Include risk information in the main part of the piece

DisputedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

For a piece to be accurate and non-misleading, risk information should be included in the main part of the piece, and not only in a separate or peripheral part.

Check

Identify the main body/primary message of the piece and confirm risk information appears in the main part, not only in an appendix, footer, or separate panel.

Escalate when

When risk content appears only outside the main body 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.

… to pay attention to and process specific features of the piece. FDA considers the following selected aspects of the layout of a print promotional piece when assessing the comparable prominence and readability of risk and efficacy information. This is not an exhaustive list; other issues, such as language comprehension and the 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 in…

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

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported: the source says 'For a piece to be accurate and non-misleading, risk information should be included in the main part of a piece', and the very next sentence supports the rule's 'not only in a separated section' clause ('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.').
- The rule statement is overstated: it renders the guidance's 'should' as 'must appear in the main body'. This guidance is non-binding, and the recommendation must not be written as an obligation.
- Authority field 'guidance' is correct — the rule does not claim to restate a regulation — so the defect is in the rule wording, which is fixable.
- Atomic: a single locational requirement.
- Judgment determinism is defensible: identifying what constitutes the 'main part' of a piece (as against an appendix, brief summary page, or matter below the logo and tagline) is an interpretive call, as the source's Examples 15-17 show.
- applies_when (promotional) is acceptable. A note, not a required change: the quoted sentence sits under 'III.C.1 Print Promotion', so a print limit would be defensible, but the principle is stated generally and leaving the rule unscoped by medium is not an error worth withholding on; the locator as recorded already identifies the print subsection.
- Locator 'Section III.C.1, Overall Location of Risk Information' matches the source heading, 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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The first quoted sentence supports the main-part recommendation, and 'should' is kept.
- The rule also adds a second, separately checkable principle from the second quoted sentence: if any part of a piece is misleading without risk information, adding that information to a separate part does not cure it. That is a check applied part by part, and it overlaps US-FB-015's same-parts recommendation. The rule's own Check tests only whether risk information appears in the main part, so the bundled second requirement is never checked. The rule is not atomic.
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 whole sentence under 'Overall Location of Risk Information'. The rule's added words 'not only in a separate or peripheral part' are supported by the next sentence, which says the problem 'cannot be corrected simply by including the risk information in a separate part of the piece'.
- The passage sits under III.C.1 'Print Promotion', but applies_when has no medium limit, so the rule is written as universal across media. The source does say some print formatting issues also apply to non-print, but it does not say this one does.
- The title 'Include risk information in the main part of the piece' is a bare command for a 'should' recommendation.

Nearby rules

US-FB-015 US-FB-016