Rules/risk disclosure/US-RISK-005

Major statement must use consumer-friendly, understandable language

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

The major statement in DTC broadcast ads must use plain, consumer-friendly, readily understandable language.

Check

Review major statement wording for medical jargon or complexity a lay consumer could not readily understand.

Escalate when

Language complexity is debatable.

Where this comes from

21 CFR 202.1(e)(1)(ii)(A). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…man drug advertisements in television or radio format—Clear, conspicuous, and neutral manner. For advertisements for prescription drugs intended for use by humans presented directly to consumers in television or radio format, the major statement must be presented in a clear, conspicuous, and neutral manner. The major statement is presented in a clear, conspicuous, and neutral manner if the following are met: (A) It is presented in consumer-friendly language and terminology that is readily understandable. (B) Its audio information, in terms of the volume, articulation, and pacing used, is at least as understandable as the audio information presented in the rest of the advertisement. (C) In advertisements in television format, it is presented concurrently using both audio and text (dual modality). To achieve dual modality: (1) Either the text displays the verbatim key terms or phrases from the corresponding audio…

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

Mediumbroadcast

Audienceconsumer

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
- Supported: the quoted clause is not an example or preamble gloss — it is subparagraph (A) of the enumerated conditions that define compliance with the mandatory standard in (e)(1)(ii) ('the major statement must be presented in a clear, conspicuous, and neutral manner'). Because the regulation states the standard is met 'if the following are met: (A)...(E)', consumer-friendly, readily understandable language is a necessary element, so stating it as a requirement follows from the text.
- Not overstated: the operative verb in the parent sentence is 'must', so framing this as an obligation rather than a recommendation is faithful. The rule does not extend the condition beyond the major statement or beyond DTC television/radio.
- Atomic: one checkable requirement (language/terminology comprehensibility). It does not bundle in the separate conditions of (B) audio understandability, (C) dual modality, (D) text legibility, or (E) distracting elements, each of which is correctly left to other rules.
- Determinism correctly set to 'judgment': whether terminology is 'readily understandable' to a lay consumer turns on impression and adequacy, not a literal match or presence/absence test. The escalation trigger ('language complexity is debatable') is consistent with that.
- Authority correctly 'binding': 21 CFR 202.1 is a codified regulation, and the locator 21 CFR 202.1(e)(1)(ii)(A) maps exactly to the quoted sentence.
- applies_when is justified by the text's own limits: (e)(1)(ii) applies to 'advertisements for prescription drugs intended for use by humans presented directly to consumers in television or radio format', which matches promotional / broadcast / consumer. Note the source limits (ii) to television or radio, whereas paragraph (e)(1)(i) also mentions telephone communications systems; if this corpus ever applies 'broadcast' to telephone-format ads, this rule should not fire there. This is an edge case, not a defect in the rule as written, since the rule statement says 'DTC broadcast ads' and the check is about wording.
- Severity 'warning' is defensible: this is a mandatory element of the clear/conspicuous/neutral standard, but non-compliance is assessed qualitatively rather than as a per se omission of required risk content.