Established name prominence must be commensurate with proprietary name prominence

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

Rule

The established name must have a prominence commensurate with the proprietary name's prominence, considering all pertinent factors such as typography, layout, contrast, and other printing features.

Check

Compare the overall visual prominence (typography, layout, contrast, printing features) of the established name against the proprietary name and judge whether they are commensurate.

Escalate when

Reviewer cannot readily judge from typography, layout, contrast, or other factors whether the established name's prominence is commensurate with the proprietary name's.

Where this comes from

21 CFR 201.10(g)(2) and 202.1(b)(2); Section II.C · page 7. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… as large as the letters of the proprietary name, FDA recommends that the smallest letter of the established Contains Nonbinding Recommendations name (upper- or lowercase letters) be printed in letters at least one half the actual size of the largest letter of the proprietary name (upper- or lowercase letters). C. Prominence of Proprietary and Established Names The regulations require that “the established name shall have a prominence commensurate with the prominence with which such proprietary name or designation appears, taking into account all pertinent factors, including typography, layout, contrast, and other printing features” (21 CFR 201.10(g)(2) and 202.1(b)(2)). Generally, FDA considers all methods used to achieve prominence in promotional labeling or advertisements when evaluating whether the established name is presented with a prominence commensurate with that of the proprietary name. The following hypothetical examples of established name presentations <u>do not</u> have commensurate prominence with the proprietary names, conside…

Open the original at page 7 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

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
- The quote is verbatim regulatory text reproduced in Section II.C (21 CFR 201.10(g)(2), 202.1(b)(2)) and the rule statement restates it without extending it — it keeps both 'commensurate' and the open 'all pertinent factors, including typography, layout, contrast, and other printing features'.
- Determinism 'judgment' is correct and is the single most important call on this rule: commensurate prominence turns on overall impression across multiple interacting factors, and the source confirms this by saying FDA 'considers all methods used to achieve prominence ... when evaluating' it, and by illustrating failures only through hypothetical examples rather than a threshold. The escalation condition is aimed squarely at that uncertainty.
- Not overstated: this is a regulatory requirement in the source, not an FDA recommendation, so 'must' is warranted; severity 'blocker' is defensible, and authority 'guidance' under-claims rather than over-claims.
- Atomic: the listed factors are inputs to one holistic prominence comparison, not independently checkable requirements — a reviewer reaches one verdict, not four.
- The check does not attempt to convert the judgment into a false measurement, which is the right handling.
- Section III imposes a parallel 'reasonable relationship' standard for multi-ingredient products' active-ingredient listings; that is a distinct standard and correctly not merged in here.