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U.S. Department of Health and Human Services

Food

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Agency Response Letter GRAS Notice No. GRN 000153

CFSAN/Office of Food Additive Safety
October 28, 2004

Heather Nelson Cortes, Ph.D.
Cognis Corporation
5325 South 9th Avenue
LaGrange, IL 60525-3602

Re: GRAS Notice No. GRN 000153

Dear Dr. Cortes:

The Food and Drug Administration (FDA) has received the notice, dated June 3, 2004, that Cognis Corporation 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)). FDA received this notice on June 10, 2004, filed it on June 15, 2004, and designated it as GRN No. 000153.

The subject of the notice is conjugated linoleic acid (CLA). The notice informs FDA of the view of Cognis Corporation, that Tonalin® CLA is GRAS, through scientific procedures, for use as a supplementary source of CLA in yogurt products, milk-based fruit drinks and beverages, meal replacement beverages, fruit juices, liquid cream substitute, powdered cream substitute, milk chocolate and bars (e.g., meal replacement).

In a letter dated August 16, 2004, you asked that FDA cease to evaluate your notice in light of the technical requirements discussed during our August 2004 telephone conversations with the understanding that Cognis may, in the future, submit another GRAS notification or make another appropriate submission for Tonalin® CLA preparation. Given your request, we ceased to evaluate GRN No. 000153 effective August 16, 2004, the date that we received your letter.

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 your notice that conforms to the information in proposed 21 CFR 170.36 ( c)(1), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www/cfsan.fda.gov/~lrd/foodadd.html).

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