Audio portion of audiovisual/broadcast material need not include established name

DisputednoteFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

FDA does not intend to object if the established name is omitted from the audio (spoken) portion of audiovisual promotional labeling or broadcast advertisements. This rule uses 'broadcast' to mean all audiovisual promotional labeling (e.g., videos shown in a health care provider's office) and broadcast advertisements, since the taxonomy has no separate audiovisual value.

Check

Do not flag the absence of a spoken established name in the audio track of audiovisual or broadcast pieces.

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.

…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 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…

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
- Verbatim support in Section II.D.2: '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.' The rule restates it accurately and keeps the enforcement-discretion framing.
- Not overstated; atomic; authority 'guidance' and severity 'note' are correct for a suppression rule.
- Determinism 'deterministic' is correct: whether the established name is spoken in the audio track is settled by presence/absence.
- Defect in applies_when: both the rule title and the rule statement say 'audiovisual promotional labeling or broadcast advertisements', and the source sentence names audiovisual promotional labeling separately from broadcast advertisements (the guidance's example of audiovisual promotional labeling is a video shown in a health care provider's office, which is not broadcast). applies_when nevertheless lists medium 'broadcast' only. Because this is a suppression rule, the narrow scope creates a live false-positive risk: a reviewer working on a non-broadcast in-office video would not see the carve-out and could wrongly flag the missing spoken established name.
- Locator 'Section II.D.2' is right.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — reject
claude-code:opus · 2026-09-21
Reviewer's reasons
- Not violable, and therefore not a rule. The statement is a pure carve-out - FDA will not object if the established name is absent from the audio portion - and the check is an explicit instruction not to flag anything ('Do not flag the absence of a spoken established name'). No promotional piece can breach it, so a reviewer has nothing to check.
- It should be folded into US-NAME-035, the audiovisual and broadcast established-name disclosure rule, as an express exclusion: the expectation there concerns superimposed on-screen text, and the audio portion is carved out of it.
- The quote is accurate and a whole sentence, and authority 'guidance' correctly reflects a non-objection statement - the defect is that the item is an exclusion rather than a requirement.
- determinism 'deterministic' is also misapplied: nothing is being determined, because the item states only that a condition will not be objected to.

Nearby rules

US-NAME-035 US-NAME-036 US-NAME-037 US-NAME-039 US-NAME-053