[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.316]
[Page 84-85]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart G Specific Labeling Requirements for Specific Drug Products
Sec. 201.316 Drugs with thyroid hormone activity for human use; required
warning.
(a) Drugs with thyroid hormone activity have been promoted for, and
continue to be dispensed and prescribed for, use in the treatment of
obesity, although their safety and effectiveness for that use have never
been established.
(b) Drugs for human use with thyroid hormone activity are misbranded
within the meaning of section 502 of the Federal Food, Drug, and
Cosmetic Act unless their labeling bears the following boxed warning at
the beginning of the ``Warnings'' section:
[[Page 85]]
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Drugs with thyroid hormone activity, alone or together
with other therapeutic agents, have been used for the
treatment of obesity. In euthyroid patients, doses within
the range of daily hormonal requirements are ineffective for
weight reduction. Larger doses may produce serious or even
life-threatening manifestations of toxicity, particularly
when given in association with sympathomimetic amines such
as those used for their anorectic effects.
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[43 FR 22009, May 23, 1978]
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