Rules/misleading presentation/US-MIS-010

No favorable authority quote without disclosing later or concurrent unfavorable data

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

A favorable statement from a recognized authority may not be used without referencing that same authority's concurrent or more recent unfavorable statements on the same subject.

Check

Research whether the quoted authority has other concurrent/more recent statements on the same topic that are unfavorable; check if disclosed.

Escalate when

Existence or relevance of contrary statements from the same authority requires research/judgment.

Where this comes from

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

…which claimed results may be due to placebo effect (information concerning placebo effect is not required unless the advertisement promotes the drug for use by man). (vii) Contains favorable data or conclusions from nonclinical studies of a drug, such as in laboratory animals or in vitro, in a way that suggests 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 packag…

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 is a verbatim, complete subparagraph of 21 CFR 202.1(e)(6)(viii), sitting under the operative lead-in '(6) Advertisements that are false, lacking in fair balance, or otherwise misleading. An advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n) of the act, among other reasons, if it:'. That is a per se list (contrast paragraph (e)(7), 'may be false'), so stating the rule as a prohibition rather than a soft caution is faithful and not an upgrade of 'may be misleading' into 'is prohibited'.
- The rule statement tracks the source element-for-element: statement by a recognized authority, apparently favorable, failure to refer to concurrent or more recent unfavorable data/statements, from the same authority, on the same subject. Nothing is added. The quote is not drawn from an example, a definition, a preamble, or a description of what the regulation does not require.
- Atomic: a single checkable obligation — when quoting an authority favorably, disclose that authority's concurrent/more recent unfavorable statements on the same subject. The check does not fold in a second independent test.
- determinism 'judgment' is correct: the reviewer must decide whether the source is a 'recognized authority', whether other statements are 'concurrent or more recent' and 'on the same subject or subjects', and whether they are 'unfavorable'. None of that is settled by literal presence/absence, and the escalate-when condition matches.
- authority 'binding' is correct — codified FDA regulation, not guidance.
- Severity 'blocker' is defensible: the provision declares such an advertisement false, lacking in fair balance, or otherwise misleading and 'otherwise violative of section 502(n)', i.e., misbranding exposure. The waiver proviso at the close of (e)(6) is petition-based and prospective and does not undercut blocker treatment of an unwaived violation.
- Locator is accurate; the sentence appears as clause (viii) of the (e)(6) enumeration in the source text.
- applies_when 'promotional' is justified: the source provision governs prescription drug advertising, which falls entirely within promotional review, and the rule does not extend itself to scientific exchange or other non-promotional material. The absence of an explicit 'prescription drug' qualifier is a domain convention of this corpus rather than a substantive broadening, and is not grounds to withhold a pass.