[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.302]

[Page 59-60]
 
                        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 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

[[Page 60]]

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.