ClaimsText Check a supplement label against the FDA labelling rules
Upload the artwork or a photo. LabelScan reads every panel, checks it against 21 CFR 101 and the disease-claim criteria, and counts the claims ClaimsText already holds for each ingredient. The counts are on screen in about a minute; the full report comes by email.
Drop your label here
or choose files · PDF artwork, PNG or JPEG · up to 3 files, 25 MB each
How it works
1. It reads what is printed
Product name, net quantity, every line of the Supplement Facts panel with its amount and % Daily Value, the other ingredients, the business address, the disclaimer, and every marketing statement. A PDF’s own text is used for the exact characters, so a misspelling is read as printed, not corrected.
2. It checks against the rules
Sixteen checks that need no judgement, each quoting its regulation: Daily Value arithmetic, units, nutrient order, the “Daily Value not established” footnote, proprietary blend weights, the disclaimer’s wording and placement, allergens, the iron warning. Then a model reviews spelling, botanical names and nutrient content claims, and each statement goes through the ten disease-claim criteria of 21 CFR 101.93(g)(2).
3. It counts what is on file
Each ingredient is filed against the ClaimsText library, which holds structure–function claims drafted from the published evidence and screened against the same ten criteria. You see how many claims are on file for each ingredient, and how many passed the screen.
What comes back
Counts on screen. The report by email.
On screen: the number of potential compliance issues and the claims on file for each ingredient. By email: every issue with the regulation it falls under and what was seen on the label, five claims you could use, and a sample substantiation memo of the kind ClaimsText produces.
Three kinds of finding
- Potential issue: seen on the label, and appears to fall short of a requirement.
- Not found on the panels supplied: required, and not visible in what you uploaded.
- Not assessed: cannot be judged from an image, such as type size.
A finding is something to check with your regulatory adviser, not a verdict. LabelScan is not legal advice.