Broadcast ads must include the major statement in audio (or audio/visual)

AI-verifiedblockerBinding lawCheckable — presence or a literal match settles it

Rule

For broadcast advertisements of prescription drugs (radio, television, or telephone communications systems), other than reminder advertisements (including price reminder ads under 21 CFR 200.200), bulk-sale drug advertisements, and prescription-compounding drug advertisements exempted under 21 CFR 202.1(e)(2), the major statement (major side effects and contraindications) must be presented in the audio, or audio and visual, portion of the presentation, unless paragraph (e)(1)(ii)(C) applies, i.e., the ad is a consumer-directed television-format ad subject to the separate audio-and-text (dual modality) requirement.

Check

Confirm the piece is a broadcast ad (radio, television, or telephone communications system) for a prescription drug and is not an (e)(2)-exempt reminder, bulk-sale, or prescription-compounding advertisement. If not exempt, confirm the major side effects and contraindications are spoken in the audio (or audio and visual) portion of the presentation. Consumer-directed television-format ads are instead governed by the dual-modality requirement of 21 CFR 202.1(e)(1)(ii)(C), which is checked by a separate rule; this rule does not apply to them.

Where this comes from

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

…indications (when used in this section, “side effects, contraindications” include side effects, warnings, precautions, and contraindications and include any such information under such headings as cautions, special considerations, important notes, etc.), and effectiveness. (i) Broadcast advertisements. Advertisements broadcast through media such as radio, television, or telephone communications systems must: (A) Include information relating to the major side effects and contraindications (“major statement”) of the advertised drugs in the audio or audio and visual parts of the presentation, unless required by paragraph (e)(1)(ii)(C) of this section 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 h…

