Established name must have prominence commensurate with the proprietary name

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

In a prescription-drug advertisement in a visual medium (print or digital/web/email), if the piece bears a proprietary name or designation for the drug or an ingredient and a corresponding established name exists, the established name's overall visual prominence — not just its type size — must be commensurate with that of the proprietary name, taking into account typography, layout, and contrast.

Check

First confirm the piece is a prescription-drug advertisement in a visual medium (print or digital/web/email) that displays a proprietary name or designation for the drug or an ingredient, and that a corresponding established name exists; if either condition is absent, this rule does not apply. Where it applies, assess the overall visual prominence (typography, layout, color, contrast, placement, boldness) of the established name relative to the proprietary name each time the proprietary name is featured; a violation is established-name text that reads as visually subordinate despite meeting minimum size ratios.

Escalate when

Sizing meets the minimum but overall visual prominence is arguably lower due to color, contrast, or placement; or it is unclear whether both a proprietary name and a corresponding established name are present, so applicability of the rule is uncertain.

Where this comes from

21 CFR 202.1(b)(2). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ationship between the proprietary name or designation and the established name shall be made clear by use of a phrase such as “brand of” preceding the established name, by brackets surrounding the established name, or by other suitable means. (2) The established name shall be printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined, and 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. (c) In the case of a prescription drug containing two or more active ingredients, if the advertisement bears a proprietary name or designation for such mixture and there is no established name corresponding to such proprietary name or designation, the quantitative ingredient information required in the advertisement by section 502(n) of the act shall be placed in direct conjunction with the most prominent display o…

Open the original at these words on ecfr.gov ↗Read our full copy →

Document: 21 CFR 202.1
Version: 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
Retrieved: 2026-09-21 from www.ecfr.gov
Fingerprint: a542640a872b3f2702d549e8…

