Rules/misleading presentation/US-MIS-017

Average results should disclose the range of variation

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

An ad may be misleading if it quotes average results without revealing the range of variation around that average.

Check

Check whether quoted average results are accompanied by variance/range information (e.g., standard deviation, range).

Escalate when

Materiality of the omitted variability data to the specific claim is debatable.

Where this comes from

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

…alance, 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 from studies the design or protocol of which are not amenable to formal statistical evaluations. (iv) Uses tables or graphs to distort or misrepresent the relationships, trends, differences, or changes among the variables or p…

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 quoted clause sits in 21 CFR 202.1(e)(7)(ii). Grammatically, both 'Uses the concept of "statistical significance"...' and 'fails to reveal the range of variations around the quoted average results' are third-person verb phrases governed by the lead-in 'An advertisement may be false, lacking in fair balance, or otherwise misleading ... if it:'. The failure-to-reveal-range prong is therefore freestanding and not merely an appendage to the statistical-significance prong, so the rule statement follows from the text rather than from an example or definition.
- Not overstated: the source's operative verb is 'may be false, lacking in fair balance, or otherwise misleading' (paragraph (e)(7) heading and lead-in), and the rule statement mirrors that with 'An ad may be misleading if...'. The title's 'should disclose' is, if anything, softer than the regulation, not stronger. The rule does not convert a conditional into an outright prohibition.
- Atomic: (e)(7)(ii) contains two independently checkable prongs (misuse of 'statistical significance' to support a claim lacking clinical significance/validity, and failure to reveal range of variation). The rule isolates only the second prong; the quote's leading clause is not smuggled into the check.
- Determinism 'judgment' is correct: although presence of a range or SD looks like a presence check, applying the rule requires deciding what counts as a 'quoted average result' and whether the variability disclosed is the relevant one, and the underlying standard is a 'may be misleading' determination. The escalation note (materiality of the omitted variability to the claim) is consistent with that.
- Authority 'binding' is correct: 21 CFR 202.1 is a codified regulation, not guidance.
- Locator is accurate; the quoted words appear verbatim at (e)(7)(ii) in the provided text.
- Severity 'warning' is defensible and consistent with the permissive '(7) Advertisements that may be false...' framing, as distinct from the mandatory violations enumerated in (e)(6).
- applies_when 'promotional' is justified: the section governs prescription-drug advertisements, and per (l)(1)-(l)(2) the surrounding promotional pieces are treated as labeling subject to comparable standards. No invented limit and no obvious missing limit within the available scope vocabulary.

Nearby rules

US-MIS-016