Rules/misleading presentation/US-MIS-050

Do not rely on a single line of text for complex qualifying information

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

Rule

If qualifying information is too complex to fit in one line of on-screen text, FDA recommends conveying it by other means (e.g., voiceover) rather than cramming it into a SUPER.

Check

Identify any SUPER conveying complex qualifying information that spans multiple lines or is dense; check whether an alternative delivery method (audio) is also used.

Escalate when

When complex qualifying information appears only as multi-line on-screen text.

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.

…video when evaluating whether it is false or misleading. If claims must be qualified to avoid misleading the audience, we recommend that the qualifier be vocalized, presented through visual images, or placed in a prominent SUPER that runs concurrently with the claim. 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., …

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 quoted sentence is operative recommendation text in Section III.C.2 ('we recommend that manufacturers use other means to convey this information'), not an example or a preamble summary, and the rule statement is a faithful restatement of it.
- Not overstated: the rule says 'FDA recommends', preserving the guidance's non-binding character. The parenthetical '(e.g., voiceover)' is offered as an illustration of 'other means', not as a mandated method, and is consistent with the surrounding discussion of audio components in non-print promotion.
- Atomic: one condition (complex qualifying information exceeding one line of text) and one recommended response (convey it by other means).
- 'judgment' is correct: whether qualifying information is 'complex' turns on an assessment, not presence/absence, even though the line count alone would be literal.
- Authority 'guidance' matches the source document. Severity 'note' is defensible for a non-binding formatting recommendation whose violation is a communication-quality concern rather than a misleading claim on its face.
- applies_when limited to non-print/broadcast is justified: the passage sits in Section III.C.2 'Non-Print Promotion' and concerns SUPERs in broadcast ads and videos. Locator and category are correct, and the quote is a complete sentence.
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 complete sentence ('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') and the rule keeps 'FDA recommends'.
- '(e.g., voiceover)' is a reasonable illustration of 'other means' consistent with the preceding sentence (vocalized/visual images).
- Complexity of qualifying information is a judgment; 'note' severity is defensible for a recommendation about delivery method; locator and broadcast scope are correct.

Nearby rules

US-MIS-048 US-MIS-049 US-MIS-051 US-MIS-052 US-MIS-053 US-MIS-054