Combination products: active ingredients should get commensurate emphasis and contrast

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

Rule

This recommendation applies only to prescription drug (including prescription biologic and animal prescription drug) promotion, not over-the-counter products. For a product with two or more active ingredients in the situations described in Section III, FDA recommends that the active ingredients be presented with a prominence commensurate with the prominence of the proprietary name's presentation (e.g., matching emphasis and contrast if the proprietary name is bold, black text on white).

Check

Confirm the piece is prescription drug promotion for a product with two or more active ingredients in a Section III situation. Compare styling choices (boldness, color, contrast) of the active-ingredient information against the proprietary name's styling and judge whether the emphasis is commensurate.

Escalate when

Reviewer is unsure whether the active-ingredient styling gives commensurate emphasis and contrast relative to the proprietary name.

Where this comes from

Section III · page 10. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… (active ingredient 1 and active ingredient 2) ♠ PROPRIETARY NAME<sup>™</sup> (active ingredient 1 and active ingredient 2) PROPRIETARY NAME<sup>®</sup> CII active ingredient 1/active ingredient 2 The regulations described in this section also require that the presentation of the active ingredients “bear a reasonable relationship to the prominence of the proprietary name” (21 CFR 201.10(h)(1) and 202.1(c)). Thus, FDA recommends that the active ingredients be presented with a prominence commensurate with the prominence of the presentation of the proprietary name. For example, if the proprietary name is printed in bold, black text against a white background, FDA recommends that the active ingredients be presented with commensurate emphasis and contrast. IV. PAPERWORK REDUCTION ACT OF 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 350…

Open the original at page 10 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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: Section III states 'Thus, FDA recommends that the active ingredients be presented with a prominence commensurate with the prominence of the presentation of the proprietary name. For example, if the proprietary name is printed in bold, black text against a white background, FDA recommends that the active ingredients be presented with commensurate emphasis and contrast.' The rule statement tracks the recommendation and its example.
- Not overstated: the rule preserves 'FDA recommends' rather than converting the recommendation into an obligation, and severity 'warning' is the right treatment. Authority 'guidance' is correct — this sentence is FDA's own recommendation implementing the regulatory requirement, not quoted regulatory text.
- Atomic: the bold/contrast material is the source's illustrative example of commensurate prominence, not a second independently checkable requirement.
- Determinism 'judgment' is correct: 'commensurate' prominence turns on emphasis and contrast, not on presence/absence. The escalation clause matches.
- Locator 'Section III' is correct.
- Scope: the rule statement does not carry the Section III limitation — the recommendation is made about products with two or more active ingredients in the situations Section III describes — and applies_when ('promotional: [promotional]') does not record that the guidance covers prescription drugs only (footnote 3 excludes over-the-counter drugs). Only the title conveys the combination-product limit, so a reviewer applying the rule text alone could apply it outside its scope.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported by the guidance speaking in its own voice: "Thus, FDA recommends that the active ingredients be presented with a prominence commensurate with the prominence of the presentation of the proprietary name." The quote is a complete sentence, and this is the guidance's own gloss on the regulation rather than a restatement of quoted regulatory text, so it properly belongs to this source.
- Not overstated: the title ("should get") and rule text keep the recommendation framing, and severity "warning" matches a non-binding recommendation. The bold-black-on-white example in the rule text is taken from the source's own illustrative sentence and is presented as an example, not as an added requirement.
- Atomic: one prominence-commensurability recommendation; emphasis and contrast are named as factors within that single judgment, not as separate checks.
- Determinism "judgment" is correct: commensurate prominence turns on impression and on "all pertinent factors, including typography, layout, contrast, and other printing features".
- Scope is right: Section III combination-product situations, prescription drugs only per footnote 3; those limits appear in the rule text because the fixed applies_when vocabulary cannot carry them.
- Violable and checkable: a piece can present the ingredient listing in faint small type beside a bold proprietary name.

Nearby rules

US-NAME-047 US-NAME-048