21 CFR § 369.8 - Warning statements in relation to conditions for use.

---
identifier: "/us/cfr/t21/s369.8"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 369.8 - Warning statements in relation to conditions for use."
title_number: 21
title_name: "Food and Drugs"
section_number: "369.8"
section_name: "Warning statements in relation to conditions for use."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "369"
part_name: "INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "39 FR 11745, Mar. 29, 1974, unless otherwise noted."
cfr_part: "369"
---


# 369.8 Warning statements in relation to conditions for use.

The mention in any warning or caution statement included in subparts A, B, and C of this part, of a disease condition does not imply a finding on the part of the Food and Drug Administration that any drug or device is efficacious in such condition; nor is any drug or device bearing labeling referring to such disease condition precluded from regulatory action under the applicable provisions of the act if such claim is considered to be misbranding.