[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR250.11]

[Page 149]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 250--SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS--Table of Contents
 
                 Subpart A--Drugs Regarded as Misbranded
 
Sec. 250.11  Thyroid-containing drug preparations intended for treatment of obesity in humans.


    (a) Investigation by the Food and Drug Administration has revealed 
that a large number of drug preparations containing thyroid or 
thyrogenic substances in combination with central nervous system 
stimulants, with or without one or more additional drug substances such 
as barbiturates or laxatives, are being marketed for or as adjuncts to 
the treatment, control, or management of obesity in humans. The 
Commissioner of Food and Drugs finds that the administration of such 
combinations for said purposes is without medical rationale except 
possibly in those relatively uncommon instances where the condition is 
directly related to hypothyroidism and there exists a concurrent need 
for appetite control (in such instances the safety and effectiveness of 
such combinations are not generally recognized). In particular, the 
Commissioner of Food and Drugs finds that neither the consensus of 
informed medical opinion nor clinical experience justifies any 
representation that such combinations are safe and effective in 
connection with the treatment, control, or management of obesity in 
patients having normal thyroid function.
    (b) Combinations of thyroid or other thyrogenic drugs with central 
nervous system stimulants with or without other drug substances when 
offered for or as adjuncts to the treatment, control, or management of 
obesity not related to hypothyroidism are regarded as misbranded. Such 
combinations when offered for obesity in humans directly attributable to 
established hypothyroidism are regarded as new drugs within the meaning 
of section 201(p) of the Federal Food, Drug, and Cosmetic Act.