Favorable claims from an inadequately designed study may be misleading

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

An ad may be misleading if it relies on favorable conclusions from a study whose design, scope, or conduct is inadequate to significantly support those conclusions.

Check

Assess the methodological adequacy (design, scope, conduct) of any study cited to support a favorable claim.

Escalate when

Adequacy of study design/scope/conduct is a matter of scientific judgment.

Where this comes from

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

…ete copy of the advertisement, and a showing that the advertisement is not false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n) of the act. (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 or otherwise violative of section 502(n) of the act if it: (i) Contains favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions. (ii) Uses the concept of “statistical significance” to support a claim that has not been demonstrated to have clinical significance or validity, or fails to reveal the range of variations around the quoted average results. (iii) Uses statistical analyses and techniques on a retrospective basis to discover and cite findings not soundly supported by the study, or to suggest scientific validity and rigor for data fro…

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 item (i) of 21 CFR 202.1(e)(7), whose chapeau reads 'An advertisement may be false, lacking in fair balance, or otherwise misleading or otherwise violative of section 502(n) of the act if it:'. The rule statement preserves that conditional framing ('An ad may be misleading if it relies on...'), so it is not written as a flat prohibition. This is the key failure mode for an (e)(7) item and this rule avoids it.
- Not overstated: the rule does not extend the provision beyond advertisements, does not claim a per se violation, and does not add a medium or audience the source does not have.
- Atomic: a single checkable condition - favorable information/conclusions drawn from a study inadequate in design, scope, or conduct. 'Design, scope, or conduct' are alternative ways the same inadequacy arises, not separate requirements.
- determinism 'judgment' is correct: methodological adequacy to 'furnish significant support' is a scientific assessment, not presence/absence or a literal match.
- authority 'binding' is correct: 21 CFR 202.1 is a regulation.
- Severity 'warning' is defensible and matches the permissive 'may be' framing of (e)(7).
- Locator '21 CFR 202.1(e)(7)(i)' matches the quoted text exactly; applies_when 'promotional' is justified because the whole section governs prescription-drug advertisements.
- Minor and not grounds to withhold a pass: the rule says 'favorable conclusions' where the source says 'favorable information or conclusions'.