Agency Additional Correspondence Letter GRAS Notice No. GRN 000232
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CFSAN/Office of Food Additive Safety
September 8, 2009
Daniel R. Dwyer
Kleinfeld, Kaplan and Becker, LLP
1140 Nineteenth Street, N.W.
Washington, DC 20036-6606
Re: GRAS Notice No. GRN 000232
Dear Mr. Dwyer:
The Food and Drug Administration (FDA) is responding to the supplement dated April 22, 2009, that you and Ms. Diane McEnroe sent regarding GRN 000232. You submitted GRN 000232 on behalf of Lipid Nutrition B.V. and Cognis GmbH (hereinafter referred to as “Lipid Nutrition and Cognis”) 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 August 2, 2007, filed it on August 13, 2007, and designated it as GRAS Notice No. GRN 000232.
The subject of the notice is a glyceride mixture composed predominantly of a 1:1 mixture of cis-9, trans-11 and trans-10, cis-12 conjugated linoleic acids (hereinafter referred to as “CLA isomers”). The notice informed FDA of the view of Lipid Nutrition and Cognis that CLA isomers are GRAS, through scientific procedures, for use as an ingredient in certain specified foods within the general categories of soy milk, meal replacement beverages and bars, milk products and fruit juices at levels not to exceed 1.5 grams (g) per serving. This level is predicated on Lipid Nutrition and Cognis’ expected use of approximately two servings per day.
The supplement dated April 22, 2009, seeks confirmation that the FDA does not disagree with the determination of Lipid Nutrition and Cognis that CLA isomers are GRAS for use in certain specified foods within the general categories of soy milk, meal replacement beverages and bars, milk products and fruit juices at levels up to 3 g per person per day.
Based on the information provided by Lipid Nutrition and Cognis in GRN 000232, the supplement dated April 22, 2009, and other information available to FDA, the agency has no questions at this time regarding Lipid Nutrition and Cognis’ conclusion that CLA isomers are GRAS at levels up to 3 g per person per day. The agency has not, however, made its own determination regarding the GRAS status of the subject use of CLA isomers. As always, it is the continuing responsibility of Lipid Nutriton and Cognis to ensure that food ingredients that 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 responding to GRN 000232, 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. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Ms. Diane C. McEnroe
Sidley Austin, LLP
787 Seventh Avenue
New York, NY 10019