Applies when

Naturepromotional

Mediumprintdigital

Productdrug

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-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the second clause of §202.1(b)(2) is an operative mandate ('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'). The rule statement tracks this clause directly and is not lifted from an example, definition, or preamble.
- Not overstated: 'shall' is mandatory, and the rule does not extend the obligation beyond what the sentence says. If anything the rule is narrower than the source (see medium scope below), not broader.
- Atomic: the rule isolates the prominence clause and deliberately leaves the separate half-size-lettering requirement in the first clause of (b)(2) to another rule ('Beyond font size...'). The listed factors (typography, layout, contrast) are inputs to a single commensurate-prominence determination, not independently checkable obligations.
- Determinism correctly 'judgment': 'prominence commensurate with' and 'all pertinent factors' cannot be settled by presence/absence or literal match; it turns on visual impression and relative emphasis. The escalate-when clause (sizing compliant but prominence arguably lower) confirms this is an assessment, not a measurement.
- Authority correctly 'binding': 21 CFR 202.1 is a codified regulation.
- Locator 21 CFR 202.1(b)(2) is accurate — the quoted sentence appears there verbatim.
- Severity 'warning' is defensible: the underlying requirement is binding, but the determination is judgment-based and the escalate-when routes borderline cases to human review rather than asserting a violation.
- Defect — medium scope: applies_when restricts the rule to 'print', but the source imposes the requirement on prescription-drug advertisements generally, not print media. The words 'printing features' are an illustrative factor within 'all pertinent factors', not a limitation of the rule to printed pieces. As drafted the rule would silently miss digital/web banner, email, and on-screen advertisements where color, contrast, and placement issues are most common.
- Defect — missing source-derived limits: the rule does not state that it applies only to prescription-drug advertisements (the scope of §202.1) and only where a proprietary name or designation is used and a corresponding established name exists (the trigger in §202.1(b)(1)). Without these, the rule reads as applying to any promotional piece bearing any product name.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quote is the operative 'shall' clause of 21 CFR 202.1(b)(2), a codified regulation, and it states precisely the obligation the rule asserts - the established name shall have prominence commensurate with the proprietary name, assessed on typography, layout, contrast and other printing features. Not drawn from an example, definition, or preamble.
- Not overstated: source says 'shall have a prominence commensurate'; the rule says 'must be commensurate'. The rule's emphasis on 'overall visual prominence, not just type size' is warranted because (b)(2) imposes the half-size-letters requirement and the commensurate-prominence requirement as two separate conjunctive obligations, so prominence is an additional test beyond size.
- Atomic: the rule isolates the prominence prong of (b)(2) and expressly leaves the >=half-size letter prong to a separate check ('despite meeting minimum size ratios'). One independently checkable requirement.
- Determinism correctly 'judgment': 'prominence commensurate with' and 'all pertinent factors' cannot be settled by presence/absence or literal match; it turns on relative visual impression.
- Authority correctly 'binding': 21 CFR 202.1 is a regulation.
- applies_when is otherwise justified: the (b)(1)/(b)(2) trigger is an ad bearing a proprietary name where a corresponding established name exists, and the check gates on exactly those two conditions plus 'each time it is featured', which tracks (b)(1). Restriction to prescription drugs matches the section heading and scope sentence.
- Locator 21 CFR 202.1(b)(2) is exactly where the quoted sentence appears.
- Severity 'warning' is defensible for a relative-prominence judgment finding rather than an outright omission.
- Defect: internal scope inconsistency. The rule statement covers 'any visual medium (print, digital/web/email, or other on-screen presentation)', which reaches broadcast/video on-screen text, but applies_when.medium lists only print and digital. A reviewer gating on applies_when would exclude video pieces the statement claims to cover.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quote is the operative second clause of 21 CFR 202.1(b)(2), an imperative 'shall' requirement in the regulatory text itself — not an example, definition, or preamble. The rule statement ('established name's overall visual prominence must be commensurate with that of the proprietary name, taking into account typography, layout, and contrast') tracks the source almost verbatim.
- Applicability is justified by context rather than invented: § 202.1 is captioned 'Prescription-drug advertisements,' and (b)(1) supplies the triggering condition the rule reproduces — an advertisement that 'bears a proprietary name or designation for the drug or any ingredient thereof' where a corresponding established name exists. Limiting to 'drug' product-type is correct; the section covers human and veterinary prescription drugs.
- Not overstated: the rule renders 'shall' as 'must' with no broadening. The carve-out 'not just its type size' is accurate — (b)(2) states the half-size letter requirement and the commensurate-prominence requirement as two distinct obligations, so treating prominence as an additional test beyond size ratios is faithful, and keeping the size-ratio arithmetic out of this rule is what makes it atomic.
- Restricting medium to print/digital is mildly under-inclusive (TV ads can display names visually), but the source's own factor list — 'typography, layout, contrast, and other printing features' — is framed around printed presentation, so the limit is defensible and errs conservative rather than overstating.
- Determinism 'judgment' is correct: 'prominence commensurate with' and 'all pertinent factors' cannot be settled by literal match or presence/absence; it turns squarely on visual impression. Authority 'binding' is correct — this is a codified CFR provision.
- Locator 21 CFR 202.1(b)(2) is exact; the quoted sentence is the second half of (b)(2).
- Severity 'warning' is defensible: it is a binding requirement, but the violation is established only by a subjective prominence comparison after minimum size ratios are met, so flagging for reviewer judgment rather than hard failure is reasonable. The escalate-when clause correctly routes the borderline color/contrast/placement cases and the ambiguous-applicability case to a human.
- The check is executable as written: it states the gating conditions, names the factors to weigh, anchors the comparison to each featured presentation of the proprietary name (consistent with (b)(1)'s 'each time it is featured'), and defines the failure condition. The extra factors it lists (color, placement, boldness) are permissible because the source says 'all pertinent factors, including' — a non-exhaustive list.

Nearby rules

US-NAME-011