FDA may object to substantially smaller font for risk information

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

Rule

FDA may object to substantial differences between the font size used for risk information and that used for benefit information, because this may seriously reduce the ability to see or comprehend the risk information. FDA does not object to a presentation on the basis of minor differences in font size alone, depending on other factors used to achieve emphasis (e.g., bolded lettering, bullets).

Check

Compare the font size used for risk information to the font size used for benefit information. Flag a substantial size differential, considering whether other emphasis factors (such as bolding or bullets) offset a minor size difference.

Escalate when

When the size differential is borderline, or other emphasis factors make it unclear whether the difference is minor or substantial.

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 Draft — Not for Implementation other factors used to achieve emphasis (e.g., bolded lettering, bullets).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.

Applies when

Naturepromotional

Mediumprint

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The subject matter is supported — the quoted sentence is FDA's own statement about font size, and the rule correctly keeps the 'substantial' threshold, which matters because the immediately preceding sentence says 'FDA does not object to a presentation on the basis of minor differences in font size alone'.
- Overstated in voice: the source says 'FDA may object to substantial differences in font size', which is a statement that such a presentation may draw objection, and the rule renders it as a flat 'should not'. For a non-binding draft guidance the recommendation should not be hardened into a prohibition.
- Not atomic: the quoted sentence contains two independently checkable conditions — (a) a substantial difference between the font size of risk information and that of benefit information (a comparison), and (b) risk information presented in a difficult-to-read font size 'irrespective of the font size of benefit information' (an absolute standard that is violated even when the two match). The rule bundles these, relegating the second to a parenthetical, and a reviewer must run them as two separate tests.
- The rule also imports a comparative readability test ('or otherwise more difficult to read than benefit information') that the quoted sentence does not make; general type-style readability is the subject of the next sentence in the source (and of US-FB-019), not this one.
- Judgment determinism is correct — 'substantial' differences and 'difficult to read' are assessments, not literal matches.
- Print medium scoping is justified (the sentence sits under 'III.C.1 Print Promotion', subheading 'Font Size and Style'), the locator is correct, authority 'guidance' is correct, and 'warning' severity is defensible.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the complete source sentence. The rule takes its first clause (substantial differences in font size) and keeps 'may object' and 'may seriously reduce', so it is not turned into a prohibition.
- The minor-differences limit comes accurately from the preceding source sentence ('FDA does not object to a presentation on the basis of minor differences in font size alone, depending on other factors used to achieve emphasis (e.g., bolded lettering, bullets)'). It is a correct limit on this rule, not a separate requirement.
- The rule is distinct from US-FB-022, which covers the separate clause about absolute legibility regardless of the benefit font size. Limiting the medium to print matches the locator (Section III.C.1, Print Promotion). Judgment determinism is correct because 'substantial' versus 'minor' is a judgment.

Nearby rules

US-FB-019 US-FB-022