MLRagent
Rules/name ingredient/US-NAME-034

Print: multi-column use of proprietary name allows established name once per page or spread

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

Rule

If the proprietary name appears in more than one column of running text without appearing above or below any column, FDA does not intend to object as long as the established name accompanies the proprietary name at least once per page or spread.

Check

For multi-column layouts where the proprietary name only appears within running text columns, confirm the established name appears at least once per page or spread.

Where this comes from

Section II.D.1 · page 8. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…oprietary name at least once per page or spread. The regulations in 21 CFR 201.10(g)(1) and 202.1(b)(1) include information regarding the frequency of the proprietary and established names if columns are used in a promotional labeling piece or advertisement (e.g., a newspaper advertisement). FDA interprets a column to mean one of two or more vertical sections of a printed page, separated by a rule or blank space. If the proprietary name appears in more than one column of running text (but does not appear outside of the text, above or below the column), FDA does not intend to object, provided that the established name accompanies the proprietary 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 t…
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.