Make risk information comparably readable as benefit information
Rule
Audiences should be able to read risk and benefit information in a promotional piece with similar ease — that is, the two should be comparably legible and understandable, as discussed in Section III.A.1.
Check
Compare the legibility and comprehensibility of risk versus benefit content: type size and style, contrast, text density, and reading level, cross-referencing the comparable-legibility discussion in Section III.A.1. Flag a piece where risk information is markedly harder to read or understand than benefit information.
Escalate when
When it is unclear whether a difference in legibility or comprehensibility between risk and benefit content is significant enough to be a problem.
Where this comes from
Section III.C, Considerations of Format · page 18. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.
… factors also may help or hinder people’s understanding of information once it has drawn their attention. When evaluating whether a promotional piece appropriately communicates risk information, FDA considers several formatting factors. Because these factors apply to information processing in general, prescription drug and medical device manufacturers should keep them in mind when developing promotional pieces. As a general matter, risk and benefit information should be comparably noticeable or conspicuous in promotional pieces, and audiences should be able to read both risk and benefit information with similar ease (e.g., comparably legible and understandable; see Section III.A.1 above). Manufacturers should note that any one of the following formatting factors could make a piece false or misleading and that each factor could interact with others to increase this problem or to create a false or misleading impression when there might not be one if a factor were considered in isolation. 1. Print Promotion The layout of a print promotional piece (generally, its plan, design, or arrangement) i…
- 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.