Print: established name once per page or spread suffices for featured proprietary name

DisputedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

For traditional print, FDA does not intend to object to fewer than every-instance accompaniment as long as the established name accompanies the proprietary name at least once per page or spread where the proprietary name most prominently appears.

Check

Identify the page or spread where the proprietary name most prominently appears and confirm the established name accompanies it there at least once; do not flag reduced frequency elsewhere on that page or spread.

Escalate when

Reviewer is unsure which appearance of the proprietary name on the page or spread is the "most prominent" one requiring the established name.

Where this comes from

Section II.D.1 · page 8. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…sements For traditional print promotional labeling and advertisements, the established name is required to accompany the proprietary name when the proprietary name is featured (e.g., headlines, taglines, logos, graphs, or pictures). Although the regulations state that the established name “shall Contains Nonbinding Recommendations accompany such proprietary name . . . each time it is featured,” 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 page or spread where the proprietary name most prominently appears. For example, if the established name follows the proprietary name in a headline, FDA does not intend to object if the established name does not also follow the proprietary name in sub-headlines, appear in the running text on the same page or spread, or appear in columns on the same page or spread. If the proprietary name is not featured but is only part of the running text, the established name is required to accom…

Open the original at page 8 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

Mediumprint

How this rule was checked

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section II.D.1 states that although the regulations require the established name each time the proprietary name is featured, '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 page or spread where the proprietary name most prominently appears.' The rule reproduces that enforcement-discretion condition without converting it into a freestanding obligation — it is framed as what FDA does not intend to object to.
- The check's instruction not to flag reduced frequency elsewhere on the page or spread is directly supported by the worked example in the source (no objection if the established name does not also follow the proprietary name in sub-headlines, in running text on the same page or spread, or in columns on the same page or spread).
- Atomic: one condition (established name accompanying the most prominent presentation at least once per page or spread).
- Determinism 'judgment' is correct: it turns on identifying which presentation of the proprietary name is 'most prominent', which the source itself says depends on typography, layout, contrast and other printing features. The escalation clause matches that.
- Authority 'guidance' is correct — this is enforcement discretion, not a regulation. Severity 'warning' is defensible: failing the safe harbor exposes the piece to the underlying regulatory requirement rather than automatically violating it.
- applies_when limited to print is justified: the passage sits under II.D.1 'Traditional Print Promotional Labeling and Advertisements'.
- The quote carries a stray footnote digit ('the 8 proprietary name') from the source's OCR; it is verbatim to the supplied source text and does not change meaning.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — reject
claude-code:opus · 2026-09-21
Reviewer's reasons
- Not violable as drafted. The rule statement is purely FDA's enforcement-discretion carve-out ('FDA does not intend to object to fewer appearances ...'), and the check instructs the reviewer not to flag reduced frequency. A permission that relaxes another rule is not itself something a promotional piece can breach, so it is not a reviewable rule.
- It should be folded into US-NAME-028, which already carries this carve-out verbatim in its own rule statement ('FDA does not intend to object to fewer appearances, provided the established name accompanies the proprietary name at least once per page or spread where the proprietary name most prominently appears'). Keeping both means the same exception is stated twice and the underlying obligation is stated nowhere on its own.
- The quote itself is accurate and a whole sentence, the authority tag 'guidance' correctly reflects a non-binding non-objection statement, and 'judgment' is right for 'most prominently appears' - the defect is the rule's nature, not its fidelity.

Nearby rules

US-NAME-032 US-NAME-033 US-NAME-034