Rules/misleading presentation/US-MIS-006

No selective presentation of information to suggest greater safety than demonstrated

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

An ad may not suggest greater safety than demonstrated by cherry-picking references/sources reporting minimal side effects.

Check

Review cited sources for selective inclusion of only favorable-safety reports while excluding representative unfavorable data.

Escalate when

Whether the selection is 'cherry-picked' versus a fair representative sample is unclear.

Where this comes from

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

…tial evidence or substantial clinical experience. (iii) Contains favorable information or opinions about a drug previously regarded as valid but which have been rendered invalid by contrary and more credible recent information, or contains literature references or quotations that are significantly more favorable to the drug than has been demonstrated by substantial evidence or substantial clinical experience. (iv) Contains a representation or suggestion that a drug is safer than it has been demonstrated to be by substantial evidence or substantial clinical experience, by selective presentation of information from published articles or other references that report no side effects or minimal side effects with the drug or otherwise selects information from any source in a way that makes a drug appear to be safer than has been demonstrated. (v) Presents information from a study in a way that implies that the study represents larger or more general experience with the drug than it actually does. (vi) Contains references to literature or studies that misrepresent the effectiveness of a drug by failure to disclose that claimed results may be due to concomitant therapy, or by failure to disclose the credible information available concerning the extent to…

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 enumerated list in 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) of the act' if it does any of the listed things. This is an operative prohibition, not an example, definition, or preamble commentary, so the rule statement follows directly from the source.
- Locator is correct: the quoted sentence is subparagraph (iv) of the (e)(6) list in the excerpt.
- Not overstated. If anything the rule is marginally narrower than the source: (e)(6)(iv) also covers selecting information 'from any source' (not only published articles/references), while the rule speaks of 'references/sources'. Narrowing is not a pass-blocking defect here, and the check's phrase 'cited sources' still captures the core conduct. The rule does not convert 'may be misleading' into a prohibition — note that (e)(6) is the mandatory 'is false' list, distinct from the (e)(7) 'may be' list, so the absolute framing is correct.
- Atomic: one checkable obligation — do not create a safer-than-demonstrated impression through selective presentation of safety information. The two limbs in the quote (published articles vs. any source) are alternative means of the same single violation, not independently checkable requirements.
- Determinism 'judgment' is right: deciding whether a set of citations is cherry-picked versus a fair representative sample turns on the overall impression created and the adequacy/representativeness of the selection, which no literal match can settle. The escalation condition is consistent with this.
- Authority 'binding' is right: 21 CFR 202.1 is a regulation implementing section 502(n) of the FD&C Act.
- Severity 'blocker' is defensible: conduct under (e)(6) renders the advertisement violative of section 502(n) per the regulation's own terms, i.e., misbranding exposure rather than a stylistic defect.
- applies_when 'promotional' is justified and not invented — 202.1(e) governs prescription drug advertisements; the rule statement itself is scoped to 'an ad', so the promotional limit is neither missing nor over-broad within the available taxonomy.