Rules/misleading presentation/US-MIS-021

No falsely presenting reports/opinions as authentic or authoritative

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

An ad may be misleading if it presents reports or opinions as authentic or authoritative when that representation is false or misleading.

Check

Verify the authenticity and authoritative status claimed for any cited report or opinion.

Escalate when

Authenticity/authoritativeness verification may require independent research.

Where this comes from

21 CFR 202.1(e)(7)(xiii). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…f an advertisement on more than one page, information relating to side effects and contraindications when such information is in a distinct part of the advertisement. (xii) Fails to include on each page or spread of an advertisement the information relating to side effects and contraindications or a prominent reference to its presence and location when it is presented as a distinct part of an advertisement. (xiii) Contains information from published or unpublished reports or opinions falsely or misleadingly represented or suggested to be authentic or authoritative. (f)-(i) [Reserved] (j)(1) No advertisement concerning a particular prescription drug may be disseminated without prior approval by the Food and Drug Administration if: (i) The sponsor or the Food and Drug Administration has received information that has not been widely publicized in medical literature that the use of the drug may cause fatalities or serious damage; (ii) The Commissioner (or in his absence the of…

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-opus-5 · 2026-09-21
Reviewer's reasons
- The quote appears verbatim in the source as item (xiii) under the heading '(7) Advertisements that may be false, lacking in fair balance, or otherwise misleading. An advertisement may be false, lacking in fair balance, or otherwise misleading ... if it:'. The rule statement reproduces that conditional framing ('An ad may be misleading if ...') rather than converting it into an absolute prohibition, so it is faithful to the source's own hedged construction.
- Not overstated: the rule does not add scope (no new media, audience, or evidentiary standard) and does not upgrade 'may be false or misleading' into 'is prohibited'. The title's shorthand ('No falsely presenting...') is more clipped than the statement, but the operative rule text and check preserve the 'may be' character, so this is a wording preference rather than a substantive overstatement.
- Atomic: a single checkable condition — a report or opinion represented/suggested to be authentic or authoritative when that representation is false or misleading. It does not bundle the neighboring (e)(7) items (out-of-context quotes, unsupported references, side-effect prominence, etc.).
- Determinism correctly set to 'judgment': whether a representation of authenticity or authoritativeness is 'falsely or misleadingly ... suggested' turns on the impression created and on verification against the underlying source, not on presence/absence of a literal string.
- Authority correctly 'binding': 21 CFR 202.1 is a codified FDA regulation, and (e)(7) violations feed the misbranding determination under section 502(n) referenced in the same paragraph.
- Locator is accurate: the quoted sentence is numbered (xiii) within paragraph (e)(7) of § 202.1, distinct from the (e)(6)(xiii) 'study on normal individuals' item that also appears in the excerpt — the rule cites the correct one.
- applies_when 'promotional' is justified: § 202.1 governs prescription-drug advertisements, and (l)(1)-(2) extends the surrounding regime across journal, broadcast, and promotional-labeling formats. Note for downstream use only (not a defect requiring change here): the underlying regulation is specific to prescription drugs, so if the corpus also covers OTC or device materials, product-class scoping should be handled at the corpus level.
- Severity 'warning' is defensible — the source frames (e)(7) items as conduct that 'may be' misleading rather than a categorical bar, which is a lower register than the (e)(6) 'shall be' provisions.
- The check ('Verify the authenticity and authoritative status claimed for any cited report or opinion') is something a reviewer can actually perform against the cited source material, and the escalation note correctly anticipates that confirming authenticity may need research beyond the piece.