Safety of MZ: publication by FDA

The macular carotenoids (pigments) lutein, zeaxanthin and meso-zeaxanthin, have been deemed suitable for human consumption (see publications section). Meso-zeaxanthin is converted from natural lutein extracted from the Aztec Marigold flower, and has been used to date in many clinical trials and several toxicity studies. A recent study of supplemental meso-zeaxanthin in human subjects has confirmed, by analysis of serum, that renal and liver function, as well as lipid profile, haematological parameters, and indicators of inflammation, are unaffected by such supplementation. For a detailed discussion on the safety of meso-zeaxanthin please refer to a recent publication by Connolly et al. A recent study of supplemental MZ in human subjects has confirmed, by analysis of serum, that renal and liver function, as well as lipid profile, haematological parameters, and indicators of inflammation, are unaffected by such supplementation. For a detailed discussion on the safety of MZ please refer to a recent publication by Connolly et al.

Regulatory information and GRAS:

Meso-zeaxanthin is being used as a supplement (food ingredient) and as such it comes under the heading of GRAS (Generally Accepted As Safe).

In 2014, the FDA responded to the GRAS notice for meso-zeaxanthin and concluded “Based on the information provided by IOSA, as well as other information available to FDA, the agency has no questions at this time regarding IOSA’s conclusion that meso-zeaxanthin is GRAS under the intended conditions of use.” See below for FDA publication. http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm400320.htm

In summary, and consistent with GRAS review, the FDA are satisfied that meso-zeaxanthin meets the criteria of GRAS, but outline that the responsibility lies with the supplier to provide appropriate safety data and quality assurance that meso-zeaxanthin is, indeed, safe.