MLRagent
Rules/fair balance/US-FB-022

FDA may object to risk information in a difficult-to-read font size

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

Rule

FDA may object to risk information presented in a difficult-to-read font size, irrespective of the font size used for benefit information, because this may seriously reduce the ability to see or comprehend the risk information.

Check

Assess whether the font size used for risk information is, on its own, difficult to read (e.g., too small to be legible), independent of any comparison to the benefit information's font size.

Escalate when

When it is unclear whether the risk information's font size is objectively difficult to read.

Where this comes from

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

…s in some patients, a statement in a part of a promotional piece that “Drug X may increase your potassium levels; see Prescribing Information (PI) for more information” is not likely to convey to consumers or healthcare professionals the magnitude (i.e., life-threatening nature) of the risk. Draft — Not for Implementation other factors used to achieve emphasis (e.g., bolded lettering, bullets). However, FDA may object to substantial differences in font size or the presentation of risk information in a difficult to read font size, irrespective of the font size of benefit information, because this may seriously reduce the ability to see or comprehend the risk information. Even with identical risk and benefit font sizes, differences in type styles can render 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 …
Open the original at page 20 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.