21 C.F.R. § 369.8 Warning statements in relation to conditions for use.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 369—INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
Subpart A—Definitions and Interpretations
§ 369.8 Warning statements in relation to conditions for use.
