Major statement audio must be at least as understandable as rest of the ad

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

The major statement's audio (volume, articulation, pacing) must be at least as understandable as the audio elsewhere in the ad.

Check

Compare audio quality/pacing of the major statement segment to the rest of the ad's audio.

Escalate when

Audio comparison is subjective or borderline.

Where this comes from

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

…r 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, or the text displays the verbatim complete transcript of the corresponding audio; and (2) The text is displayed for a sufficient duration to allow it to be read easily. For purp…

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 quote is the full operative text of subparagraph (B), which sits under the mandatory framing 'the major statement must be presented in a clear, conspicuous, and neutral manner... if the following are met.' It is a condition of compliance, not an example, definition, or description of what is not required.
- Not overstated: the source uses 'must' and the rule states a must; no hortatory language has been converted into an obligation, and nothing is broadened beyond the quoted comparative standard.
- applies_when is justified by the chapeau of (e)(1)(ii): 'advertisements for prescription drugs intended for use by humans presented directly to consumers in television or radio format' maps to promotional + broadcast + consumer. Note (e)(1)(i) also reaches telephone communications systems while (ii) does not, so 'broadcast' is marginally wider than the source, but not materially so for consumer TV/radio ads.
- Atomic: volume, articulation, and pacing are enumerated dimensions of one comparative test (major statement audio vs. rest of ad audio), not separately checkable obligations.
- determinism 'judgment' is correct: 'at least as understandable' cannot be settled by presence/absence or literal match; it requires a comparative impression assessment. The escalate-when clause is consistent with this.
- authority 'binding' is correct: 21 CFR 202.1 is a codified regulation.
- Severity 'warning' is defensible: binding requirement, but compliance turns on a reviewer's comparative judgment rather than an objective, hard-fail criterion.
- Locator 21 CFR 202.1(e)(1)(ii)(B) matches the quoted sentence verbatim.
- The check is actionable: a reviewer can compare the major statement's audio delivery against the rest of the ad's audio.