On-screen major statement text must remain readable for a sufficient duration

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

In television-format prescription drug advertisements, the on-screen text of the major statement must be displayed for a sufficient duration to allow it to be read easily. This duration requirement is deemed satisfied if the text display begins at the same time as, and ends at approximately the same time as, the corresponding audio (a safe harbor); other timing must still independently allow easy reading.

Check

Compare the on-screen major statement text's start/end timing to the corresponding audio. If the text display begins at the same time as, and ends at approximately the same time as, the audio, the duration requirement is satisfied. If timing does not match this pattern, assess whether the actual display duration nonetheless allows the text to be read easily (considering length of text, pacing, and reading speed); flag as a violation only if the duration is inadequate for easy reading.

Escalate when

Timing does not conform to the begins-with/ends-approximately-with-audio safe harbor and it is unclear, based on text length and display speed, whether the actual duration still permits easy reading.

Where this comes from

21 CFR 202.1(e)(1)(ii)(C)(2). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… 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 purposes of the standard in this paragraph (e)(1)(ii)(C)(2), the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio. (D) In advertisements in television format, for the text portion of the major statement, the size and style of font, the contrast with the background, and the placement on the screen allow the information to be read easily. (E) During the presentation of the major statement, the advertisement does not include audio or visual elements, alone or in combination, that are likely to interfere with comprehension of the …

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

Audienceconsumer

Mediumbroadcast

Ad formattelevision

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 — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The operative requirement in 21 CFR 202.1(e)(1)(ii)(C)(2) is that 'The text is displayed for a sufficient duration to allow it to be read easily.' The quoted sentence is a deeming clause ('the duration is considered sufficient if...'), i.e. a safe harbor stating one way to satisfy the standard. The rule restates that sufficient condition as a mandatory one ('must remain displayed for a duration matching the start/end of the corresponding audio'), which is stronger than the source: text held on screen longer than the audio would fail this rule but not the regulation.
- The check inherits the same inversion — it verifies conformance to the safe harbor rather than to the 'sufficient duration to allow it to be read easily' standard, so it would generate false findings.
- applies_when medium is too broad. Paragraph (e)(1)(ii) covers 'television or radio format,' but subparagraph (C) is expressly limited: 'In advertisements in television format, it is presented concurrently using both audio and text (dual modality).' The text-duration requirement in (C)(2) therefore has no application to radio, which has no on-screen text. 'broadcast' sweeps radio in.
- promotional and consumer scoping are justified by the source language 'For advertisements for prescription drugs intended for use by humans presented directly to consumers.'
- determinism 'judgment' is correct: the governing standard is 'read easily' (adequacy), and even the safe harbor turns on 'approximately the same time.'
- authority 'binding' is correct — this is codified regulation, not guidance.
- Locator 21 CFR 202.1(e)(1)(ii)(C)(2) is precise and the quote appears verbatim there.
- The rule is atomic: a single timing requirement for a single element.
- Severity 'warning' is arguably light for a binding requirement bearing on the major statement, but it is defensible given the provision is framed as a deeming standard rather than a flat prohibition; not a blocking defect.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Quote is verbatim operative regulatory text from 21 CFR 202.1(e)(1)(ii)(C)(2), not a definition, example, preamble, or statement of what the rule does not require; the locator matches exactly.
- The rule faithfully preserves the structure of the source: a standard ('sufficient duration to allow it to be read easily') plus a deeming provision ('is considered sufficient if'). Critically, it treats the begins-with/ends-approximately-with-audio condition as a sufficient safe harbor, not a mandatory timing pattern, which is the correct reading and avoids the classic overstatement.
- The residual clause ('other timing must still independently allow easy reading') is directly supported by the first sentence of the quoted text, which states the underlying standard independent of the deeming provision.
- applies_when is fully traceable to the source's own scoping: (e)(1)(ii) limits to human drugs 'presented directly to consumers in television or radio format' (consumer, broadcast), and (C) narrows to 'advertisements in television format' (television ad-format), correctly excluding radio where on-screen text cannot exist. No invented conditions and no obvious limit omitted; (e)(2)-exempt reminder ads carry no major statement, so the check is simply vacuous there.
- Atomic: a single obligation about display duration. The verbatim-text requirement in (C)(1) and the font/contrast/placement requirement in (D) are separate and are not bundled in.
- determinism 'judgment' is correct: although the safe-harbor branch alone would be a literal timing match, the rule's fallback turns on whether the actual duration permits easy reading given text length, pacing and reading speed, which is an adequacy assessment.
- authority 'binding' is correct: this is codified federal regulation using 'must' and a definitional 'is considered,' not non-binding guidance language.
- Severity 'warning' is defensible given that the check flags only when duration is actually inadequate for easy reading rather than on any deviation from the safe harbor, and the escalation trigger correctly isolates the ambiguous non-safe-harbor case.