[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR369.8]

[Page 306]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE--Table of Contents
 
               Subpart A--Definitions and Interpretations
 
Sec. 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.