Statistical analyses inconsistent with established statistical principles may be misleading

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

An ad may be misleading if it uses reports or statements represented to be statistical analyses, interpretations, or evaluations that are inconsistent with or violate established principles of statistical theory, methodology, applied practice, and inference, or that are derived from clinical studies whose design, data, or conduct substantially invalidate the application of those statistical analyses, interpretations, or evaluations.

Check

Have a qualified reviewer assess whether cited material represented to be a statistical analysis, interpretation, or evaluation conforms to established statistical theory, methodology, applied practice, and inference, and whether it derives from a clinical study whose design, data, or conduct substantially invalidates applying that analysis, interpretation, or evaluation.

Escalate when

Statistical methodology questions, or whether a clinical study's design, data, or conduct undermines the validity of an applied statistical analysis, generally require expert (biostatistician) review.

Where this comes from

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

… 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 products studied; for example, by failing to label abscissa and ordinate so that the graph creates a misleading impression. (v) Uses reports or statements represented to be statistical analyses, interpretations, or evaluations that are inconsistent with or violate the established principles of statistical theory, methodology, applied practice, and inference, or that are derived from clinical studies the design, data, or conduct of which substantially invalidate the application of statistical analyses, interpretations, or evaluations. (vi) Contains claims concerning the mechanism or site of drug action that are not generally regarded as established by scientific evidence by experts qualified by scientific training and experience without disclosing that the claims are not established and the limitations of the supporting evidence. (vii) Fails to provide sufficient emphasis for the information relating to side effects and contraindications, when…

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-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is part of item (v) of 21 CFR 202.1(e)(7), an operative list, so the substance is supported by the source.
- Overstated in the title. The title reads 'Statistical analyses must follow established statistical principles', converting an (e)(7) 'may be false, lacking in fair balance, or otherwise misleading' factor into a flat obligation. The rule statement correctly keeps 'may be misleading', so the title contradicts the rule body and is the stronger claim a reviewer will read first.
- The quote truncates (v) mid-item. The source also covers reports or statements 'derived from clinical studies the design, data, or conduct of which substantially invalidate the application of statistical analyses, interpretations, or evaluations.' The rule statement drops that second branch entirely, so a real (v) problem could pass this rule.
- The source is narrower than the rule statement in one respect: it targets 'reports or statements represented to be statistical analyses, interpretations, or evaluations'. The rule's 'its statistical analyses/interpretations' is a reasonable restatement but should keep the 'represented to be' framing so the scope is the material the ad presents as statistical.
- Atomic: one factor - statistical material inconsistent with established statistical principles. The enumerated principles (theory, methodology, applied practice, inference) are facets of one condition.
- determinism 'judgment' is correct: conformance to established statistical principles is expert assessment, not a literal match. The escalate-when note (biostatistician review) is consistent.
- authority 'binding' is correct: 21 CFR 202.1 is a regulation.
- Severity 'warning' is defensible and matches the permissive framing of (e)(7).
- Locator '21 CFR 202.1(e)(7)(v)' is correct for the quoted text.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the full text of 202.1(e)(7)(v) and the locator matches.
- The rule statement is framed as 'may be misleading', matching the (e)(7) chapeau ('An advertisement may be false, lacking in fair balance, or otherwise misleading ... if it'). No obligation stronger than the source's is asserted.
- The two limbs (analysis inconsistent with established statistical principles; analysis derived from a study whose design, data or conduct substantially invalidates applying it) are the source's own disjunctive conditions for a single enumerated factor, not two independently imposed requirements.
- 'Judgment' is plainly correct — conformity with established statistical theory and whether a study's conduct invalidates an analysis are expert assessments; the escalate condition correctly routes this to a biostatistician.
- Authority 'binding' is correct, and 'warning' is the right severity for a presumptive (e)(7) factor rather than a conclusive (e)(6) one.