Agency Additional Information Letter GRAS Notice No. GRN 000147
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CFSAN/Office of Food Additive Safety
November 14, 2008
Robert G. Hibbert
Kirkpatrick & Lockhart Preston Gates Ellis, LLP
1601 K Street NW
Washington, DC 20006-1600
Re: GRAS Notice No. GRN 000147
Dear Mr. Hibbert:
The Food and Drug Administration (FDA) is providing additional information relevant to the notice that you submitted on March 3, 2004, on behalf of Proteus Industries, Inc. (Proteus), 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 March 8, 2004, filed it on March 10, 2004, and designated it as GRAS Notice No. GRN 000147 (GRN 147). In a letter dated August 26, 2004, FDA informed Proteus that the agency had no questions at that time regarding the conclusion of Proteus 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 term used to describe the subject of the notice in FDA's response letter to Proteus regarding GRN 147.
In GRN 147, Proteus refers to the subject of the notice by the specific names "(species) protein" and "concentrated (species) protein" and by the general terms "concentrated fish protein" and "extracted protein." For the purpose of FDA's correspondence with Proteus at that time, we referred to the subject of the notice as "extracted fish protein." Subsequently, we have reconsidered that the sources of extracted protein could include cod, flounder, whiting, Alaska pollock, scallop, lobster, and shrimp. We now believe that the term "extracted fish protein" does not accurately describe the subject food ingredient in GRN 147 and is therefore inadequate. Rather, we believe that the term "extracted "seafood species" protein," more accurately describes protein extractions derived from fish and non-fish (e.g., mollusks and Crustacean shellfish) sources. Consequently, we will refer to the subject food ingredient by the term "extracted "seafood species" protein" on the GRAS Inventory, available via the "Generally Recognized as Safe (GRAS)" page of the "Food Ingredients and Packaging" section of the FDA home page (on the Internet at http://www.fda.gov), and in future correspondence related to GRN 147.
Title 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. Our use of "extracted "seafood species" protein" in this 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. Issues associated with labeling and the appropriate common or usual name of a food are the responsibility of the Office of Nutrition, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter providing additional information relevant to GRN 147, as well as a copy of the information in this notice that conforms to the information in the proposed 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