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

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: the quote is the operative imperative of 21 CFR 202.1(e)(1)(i)(A), introduced by 'Advertisements broadcast through media such as radio, television, or telephone communications systems must:'. It is a binding requirement, not guidance, an example, a definition, or a description of what is not required.
- Not overstated: the rule tracks the source's 'must', is confined to broadcast media as the source is, and does not convert a misleading-risk statement into a prohibition. The rule also preserves the source's own carve-out by referencing the dual-modality requirement of (e)(1)(ii)(C) in the check.
- Atomic: a single checkable requirement about the modality in which the major statement is delivered.
- Determinism defensible as 'deterministic': the check turns on whether the major statement is spoken (audio) versus silent on-screen text only, which a script or storyboard settles by inspection; it does not turn on adequacy, prominence, or overall impression (those tests live in (e)(1)(ii), which this rule does not reach).
- Authority 'binding' is correct — 21 CFR is regulation.
- Severity 'blocker' is defensible: omission of the major statement from the audio of a broadcast ad is a direct violation of an express regulatory 'must'.
- Locator 21 CFR 202.1(e)(1)(i)(A) is exact and matches the quoted text.
- Defect in applies_when: the source at 202.1(e)(2) expressly exempts reminder advertisements, bulk-sale drug advertisements, and prescription-compounding drug advertisements from 'the requirements of paragraph (e)(1) of this section' — the very paragraph this rule is drawn from. Broadcast reminder ads (including price reminders under 200.200) carry no major statement lawfully, so the rule as scoped would generate false blocker findings.
- Secondary scope gap: 202.1 applies to prescription-drug advertisements (per the section's opening scope sentence); applies_when does not carry that limit.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Support: the quote is verbatim binding regulatory text from 21 CFR 202.1(e)(1)(i)(A), sitting under the chapeau '(i) Broadcast advertisements. Advertisements broadcast through media such as radio, television, or telephone communications systems must:'. The rule statement — major statement in the audio, or audio and visual, parts of the presentation for broadcast Rx ads — is a direct restatement of the operative 'must' language, not an example, definition, or negative statement.
- Scope: applies_when (promotional, broadcast, prescription, no advertisement exemption) is justified. 'Prescription drug' is defined in the opening sentence of § 202.1 by reference to FDCA 503(b)(1)/§ 201.105; the (e)(2) exemptions (reminder incl. § 200.200 price reminders, bulk-sale, prescription-compounding) are expressly carved out of paragraph (e)(1) by the source, so the exemption limit is neither invented nor missing. The '(e)(1)(ii)(C)' carve-out and its limitation to consumer-directed television-format ads correctly tracks (e)(1)(ii) and (e)(1)(ii)(C).
- Not overstated: the source says 'must', and the rule says 'must'; no non-binding language is being hardened, and the rule is confined to the broadcast medium the source addresses. Severity 'blocker' is defensible — failure to include the major statement in a broadcast ad renders the ad in violation of § 202.1(e)(1) and the drug misbranded.
- Authority 'binding' is correct (codified regulation). Locator 21 CFR 202.1(e)(1)(i)(A) is exactly where the quoted sentence appears.
- Atomicity failure: the Check does not stop at the modality requirement in (A). It affirmatively instructs the reviewer, for consumer-directed TV-format ads, to 'confirm dual-modality (concurrent audio and text) per (e)(1)(ii)(C) instead.' That is a separate, independently checkable requirement with its own sub-criteria in the source ((C)(1) verbatim key terms or complete transcript; (C)(2) text displayed for a sufficient duration / co-timed with the audio). Verifying dual modality compliance belongs to a distinct rule keyed to (e)(1)(ii)(C); here it should function only as a scope carve-out.
- Determinism: for the requirement actually stated in (A) — is the major statement carried in audio (or audio+visual) rather than silent on-screen text only — presence/absence settles it, so 'deterministic' is defensible. But note that if the dual-modality verification stays inside this rule's Check, the flag becomes wrong, because (e)(1)(ii)(C)(2)'s 'sufficient duration to allow it to be read easily' and (D)'s 'read easily' are impression/adequacy judgments. Removing the bundled dual-modality confirmation keeps 'deterministic' accurate.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Directly supported: § 202.1(e)(1)(i)(A) is an operative mandate ('Advertisements broadcast through media such as radio, television, or telephone communications systems must: (A) Include information relating to the major side effects and contraindications ("major statement") ... in the audio or audio and visual parts of the presentation'). The rule statement restates this without expansion.
- Not overstated: the source uses 'must', and the rule renders it as an obligation of the same scope. The rule's carve-out for (e)(1)(ii)(C) mirrors the source's own 'unless required by paragraph (e)(1)(ii)(C)' clause, and the characterization of (C) as consumer-directed television-format dual-modality is accurate against (e)(1)(ii) and (e)(1)(ii)(C).
- applies_when is justified and appropriately limited: the source expressly scopes this to broadcast media (radio, television, telephone communications systems) for prescription drugs, and (e)(2) exempts reminder, bulk-sale, and prescription-compounding advertisements from all of (e)(1) — the rule's exclusions track (e)(2)(i)–(iii) and the § 200.200 price-reminder condition stated in (e)(2)(i).
- Atomic: a single operative requirement (major statement delivered in the audio, or audio and visual, portion). The exemption list and the (C) carve-out are scoping conditions, not separate checkable obligations; the brief-summary/adequate-provision duty of (e)(1)(i)(B) is correctly left out, and dual modality is explicitly deferred to a separate rule.
- determinism: the operative question is modality — whether the major statement is carried in the audio track rather than only in on-screen text — which is settled by presence/absence, so 'deterministic' is defensible. (Content sufficiency of what counts as 'major' is a labeling-comparison question left to other rules and does not turn on impression or prominence here.)
- authority 'binding' is correct — 21 CFR 202.1 is a codified regulation; locator 21 CFR 202.1(e)(1)(i)(A) is the exact subparagraph quoted.
- Severity 'blocker' is defensible: omission of the major statement from the audio of a broadcast ad renders the ad misbranded under the (e)(1) true-statement requirement and is not a curable cosmetic defect.