Combination products: avoid intervening matter between proprietary name and active-ingredient information

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

Rule

This applies to products with two or more active ingredients in the Section III situations, where active-ingredient information is the required information accompanying the proprietary name, and only to prescription drug (including prescription biologic and animal prescription drug) promotion, not over-the-counter products. FDA recommends against placing intervening matter, such as a logo, tagline, or other graphics, between the proprietary name and the required active-ingredient information. Trademark symbols associated with the proprietary name (registered ® or unregistered ™) and controlled substance symbols (e.g., CII) are not intervening matter and must not be flagged.

Check

Confirm the piece is prescription drug promotion for a product with two or more active ingredients in a Section III situation. Examine anything placed between the proprietary name and the active-ingredient information (logos, taglines, graphics) and judge whether it separates or obscures the relationship, excluding trademark symbols (®, ™) and controlled-substance symbols (e.g., CII), which are not intervening matter.

Escalate when

Reviewer is unsure whether intervening content meaningfully separates or obscures the proprietary name's relationship to the active-ingredient information.

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.

…e. FDA also recommends that the proprietary name and the required information regarding the active ingredients not be separated Contains Nonbinding Recommendations by placement of intervening matter that would in any way detract from, obfuscate, or de-emphasize the active ingredients of the product or obscure the relationship between the proprietary name and the active ingredients. For example, FDA recommends that the proprietary name and the required information regarding the active ingredients not be separated by intervening matter, such as a logo, tagline, or other graphics. As noted in section II.A of this guidance, FDA does not consider trademark symbols associated with proprietary names (e.g., registered trademark symbols (®) or unregistered trademark symbols (™)) or controlled substance symbols (e.g., CII) to be intervening matter. Examples of appropriate juxtaposition include, but are not limited to, the following: PROPRIETARY NAME® (active ingred…

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 'FDA also recommends that the proprietary name and the required information regarding the active ingredients not be separated by placement of intervening matter that would in any way detract from, obfuscate, or de-emphasize the active ingredients ... For example, FDA recommends that the proprietary name and the required information regarding the active ingredients not be separated by intervening matter, such as a logo, tagline, or other graphics.'
- Not overstated in force: the rule says 'FDA recommends against', matching the source's 'recommends', and severity 'warning' fits a non-binding recommendation. Authority 'guidance' is correct — this is FDA's own recommendation, not quoted regulatory text.
- Determinism 'judgment' is correct: the underlying test is whether intervening matter detracts from, obfuscates or de-emphasizes the active ingredients or obscures the relationship, which turns on impression. The escalation clause matches.
- Atomic: a single prohibition on separating matter.
- Locator 'Section III' is correct.
- Material omission: the same passage carves out an express exception — 'FDA does not consider trademark symbols associated with proprietary names (e.g., registered trademark symbols (R) or unregistered trademark symbols (TM)) or controlled substance symbols (e.g., CII) to be intervening matter.' The check as written ('Examine anything placed between the proprietary name and the active-ingredient information') would have a reviewer flag a trademark or CII symbol that the source explicitly permits. Section III's example presentations also show these symbols in acceptable layouts.
- Scope: the rule statement does not say it applies only to the Section III combination-product situations; only the title carries that limit. applies_when ('promotional: [promotional]') also does not record that the guidance covers prescription drugs only (footnote 3 excludes over-the-counter drugs).
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 in its own voice: "For example, FDA recommends that the proprietary name and the required information regarding the active ingredients not be separated by intervening matter, such as a logo, tagline, or other graphics." The quote is a complete sentence and is not a quoted regulation, so the rule belongs to this source.
- Not overstated: title and rule text keep "recommends"/"recommends against" framing, and severity "warning" is appropriate for a non-binding recommendation.
- Atomic: a single prohibition on intervening matter. The trademark/controlled-substance exclusion is a carve-out on the same requirement, not an independently checkable second requirement, and it is squarely supported: "FDA does not consider trademark symbols ... or controlled substance symbols (e.g., CII) to be intervening matter." Stating it prevents false positives rather than adding a check.
- Determinism "judgment" is correct: the source's concern is matter that would "detract from, obfuscate, or de-emphasize" the active ingredients or "obscure the relationship", which turns on impression.
- Scope is right: Section III situations, two or more active ingredients, prescription drugs only (footnote 3 excludes over-the-counter drugs). The prescription-drug and combination-product limits are stated in the rule text because the fixed applies_when vocabulary cannot express them.
- Violable: a piece can place a logo or tagline between the proprietary name and the ingredient listing.

Nearby rules

US-NAME-047 US-NAME-050