DTC TV/radio major statement must be clear, conspicuous, and neutral

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

In DTC TV/radio ads for human prescription drugs, the major statement (side effects/contraindications) must be presented clearly, conspicuously, and neutrally.

Check

Assess overall presentation of the major statement for clarity, conspicuousness, and neutrality relative to the rest of the ad.

Escalate when

Any element of clarity, conspicuousness, or neutrality is borderline.

Where this comes from

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

…ection to present the major statement using audio and text; and (B) Contain a brief summary of all necessary information related to side effects and contraindications, unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation. (ii) Human 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 televisio…

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 operative chapeau of 21 CFR 202.1(e)(1)(ii), a mandatory 'must' in regulatory text, not an example, definition, preamble, or description of what is not required. The rule statement adds nothing beyond it.
- Not overstated: the source says 'must'; the rule preserves every scope limit in the source sentence (human prescription drugs, direct-to-consumer, television or radio). It does not extend to print, HCP audiences, or other media.
- Atomic: 'clear, conspicuous, and neutral manner' is a single composite standard stated as one obligation in the source. Subcriteria (A)-(E) are separate downstream rules; this umbrella rule does not bundle independently sourced obligations.
- Determinism correct: conspicuousness and neutrality turn on impression and on comparison to 'the rest of the advertisement' per (B); no literal match or presence/absence test settles them, so 'judgment' is right.
- Authority correct: 21 CFR is codified regulation, so 'binding' is accurate.
- applies_when is justified and correctly narrow: (e)(1)(ii) applies only to ads 'presented directly to consumers in television or radio format', which is narrower than (e)(1)(i) (which also covers telephone systems and non-DTC broadcast). The (e)(2) reminder-ad exemption is not a missing limit because a reminder ad carries no major statement and the rule cannot trigger.
- Locator correct: the quoted sentence is the first sentence of paragraph (e)(1)(ii).
- Severity defensible: 'warning' fits a judgment-based presentational standard requiring human adjudication rather than a mechanical fail.
- Minor non-blocking note: the check's phrase 'relative to the rest of the ad' is strictly accurate only for the audio-comparability prong at (B); clarity and legibility are assessed on their own terms. This is a wording preference, not a defect.