Risk information should not be presented in only one location of the piece

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

Rule

Risk information should not be presented in only one location in a piece (e.g., only on a brief summary page or after the logo/tagline); like benefit information, it should appear as an integral part of the piece.

Check

Map where benefit claims appear versus where risk information appears throughout the piece; flag pieces where risk content is isolated to a single spot while benefit content is distributed throughout.

Escalate when

When risk content is concentrated in one section while benefit content recurs throughout the piece.

Where this comes from

Section III.A.4, Hierarchy of Risk Information · page 13. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ormation at the end will be as well-comprehended as the information at the beginning. If a product’s most important risks are located in the middle of a list of less important risks, the important risks may not be effectively communicated. FDA therefore recommends that the most important risk information, including relevant warnings and contraindications, be placed or stated first, especially in print materials. As discussed in Section III.C.1 (below), manufacturers should also note, however, that risk information should not just be presented in one location in a piece, but should, like benefit information, appear as an integral part of the piece. FDA also considers the order in which risk information is presented to determine whether this ordering suggests that certain risks apply only to certain populations or only under certain conditions when this is not the case. > Example 10: A statement in a broadcast ad that “Patients should not drink alcohol when taking > Drug X. Common side effects are drowsiness and nausea” may suggest that these side effect…

Open the original at page 13 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
- Supported: the quoted sentence is operative guidance text at the close of Section III.A.4 stating that risk information should not just be presented in one location in a piece but should, like benefit information, appear as an integral part of the piece. The rule statement is a faithful restatement, including the comparison to benefit information.
- Not overstated: the rule keeps 'should' and frames the requirement as distribution parallel to benefit information, exactly as the source does. It does not convert the recommendation into a prohibition.
- Atomic: one property — whether risk information is confined to a single location while benefit information is distributed.
- 'judgment' is correct: whether risk information is 'an integral part of the piece' turns on prominence and impression rather than presence/absence or a literal match.
- Authority 'guidance' matches the source document and the rule claims no more. Category 'risk-disclosure', severity 'warning' and the unrestricted 'promotional' scope are defensible; the source states the principle generally and cross-references Section III.C.1 for both print and non-print discussion, so no medium limit is missing.
- The locator (Section III.A.4, Hierarchy of Risk Information) matches where the sentence sits, even though it forward-references Section III.C.1.
- The quote is a complete sentence with its subject intact and does not run into the following paragraph on the order of risk information.
Revised by the drafter
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 Section III.A.4. Section III.C.1 ('Location of Risk Information within a Part of the Promotional Piece') supports it directly: 'risk information should appear as an integral part of the piece, just as benefit information does. For example, a prescription drug ad should not present risks only on a brief summary page.' Example 16 illustrates the same point. The rule is supported and is guidance-level.
- The title 'Do not confine risk information to a single location in the piece' is a bare imperative. It turns 'should' into a directive.
- The rule text says risk information 'should appear throughout the piece'. That is broader than the source. The source says risk information should 'not just be presented in one location' and should be 'an integral part of the piece', 'like benefit information'. Section III.C.1 adds that it 'should generally appear in the same parts of the piece as the benefits'. The source ties placement to where benefits appear, not to every part of the piece. The Check already frames it this way, benefit placement against risk placement, and the rule statement should match.
- 'judgment' is correct because 'integral part' is an impression and prominence question. The applies_when, 'warning' severity and locator are acceptable.
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 verbatim whole sentence from Section III.A.4. It states that risk information 'should not just be presented in one location in a piece, but should, like benefit information, appear as an integral part of the piece.'
- The rule's examples (risk only on a brief summary page, or placed below the logo/tagline) come from the Section III.C.1 discussion that the quote cross-references ('a prescription drug ad should not present risks only on a brief summary page'; Example 15). They are faithful illustrations, not additions.
- The rule and title use 'should', which fits the non-binding draft guidance. The rule is a single recommendation, so it is atomic. Judgment is correct because 'integral part of the piece' is an impression question.
- The check compares how risk and benefit content are distributed, which follows from 'like benefit information'. The scope, severity and locator are appropriate.
- Minor, not required: the 'Escalate when' text restates the flag condition rather than describing an ambiguous case.

Nearby rules

US-MIS-047 US-RISK-029