Established-name lettering ≥ half size of featured proprietary name in Rx drug ads

DisputedblockerBinding lawRaised as a question — a person decides

Rule

In prescription drug advertisements, wherever the established name is joined with the proprietary name, the established name's lettering must be at least half as large as the proprietary name's lettering. This section governs advertisements for prescription drugs only, not promotional labeling or non-prescription products.

Check

Identify each place in the prescription drug advertisement (print, digital, or other visually displayed format) where the proprietary name is featured — i.e., presented in a prominent, standalone manner rather than embedded in plain running text — and confirm the established name is joined with it in letters that, by visual comparison of letter height across the two typefaces, are at least 50% as large as the proprietary name's letters; larger established-name type is also compliant, since 50% is a floor, not a target. Appearances of the proprietary name only in running text, or in a column of running text containing detailed composition/prescribing/side-effect/contraindication information, are governed by a different provision (21 CFR 202.1(b)(1)) and are not evaluated under this check.

Escalate when

Escalate when it is unclear, given the layout and typography, whether a given appearance of the proprietary name is "featured" (triggering this half-size floor) or falls instead within running text or a detailed-information column governed by 21 CFR 202.1(b)(1); or when the two typefaces differ enough in style, weight, or design that comparing letter sizes to the 50% threshold is not a straightforward visual judgment.

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.

…ed in association with the proprietary name or designation, the established name shall be placed in direct conjunction with the proprietary name or designation, and the relationship 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 th…

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

Content typeadvertisement

Rx statusprescription

How this rule was checked

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Quote is the verbatim operative command of 21 CFR 202.1(b)(2) ('shall be printed in letters that are at least half as large...'), a binding regulatory obligation, not an example, definition, or preamble gloss; the rule statement and check follow directly from it.
- Atomic: (b)(2) contains two distinct requirements — the half-size lettering floor and the separate 'prominence commensurate... taking into account typography, layout, contrast' test. The rule correctly isolates only the first and leaves the judgment-based prominence test to a separate rule.
- Determinism correct: type size measurement and a ≥50% arithmetic comparison settle the question; no impression, adequacy, or balance judgment is invoked because the prominence clause was excluded.
- Authority correct: 21 CFR is a regulation, properly flagged binding. Locator 202.1(b)(2) is accurate for the quoted sentence. Blocker severity is defensible for a facial regulatory violation bearing on 502(n) compliance.
- Overstated on scope: § 202.1 governs prescription drug *advertisements* ('§ 202.1 Prescription-drug advertisements'; (b)(1) conditions on 'an advertisement for a prescription drug'). The applies_when is an unqualified 'promotional', so as written the rule reaches promotional labeling and non-prescription materials that this section does not govern; the parallel labeling provision is not in the cited source.
- Check is incomplete as a compliance test: under (b)(1), where the proprietary name appears in running text in the same size type, the established name must be used 'in the same type size used in the running text' — not half. A reviewer applying only the ≥50% floor would clear a running-text presentation that (b)(1) requires at 100%.
- The medium limit to 'print' is defensible from 'printed in letters' and is not an invented restriction, though it should be read to cover printed/displayed text generally rather than paper-only pieces.
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 mandate of 21 CFR 202.1(b)(2) ('shall be printed in letters that are at least half as large'), not an example, definition, or description of what is not required. The rule statement follows directly from it.
- Scope claim justified: limiting to prescription drug advertisements is supported by the section heading '202.1 Prescription-drug advertisements' and the opening scope sentence; the 'at least half' floor reading is also correct.
- Correctly atomized away from the second clause of (b)(2) (prominence commensurate, typography/layout/contrast), which is a separate judgment-based obligation.
- Not atomic: the check appends a second, independently checkable obligation from a different subsection - the 202.1(b)(1) requirement that in running text or a detailed-information column with the proprietary name not enlarged, the established name must be in the SAME type size. A reviewer can pass or fail that test independently of the (b)(2) 50% test; it belongs in its own rule.
- Determinism wrong: applying the 50% floor first requires deciding which appearances are 'featured', an undefined prominence-dependent concept the source never reduces to a literal test; the rule's own escalation clause also concedes ambiguous visual comparison across typefaces. This is judgment, not deterministic.
- applies_when internally contradictory: medium is encoded as ['print'] while the check states that 'print' means any printed or displayed lettering in any medium including digital/screen. As encoded the rule would be skipped on digital ads while the prose insists it applies there.
- applies_when incomplete: the Rx-advertisement-only scope asserted in the rule statement (excluding promotional labeling and non-prescription products) is not represented in any machine-readable field.
- Authority correct: codified federal regulation, binding. Severity blocker is defensible for a mandatory name-disclosure requirement tied to section 502(n) misbranding.
- Locator correct: the quoted sentence appears verbatim at 21 CFR 202.1(b)(2).
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Core requirement is verbatim operative regulatory text: 21 CFR 202.1(b)(2) states 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.' The rule statement follows directly from it.
- Authority 'binding' is correct — codified federal regulation, mandatory 'shall'. Locator 21 CFR 202.1(b)(2) is accurate for the quoted sentence.
- Determinism 'judgment' is correct: identifying a 'featured' presentation and comparing letter height across differing typefaces turns on visual impression, not presence/absence or literal match.
- Severity 'blocker' is defensible — failure violates a mandatory ingredient/naming provision implementing FD&C 502(n), rendering the advertisement noncompliant on its face.
- Atomic: the rule properly isolates the half-size lettering floor and leaves the second clause of (b)(2) (prominence commensurate, considering typography/layout/contrast) to a separate rule; the trailing scope sentence is a scope note, not a second checkable obligation.
- Not overstated — if anything the check is narrower than the source (see scope defect below).
- DEFECT — rule statement and check contradict each other on scope, and the check under-reaches the source. The statement says the floor applies 'wherever the established name is joined with the proprietary name,' but the check excludes all running-text and detail-column appearances as 'governed by a different provision … and not evaluated under this check.' (b)(2) contains no such carve-out; it is a general typographic provision reaching any joined presentation, and (b)(1)'s own provisos independently impose a half-as-large floor for larger-type proprietary names in running text and in detailed-information columns. A reviewer following the check would skip violations the cited provision covers.
- DEFECT — the gloss defining 'featured' as 'presented in a prominent, standalone manner rather than embedded in plain running text' is the drafter's inference from (b)(1)'s featured/running-text contrast, not language in the source, and it is used to shrink the reach of (b)(2).
- DEFECT — medium scope is internally inconsistent: applies_when.medium lists only ['print','digital'] while the check text reads 'print, digital, or other visually displayed format.' The source's 'printed in letters' supports visually displayed matter generally; the two fields must agree.
- DEFECT — the sentence 'This section governs advertisements for prescription drugs only, not promotional labeling or non-prescription products' is only partly supported. The excerpt establishes the section covers prescription-drug advertisements but says nothing about promotional labeling. It also expressly defines prescription drug to include veterinary drugs under § 201.105, which the flat statement and the rx-status filter obscure.

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