FDA recommends stating the most important risk information first, especially in print

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

Rule

FDA recommends that the most important risk information, including relevant warnings and contraindications, be placed or stated first, especially in print materials. For broadcast ads, FDA recommends that the beginning or end, or both, be reserved for the most important risk information.

Check

For broadcast and other audio/video pieces, confirm the most important risks (warnings, contraindications) appear at the beginning or end of the risk presentation; do not flag placement at the end, only flag if they are buried in the middle. For print pieces, confirm the most important risks are placed first; flag if they are not.

Escalate when

When it is unclear whether the most important risks are effectively positioned under the medium-specific expectation (beginning or end for broadcast, first for print) versus buried in the middle.

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.

…ther hand, when reading a print promotional piece under normal circumstances, readers may lose interest toward the end of a lengthy paragraph, and it is not likely that the information 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 un…

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

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
- Supported: the quote is FDA's own recommendation in Section III.A.4 that the most important risk information, including relevant warnings and contraindications, be placed or stated first.
- Overstated in scope because the rule drops the source's own qualifier and contradicts the immediately preceding text. The quoted sentence says 'especially in print materials', and two sentences earlier the source says that in a broadcast ad 'the beginning or end, or both, should be reserved for the most important risk information'. The rule as written ('at the beginning ... rather than buried in the middle') is paired with a check that confirms the serious risks appear 'at or near the start of the risk listing, not after less important risks', which would flag a broadcast ad that places major risks at the end — a placement the source expressly endorses.
- Modality itself is fine: the rule says 'FDA recommends', preserving the non-binding character.
- Atomic: one placement question.
- 'judgment' is correct: identifying which risks are 'most important' and whether they appear early enough is an assessment, not a literal match.
- Authority 'guidance' matches the source document, and the rule claims no more. Category 'risk-disclosure', severity 'warning' and the locator (Section III.A.4, Hierarchy of Risk Information) are appropriate; the unrestricted 'promotional' scope is justified since the source says the ordering factor applies regardless of whether the piece is directed at healthcare professionals or consumers.
- The quote is a complete sentence with its subject intact.
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 quote is a complete sentence from Section III.A.4 (Hierarchy of Risk Information), and the rule text correctly keeps 'FDA recommends'.
- The title 'Place the most important risk information first' is a bare imperative. It turns a guidance recommendation ('FDA therefore recommends') into a directive.
- The rule, check and escalation drop the source's medium qualifier. The recommendation applies 'especially in print materials'. The sentence just before it says that for a broadcast ad 'the beginning or end, or both, should be reserved for the most important risk information'. The escalation condition flags the most serious risks appearing at the 'end' of a list. For broadcast, the source treats that as an acceptable position, so the rule is broader than its source.
- 'judgment' is correct: deciding which risks are 'most important' and whether they are 'effectively communicated' is not a literal match. The locator and 'warning' severity are fine.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote 'FDA therefore recommends that the most important risk information, including relevant warnings and contraindications, be placed or stated first, especially in print materials.' is a verbatim whole sentence from Section III.A.4. It supports the first sentence of the rule, and the title correctly keeps 'FDA recommends'.
- The rule and check bundle a second, separate recommendation: for broadcast ads, the beginning or end, or both, should be reserved for the most important risk information. That comes from a different sentence ('Consequently, in a broadcast ad, ... the beginning or end, or both, should be reserved for the most important risk information'), which is not quoted. It sets a different placement expectation for a different medium, so it can be checked independently. The rule is not atomic, and its broadcast half is not tied to its quote.
- The check also stretches the broadcast statement to 'other audio/video pieces'. The source's reasoning is specific to broadcast ads, where viewers cannot control the pace of information.
- Judgment is correct: identifying the 'most important' risks and whether they are effectively placed is an assessment.
- The locator is correct and the warning severity is defensible.

Nearby rules

US-MIS-047 US-RISK-030