FDA Doesn't Object to Lutemax 2020® GRAS Status

MORRISTOWN, N.J.OmniActive  received a "no objection Letter" from FDA with reference to the GRAS (generally recognized as safe) status for Lutemax 2020®, allowing the eye heath ingredient to be formulated into functional foods and beverages in the United States. Lutemax 2020, which was already available for use in supplements, was filed under GRAS Inventory Number GRN 000385 in December 2011.

Through scientific procedures, OmniActive submitted a notice to inform FDA of the company's view that its lutein preparation was GRAS for use as an ingredient in a variety of foods and beverages. To substantiate this claim, OmniActive included the report of a panel of individuals, qualified by scientific training and experience. The company then described the method of manufacturing, provided the identity and specifications, and provided an estimate for daily intake (EDI) for its lutein preparation as well as discussed the safety of lutein ingredients that had been the subject of four prior GRAS notices.

Further, it discussed published and unpublished safety studies on lutein preparation from T. erecta, as well as lutein, zeaxanthin and meso-zeaxanthin from sources conducted in various animals and humans with respect to absorption, distribution, metabolism, excretion (ADME) and toxicity. OmniActive also summarized relevant toxicological studies, shared unpublished acute and subchronic oral toxicity studies in rates and in vitro genotoxicity/mutagenicity studies on its Lutein preparation, as well as the meso-zeaxanthin isomer. OmniActive concluded that the results of these studies showed that there are no toxic adverse effects from the consumption of Lutein preparation and that the use of lutein and zeaxanthin was safe based on the totality of the published and unpublished studies. OmniActive self-affirmed Lutemax 2020's GRAS status in November 2012.

In 2012, OmniActive will be launching a variety of initiatives to help formulators create new products with Lutemax 2020. While developing the GRAS dossier for Lutemax 2020, OmniActive has been able to demonstrate the potential to use this ingredient across a wide range of food categories such as functional foods, beverages, baked and snack foods, dairy products, confectionaries, cereals, etc.

What to get your ingredient recognized as GRAS? Check out the on-demand video, " GRAS Associates CEO outlines the Roadmap to Compliance " at the SupplySide Store.