Agency Additional Correspondence Letter GRAS Notice No. GRN 000131
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CFSAN/Office of Food Additive Safety
May 7, 2004
Daniel R. Dwyer
Kleinfeld, Kaplan and Becker, LLP
1140 19th Street, NW
Washington, DC 20036
Re: GRAS Notice No. GRN 000131
Dear Mr. Dwyer:
The Food and Drug Administration (FDA) is providing additional information relevant to the notice that you submitted on May 28, 2003, on behalf of Loders Croklaan B.V. (Loders Croklaan) 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 May 29, 2003, filed it on June 9, 2003, and designated it as GRAS Notice No. GRN 000131. In a letter dated December 4, 2003, FDA informed Loders Croklaan that the agency had no questions at that time regarding the conclusion of Loders Croklaan that the subject of the notice is GRAS under the intended conditions of use. The additional information that we provide in this letter relates to the name used to declare the subject of GRN 000131 in the ingredient statement of the food product that contains it.
In GRN 000131, Loders Croklaan refers to the subject of the notice by both a trade name ("Betapol") and a chemical term ("structured triglycerides"). For the purpose of FDA's letter dated December 4, 2003, we referred to the subject of the notice as "high 2-palmitic vegetable oil (vegetable oil, enzyme-modified to increase the content of palmitic acid at the C-2 hydroxyl of the glycerol backbone)."
The substance that is the subject of GRN 000131 is intended for use as an ingredient in infant formula. In our December 2003 letter, we informed you that under section 412 of the Federal Food, Drug, and Cosmetic Act, a manufacturer of a new infant formula must make a submission to FDA, providing required assurances about the formula, at least 90 days before the formula is to be marketed. As part of that submission, the manufacturer of the infant formula must provide a quantitative formulation that lists all ingredients and the amounts used in the formula.
Our use of "high 2-palmitic vegetable oil" in the December 2003 letter should not be considered an endorsement or recommendation of that term as an appropriate common or usual name for the purpose of declaring the substance in the ingredient statement of foods that contain that ingredient. 21 CFR 101.4 states that all ingredients must be declared by their common or usual name. In addition, 21 CFR 102.5 outlines general principles to use when establishing common or usual names for nonstandardized foods. Issues associated with labeling and the appropriate common or usual name of a food are the responsibility of the Office of Nutritional Products, Labeling, and Dietary Supplements.
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 on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
George H. Pauli, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition