blocked to automation — nsf.org Cloudflare 403 with an empty Angular shell at listings.nsf.org, and Akamai 403 at both quality-supplements.org and usp.org, two attempts each. Record this as "none claimed, unverified either way", never as "does not hold certification".
- EvidenceBiotics® status
- A BioGaia trademark, not a certification — the brand's own page defines it as "a category of premium probiotics held to the highest scientific and quality standards", with no issuer, no register and no audit behind it. "Clinically proven" is likewise a label statement rather than a mark.
- The funding behind the trial the product's lead claim rests on
- Trial funding for PMID 29926979, the positive bone trial, is not in the PubMed record and was not retrieved. Nothing is asserted either way about who paid for it.
- Whether any third-party certification is held
- NSF's and USP's registers are both hard-blocked — Cloudflare 403, an Angular shell with no data, and Akamai 403 on two USP paths, two attempts each. No independent confirmation was possible in either direction. The brand claims none, which makes this close to moot, but the distinction is kept.
- The government's own scanned label documents
- DSLD's label-scan PDFs did not serve on this pass — the s3 path returns HTTP 403 and the v9 path returns the single-page-application HTML shell. The panel here therefore rests on DSLD's structured transcription plus the brand's own Supplement Facts image, which agree with each other exactly.
- A men's-versus-women's diff for this brand
- It cannot be run, because only one side exists. This SKU is itself the women's product, and BioGaia's US catalogue contains no men's SKU at all — confirmed three independent ways on 2026-07-31: a full products.json enumeration returning 23 products with no men's item; three men's collection URLs all returning HTTP 404; and the on-site search for "men's" returning, verbatim, "Search: 0 results found for "men's"". The absence is the finding.
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.
This is not a men’s product. It is explicitly a women’s one — “A women’s probiotic for daily use”, in the brand’s own Shopify description, with the alt text on its own images describing “women’s health before during and after menopause”. It is on this site for a different reason, and the reason is the best single piece of evidence the audit has found about whether a men’s probiotic is a real thing.
The strain in this bottle was tested in men, for testosterone, and it did nothing. PMID 38770015: a twelve-week double-blind placebo-controlled trial in healthy men aged 55–65, high dose against low dose against placebo. Verbatim: “The supplementation had no effect on testosterone levels, neither using high- or low dose, nor placebo.” And: “The present study does not support the hypothesis that a probiotic supplementation can increase testosterone levels in ageing men.” The conflict-of-interest statement reads “Jakob Axelsson is an employee of Biogaia AB.”
The brand that owns the strain co-authored the trial, published the null, and does not sell a testosterone product. That is the behaviour of a company that reads its own data — and it means every “L. reuteri 6475 for men’s testosterone” page on the internet is contradicted by the strain owner’s own randomised trial.
The panel here is the cleanest in the project. One organism. One full ATCC designator. One unambiguous CFU number. One vitamin with a percent Daily Value against it. A four-item excipient list. No blend, no “proprietary”, no thirty-organism kitchen sink. The brand’s own image and the government transcription agree exactly.
What sits on top of it is harder. The lead claim is “Clinically shown to improve bone health in adults with low bone density.” Take it apart:
“Improve” is not what the positive trial showed. Bone density fell in both arms; it fell 1.02 percentage points less in the probiotic arm, with a confidence interval whose lower bound is 0.02% — it cleared significance by a hair, in 70 completers, at one centre.
“Adults” is unsupported by anything. Both bone trials of this strain enrolled women only.
And the claim has been tested again since. PMID 38865129, in JAMA Network Open: 239 early-postmenopausal women, two years, capsules at 5 × 10⁹ CFU twice daily each carrying 200 IU of cholecalciferol — which is this product’s regimen, capsule for capsule. The result: “no group-to-group differences”, “no significant treatment effects on any other predefined outcomes”, “L reuteri had no effect on bone loss or bone turnover over 2 years.” The exact formulation, at twice the duration and 2.7 times the sample size, failed on every predefined endpoint.
Two smaller things a careful reader is owed. The CFU number exists only inside a PNG — it appears nowhere in the page text, and it carries no temporal basis at all, so there is no date at which the ten billion is claimed to be true. And this is the one BioGaia product that is not gluten-free, a fact the FAQ states plainly and the product page does not.