Use headlines/signals for risk information whenever benefit information is signaled

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.

…nformation in the text may not remedy a false headline [or signal] because reasonable consumers may only glance at the headline” and skip the remainder of the text. Signals are also used in broadcast situations, such as when an announcer draws attention to different items of information, when a word on the screen identifies a new topic, or when headlines emphasize some messages but not others. When reviewing promotional materials, FDA looks to see if the use of signals is consistent across benefit and risk information, so that the materials provide accurate and non-misleading impressions of a drug or device. > Example 4: If a piece contains headlines that signal benefit information, (e.g., “Drug X Provides > Highly Effective Control”), some sort of headline should also signal risk information (e.g., “Side > Effects for Drug X”). However, the mere presence of similar signals for both benefit and risk information is not necessarily sufficient to make a piece accurate and non-misleading. The content of the signals i…

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

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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.