Agency Response Letter GRAS Notice No. GRN 000026
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CFSAN/Office of Premarket Approval
December 16, 1999
Dr. R. John Pearce
P.O. Box 123 Nowra
N.S.W. Australia 2541
Re: GRAS Notice No. GRN 000026
Dear Dr. Pearce:
The Food and Drug Administration (FDA) is responding to the notice, dated June 30, 1999, that you 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 July 8, 1999 and designated it as GRAS Notice No. GRN 000026.
The subject of your notice is isolated wheat protein. The notice informs FDA of the view of the Manildra Group that isolated wheat protein is GRAS, through scientific procedures, for use as a food emulsifier, foam stabiliser, water retention agent, thickening and gelling agent, microencapsulation aid, film formation aid, adhesion aid and stretchability agent in powdered shortenings in baked goods, milk-like beverages, beverage whiteners, cheese analogues, manufactured meat and fish products, whole muscle cooked meats, soups, sauces and marinades, mousses and meringues, and edible films and coatings at a level of use ranging from 1 to 50 grams per kilogram.
The Manildra Group prepares isolated wheat protein from a commonly consumed food substance, i.e., wheat gluten (which is affirmed as GRAS as a direct human food ingredient, 21 CFR 184.1322). According to your notice, dietary exposure to isolated wheat protein at this use level would be substantially equivalent to the present dietary exposure of gluten and gluten derivatives.
The notice provides information about the identity, characterizing specifications, method of manufacture, and conditions of use of isolated wheat protein. In an electronic mail message dated November 25, 1999, you informed FDA of one additional specification for isolated wheat protein - i.e., a lead specification of less than 0.5 mg/kg.
The Office of Premarket Approval consulted with the Office of Food Labeling (OFL) regarding the Manildra Group's proposal to declare the presence of isolated wheat protein by the common or usual name "wheat protein." OFL advises that the proposed name "wheat protein" would sufficiently describe the ingredient and would alert consumers who are allergic to wheat to the presence of a wheat-derived ingredient.
Based on the information provided by Manildra Group, as well as other information available to FDA, the agency has no questions at this time regarding the Manildra Group's conclusion that isolated wheat protein is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of isolated wheat protein. As always, it is the continuing responsibility of the Manildra Group to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
FDA consulted with the Labeling and Additives Policy Division (LAPD) of the Food Safety and Inspection Service (FSIS), United States Department of Agriculture, regarding the use of isolated wheat protein in meat or meat-type products. With the exception of the implications of meat product standards, LAPD did not identify any concerns regarding the suitability of the intended use of isolated wheat protein in meat or meat-type products. LAPD requested that we advise you to seek regulatory guidance regarding whether the use of isolated wheat protein in meat or meat-type products requires rulemaking under the statutes that FSIS implements. You should direct your inquiry to Dr. Robert Post, Director, LAPD, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, 300 12th Street, SW, Room 602, Washington, DC 20250-3700. The telephone number for LAPD is (202) 205-0279 and the FAX number is (202) 205-3625.
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 Office of Premarket Approval's homepage on the World Wide Web.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
cc: Dr. Robert Post, Director, LAPD
Office of Policy, Program Development and Evaluation
Food Safety and Inspection Service
300 12th Street, SW, Room 602
Washington, DC 20250-3700