[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: 21CFR201.302]
[Page 76-77]
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. 201.302 Notice to manufacturers, packers, and distributors of drugs for
internal use which contain mineral oil.
(a) In the past few years research studies have altered medical
opinion as to the usefulness and harmfulness of mineral oil in the human
body. These studies have indicated that when mineral oil is used orally
near mealtime it interferes with absorption from the digestive tract of
provitamin A and the fat-soluble vitamins A, D, and K, and consequently
interferes with the utilization of calcium and phosphorus, with
[[Page 77]]
the result that the user is left liable to deficiency diseases. When so
used in pregnancy it predisposes to hemorrhagic disease of the newborn.
(b) There is accumulated evidence that the indiscriminate
administration of mineral oil to infants may be followed by aspiration
of the mineral oil and subsequent ``lipoid pneumonia.''
(c) In view of these facts, the Department of Health and Human
Services will regard as misbranded under the provisions of the Federal
Food, Drug, and Cosmetic Act a drug for oral administration consisting
in whole or in part of mineral oil, the labeling of which encourages its
use in pregnancy or indicates or implies that such drug is for
administration to infants.
(d) It is also this Department's view that the act requires the
labelings of such drugs to bear a warning against consumption other than
at bedtime and against administration to infants. The following form of
warning is suggested: ``Caution: To be taken only at bedtime. Do not use
at any other time or administer to infants, except upon the advice of a
physician.''
(e) This statement of interpretation does not in any way exempt
mineral oil or preparations containing mineral oil from complying in all
other respects with the requirements of the Federal Food, Drug, and
Cosmetic Act.
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