What are the current good manufacturing practice (cGMP) requirements for dietary supplements?
Anyone who manufactures, packages, labels, or holds a dietary supplement must follow the FDA's current good manufacturing practice (cGMP) regulations in 21 CFR Part 111, which include establishing written specifications to ensure the supplement's identity, purity, strength, and composition.
The answer
Who must comply
21 CFR § 111.1 sets the scope: you are subject to Part 111 if you manufacture, package, label, or hold a dietary supplement, including a supplement you manufacture that is packaged or labeled by another person, and one imported or offered for import.
The specification requirement
21 CFR § 111.70 requires you to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the supplement and that it is packaged and labeled as specified in the master manufacturing record.
The judged input
What the AI drafted
Submitted to the judgeThis is an excerpt from a draft GMP compliance memo — the kind of work product a lawyer generates with a legal-AI drafting tool, then has to stand behind. Kingsfield does not write it; it rules on the citations the model put in it. This draft cites three authorities; one of them is wrong.
The judge ruled on every citation as the draft used it — it accepted 21 CFR § 111.1 and 21 CFR § 111.70 and rejected 21 CFR § 110.3. Here is why.
The verdict
How Kingsfield ruled
Ruled 2026-06-22Each citation in the draft above was submitted to the Kingsfield judge and ruled against the primary-law corpus — Accept, Reject, or Inconclusive, per citation. These are live verdicts, not editorial. Each card shows the claim the draft made and the verbatim authority the verdict was rendered against.
The draft claimed: The cGMP regulations in this part apply to those who manufacture, package, label, or hold a dietary supplement.
“§ 111.1 Who is subject to this part? (a) … you are subject to this part if you manufacture, package, label, or hold a dietary supplement…”
Cite found; proposition supported by the cited text.
The draft claimed: A manufacturer must establish specifications for points in the process where control is necessary to ensure the quality of the dietary supplement.
“§ 111.70 What specifications must you establish? (a) You must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement…”
Cite found; proposition supported by the cited text.
The draft claimed: 21 CFR 110.3 sets the current good manufacturing practice specifications required for dietary supplements.
Cite found, but the cited text does not support the proposition. 21 CFR 110.3 is the general food cGMP definitions section, not the dietary-supplement specification rule. Regenerate with the Part 111 authority.
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Connect the Judge See the architectureThis page is legal information, not legal advice, and does not create an attorney-client relationship. The draft shown is an illustration of a typical AI answer; verdicts reflect the cited authority in the Kingsfield corpus as of the ruling date shown above.