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CFSAN/Office of Food Additive Safety
November 21, 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 responding to your supplement dated March 10, 2008, that you sent regarding additional uses for the subject of GRAS Notice No. GRN 000147 (GRN 147). You initially submitted GRN 147, 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 GRN 147. The notice informed FDA of the view of Proteus that extracted "seafood species" protein is GRAS, through scientific procedures, for use as a protein source in finished seafood products of the same species as the extracted protein. 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. In the August 26 letter, the agency referred to the subject of GRN 147 using the term "extracted fish protein." Subsequently, FDA issued additional correspondence, dated November 14, 2008, informing Proteus that the agency considers "extracted "seafood species" protein" to be a more accurate term, given the fish and non-fish (e.g., mollusks and Crustacean shellfish) sources of the protein extractions.
In a letter dated March 10, 2008, you informed FDA of Proteus' determination that extracted "seafood species" protein is GRAS for use in fresh or frozen seafood (1) as a protein coating (only) by dip; (2) applied as a portion of the batter (only); or, (3) as a portion of the batter and coating (together). Proteus describes the ranges of extracted "seafood species" protein that are applied as a coating and/or batter: 0.06 – 0.80 percent when used as a protein coating (only); 0.04 – 0.35 percent when used as a batter (only); and, 0.11 – 0.89 percent when used in both the batter and coating (together). Proteus states that these ranges are generally consistent with the use levels described in GRN 147. Proteus further states that the extracted "seafood species" protein may be added to seafood of the same species or to a secondary processed seafood product of a different species. In both cases, Proteus states that the extracted "seafood species" protein will be identified as "(species) protein" on the finished product label.
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that the label of a food that is or contains an ingredient that bears or contains a "major food allergen" declare the presence of the allergen (section 403(w)). FALCPA defines a "major food allergen" as one of eight foods or food groups (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) or a food ingredient that contains protein derived from one of those foods. Issues associated with labeling food are the responsibility of the Center for Food Safety and Applied Nutrition's Office of Nutritional Products, Labeling, and Dietary Supplements.
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of Proteus' supplement that extracted "seafood species" protein is GRAS for use in fresh or frozen seafood (1) as a protein coating (only) by dip; (2) applied as a portion of the batter (only); or, (3) as a portion of the batter and coating (together), FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing extracted "seafood species" protein. Accordingly, this response should not be construed to be a statement that foods that contain extracted "seafood species" protein, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Proteus in GRN 147, the supplement dated March 10, 2008, and other information available to FDA, the agency has no questions at this time regarding Proteus' conclusion that extracted "seafood species" protein is GRAS under the intended conditions of use in fresh or frozen seafood (1) as a protein coating (only) by dip; (2) applied as a portion of the batter (only); or, (3) as a portion of the batter and coating (together). The agency has not, however, made its own determination regarding the GRAS status of the subject use of extracted "seafood species" protein. As always, it is the continuing responsibility of Proteus 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 the supplement submitted regarding 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.
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
