Digital: established name required once in running text when proprietary name not featured

AI-verifiedblockerFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

In electronic and computer-based promotion, if the proprietary name is not featured but appears only in running text, the established name is required to accompany it at least once in that running text.

Check

For digital running text where the proprietary name is not featured, confirm the established name appears at least once in that running text.

Where this comes from

21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.D.3 · page 9. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…not contain text pages like print media. However, promotion in such media often contains information or running text equivalent to many pages of traditional printed text. FDA does not intend to object to fewer appearances of the established name, provided that the established name accompanies the proprietary name at least once per web page where the proprietary name most prominently appears on the web page. However, if the proprietary name is not featured but is part of the running text, the established name is required to accompany the proprietary name at least once in the running text (21 CFR 201.10(g)(1) and 202.1(b)(1)). Columns of running text should be treated similarly to columns on the printed page. III. PRODUCTS WITH TWO OR MORE ACTIVE INGREDIENTS A product with two or more active ingredients might not have a single established name corresponding to the proprietary name. In such instances, the regulations in 21 CFR 201.10(h)(1) and 202.1(c) state that: [T]he quantitative ingredient i…

Open the original at page 9 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

Mediumdigital

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported by Section II.D.3, which states the requirement and cites the regulations for it: 'However, if the proprietary name is not featured but is part of the running text, the established name is required to accompany the proprietary name at least once in the running text (21 CFR 201.10(g)(1) and 202.1(b)(1)).' The rule keeps both conditions and the single-occurrence threshold.
- Not overstated: the mandatory phrasing comes from the cited regulations, not from a guidance 'should'. Note that the source states this as the exception to the preceding non-objection paragraph, and the rule correctly treats it as an exception (it applies only where the proprietary name is not featured).
- Atomic: one occurrence of one element in one place.
- Determinism 'deterministic' is defensible: whether the established name appears at least once in the running text is presence/absence.
- Severity 'blocker' is defensible for a regulatory disclosure requirement; applies_when medium 'digital' matches Section II.D.3; the locator correctly names both the CFR provisions and the guidance section.
- Observation, not a required change: because the operative obligation is regulatory, an authority of binding would also be defensible; tagging it 'guidance' follows the source document's authority and understates rather than overclaims.