Use similar type styles for risk and benefit information

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

Rule

FDA recommends using similar typographical style (capitalization, serifs, weight, italics, spacing) for risk information as for benefit information so both are comparably readable.

Check

Compare typeface style attributes (capitalization, weight, spacing) between risk and benefit text blocks.

Escalate when

When style differences plausibly make risk text harder to read than benefit text.

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.

…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 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…

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence including its purpose clause, and it is explicitly framed as a recommendation ('FDA recommends that risk and benefit information be presented in type styles that are similar in ...'); the rule statement preserves that framing verbatim in substance, so nothing is hardened into an obligation.
- Atomic: this is one comparability requirement. The listed items (capitalization, serifs, weight, angle of the letters, flourishes and scripting, spacing) are factors bearing on a single question — are the type styles similar — not separate requirements, and the source itself presents them as a non-exhaustive list closing with 'other typographical factors'.
- The rule's paraphrase 'italics' for the source's 'angle of the letters' is a faithful restatement and not a narrowing worth withholding a pass over.
- Judgment determinism is correct: 'similar' type styles is an assessment, and the source's own rationale ('differences in type styles can render some information easier to read than other information') is about readability, not a literal match.
- Severity 'note' is defensible for a typographical-similarity recommendation that the source presents as a refinement applying even when font sizes are identical; the print medium scoping matches the 'III.C.1 Print Promotion' placement; locator and authority are correct.
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 a complete sentence introduced by 'FDA recommends', and the rule keeps 'recommends'. The line breaks in the quote are source layout, not stray text.
- 'Italics' in the rule is a fair gloss of 'the angle of the letters'. The Check lists a subset of the attributes, which is a minor wording point.
- 'Note' severity fits a typographic recommendation. The print scope matches the locator, and judgment determinism is correct.

Nearby rules

US-FB-018 US-FB-022