Quantitative ingredient info prominence must reasonably relate to proprietary name prominence

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

For a prescription drug containing two or more active ingredients advertised under a proprietary name or designation for the mixture with no corresponding established name, the prominence of the required quantitative ingredient information must bear a reasonable relationship to the prominence of the proprietary name.

Check

Confirm the product is a multi-active-ingredient prescription drug promoted under a proprietary name with no corresponding established name; if so, compare the visual weight (type size, placement, contrast, layout) of the quantitative ingredient information against the most prominent display of the proprietary name.

Escalate when

Prominence levels are close and reasonableness of the relationship is debatable.

Where this comes from

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

…g 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 of the proprietary name or designation. The prominence of the quantitative ingredient information shall bear a reasonable relationship to the prominence of the proprietary name. (d)(1) If the advertisement employs one proprietary name or designation to refer to a combination of active ingredients present in more than one preparation (the individual preparations differing from each other as to quantities of active ingredients and/or the form of the finished preparation) and there is no established name corresponding to such proprietary name or designation, a listing showing the established …

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

Productdrug

Active ingredient counttwo-or-more

Proprietary name basismixture-designation

Established name statusnone-for-mixture-designation

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
- The quote is verbatim from 21 CFR 202.1(c) and the locator is correct; the sentence is an operative requirement ('shall bear a reasonable relationship'), not an example, definition, or description of what is not required, so the underlying obligation is genuinely established.
- The rule is overbroad in scope. Paragraph (c) is expressly conditional: it opens '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 cited sentence is the second sentence of that conditional paragraph and inherits all three conditions. As drafted, applies_when is simply 'promotional', which would fire the rule on single-ingredient products, on pieces with no proprietary name, and on products that do have a corresponding established name — none of which are covered by (c). The whole section is also limited to prescription-drug advertisements (§ 202.1), not promotional material generally.
- The rule statement softens a binding obligation: the regulation says the prominence 'shall' bear a reasonable relationship, while the rule says it 'should reasonably match'. With authority marked binding, the statement should use mandatory language.
- Atomic: yes — it isolates the prominence-relationship requirement and correctly leaves the separate '(placed in) direct conjunction with the most prominent display' requirement of the same paragraph to a different rule.
- Determinism 'judgment' is correct: 'reasonable relationship' between prominence levels turns on typography, size, placement and contrast, which cannot be settled by literal match or presence/absence. The escalate-when condition is consistent with this.
- Authority 'binding' is correct (Code of Federal Regulations). Severity 'warning' is defensible for a prominence-balance defect that is corrigible and judgment-dependent.
- Category 'name-ingredient' is appropriate.
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 second sentence of the operative requirement in § 202.1(c), stated in mandatory 'shall' terms, not an example, definition, or preamble gloss. The rule statement tracks it directly.
- applies_when mirrors the paragraph's own three conditions verbatim in substance: prescription drug containing two or more active ingredients (active-ingredient-count: two-or-more), advertisement bearing a proprietary name or designation for the mixture (proprietary-name-basis: mixture-designation), and no corresponding established name (established-name-status: none-for-mixture-designation). None of these limits is invented or omitted.
- Not overstated: 'shall bear a reasonable relationship' is rendered as 'must bear a reasonable relationship' — no strengthening, no broadening to labeling or to single-ingredient or established-name products. The rule correctly does not extend the analogous listing requirement of (d)(1) or the placement requirement of (c)'s first sentence.
- Atomic: only the prominence-relationship obligation is carried. The co-located 'direct conjunction with the most prominent display' requirement in the same sentence-pair of (c) is deliberately left out, so no bundling of independently checkable duties.
- determinism = judgment is right: 'reasonable relationship' between prominences cannot be settled by presence/absence or a literal match; it turns on type size, layout, contrast, and overall impression, and the escalate-when clause appropriately targets the close-call band.
- authority = binding is right: this is a codified FDA regulation (21 CFR 202.1), not guidance.
- Locator 21 CFR 202.1(c) is exact — the quoted sentence appears in paragraph (c), not in (b)(2) or (d)(1), which contain the similar but distinct half-size-type and active-ingredient-listing prominence rules.
- Severity 'warning' is defensible: the obligation is binding, but a finding requires a judgment about relative prominence, so flagging for reviewer resolution rather than automatic violation is proportionate.
- Minor, non-blocking: the check says 'promoted' where the regulation says 'advertisement'; the rule statement itself correctly says 'advertised', so the scope is not actually widened.

Nearby rules

US-NAME-013