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While the benefits of dietary consumption of lutein and zeaxanthin are becoming increasingly evident, what is known about their safety profile? Both compounds have been in the U.S. diet for a long time, and Average Daily Intakes (ADI) look to be between 1 and 6 mg/day.
Lutein supplements have been on the U.S. market since 1995-96 without reports of adverse effects. Recently, several companies have completed GRAS self-affirmation processes for lutein and lutein-esters to extend the uses into food fortification.
A review of the safety of zeaxanthin shows that there is an adequate technical basis for safety assessment. Acute studies show an LD50 greater than 8,000 mg/kg. Sub-chronic (90 days) show no toxicity at 1,000 mg/kg/day. These studies in five species of animals showed a NOAEL (no adverse effect level) for a 60 kg human of 1,200 mg/day.
These same safety criteria were also established for maternal, fetal, or teratotoxicity. Mutagenicity testing in multiple batteries of microbial tests was also negative. The extensive safety review shows no adverse effects.
Currently, there are promising benefits possible from increased consumption of lutein and zeaxanthin. The safety margin for consumption is excellent. The safety (risk) benefit is strongly in favor of increased usage. |