Rules/misleading presentation/US-MIS-051

Make SUPERs reasonably visible under typical viewing conditions

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

Rule

Any SUPER used in a broadcast piece should be reasonably visible to a viewer under typical viewing conditions (size, placement, contrast).

Check

Assess SUPER size, duration, contrast, and placement against typical viewing conditions (e.g., standard screen distance).

Escalate when

When SUPER visibility is borderline given its size/contrast/placement.

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.

… If SUPERs do not appear close enough to the claim or risk information requiring qualification, 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 c…

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: the quote is a complete bullet sentence from the list introduced by 'Other issues FDA considers important that manufacturers should keep in mind include the following' — operative recommendation text, not an illustrative example.
- Not overstated: the rule keeps 'should' and reproduces the source's 'if used' condition and 'typical viewing conditions' standard without hardening it.
- Atomic: a single visibility assessment of each SUPER. The parenthetical '(size, placement, contrast)' names the inputs to that one assessment rather than adding separate requirements, and those factors are named in the adjacent source text on font size, type style and contrast.
- 'judgment' is correct: 'reasonably visible under typical viewing conditions' turns on prominence and impression, not a literal match.
- Authority 'guidance' matches the source document; severity 'warning' is defensible because an unreadable SUPER can defeat a risk disclosure. Category, locator (Section III.C.2, Non-Print Promotion, Textual Elements) and the broadcast/non-print applies_when limit are all supported by the passage's placement.
- The check overlaps slightly with US-MIS-052 by listing duration among the factors, but the rule statement itself is confined to visibility, so it remains separately checkable.

Nearby rules

US-MIS-048 US-MIS-049 US-MIS-050 US-MIS-052 US-MIS-053 US-MIS-054