Rules/misleading presentation/US-MIS-004

No presenting since-invalidated favorable information as current

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

An ad may not present favorable information/opinions that were once regarded as valid but have since been invalidated by more credible recent information.

Check

Check dates and currency of cited favorable data/opinions against more recent, more credible contrary findings.

Escalate when

Whether newer information is 'more credible' and truly invalidates the older claim requires judgment.

Where this comes from

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

…epresentation or suggestion is made directly or through use of published or unpublished literature, quotations, or other references. (ii) Contains a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience. (iii) Contains favorable information or opinions about a drug previously regarded as valid but which have been rendered invalid by contrary and more credible recent information, or contains literature references or quotations that are significantly more favorable to the drug than has been demonstrated by substantial evidence or substantial clinical experience. (iv) Contains a representation or suggestion that a drug is safer than it has been demonstrated to be by substantial evidence or substantial clinical experience, by selective presentation of information from published articles or ot…

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
- Supported: the quote is the operative first clause of 21 CFR 202.1(e)(6)(iii), which sits under the chapeau '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:'. This is a per-se listing of violative content, not an example, definition, or preamble commentary, so the prohibitory rule statement follows directly.
- Not overstated: the regulation states such an advertisement IS false/misleading (contrast with paragraph (e)(7), which uses the weaker 'may be false...'); the rule correctly draws from (e)(6) and uses a prohibitory framing. The rule also does not overreach into the second clause of (iii) about literature references being significantly more favorable than demonstrated.
- Atomic: the rule captures only the 'invalidated favorable information/opinions' obligation and leaves the separate literature-reference clause of (iii) to another rule.
- determinism 'judgment' is right: applying this turns on evaluating whether newer information is 'contrary and more credible' and whether it renders the older favorable information invalid — a substantive assessment, not presence/absence or literal match. The escalation note matches.
- authority 'binding' is right: 21 CFR 202.1 is a codified regulation implementing section 502(n) of the FD&C Act.
- Severity 'blocker' is defensible: content meeting this description makes the advertisement false/misleading and violative of section 502(n) per the regulation's own terms, subject only to the narrow written FDA waiver procedure described at the end of paragraph (e)(6).
- Locator '21 CFR 202.1(e)(6)(iii)' matches the quoted text exactly as it appears in the source.
- applies_when 'promotional' is justified — the provision governs advertisements — and does not invent a limit or drop an obvious one, though reviewers should note the source provision is framed specifically for prescription drug advertisements.

Nearby rules

US-MIS-005