Rules/misleading presentation/US-MIS-044

Risk information should be preceded by a signal indicating risk information follows

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

Rule

Risk information should be introduced by a signal (e.g., a headline, subhead, or audio cue) indicating that risk information follows, and should not be opened with unrelated information such as indication or dosing, since either can minimize the risks and mislead the audience.

Check

For each risk-information block, confirm it is preceded by a signal indicating risk information follows, and that it does not begin with unrelated content (e.g., indication, dosing, or benefit headlines such as "Now Approved for...").

Escalate when

When a risk section has no clear signal and it's unclear whether this minimizes the risk message.

Where this comes from

Section III.A.2, Use of Signals · page 11. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… > Example 5: The headline “Important Risk Information about Device X” is preferable to > “Important Information about Device X” because the former headline indicates what type of > information follows. Similarly, “Common Side Effects Seen with Drug X,” is preferable to > “Other Information about Drug X.” Specific and clear signals are preferable because they are > more effective than vague or abstract terms. Presenting risk information with no signal, or beginning the presentation of risk information with unrelated information (e.g. presenting risk information in a paragraph that begins with information on indication or dosing) can also minimize the risks of the product and mislead the audience. For example, the headlines in the following example convey additional benefit information, potentially misleading the audience about the overall risk-benefit profile of the product. > Example 6: Placing risk information under headlines such as “Now Approved for Epilepsy” or > “Safe Enough for Children Under 5” minimizes the risk information that follows, particularly if > individuals only look at the headline…

Open the original at page 11 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 cited sentence (lines 246-248) does establish both failure modes named: presenting risk information with no signal, and beginning a risk presentation with unrelated information such as indication or dosing. The surrounding Section III.A.2 text (Examples 4-6, 'headlines preceding risk presentations should signal that a risk presentation follows') supports the signal requirement independently, so the rule statement follows from the source.
- Modality is correct for a non-binding guidance: the rule says 'should be introduced' and 'should not open with', matching the guidance's own framing.
- Not atomic. The rule bundles two requirements that are checked separately and can fail separately: (a) a risk block is preceded by its own risk signal, and (b) a risk block does not open with indication/dosing/other unrelated content. A piece can satisfy one and violate the other; the check text itself asks two distinct questions ('is there a clear risk signal, and does the block begin with risk content').
- 'judgment' is right: whether a headline counts as a risk signal and whether opening content is 'unrelated' turn on impression, not a literal match.
- Authority 'guidance' matches the source document, and the rule claims no more than guidance. Category 'misleading-presentation', severity 'warning', applies_when 'promotional', and the locator (Section III.A.2, Use of Signals) are all consistent with the source.
- The quote is a complete sentence and does not run into unrelated material.
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 and, with Example 6 ('headlines preceding risk presentations should signal that a risk presentation follows'), supports a rule that risk information should not be left unsignaled.
- However the rule text ('mirroring the signals used to introduce benefit information') and the check ('comparable to the signals used for benefit information') restate US-MIS-043 (consistency of signals between benefit and risk) in this same packet, so the rule bundles its own requirement with a duplicate of 043.
- The rule also omits the second failure mode its own quote names — opening the risk presentation with unrelated information such as indication or dosing — which is what distinguishes this rule from 043 and is needed for the check to reflect the quote.
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 from III.A.2 Use of Signals. Its line breaks are layout only; there are no stray line numbers. The rule's softened 'should' plus 'can minimize... and mislead' fairly reflects the source, and the surrounding text supports it: Example 6 says 'headlines preceding risk presentations should signal that a risk presentation follows'.
- The rule bundles two independently checkable requirements: (1) risk information is preceded by a signal, and (2) the risk presentation does not begin with unrelated information such as indication or dosing. A piece can pass one and fail the other, and the Check tests them separately.
- Judgment is correct.

Nearby rules

US-MIS-043 US-MIS-057