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  1. GRAS Notice Inventory

Agency Response Letter GRAS Notice No. GRN 000611

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See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

May 27, 2016

Emmanuel Treuil
Armor Protéines S.A.S.
19 bis, rue de la Liberation
35460 saint-Brice-en-Cogles
FRANCE

Re: GRAS Notice No. GRN 000611

Dear Mr. Treuil:

The Food and Drug Administration (FDA) is responding to the notice, dated November 12, 2015, that you submitted  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 November 25, 2015, filed it on December 15, 2015, and designated it as GRAS Notice No. GRN 000611.

The subject of the notice is fractionated whey protein isolate containing cow’s milk derived lactoferrin, lactoperoxidase, and transforming growth factor β2.  The notice informs FDA of the view of Armor Protéines S.A.S. that fractionated whey protein isolate containing cow’s milk derived lactoferrin, lactoperoxidase, and transforming growth factor β2 is GRAS, through scientific procedures, for use as an ingredient in meal replacement beverages at levels up to 100 milligrams (mg) per serving (240 milliliter) and in medical foods at varying levels so that resulting intake of the ingredient does not exceed 610 mg per person per day.

In an email dated April 15, 2016, you asked that FDA cease to evaluate your notice.  Given your request, we ceased to evaluate your GRAS notice, effective April 15, 2016, the date that we received your email.  You indicated that you will need time to answer our questions and will make a new submission later.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000611, 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 http://www.fda.gov/grasnoticeinventory.

Sincerely,

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