Rules/misleading presentation/US-MIS-011

No quoting or paraphrasing out of context to mislead

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

Quotes or paraphrases must not be used out of their original context in a way that conveys a false or misleading idea.

Check

Compare the quoted/paraphrased text to its full original context to check whether meaning is distorted.

Escalate when

Whether the excerpt materially distorts the original meaning is a matter of judgment.

Where this comes from

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

…l studies of a drug, such as in laboratory animals or in vitro, in a way that suggests they have clinical significance when in fact no such clinical significance has been demonstrated. (viii) Uses a statement by a recognized authority that is apparently favorable about a drug but fails to refer to concurrent or more recent unfavorable data or statements from the same authority on the same subject or subjects. (ix) Uses a quote or paraphrase out of context to convey a false or misleading idea. (x) Uses literature, quotations, or references that purport to support an advertising claim but in fact do not support the claim or have relevance to the claim. (xi) Uses literature, quotations, or references for the purpose of recommending or suggesting conditions of drug use that are not approved or permitted in the drug package labeling. (xii) Offers a combination of drugs for the treatment of patients sufferi…

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 is verbatim from the operative enumerated list at 21 CFR 202.1(e)(6), whose chapeau states an advertisement 'is false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n)' if it does any listed thing. Item (ix) is therefore a binding prohibition, not an example, definition, or preamble summary.
- The rule statement preserves every element of the source, including the essential qualifier 'to convey a false or misleading idea.' It does not convert any decontextualized quotation into a violation, which would have been the obvious overstatement here.
- The source item sits in the (e)(6) 'is' list rather than the (e)(7) 'may be false... or otherwise misleading' list, so stating it as a flat obligation rather than a risk is faithful to the text.
- Single testable proposition; it is properly separated from the adjacent and distinct items (e)(6)(viii) (favorable authority statement omitting contrary data) and (e)(6)(x) (references that do not in fact support the claim).
- Determinism 'judgment' is right: nothing is resolved by presence/absence or literal match; the reviewer must retrieve the original source and judge whether meaning was materially distorted. The escalation note states this correctly.
- Authority 'binding' is right: this is codified federal regulation carrying a section 502(n) consequence.
- Severity 'blocker' is defensible because material falling under (e)(6) is deemed false or misleading by the regulation itself, not merely at risk of being so.
- Locator verified: the quoted sentence appears at subparagraph (ix) within paragraph (e)(6) of the excerpt.
- Scope note (not a defect): the regulation governs prescription drug advertisements, while applies_when uses the coarse 'promotional' tag; the locator makes the governing scope explicit and no finer bucket is available in the schema. The (e)(6) waiver-by-petition proviso is an exception process and does not alter the default obligation.