Does FDA require a written "quality agreement" for dietary supplements?

Not by that name. FDA has published quality-agreement guidance for drug contract manufacturing, but not an equivalent for dietary supplements. What Part 111 does require, namely specifications (111.70), a documented basis for relying on a supplier's testing (111.75), and records available to FDA (111.610), is easiest to satisfy when both sides have agreed on it in writing.

Who is responsible for Part 111 compliance if I don't manufacture my own product?

Part 111 applies to whoever performs manufacturing, packaging, labeling, or holding operations, so a brand owner and a contract manufacturer can each be "you" under 21 CFR 111.1 for the operations they perform. Contracting out the physical work does not contract out a brand owner's responsibility for the product it puts its name on.

Can I just rely on my manufacturer's Certificate of Analysis instead of testing myself?

21 CFR 111.75 allows it, but only if you first qualify the supplier by confirming their test results, document how you qualified them, periodically re-confirm the certificate, and have quality control personnel review that documentation. A quality agreement is where that qualification and re-confirmation commitment gets written down.

What if I don't have a quality agreement with my manufacturer today?

Ask for one in writing. Even a short one covering specs, COA delivery per lot, and a change-notification commitment is better than none. In the meantime, keep every COA, spec sheet, and cGMP certificate your manufacturer sends, since that correspondence is the evidence you'd otherwise be relying on the agreement to guarantee.

How long do I need to keep the records a quality agreement produces?

21 CFR 111.605 sets the floor: 1 year past the product's shelf-life date if shelf life dating is used, or 2 years beyond the date the last batch tied to those records was distributed, whichever applies. Records must also be readily available for FDA to inspect and copy under 111.610.

Guide

What should a quality agreement with a contract manufacturer include?

By Jake, founder · Published 2026-08-17 · Updated 2026-08-17

A quality agreement is a written contract between a brand and its contract manufacturer assigning who sets specifications, who tests, who delivers the Certificate of Analysis and when, who sees whose records, who is told about a change, and who does what in a recall. It is written down because Part 111 does not use the term.

What a quality agreement is

A quality agreement is a written contract, separate from the commercial supply agreement, that assigns specific quality responsibilities between a brand owner and its contract manufacturer: who writes the specification, who tests against it, who delivers which document and on what schedule, who can inspect whose records, who is told about a change before it happens, and who does what if a recall is needed. FDA has published quality-agreement guidance for contract drug manufacturing; there is no equivalent guidance document for dietary supplements under 21 CFR Part 111. The practical need for one comes from Part 111's own mechanics, not from a named FDA requirement.

Why Part 111 pushes toward having one anyway

21 CFR 111.1 defines "you" broadly: a firm is subject to Part 111 if it manufactures, packages, labels, or holds a dietary supplement, including "a dietary supplement you manufacture but that is packaged or labeled by another person." A brand owner that contracts out manufacturing does not stop being a "you" under Part 111 for the operations it still controls or for the product it releases under its own label.

Two sections make the paperwork concrete. 21 CFR 111.70 requires written specifications for components, in-process steps, packaging, the finished batch, and labeling: identity, purity, strength, composition, and contamination limits. 21 CFR 111.75 then requires that those specifications be checked: either by testing directly, or by relying on a supplier's Certificate of Analysis, but only after first qualifying the supplier by confirming their test results, documenting how the supplier was qualified, periodically re-confirming the certificate, and having quality control personnel review that documentation. A brand owner that doesn't run its own lab is, in practice, choosing the second path, and 111.75's qualification and re-confirmation steps are exactly what a quality agreement puts in writing.

Underneath both is 21 CFR 111.610: records required under Part 111 must be readily available for FDA to inspect and copy on request, for the retention period set by 21 CFR 111.605: one year past the shelf-life date if used, or two years past distribution of the last associated batch, whichever applies. If a manufacturer holds records a brand owner would need to produce, an agreement establishing access to them is what keeps that obligation workable.

