21 CFR Part 111 for brand owners
The four sections that change how you evaluate manufacturers.
By Greg Huang
Founder of multiple consumer brands in the dietary supplement and nutrition industry since 2009 · Reviewed by Dr. James Pendleton, ND, licensed primary care physician, 20+ years in naturopathic medicine
Last verified April 25, 2026Published April 25, 2026
Answer
Brand owners do not have to comply with 21 CFR Part 111 directly, your manufacturer does. But four sections govern what your manufacturer must do for you: §111.75 (incoming ingredient identity testing), §111.105 (quality-control personnel responsibilities and approvals), §111.210 (Master Manufacturing Record contents), and §111.320 (scientifically valid laboratory methods). If a manufacturer cannot produce evidence in any one of these areas, they are not Part-111-compliant, regardless of what their website says.
| Section | What it requires | What to ask your CM |
|---|---|---|
| §111.75 | At least one appropriate identity test or examination on incoming dietary ingredients (lot-by-lot is best practice; §111.75(a)(2) provides a supplier-COA reliance pathway with periodic re-confirmation) | Show me a recent identity COA for vitamin D3 with method ID |
| §111.105 | Quality-control personnel must approve or reject processes, specifications, deviations, and finished-batch test results, and review supplier qualifications | QC sign-off log for a recent batch + your QC personnel responsibilities document |
| §111.210 | Written Master Manufacturing Record per product (formula, components, theoretical yield, controls, sampling and testing protocols, written instructions) | Sample MMR (redacted) for a comparable product |
| §111.320 | Verify that laboratory methods are appropriate; identify and use scientifically valid methods for each established specification | Method validation reports or USP / AOAC method IDs |