A risk-information presentation should not open with unrelated content

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…

Document

FDA guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion (see document)

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as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file

Retrieved

2026-09-21 from www.fda.gov

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FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.