The safety of β‐carotene

Abstract

Epidemiological studies have associated low dietary and/or plasma level of carotenoids with higher incidences of certain cancers. This evidence has led the National Cancer Institute to initiate more than a dozen prospective clinical trials in which supplements of β‐carotene alone, or in combination with other micronutrients, are being taken. In these trials, the β‐carotene supplements are given in the range of 15–50 mg/day. The safety of this level of intake is well documented. β‐Carotene has been successfully used to treat inherited photo‐sensitivity diseases for more than 15 years at dosages of 180 mg/day or more, without any adverse effects other than hypercarotenemia. Toxicity studies in animals have shown that β‐carotene is not carcinogenic, mutagenic, embryotoxic, or teratogenic and does not cause hypervitaminosis A. In the few isolated reports of carotenoid‐related toxicity, the findings are associated with very large intakes of foods containing β‐carotene, among other constituents, and have not been substantiated in individuals who have taken high doses of β‐carotene for several years.