Clauses that matter to a small brand

Clauses a quality agreement should cover, and the Part 111 mechanic behind each
Clause	What it settles	Part 111 mechanic behind it
Specifications	Whose specification is authoritative, and how changes to it are approved.	111.70 requires written specifications for identity, purity, strength, and composition.
Testing vs. COA reliance	Whether the brand tests independently or relies on the manufacturer's COA, and the qualification steps behind that choice.	111.75 permits COA reliance only with documented supplier qualification and periodic re-confirmation.
COA delivery	That a current COA is sent with every lot, not on request after the fact.	Downstream of 111.75: a COA that isn't delivered can't be relied on.
Record access	That the brand can obtain manufacturing and testing records the manufacturer holds, on a stated timeline.	111.610 requires records be readily available to FDA; the brand needs them from the manufacturer to produce them.
Change notification	That the brand is told before a formulation, supplier, or process change that would affect the specification.	Downstream of 111.70: a specification that changes without notice is no longer being checked against.
Recall cooperation	Who does what (traceability data, batch records, customer notice support) if a recall becomes necessary.	Not a named Part 111 clause; standard practice given the retention and traceability records Part 111 already requires be kept.

Part 111 does not mandate a document titled "quality agreement" or dictate its exact contents; the clauses above are the practical response to the specification, testing, and record-access rules cited beside them, not a direct FDA requirement for each row. Verify specifics with a regulatory attorney or consultant before relying on any agreement as a compliance substitute.

What tends to go wrong without one

Most of the friction a small brand runs into with a contract manufacturer traces back to one of these clauses being unwritten rather than written and broken. A COA that arrives weeks after a lot ships, rather than with it, is a delivery-schedule gap. A formulation change discovered only when a new spec sheet doesn't match the old one is a change-notification gap. A manufacturer that won't produce batch records when a retailer or TIC provider asks is a record-access gap. None of these is necessarily bad faith: a manufacturer serving many brands has no way to know a specific brand needs a COA per lot automatically unless that expectation was written down and agreed to.

What to do if you don't have one

Ask your manufacturer, in writing, for a short quality agreement. Even one page covering specs, COA delivery per lot, and change notification is better than none.
Until it exists, treat every email that carries a spec sheet, COA, or cGMP certificate as the record of what was agreed, and keep it filed by lot, not by inbox search.
If the manufacturer won't put anything in writing, that itself is worth weighing against the questions to ask before choosing a contract manufacturer.
Know what you already have on file for each SKU with the free check. It shows which documents are current and which are missing before a retailer or TIC review asks.

A quality agreement is not a substitute for the underlying documents; it's the commitment that they'll keep arriving.
Nothing here states that having a quality agreement, by itself, settles whether a product meets its requirements. That is decided against the specification and the test results, not against the contract.
Compliant Always files the documents a quality agreement produces (COAs, spec sheets, cGMP certificates) by lot, but does not draft or review the agreement itself, which is a legal document.

Sources

21 CFR 111.1, Who is subject to this part? (Cornell Law mirror of eCFR) accessed 2026-08-17
21 CFR 111.70, Specification requirements accessed 2026-08-17
21 CFR 111.75, What must you do to determine whether specifications are met? accessed 2026-08-17
21 CFR 111.605, Record retention requirements accessed 2026-08-17
21 CFR 111.610, What records must be made available to FDA? accessed 2026-08-17

Frequently asked questions

Does FDA require a written "quality agreement" for dietary supplements?: Not by that name. FDA has published quality-agreement guidance for drug contract manufacturing, but not an equivalent for dietary supplements. What Part 111 does require, namely specifications (111.70), a documented basis for relying on a supplier's testing (111.75), and records available to FDA (111.610), is easiest to satisfy when both sides have agreed on it in writing.
Who is responsible for Part 111 compliance if I don't manufacture my own product?: Part 111 applies to whoever performs manufacturing, packaging, labeling, or holding operations, so a brand owner and a contract manufacturer can each be "you" under 21 CFR 111.1 for the operations they perform. Contracting out the physical work does not contract out a brand owner's responsibility for the product it puts its name on.
Can I just rely on my manufacturer's Certificate of Analysis instead of testing myself?: 21 CFR 111.75 allows it, but only if you first qualify the supplier by confirming their test results, document how you qualified them, periodically re-confirm the certificate, and have quality control personnel review that documentation. A quality agreement is where that qualification and re-confirmation commitment gets written down.
What if I don't have a quality agreement with my manufacturer today?: Ask for one in writing. Even a short one covering specs, COA delivery per lot, and a change-notification commitment is better than none. In the meantime, keep every COA, spec sheet, and cGMP certificate your manufacturer sends, since that correspondence is the evidence you'd otherwise be relying on the agreement to guarantee.
How long do I need to keep the records a quality agreement produces?: 21 CFR 111.605 sets the floor: 1 year past the product's shelf-life date if shelf life dating is used, or 2 years beyond the date the last batch tied to those records was distributed, whichever applies. Records must also be readily available for FDA to inspect and copy under 111.610.