Established name should accompany proprietary name at its most prominent web-page display

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

Rule

For prescription drug electronic and computer-based promotion, FDA does not intend to object to fewer appearances of the established name, provided the established name accompanies the proprietary name at least once per web page where the proprietary name most prominently appears on that web page.

Check

Confirm each web page featuring the proprietary name includes the established name at least once accompanying (in direct conjunction with) the proprietary name at its most prominent display on that page. Do not flag the absence of the established name elsewhere on the page once this condition is met.

Escalate when

Escalate when the reviewer cannot confidently identify the most prominent display of the proprietary name on a web page (e.g., due to responsive layouts across devices).

Where this comes from

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.

…tary name. Under most circumstances, this is the first occurrence in the broadcast. Contains Nonbinding Recommendations 3. Electronic and Computer-Based Promotion Promotion in electronic and computer-based media also does 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 ha…

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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the guidance's own enforcement-discretion statement in Section II.D.3 and is a complete sentence, so the first half of the rule is properly sourced here.
- Not atomic. The rule bundles two independently checkable things: (1) the guidance's per-web-page safe harbour for the featured proprietary name, and (2) "If the proprietary name is not featured but appears only in running text, the established name must accompany it at least once in the running text." These are different conditions, triggered by different facts, and a piece can fail either one alone. The Check section only covers the first.
- The second sentence is also outside the quote and is not the guidance speaking: the source states it as a regulatory requirement — "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))." A rule for that requirement belongs to 21 CFR 201.10(g)(1) and 202.1(b)(1) and should be drafted from those regulations, not from this guidance.
- Overstated in the metadata. The title, "Established name must appear once per web page in electronic promotion", converts a statement of what FDA does not intend to object to into a flat obligation, and it drops the qualifier that the required appearance is on the page where the proprietary name most prominently appears. The rule body is framed correctly; the title is not.
- Determinism "judgment" is correct: identifying the "most prominent" display of the proprietary name on a page turns on prominence and, per footnote 10, on how the page renders across devices.
- applies_when {medium: [digital]} is justified by Section II.D.3 ("internet, social media, emails, CD-ROMs, DVDs"). The prescription-drug limit from footnote 3 is stated in the rule text, which is the only place the fixed scoping vocabulary allows it. Locator and severity are defensible.
- Note that the source's phrasing is "accompanies the proprietary name at least once per web page where the proprietary name most prominently appears on the web page"; the Check's looser "at or near the proprietary name's most prominent display" is acceptable but should not be read as adding a proximity test beyond direct conjunction.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence from Section II.D.3, and the rule text faithfully restates FDA's enforcement-discretion position for electronic and computer-based promotion. The title uses 'should'.
- The locator begins with '21 CFR 201.10(g)(1) and 202.1(b)(1)', but the quoted text is guidance language in Section II.D.3, not regulation text. Citing the CFR as the locator implies binding regulatory text and misdirects a reviewer looking for the quote.
- The Check loosens the source condition. The source requires that the established name 'accompanies the proprietary name' at its most prominent display on the page. In this guidance, 'accompany' means direct conjunction (Section II.A). The Check's 'at or near' would pass a piece where the established name is merely somewhere nearby.
- The medium is correctly restricted to digital. Judgment is correct because identifying the most prominent display depends on layout and device (footnote 10). Blocker severity is defensible: failing even this relaxed condition means the established name does not accompany the featured proprietary name, which the cited regulation requires.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Quote is a complete verbatim sentence from Section II.D.3 (Electronic and Computer-Based Promotion); locator is correct.
- Rule statement preserves the enforcement-discretion framing ('FDA does not intend to object ... provided that') rather than converting it into an obligation; the title uses 'should', which does not overstate the guidance.
- Violable: a web page where the proprietary name is featured but the established name never accompanies it at its most prominent display falls outside the discretion and back under the 21 CFR 201.10(g)(1)/202.1(b)(1) each-time requirement the guidance quotes, so blocker severity is defensible.
- Reading 'accompanies' as direct conjunction is consistent with Section II.A in the same guidance.
- Identifying the most prominent display turns on layout and device rendering (footnote 10), so 'judgment' is correct; the escalation trigger reflects footnote 10.
- applies_when (promotional, digital) matches the section's scope. Not a duplicate of the other rule in this packet.

Nearby rules

US-NAME-040