C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 201—LABELING › Subpart G—Specific Labeling Requirements for Specific Drug Products

21 C.F.R. § 201.302

Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil

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(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 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.

Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2021–2021 · leading case: Sharma v. Amarin Corp., Plc (D.N.J. 2021).
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Sharma v. Amarin Corp., Plc (D.N.J. 2021). “endants were misleading when made in the context of the FDA’s prior concerns with the mineral oil placebo in the ANCHOR trial, the FDA’s rejection of the ANCHOR supplemental new drug application (“sNDA”), the FDA’s direction to Amarin to monitor the placebo arm in the REDUCE-IT…”
— 21 C.F.R. § 201.302(G)(a) — 1 case
Sharma v. Amarin Corp., Plc (D.N.J. 2021). “endants were misleading when made in the context of the FDA’s prior concerns with the mineral oil placebo in the ANCHOR trial, the FDA’s rejection of the ANCHOR supplemental new drug application (“sNDA”), the FDA’s direction to Amarin to monitor the placebo arm in the REDUCE-IT…”
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