Dietary Supplement CoAs: When Is Supplier Reliance Allowed?
A supplier certificate of analysis does not automatically replace dietary-ingredient identity testing. Part 111 treats identity verification and permitted CoA reliance differently.
Identify which specification is being verified
Under 21 CFR 111.75(a)(1), a manufacturer must conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, unless FDA has approved the specified petitioned exemption. A supplier’s certificate alone is not that exemption.
Section 111.75(a)(2) provides conditions for reliance on a supplier certificate for the specifications it covers, including identity of components that are not dietary ingredients and other applicable component specifications. Read the provision for the actual component and specification; do not turn it into a general rule that all incoming tests can be outsourced to a piece of paper.
What supports a CoA-reliance decision?
The regulation addresses qualification of the supplier through confirmation of test or examination results, the information on the certificate, documented qualification, periodic reconfirmation, and quality-control review and approval. The CoA needs more than a general statement that material passed.
- Match the certificate to the received material and lot.
- Identify the specification and method supporting each reported result.
- Find the supplier-qualification basis and approval.
- Check the documented reconfirmation approach.
- Keep your own identity-testing obligation separate from other specifications.
Review one received lot from receipt to disposition
A practical audit trace can begin with the receiving record and follow the material through sampling, applicable testing or justified reliance, quality-control review, and release or rejection. Ask where the evidence resides when an outside laboratory or broker participates.
The aim is to demonstrate the actual decision. An approved-supplier list is useful context, but it does not show by itself that the conditions for reliance were met for a particular specification.
Avoid invented test-method mandates
The appropriate method depends on the material and the requirement. This guide does not say FDA requires every manufacturer to use one named chromatography or spectroscopy technique. The selected test or examination and its suitability need a defensible basis.
Related inspection resources
- Reserve-sample requirements
- The broader Part 111 inspection checklist
- Dietary supplement inspection consulting
Primary sources
Sources reviewed October 20, 2026. The preparation steps above are practical suggestions; the linked regulations and FDA documents define the applicable requirements.