Make risk information comparably noticeable as benefit information

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

Rule

As a general matter, risk information should be comparably noticeable or conspicuous to benefit information in a promotional piece.

Check

Compare how noticeable or conspicuous the risk information is relative to the benefit information: placement, headers, graphics, white space, and other visual signals that draw attention. Flag a piece where these formatting choices make risk information markedly less noticeable than benefit information.

Escalate when

When it is unclear whether a difference in noticeability or conspicuousness 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…

Open the original at page 18 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

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 quote is a complete sentence from the opening of the Considerations of Format section and the rule statement restates it faithfully in 'should' voice, so it is supported and not overstated.
- It is not atomic: the source joins two independently checkable requirements — (a) risk and benefit information should be 'comparably noticeable or conspicuous', and (b) audiences should be able to read both 'with similar ease (e.g., comparably legible and understandable)'. These fail separately: risk text can be set in large, high-contrast type yet be buried where no one will notice it, and it can sit in a prominent position yet be dense, small-set or written at a much harder reading level than the benefit copy. A reviewer performs two different examinations — placement/emphasis on the one hand, legibility and comprehensibility on the other.
- The rule's own check betrays the bundle by running 'size, placement, contrast, legibility' together as a single comparison.
- Judgment determinism is correct for both halves — noticeability and ease of reading are impression and adequacy questions.
- Authority 'guidance' is correct, 'promotional' scope matches the source's subject, the 'Section III.C, Considerations of Format' locator is right (the sentence precedes the 'III.C.1 Print Promotion' subheading), 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 whole source sentence, and the rule takes only its first clause (comparably noticeable or conspicuous). That keeps the rule atomic; the readability clause is a separate requirement.
- 'As a general matter' and 'should' are both kept, so there is no overstatement.
- The Check's factors (placement, headers, graphics, white space) are the formatting factors that Section III.C goes on to discuss. Noticeability is a matter of judgment, and warning severity is appropriate.

Nearby rules

US-FB-021