Agency Response Letter GRAS Notice No. GRN 000416

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See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory

CFSAN/Office of Food Additive Safety

April 13, 2012

Mr. Mark L. Itzkoff
Olsson Frank Weeda Terman Matz PC
600 New Hampshire Ave., NW
Washington, DC 20037

Re: GRAS Notice No. GRN 000416

Dear Mr. Itzkoff:

The Food and Drug Administration (FDA) is responding to the notice, dated January 17, 2012, that you submitted on behalf of Industrial Organica S.A. de C.V. (Industrial Organica) in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on January 18, 2012, filed it on January 26, 2012, and designated it as GRAS Notice No. GRN 000416.

The subject of the notice is lutein diacetate. The notice informs FDA of the view of Industrial Organica that lutein diacetate is GRAS, through scientific procedures, for use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, infant and toddler foods, milk and milk products, processed fruits and fruit juices, soft candy, and soup and soup mixes at a level of 3 milligrams lutein diacetate per serving.

In a letter dated March 20, 2012, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective March 20, 2012, the date that we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000409, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at


Antonia Mattia, Ph.D.
Division of Biotechnology
and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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