Cited literature/references must actually support the claim made

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

Cited literature, quotations, or references must genuinely support and be relevant to the specific claim they are used to substantiate.

Check

For each cited reference, verify it actually supports the specific claim and is relevant, not merely tangential.

Escalate when

Relevance or degree of support provided by the reference is disputable.

Where this comes from

21 CFR 202.1(e)(6)(x). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…s they have clinical significance when in fact no such clinical significance has been demonstrated. (viii) Uses a statement by a recognized authority that is apparently favorable about a drug but fails to refer to concurrent or more recent unfavorable data or statements from the same authority on the same subject or subjects. (ix) Uses a quote or paraphrase out of context to convey a false or misleading idea. (x) Uses literature, quotations, or references that purport to support an advertising claim but in fact do not support the claim or have relevance to the claim. (xi) Uses literature, quotations, or references for the purpose of recommending or suggesting conditions of drug use that are not approved or permitted in the drug package labeling. (xii) Offers a combination of drugs for the treatment of patients suffering from a condition amenable to treatment by any of the components rather than limiting the indications for use to patients for whom concomitant therapy as provid…

Open the original at these words on ecfr.gov ↗Read our full copy →

Document: 21 CFR 202.1
Version: 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
Retrieved: 2026-09-21 from www.ecfr.gov
Fingerprint: a542640a872b3f2702d549e8…

Applies when

Naturepromotional

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the complete, verbatim text of (e)(6)(x), which under the (e)(6) chapeau is a binding statement of when an ad is false or misleading, so it supports a requirement rather than merely describing an example.
- Not overstated: the source condemns references that 'purport to support an advertising claim but in fact do not support the claim or have relevance to the claim,' and the rule's 'must genuinely support and be relevant to the specific claim they are used to substantiate' is the same standard stated affirmatively, with the same tie to the specific claim being made.
- Atomic: 'support' and 'relevance' are stated as a single disjunctive failure condition in the source and are assessed in one pass over each cited reference; this is not a bundle of independently checkable requirements.
- determinism 'judgment' is right: whether a reference in fact supports or is relevant to a claim turns on adequacy and interpretation, not presence/absence or literal match.
- authority 'binding' is correct; severity 'blocker' is defensible; locator 21 CFR 202.1(e)(6)(x) matches the quoted text; applies_when 'promotional' is justified.
- The Check's scoping to references actually used to substantiate a claim is faithful to the source's 'purport to support an advertising claim' framing, and the escalation condition correctly names the interpretive edge.