Rules/misleading presentation/US-MIS-052

SUPERs should remain on screen long enough to be read and understood

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

Rule

Every SUPER should remain on screen long enough to allow the audience to read and understand its full content.

Check

Time each SUPER's on-screen duration against its text length/complexity to determine whether a typical viewer could read it in full.

Escalate when

When SUPER duration appears too short relative to its text length.

Where this comes from

Section III.C.2, Non-Print Promotion, Textual Elements · page 22. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: Other issues FDA considers important that manufacturers should keep in mind include the following:

…, a misleading impression of the product may result. In addition, if qualifying information is complex and requires more than one line of text, we recommend that manufacturers use other means to convey this information. Other issues FDA considers important that manufacturers should keep in mind include the following: — SUPERs, if used, should be reasonably visible to a person under typical viewing conditions. — All SUPERs should be on screen long enough to allow the audience to read and understand their full content. — Graphics that distract from the presentation of risk information, including from risk-related SUPERs (e.g., busy scenes, frequent scene changes, vivid and compelling visuals and moving camera angles) can misleadingly minimize the risks of the product being promoted by detracting from the audience’s comprehension of the risk presentation. — Competition from other SUPERs (e.g., presenting a SUPER related to a p…

Open the original at page 22 on fda.gov ↗Read our full copy →

Document: FDA guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion (see document)
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: f5654ab082f6cd4408143f16…

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

Mediumbroadcast

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: the quoted bullet ('All SUPERs should be on screen long enough to allow the audience to read and understand their full content') is operative recommendation text and directly establishes the substance of the rule.
- Overstated in modality. The source says 'should'; the rule says 'Every SUPER must remain on screen long enough'. This turns a non-binding FDA recommendation into an obligation, which is the specific failure this review guards against. Unlike the hedged formulations elsewhere in this set, nothing in the rule statement preserves the recommendation character.
- Atomic: one property — on-screen duration adequate to the SUPER's content.
- 'judgment' is correct: whether the duration allows the audience to read and understand the full content turns on adequacy, not a literal threshold.
- Authority 'guidance' matches the source document and the rule does not claim regulatory status beyond it. Category, severity 'warning', the Section III.C.2 locator and the broadcast/non-print applies_when limit are all appropriate.
- The quote is a complete sentence with its subject intact.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The rule faithfully restates the source item and keeps 'should'; duration adequacy is a judgment; warning severity and locator are correct.
- The quote is a bare bulleted list item: it is the second item under the lead-in 'Other issues FDA considers important that manufacturers should keep in mind include the following:', which is not adjacent to it (the 'reasonably visible' item intervenes). The rule carries no lead_in, so the list framing (issues FDA considers, which manufacturers should keep in mind) is lost.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a whole list item. Its lead_in 'Other issues FDA considers important that manufacturers should keep in mind include the following:' is verbatim and correctly paired with it.
- The rule statement and title keep 'should'. The Check (on-screen duration against text length) follows from the item. Judgment is correct, and the broadcast medium limit fits the Non-Print Textual Elements section.

Nearby rules

US-MIS-048 US-MIS-049 US-MIS-050 US-MIS-051 US-MIS-053 US-MIS-054