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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000148

CFSAN/Office of Food Additive Safety
October 28, 2004

Andreas Menzel, Ph.D.
R&D Program Manager
Lipid Nutrition, Loders Croklaan B.V.
P.O. Box 4
1520 AA Wormerveer
The Netherlands

Re: GRAS Notice No. GRN 000148

Dear Dr. Menzel:

The Food and Drug Administration (FDA) has received the notice, dated March 10, 2004, that Loders Croklaan B.V. 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 March 12, 2004, filed it on March 16, 2004, and designated it as GRN No. 000148.

The subject of the notice is vegetable oil conjugated linoleic acid (VCLA). The notice informs FDA of the view of Loders Croklaan, that VCLA is GRAS, through scientific procedures, for use as a supplementary source of CLA in yogurt products (and similar non-standardized products), milk-based meal replacements, frozen or shelf-stable plate meals (with meat, poultry, or fish as a major ingredient), bars (e.g., protein, breakfast, meal replacement, granola, power) and low-calorie and reduced calorie salad dressings (and similar non-standardized products).

In a letter dated August 31, 2004, you asked that FDA cease to evaluate Loders Croklaan's notice in light of the technical requirements discussed during our August 2004 telephone conversations with the understanding that Loders Croklaan may, in the future, submit another GRAS notification or make another appropriate submission for Clarinol™ G-80 (VCLA) preparation. Given your request, we ceased to evaluate GRN No. 000148 effective August 31, 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

cc: Dr. Robert Post, Director
     Labeling and Consumer Protection Staff
     Office of Policy, Program Development and Evaluation
     Food Safety and Inspection Service
     1400 Independence Ave., SW, Suite 602, Annex
     Washington, DC 20250-3700