Rules/misleading presentation/US-MIS-020

Tables and graphs must not distort study relationships or trends

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

Tables or graphs may be misleading if they distort or misrepresent the relationships, trends, differences, or changes among the studied variables or products (e.g., mislabeled axes).

Check

Review graphic/table axis labeling, scale, and presentation for distortion of the underlying data relationships.

Escalate when

Whether a graphic creates a distorted impression is a matter of visual/statistical judgment.

Where this comes from

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

…ted 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 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 …

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 appears verbatim in the source at 21 CFR 202.1(e)(7)(iv), within the operative list under '(7) Advertisements that may be false, lacking in fair balance, or otherwise misleading' — an operative regulatory provision, not a definition, preamble, or example of what is not required. The rule statement follows directly.
- The rule statement preserves the source's hedged framing ('may be misleading'), matching the (e)(7) chapeau 'An advertisement may be false, lacking in fair balance, or otherwise misleading... if it'. The title ('must not distort') reads as a categorical shorthand, but the substantive rule text and the 'warning' severity keep it aligned with the 'may be' character of paragraph (e)(7); this is a labeling preference, not a substantive overstatement.
- The parenthetical example in the rule ('mislabeled axes') and the check's reference to axis labeling are drawn from the source's own illustration: 'for example, by failing to label abscissa and ordinate so that the graph creates a misleading impression.' Not invented.
- Atomic: one checkable condition — whether a table or graph distorts/misrepresents the data relationships. Axis labeling, scale and presentation are listed as inspection points for that single condition, not as separate independent requirements.
- Determinism 'judgment' is correct: the source's own test turns on whether the graph 'creates a misleading impression' and whether relationships are 'distorted' — impression-based, not settled by presence/absence or literal match. The escalate note is apt.
- Authority 'binding' is correct — 21 CFR 202.1 is a codified regulation; the source header confirms binding authority.
- applies_when 'promotional' is justified and appropriately limited: § 202.1 governs prescription-drug advertisements (and, per (l)(2), promotional labeling pieces), not non-promotional materials. Neither invented nor missing an obvious limit.
- Severity 'warning' is defensible given placement in the 'may be' list of (e)(7) rather than the per se violations of (e)(6), and given that a finding requires judgment about the impression created.
- Locator '21 CFR 202.1(e)(7)(iv)' matches the paragraph in which the quoted text appears in the source.