The Food and Drug Administration (FDA) permits lanolin to be used in Over-the-Counter (OTC) drugs that protect the skin, and in OTC drugs that protect the anorectal area. Lanolin is also permitted to be used as an opthalmic emollient in OTC ophthalmic drug products. In food, FDA permits the use of lanolin as a softener in chewing gum. Lanolin is also approved for use as an indirect food additive. For example, it may be used as a component of cellophane that comes in contact with food. The safety of lanolin and lanolin-derived ingredients has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that lanolin, lanolin oil, lanolin wax, lanolin alcohol, acetylated lanolin, acetylated lanolin alcohol, hydrogenated lanolin and hydroxylated lanolin were safe for use in cosmetics and personal care products. In 2003, the Expert Panel considered available new data on lanolin and the other lanolin-derived ingredients and reaffirmed the above conclusion.
The Expert Panel noted that lanolin and related ingredients, as a group, are used extensively in cosmetics and personal care products, as well as in many other consumer products, and there has been ample opportunity for a large proportion of the population to be exposed to some of these materials. Tests with acetylated lanolin, its related cosmetic ingredients, and with numerous cosmetics and personal care products containing these materials attest to the safety of these ingredients used in cosmetics and personal care products. The acute toxicity of these materials is low and tests for skin sensitization are negative.
Extensive clinical experience indicates that there is a low incidence of sensitivity to these materials among exposed persons. This appears to be mainly due to the lanolin alcohols. There was no evidence of photosensitization. However, comedogenic effects, or the formation of pimples, from cosmetics and personal care products containing lanolin and related materials have been reported.
FDA: Link to Code of Federal Regulations for the OTC uses of lanolin.
FDA: Link to Code of Federal Regulations for the food additive uses of lanolin.
When conforming to European Union animal by-products legislation, lanolin and lanolin-derived ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.