MLRagent
Rules/name ingredient/US-NAME-053

Audiovisual supers: established name should accompany prominent proprietary-name display

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

Rule

For audiovisual promotional labeling (e.g., videos shown in a health care provider's office) and broadcast advertisements for prescription drugs, when superimposed text ('supers') is equivalent to a headline or tagline, FDA does not intend to object to fewer appearances of the established name provided the established name is placed in direct conjunction with the most prominent display of the proprietary name. Superimposed text along the bottom of the screen is not required to include the established name, and FDA does not intend to object if the established name is not included in the audio portion.

Check

Identify the most prominent display of the proprietary name in the piece. Flag the piece if the established name is not placed in direct conjunction with that display (unless it accompanies every headline/tagline-equivalent super). Do not flag a missing established name in other headline-equivalent supers once this condition is met, in bottom-of-screen supers, or in audio narration.

Escalate when

Escalate when the reviewer cannot determine whether a given super is equivalent to a headline/tagline or is instead bottom-of-screen text.

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