MLRagent
Rules/misleading presentation/US-MIS-053

Distracting graphics during risk presentations should be avoided

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

Rule

Graphics that distract from the presentation of risk information or risk-related SUPERs (busy scenes, frequent scene changes, vivid and compelling visuals, moving camera angles) can misleadingly minimize the product's risks by detracting from the audience's comprehension, and should be avoided during risk presentations.

Check

Review the visual content playing during risk disclosure for busy scenes, rapid cuts, or highly compelling imagery that could pull attention away from the risk message.

Escalate when

When distracting visuals coincide with risk disclosure and the degree of distraction is a judgment call.

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:

…ires 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 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…
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.