Rules/misleading presentation/US-MIS-054

Risk-related SUPERs should not compete with unrelated SUPERs on screen

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

Rule

A risk-related SUPER should not be displayed at the same time as unrelated SUPERs, since competing on-screen text hampers the audience's ability to read and understand the risk information.

Check

Check whether multiple SUPERs appear simultaneously on screen, and whether an unrelated SUPER is competing for attention with a risk-related SUPER.

Escalate when

When simultaneous SUPERs appear and it is unclear whether they meaningfully compete for attention.

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:

…ough 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 particular risk while unrelated SUPERs are on the screen) hampers the audience’s ability to read and understand the SUPERs and could compromise the communication of risk information and make a piece misleading. — Factors such as font size, type style, and capitalization can also affect the readability of SUPERs. Words presented in all upper case letters are more difficult to read than words presented in upper and lower case letters. Contains Nonbinding Recommendations Draft — Not for Implementation Contrast Contrast is an important visual factor that FDA considers when evaluating television ad…

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. Not yet independently verified — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: the quoted bullet establishes that competition from other SUPERs hampers the audience's ability to read and understand the SUPERs and could compromise risk communication and make a piece misleading. The rule statement tracks this.
- Not overstated: the rule says 'should not be displayed at the same time', matching the guidance's non-binding recommendation, and its rationale clause reproduces the source's own 'hampers the audience's ability to read and understand' language rather than escalating to a prohibition or a finding of illegality.
- Atomic: one condition — a risk-related SUPER on screen concurrently with unrelated SUPERs.
- 'judgment' is correct: although simultaneity alone would be literal, the operative question the source poses is whether the other SUPERs compete for attention with the risk SUPER, which turns on impression; the check and escalation text are framed accordingly.
- Authority 'guidance' matches the source document. Category, severity 'warning', the Section III.C.2 locator and the broadcast/non-print applies_when limit are all supported by the passage's context.
- The quote is a complete sentence with its subject intact and does not run into the adjacent bullet on font size and capitalization.
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 the complete list item and supports that unrelated SUPERs displayed with a risk SUPER hamper readability and could make a piece misleading; the rule uses 'should not', within the guidance's authority.
- Whether simultaneous SUPERs meaningfully compete is a judgment; warning severity and broadcast scope are defensible.
- The quote is a bare bulleted list item whose lead-in ('Other issues FDA considers important that manufacturers should keep in mind include the following:') is not adjacent to it (three items intervene), and the rule carries no lead_in.
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 verbatim, complete list item in Section III.C.2 (Non-Print Promotion, Textual Elements). The lead_in 'Other issues FDA considers important that manufacturers should keep in mind include the following:' is verbatim and introduces that list. Together they support a recommendation against showing unrelated SUPERs at the same time as a risk-related SUPER.
- The rule statement uses 'should not', which is consistent with the 'should keep in mind' lead-in and the source's statement that competing SUPERs 'could compromise the communication of risk information and make a piece misleading'.
- The title 'Avoid competing SUPERs displayed alongside risk-related SUPERs' is a bare command. The source is non-binding draft guidance that says only that the practice could make a piece misleading, so the title overstates it.
- The rule covers one concern, competing SUPERs, so it is atomic. Judgment is correct because whether SUPERs meaningfully compete is an impression question.
- The scope (promotional, broadcast) fits the non-print SUPER discussion. The warning severity and the locator are correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21

Nearby rules

US-MIS-048 US-MIS-049 US-MIS-050 US-MIS-051 US-MIS-052 US-MIS-053