State prominently that FDA has not approved or cleared the discussed use

Where this comes from

Section V, Recommendation 6 (A prominent statement notifying … bullet) · page 12. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: Information distributed in response to an unsolicited request should be accompanied by the following:

…sponses to unsolicited questions or requests for off-label information. 6. Information distributed in response to an unsolicited request should be accompanied by the following: \ A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet) \ A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided \ A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product \ A prominent statement providing all important safety information including, if applicable, any boxed warning for the product \ A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or sci…

Document

FDA guidance: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (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.