Solutions / Dietary supplements
COA checks for dietary supplement brands
Be ready when an auditor asks how you relied on a COA: 21 CFR 111 conditions, USP <2232> and Prop 65 worked out at your serving, and a named person on every lot.
Check One Supplement COA FreeStart With the 21 CFR 111 Preset
Runs the TIC readiness rules with your serving weight. No account.
For Supplement Brands: Audit Readiness on Every COA
1 / 5The audit question
- Dietary ingredientSupplier COA only, no identity testBlocker
- Other componentCOA states methods and limitsAccepted
The audit question
Three document traps, and what the preset does
The supplier’s COA used as the identity test
What goes wrongA dietary ingredient is released on the supplier’s certificate, with no identity test of your own or from a third party.
What the preset doesThe 21 CFR 111 template stops the lot and names the rule, 111.75(a)(1)(i).
IDENTITY_FROM_SUPPLIER_COALead that passes per gram and fails per day
What goes wrong0.4 ppm looks fine on the page. At a 30 g scoop once a day it is 12 µg a day, against a USP <2232> limit of 5.
What the preset doesThe exposure is worked out at your label’s serving, and the finding shows both numbers.
CONTAMINANT_OVER_LIMIT“Not detected” at a useless LOQ
What goes wrongLead reads ND, but the lab’s limit of quantitation is above your maximum, so the result proves nothing.
What the preset doesThe finding is inconclusive and the lot goes to a person. It is never counted as a pass.
LOQ_NOT_SUFFICIENT
The preset: 21 CFR 111 Dietary Supplement
- 21 CFR 111.75(a)(1)
- Dietary ingredient: your own or a third-party identity test. A supplier COA alone does not count.
- 21 CFR 111.75(a)(2)
- Other component on a supplier COA: qualified supplier, stated methods and limits, periodic re-confirmation, QC approval.
- 21 CFR 111.70(e), 111.75(c)
- Finished batch: specs for identity, purity, strength, composition and contaminants, each covered by a result.
- USP <2232> template
- Lead 5, cadmium 5, inorganic arsenic 15, total mercury 15, methylmercury 2 µg a day, at your serving.
- Prop 65 template
- Lead 0.5 µg a day, as a warning or as your no-warning policy. Cadmium and arsenic levels come from a secondary source.
What it does not do
- COA Proof does not run a skip-lot program. It keeps the findings and the named decision on each lot, which you can use as evidence for a plan you own.
- A product has one active spec at a time. Choose the 21 CFR 111 template, or USP <2232>, Prop 65 or microbial, per product; a custom spec can also carry the exposure profiles.
- The free check uses the TIC readiness rules, which include USP <2232> and Prop 65 exposure. The 21 CFR 111 conditions run in a workspace, because they need your supplier and identity records.
Check One Supplement COA FreeStart With the 21 CFR 111 Preset
COA Proof checks documents against the limits you set. It never tests, certifies or approves a product, and it is not affiliated with FDA or Amazon. Examples on this page are fictional and are not customer results. This is not legal advice.