I spent many hours researching this yesterday. Small amounts of lutein are found in many substances that we consume. As a result there has always been small amounts in all formula because of the other ingredients used.
There was at least one study that was done to test the 'safety' of the increased dosage. A 16 weeks trial that looked at infants growth with use of the added Lutein. http://www.nutritionj.com/content/9/1/22
According to this study : ""lutein has been determined by the WHO/FAO/Codex Joint Evaluation Committee on Food Additives (JECFA) to be safe for use as a nutrient fortification"
From what I found the FDA labeled lutein as GRAS (Generally Recognized as Safe) in 2004.
Jessica Callahan RN, IBCLC
NC, USA
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