The U.S. Food and Drug Administration (FDA) has reviewed the safety of mineral oil and permits its use as a multipurpose direct food additive. FDA also permits the use of mineral oil as an active ingredient in the following OTC drug product categories: anorectal drugs, skin protectants and ophthalmic emollients.
Mineral oil may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Mineral oil as a food ingredient was reviewed in 2013 by the Joint FAO/WHO Expert Committee on Food Additives and Contaminants. The Expert Committee allocated an Acceptable Daily Intake of 0-10 mg/kg/day for Class 1 low to medium viscosity mineral oil (i.e., food grade mineral oil, white mineral oil).
White mineral oil has a long history of safe use by humans in orally ingested and topically applied products. A re-evaluation of the use of certain mineral hydrocarbons used in the preparation of food items by regulators in the UK, however, prompted additional safety studies and a critical assessment of the toxicological effects of white mineral oil. As white mineral oil is present in many topically applied drug and non-drug products, it was of interest to review the toxicological effects of mineral oil produced by this route of exposure. Initial concern about possible tissue inflammation in liver and lymph nodes of rats after they orally ingested white mineral oils has been proven to be unfounded with no scientific basis for concern.
These studies were reviewed in 1996 by the Cosmetic Toiletry and Fragrance Association’s (now known as the Personal Care Products Council) Mineral Oil Task Force as part of an examination of available published scientific literature. After a review of the literature, which included findings of negligible skin penetration for topically applied white mineral oil, the CTFA Task Force determined that there was no valid scientific evidence in the published literature of any hazard identified for topical exposure to white mineral oil at any dose in multiple species. This determination is supported by the long history of safe human use of white mineral oil in drug and non-drug topically applied products.
Find out more about the regulation of over-the-counter drugs by the U.S. Food and Drug Administration