Lutein: Safety Assessment

In 2011, EFSA published an Acceptable Daily Intake (ADI) value for lutein and an intake value (No Observed Adverse Effect Level, NOAEL) at which no adverse effects were observed from ingestion of the substance, in this case lutein and its equivalents.In this case, the NOAEL corresponds to the highest value tested to date.

The ADI is 1 mg of lutein per kilogram of body weight.At this determination, the lutein had a highly concentrated carotenoid content from the plant Tagetes erecta and an ester content of at least 60%.The NOAEL was set by EFSA at 1,000 mg of lutein per kg of body weight and at 538 mg of lutein equivalents per kg of body weight.

One study showed that an intake of up to 10 mg of lutein for 3 months caused no side effects in people aged 60 years and older. Vision and liver function remained unchanged, and concentrations of other antioxidant vitamins did not change with supplementation.