MLRagent

Do not give benefit information greater contrast than risk information

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

Rule

The visual contrast between text and background used for risk information should be at least as strong as that used for benefit information.

Check

Compare text/background contrast ratios or color choices used for risk text versus benefit text.

Escalate when

When risk text uses a lower-contrast color combination than benefit text.

Where this comes from

Section III.C.1, Contrast · page 20. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… some information easier to read than other information. To be comparably prominent and readable, FDA recommends that risk and benefit information be presented in type styles that are similar in the use of capitalization, serifs, the weight of the type-face, the angle of the letters, the degree of flourishes and scripting, and other typographical factors such as spacing (e.g., leading and kerning). \ Contrast Contrast between text and background should not highlight the benefit information more than the risk information. > Example 18: If benefit information in a piece is presented in white letters on a black background, > risk information should be presented with similar contrast. If the piece presents risk information > in a way that would make it difficult to discern (e.g., using white letters on a light gray > background or gray letters on a black background), the presentation may be considered false or > misleading…
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.