Audiovisual/broadcast headline: place established name in conjunction with proprietary name's most prominent display

DisputedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

In audiovisual promotional labeling and broadcast advertisements, where superimposed text is equivalent to a headline or tagline, the established name should be placed in direct conjunction with the most prominent display of the proprietary name. Where that is done, FDA does not intend to object to fewer appearances of the established name elsewhere in the piece. This rule uses 'broadcast' to cover both broadcast advertisements (e.g., television ads) and non-broadcast audiovisual promotional labeling (e.g., videos shown in a health care provider's office), since the taxonomy has no separate audiovisual value.

Check

Identify the most prominent on-screen display of the proprietary name in the audiovisual or broadcast piece and confirm the established name is directly conjoined with it there.

Escalate when

Reviewer is unsure which on-screen display of the proprietary name is the most prominent one.

Where this comes from

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.

…ary name at least once per page or spread. 2. Audiovisual Promotional Labeling and Broadcast Advertisements Audiovisual promotional labeling (e.g., videos shown in a health care provider’s office) and audiovisual broadcast advertisements (e.g., television ads) do not contain text pages like print media. However, promotional labeling and advertisements in such media often contain superimposed text or “supers.” For superimposed text that is equivalent to a headline or tagline, FDA does not intend to object to fewer appearances of the established name if the established name is placed in direct conjunction with the most prominent display of the proprietary name in the audiovisual promotional labeling or broadcast advertisement. When the established name accompanies the proprietary name, FDA recommends that the established 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 p…

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

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim from Section II.D.2 and the rule faithfully preserves both the 'does not intend to object' framing and the limit to superimposed text equivalent to a headline or tagline.
- Determinism 'judgment' is correct: the check turns on which on-screen display of the proprietary name is 'most prominent', which the source's footnote says depends on typography, layout, contrast and type size. The escalation clause matches.
- Authority 'guidance' and severity 'warning' are both correct for an enforcement-discretion statement.
- Defect in applies_when: the rule statement and title both say 'audiovisual/broadcast', and the source sentence expressly covers 'the audiovisual promotional labeling or broadcast advertisement' — the guidance defines audiovisual promotional labeling to include non-broadcast material such as videos shown in a health care provider's office. But applies_when lists medium 'broadcast' only, so the rule will not fire on in-office videos and other non-broadcast audiovisual promotional labeling that the source covers. The metadata contradicts the rule's own text.
- Atomic and supported otherwise; locator 'Section II.D.2' is right.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete, verbatim sentence from Section II.D.2 and is FDA's own position, so the rule is properly drawn from this guidance rather than from a regulation it quotes.
- As drafted, however, the rule statement is only the enforcement-discretion half ('FDA does not intend to object to fewer appearances ...'), which by itself is a permission a piece cannot breach. The operative content - that in audiovisual and broadcast material the established name should be in direct conjunction with the most prominent display of the proprietary name - is present only as a proviso, and only the check states it affirmatively. Stated as a non-objection, a reviewer has nothing to flag.
- This is fixable rather than fatal, because unlike a pure carve-out this sentence does carry the operative frequency expectation for audiovisual and broadcast pieces, and no other rule in this packet states it.
- Not overstated once restated: the source is a non-objection, so the rule must not become a flat 'must'. Authority 'guidance' and severity 'warning' are correct for that.
- determinism 'judgment' is right - identifying 'the most prominent display' and 'direct conjunction' on screen turns on prominence and layout, not presence/absence.
- applies_when using 'medium: broadcast' is acceptable: the source covers both broadcast advertisements and non-broadcast audiovisual promotional labeling, the fixed vocabulary has no audiovisual value, and the rule text says so explicitly - that limit cannot be expressed in applies_when, so stating it in the rule text is fine.
- Locator Section II.D.2 is correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence from Section II.D.2 and supports the rule: for headline/tagline-equivalent supers, FDA does not intend to object to fewer appearances of the established name if it is placed in direct conjunction with the most prominent display of the proprietary name. The rule text keeps this as 'should', with the enforcement-discretion framing, so it is not overstated.
- The rule text contains a note to the pipeline ('This rule uses 'broadcast' to cover both ... since the taxonomy has no separate audiovisual value'). Stating the scope limit inside the rule text is acceptable. Commentary about the taxonomy is not rule content and must not be shown to reviewers.
- Judgment is correct: identifying the 'most prominent display' requires weighing typography, size and layout (footnote 9).
- This rule has the same quote, locator section and substance as US-NAME-053, which has severity 'blocker' where this one has 'warning'. The corpus should not carry two rules with the same source and different severities. One of them should be kept.

Nearby rules

US-NAME-036 US-NAME-037 US-NAME-038 US-NAME-039 US-NAME-053