In TV-format DTC ads, major statement text must be easily readable

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

In television-format direct-to-consumer advertisements for prescription drugs intended for use by humans, the font size and style, contrast with the background, and on-screen placement of the text portion of the major statement must allow the information to be read easily.

Check

For TV-format ads only: assess legibility of the on-screen major statement text — font size relative to screen, style, contrast with the background, and placement (e.g., not obscured, cut off, or too small to read). Do not apply this check to radio or other audio-only broadcast media, and do not assess duration of text display here (governed separately by 21 CFR 202.1(e)(1)(ii)(C)(2)).

Escalate when

Legibility is marginal — e.g., contrast, font size, or placement is arguably adequate but not clearly compliant, requiring a human visual/human-factors judgment call.

Where this comes from

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

…e 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 major statement. (2) Exempt advertisements. The following advertisements are exempt from the requirements of paragraph (e)(1) of this section under the conditions specified: (i) Reminder advertisements. Reminder adverti…

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

Productdrug

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
- Supported in substance: 21 CFR 202.1(e)(1)(ii)(D) is an operative regulatory condition (not an example, definition, or preamble gloss) stating that 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.' This is one of the (A)-(E) conditions that establish the mandatory 'clear, conspicuous, and neutral manner' presentation, so a requirement framing is faithful.
- Overstated on medium: (D) is expressly limited to 'advertisements in television format,' but the rule statement and check say nothing about television and applies_when.medium is 'broadcast', which on its face reaches radio and telephone communications systems under (e)(1)(i). Radio has no on-screen text, so as written the rule can be applied outside the scope the source sets. The television-format limitation must appear in the rule statement itself, not be left implicit in a broad medium tag.
- Scope also omits the source's subject limitation: (e)(1)(ii) applies to 'advertisements for prescription drugs intended for use by humans presented directly to consumers.' The consumer audience tag captures half of this; the human prescription drug limitation is not reflected anywhere in the rule.
- Atomic: although three factors are named (font size/style, contrast, placement), the source treats them as conjunctive inputs to a single outcome test - whether the text can be read easily. A reviewer makes one determination, so this is not an improper bundle.
- Determinism correctly set to judgment: 'allow the information to be read easily' turns entirely on legibility impression, not on presence/absence or a literal match.
- Authority correctly set to binding: this is a codified FDA regulation, not guidance.
- Locator 21 CFR 202.1(e)(1)(ii)(D) matches the quoted sentence exactly.
- Severity 'warning' is defensible: failing this condition means the major statement is not presented in a clear, conspicuous, and neutral manner, but the determination is a graded legibility judgment rather than a bright-line omission, and the escalation trigger ('legibility is marginal') is sensible.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quote is the operative text of 21 CFR 202.1(e)(1)(ii)(D), a substantive condition in a binding regulation, not an example, definition, or description of what is not required. The chapeau at (e)(1)(ii) makes the clear/conspicuous/neutral presentation mandatory and lists (D) among the conditions for meeting it, so stating it as a 'must' is faithful.
- Not overstated: the rule statement reproduces the three factors and the 'read easily' standard without adding force or breadth; it does not convert a 'should' into an obligation.
- applies_when is justified by the source on every axis: (e)(1)(ii) covers 'prescription drugs intended for use by humans presented directly to consumers' (consumer, drug, promotional), and (D) is expressly limited to 'advertisements in television format'. Because the medium taxonomy value 'broadcast' is coarser than the regulation, the TV-only limit is correctly carried in the rule statement and the check's explicit exclusion of radio/audio-only media.
- determinism 'judgment' is correct: 'read easily', contrast, and placement turn on legibility and adequacy, not on literal presence or absence.
- authority 'binding' is correct: 21 CFR is a regulation.
- Locator 21 CFR 202.1(e)(1)(ii)(D) is exact; the quoted sentence appears verbatim at that paragraph.
- Atomic: although three factors are listed, the regulation frames them as a single conjunctive legibility test resolving to one outcome ('allow the information to be read easily'), so this is one checkable requirement.
- Severity 'warning' is on the lenient side for a binding presentation requirement, but defensible given the evaluative standard and the escalation clause for marginal legibility.
- Defect requiring revision: the check tells the reviewer to flag text that is 'too small/brief to read'. Display duration is not governed by (D); it is governed by the separate paragraph (e)(1)(ii)(C)(2) ('The text is displayed for a sufficient duration to allow it to be read easily'), which carries its own safe harbor (text begins and ends at approximately the same time as the corresponding audio). Including duration attaches findings to the wrong locator, circumvents that safe harbor, and adds an independently checkable requirement to an otherwise atomic rule.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quoted clause appears verbatim as operative regulatory text at (e)(1)(ii)(D), governed by the mandatory chapeau at (e)(1)(ii) ('the major statement must be presented in a clear, conspicuous, and neutral manner'). It is not drawn from an example, definition, preamble, or a description of what the rule does not require.
- Not overstated: the rule preserves every limit the source imposes — prescription drugs, intended for use by humans, presented directly to consumers, and (per (D)'s own opening words) television format only. The 'read easily' standard is carried over without inflation. The chapeau's 'is presented ... if the following are met' phrasing makes (A)-(E) formally sufficient conditions, but rendering (D) as a 'must' is the standard reading given the mandatory chapeau, and the warning severity plus escalation language avoids asserting an automatic violation.
- Atomic: font size/style, contrast, and placement are a single conjunctive clause resolving to one outcome test ('allow the information to be read easily'), not independently checkable obligations. The rule correctly does not bundle in the separate duration requirement at (e)(1)(ii)(C)(2), and the check text expressly disclaims it.
- Determinism correct as 'judgment': legibility of on-screen text turns on visual impression and adequacy, not on presence/absence or literal match. The escalation trigger for marginal contrast/size/placement is well-aligned.
- Authority correct as 'binding': 21 CFR 202.1 is a codified regulation.
- applies_when is justified and not invented: consumer audience, prescription drug, and promotional all derive from the (e)(1)(ii) chapeau. 'broadcast' is nominally broader than 'television format', but the check explicitly excludes radio and audio-only media, so the applied scope matches the source and 'broadcast' appears to be the nearest available taxonomy value.
- Locator 21 CFR 202.1(e)(1)(ii)(D) matches the quoted clause exactly.
- Severity 'warning' is defensible: the obligation is binding, but non-compliance is established only via a legibility judgment rather than a bright-line failure, and marginal cases are routed to human review.