No toxicities or adverse effects have been reported for lutein and zeaxanthin since more than 20 years (25, 26).

In intervention trials daily doses of up to 30 mg lutein showed no negative effects over a long period (27).

The Joint Food and Agricultural Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) assessed the safety of FloraGLO® Lutein for use in foods in June of 2004.  Based upon their review, JECFA established an Acceptable Daily Intake (ADI) for lutein and zeaxanthin from marigolds at 2 mg/kg body weight/day (i.e.140 mg/day for a person weighing 154 pounds).  This amount is considerably higher than the amounts commonly recommended for the daily intake in vitamin/dietary supplement products sold in the market.

Additionally, the European Food Safety Authority (EFSA) confirmed the safety of lutein using a more conservative ADI of 1 mg/kg body weight/day while simultaneously confirming the safety of lutein for nutritional uses by infants and young children in 2006.

There is no reason to limit the consumption of carotenoid-rich fruits and vegetables during pregnancy (26).

Tolerable upper intake levels

Presently, no tolerable upper intake level (UL) has been set for lutein and zeaxanthin.

Drug interactions

There are no well-known drug interactions with lutein or zeaxanthin.

Authored by Dr Peter Engel in 2010, reviewed and revised by Jonas Wittwer on 13.06.2017