Sample report
A real report, on a real product
This is the ClaimsText report for Ashwagandha, run by Tim Goodwin, ClaimsText’s founder, for his own US supplement brand, BioStack Labs. Nothing has been edited out. It is the same document a subscriber receives.
Downloads
Clinical evidence report
Every study the search found, what each one measured, the findings for and against, and the dose each one used.
Being finalised. Check back shortly.
Substantiation memo
The claims selected for the label, the evidence behind each, the disease-claim screen, and the signature of the person responsible.
Being finalised. Check back shortly.
The report is being re-run on the current pipeline so that what you download is exactly what the app produces today. Both files will appear here when it is signed.
What to look for
Six things a compliance reviewer checks first, and where each one is in the report.
How much of the literature it read
The search methodology section says how many records matched each search and how many were retrieved. Where a search was capped, the report says so rather than implying it read everything.
The findings that went against the ingredient
Trials where ashwagandha did not beat placebo are in the evidence table beside the ones where it did. The FTC names discarding unfavourable results as deceptive; the report keeps them.
Dose fit
Each claim shows the studied dose against the dose the product actually delivers per day. A claim whose evidence comes from a dose the product does not reach is marked, not hidden.
The ten-criterion disease-claim screen
Every selected claim is tested, one criterion at a time, against 21 CFR 101.93(g)(2). The compliance section shows each verdict and the wording that triggered it.
A confidence rubric you can argue with
Confidence is scored on eight named components, with the reasoning written out, so a reviewer can disagree with a specific line rather than with a number.
A signature and a lock
The memo names the responsible person who signed it, and a signed report cannot be edited afterwards. That is what makes it a record rather than a draft.
What it is not
It is not legal advice, and the software approved nothing. The claims in the memo were selected and signed by the responsible person named in it, on the evidence shown. Where the report could not assess something, it says “not assessed” rather than staying silent. Your own report will be reviewed and signed by you.
Start with your own label
LabelScan checks it against 21 CFR 101 and screens each statement against the same ten disease-claim criteria as this report. Free; the full report comes by email.