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CFSAN/Office of Food Additive Safety
October 31, 2008
Bruce K. Bernard, Ph.D., President
SRA International Inc.
5235 Ragged Point Road
Cambridge, MD 21613
Re: GRAS Notice No. GRN 000199
Dear Dr. Bernard:
The Food and Drug Administration (FDA) is responding to your supplement dated February 5, 2008, that you submitted on behalf of Calpis Co. Ltd. (Calpis) regarding additional uses for the subject of GRN 000199. SRA International Inc. initially submitted GRN 000199 on behalf of Calpis 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)). FDA received this notice on May 5, 2006, filed it on May 9, 2006, and designated it as GRN No. 000199. The notice informed FDA of the view of Calpis that concentrated hydrolyzed milk protein is GRAS, through scientific procedures, for use as an ingredient in orange juice, yogurt (including yogurt drinks), nutrition bars and margarine spread. In a letter dated May 11, 2007, FDA informed Calpis that the agency had no questions at that time regarding the conclusion of Calpis that the subject of the notice is GRAS under the intended conditions of use.
In a letter dated February 5, 2008, SRA International Inc. informed FDA of Calpis' determination that concentrated hydrolyzed milk protein is GRAS for use in hard and soft candies, cereal, cheese, chewing gum, chocolate, cookies, crackers, cranberry juice, energy drinks, frozen dinners, grape juice, ketchup, meal replacements, milk/dairy-based beverages, tea beverages, and tomato juice. The supplement reflected Calpis' conclusion that these additional uses would not significantly increase consumer exposure to the concentrated hydrolyzed milk protein that was the subject of GRN 000199 with respect to the background dietary exposure from dairy products. Calpis based their determination on information submitted in the original GRAS Notice as well as information submitted in the supplement.
Section 301 (ll) of the Federal, Food, and Cosmetic Act (FFDCA)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of Calpis' supplement that concentrated hydrolyzed milk protein is GRAS for these additional uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing concentrated hydrolyzed milk protein. Accordingly, this response should not be construed to be a statement that foods that contain concentrated hydrolyzed milk protein, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Calpis in GRN 000199, the supplement dated February 5, 2008, additional correspondence dated October 14, 2008, which included specifications for the ingredient and clarified issues concerning units reported in a Table in the February 5, 2008, submission, and other information available to FDA, the agency has no questions at this time regarding Calpis' conclusion that the concentrated hydrolyzed milk protein is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of this concentrated hydrolyzed milk protein ingredient. As always, it is the continuing responsibility of Calpis to ensure that the food ingredients the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in the notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying in the Food Ingredients and Packaging section under the Foods topic of www.fda.gov.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition