Established name must accompany proprietary name presentation in radio/telephone ads

AI-verifiedblockerFDA guidance · non-bindingRaised as a question — a person decides

Rule

For prescription drug radio and telephone advertisements, FDA does not intend to object if the established name is disclosed in direct conjunction with the most prominent presentation of the proprietary name, which under most circumstances is the first occurrence in the broadcast.

Check

Confirm that the established name is disclosed in direct conjunction with the most prominent (generally the first) presentation of the proprietary name in the ad.

Escalate when

Escalate when the reviewer cannot identify which presentation of the proprietary name in the broadcast is the most prominent one.

Where this comes from

21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.D.2 · page 8. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…lished name be displayed on the screen for the same amount of time as the proprietary name. For superimposed text that typically appears along the bottom of the screen, the established name does not have to be included with the proprietary name. FDA does not intend to object if the established name is not included in the audio portion of audiovisual promotional labeling or in an audiovisual broadcast advertisement. For radio and telephone advertisements, FDA does not intend to object if the established name is disclosed in direct conjunction with the most prominent presentation of the proprietary name. Under most circumstances, this is the first occurrence in the broadcast. Contains Nonbinding Recommendations 3. Electronic and Computer-Based Promotion Promotion in electronic and computer-based media also does not contain text pages like print media. However, promotion in such media often contains information or running text equivalent to many pages of traditional printed text. FDA does n…

Open the original at page 8 on fda.gov ↗Read our full copy →

Document: FDA guidance: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: f6f78606542ef91596ef21f6…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

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-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: the quote is a complete sentence from Section II.D.2 and is the guidance's own enforcement-discretion statement, not quoted regulatory text. The rule's added clause ("which under most circumstances is the first occurrence in the broadcast") is taken verbatim in substance from the very next sentence of the source, "Under most circumstances, this is the first occurrence in the broadcast."
- Not overstated: the Rule body preserves the "FDA does not intend to object if" framing and does not upgrade it to an obligation; the "must" in the title is shorthand for the operative check the body and Check section state correctly, and the "most prominent presentation" qualifier is carried through.
- Atomic: one condition — the established name disclosed in direct conjunction with the most prominent presentation of the proprietary name. The first-occurrence clause is a decision aid for identifying that presentation, not a second requirement.
- Determinism "judgment" is correct: which presentation is "most prominent" in an audio ad, and whether disclosure is in "direct conjunction", cannot be settled by presence/absence or a literal match.
- applies_when {medium: [broadcast]} fits radio advertisements; telephone advertisements have no separate term in the fixed scoping vocabulary and are correctly named in the rule text instead. The prescription-drug limit (footnote 3 excludes over-the-counter drugs) is likewise stated in prose because applies_when cannot express it.
- Locator (Section II.D.2) is right, severity blocker is defensible for a missing established-name disclosure, and the rule is violable: a radio spot can name the brand first and the established name only later or not at all.
- The Escalate-when clause matches the judgment call the rule actually requires.