text: No adverse effects other than carotenemia have been reported for consumption of β-carotene rich foods. Supplementation with β-carotene does not cause hypervitaminosis A. Two large clinical trials (ATBC and CARET) were conducted in tobacco smokers to see if years of β-carotene supplementation at 20 or 30 mg/day in oil-filled capsules would reduce the risk of lung cancer. These trials were implemented because observational studies had reported a lower incidence of lung cancer in tobacco smokers who had diets higher in β-carotene. Unexpectedly, this high-dose β-carotene supplementation resulted in a higher incidence of lung cancer and of total mortality. Taking this and other evidence into consideration, the U.S. Institute of Medicine decided not to set a Tolerable Upper Intake Level (UL) for β-carotene. The European Food Safety Authority, acting for the European Union, also decided not to set a UL for β-carotene.