Present risk information in the same parts of the piece as benefits

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

Rule

Risk information should generally appear alongside or within the same sections of the piece where benefit claims appear, not confined to a separate part.

Check

For each section containing benefit claims, confirm corresponding risk information appears in or adjacent to that same section.

Escalate when

When benefit claims and risk information are segregated into different parts of the piece.

Where this comes from

Section III.C.1, Overall Location of Risk Information · page 18. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…e risk hierarchy, are covered in other sections. Overall Location of Risk Information For a piece to be accurate and non-misleading, risk information should be included in the main part of a piece. If the omission of risk information in any part of a piece makes that part of the piece false or misleading, the problem cannot be corrected simply by including the risk information in a separate part of the piece. To be comparably prominent to benefit information, risk information should generally appear in the same parts of the piece as the benefits. Complete separation of benefit and risk information (e.g., presenting several pages of benefits before any risks) is one example of a lack of appropriate prominence. FDA will also look to see that risk information is not placed in such a way as to interfere with readers’ perceptions of the relative importance or utility of the information. \ Location of Risk Information within a Part of the P…

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence including its purpose clause ('To be comparably prominent to benefit information, risk information should generally appear in the same parts of the piece as the benefits.'), and the rule statement preserves both the hedge 'generally' and the 'should' voice, so it neither overstates nor drops the qualifier.
- The check — for each section containing benefit claims, confirm corresponding risk information appears in or adjacent to that section — follows directly from the quote and from the immediately following text on complete separation and on risk information appearing 'with or near benefit presentations'.
- Atomic: one co-location requirement, distinct from US-FB-014's requirement that risk information be in the main part at all.
- Judgment determinism is correct — 'generally' and 'comparably prominent' make this an assessment rather than a literal match.
- applies_when (promotional), guidance authority, the Section III.C.1 'Overall Location of Risk Information' locator and 'warning' severity are all consistent with the source.
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, and the rule keeps both 'should' and 'generally'.
- The Check (risk information in or adjacent to each section that carries benefit claims) follows from 'should generally appear in the same parts of the piece as the benefits'. 'Generally' leaves room for the concise-presentation-with-prominent-reference approach described in footnote 41.
- The medium is not limited to print, which is defensible. The rule sits under Print Promotion, but Section III.C.2 says that for non-print promotion 'As with print, FDA considers factors such as location, proximity...'. Judgment determinism and warning severity are appropriate.

Nearby rules

US-FB-014 US-FB-016