An ad fails the true-statement test if false or misleading on safety/effectiveness

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

An advertisement fails the required 'true statement' standard if it is false or misleading regarding side effects, contraindications, or effectiveness.

Check

Assess the brief summary and related claims for factual accuracy and absence of misleading impression on these topics.

Escalate when

Falsity/misleadingness is a matter of interpretation.

Where this comes from

21 CFR 202.1(e)(5)(i). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…r permitted in the package labeling by §§ 201.100 or 201.105 of this chapter of the drug dosage form(s) or shall otherwise conform to the provisions of paragraph (e)(3)(iii) of this section. (5) “True statement” of information. An advertisement does not satisfy the requirement that it present a “true statement” of information in brief summary relating to side effects, contraindications, and effectiveness if: (i) It is false or misleading with respect to side effects, contraindications, or effectiveness; or (ii) It fails to present a fair balance between information relating to side effects and contraindications and information relating to effectiveness of the drug in that the information relating to effectiveness is presented in greater scope, depth, or detail than is required by section 502(n) of the act and this information is not fairly balanced by a presentation of a summary of true information relating to si…

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-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the operative text of (e)(5)(i), which is a binding regulatory standard: an advertisement 'does not satisfy the requirement that it present a "true statement"' if it 'is false or misleading with respect to side effects, contraindications, or effectiveness.' The rule statement restates that condition without adding force; it is not drawn from an example, definition, or preamble.
- Not overstated: the source states a flat failure condition, and the rule says the ad 'fails the required true-statement standard' — the same strength. The three subject areas (side effects, contraindications, effectiveness) are listed disjunctively in the source and the rule keeps them that way.
- Atomic: this is a single check — is the presentation false or misleading on the named topics. The sibling failure conditions (e)(5)(ii) fair balance and (e)(5)(iii) material facts are correctly left out rather than bundled in.
- determinism 'judgment' is right: 'false or misleading' turns on the impression created, not on presence/absence or a literal match.
- authority 'binding' is right: 21 CFR 202.1 is a regulation.
- Severity 'blocker' is defensible — failing the (e)(1) true-statement requirement makes the drug misbranded under section 502(n) per paragraph (k).
- Locator 21 CFR 202.1(e)(5)(i) matches the quoted text exactly.
- applies_when 'promotional' is justified: (e)(1) applies to 'all advertisements for any prescription drug' subject to the (e)(2) exemptions; limiting to promotional material is neither invented nor an omission of an obvious limit.