Agency Response Letter GRAS Notice No. GRN 000211
CFSAN/Office of Food Additive Safety
April 11, 2007
George A. Burdock, Ph.D.
888 Seventeenth St., NW, Suite 810
Washington, DC 20006
Re: GRAS Notice No. GRN 000211
Dear Dr. Burdock:
The Food and Drug Administration (FDA) is responding to the notice, dated August 21, 2006, that you submitted on behalf of CP Kelco (Kelco) 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 August 24, 2006, filed it on August 30, 2006, and designated it as GRAS Notice No. GRN 000211.
The subject of the notice is xanthan gum (reduced pyruvate). The notice informs FDA of the view of Kelco that xanthan gum (reduced pyruvate) is GRAS, through scientific procedures, for use in foods in general, except in meat and poultry, as a stabilizer, emulsifier, thickener, suspending and bodying agent, and foam enhancer. For the purpose of this letter, FDA refers to the xanthan gum variant that is the subject of GRN 000211 as XGRP.
Our use of "xanthan gum (reduced pyruvate) or XGRP" 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. 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 the Center for Food Safety and Applied Nutrition.
As part of its notice, Kelco includes the report of a panel of individuals (Kelco's GRAS panel) who evaluated the data and information that are the basis for Kelco's GRAS determination. Kelco considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Kelco's GRAS panel report states that the lower pyruvate levels in XGRP compared with xanthan gum do not affect safety based on a comprehensive search of the scientific literature for safety and toxicity information on xanthan gum and related compounds. Based on this review, Kelco's GRAS panel concluded that the intended use of XGRP is GRAS according to scientific procedures. Kelco's GRAS panel also noted xanthan gum is an approved food additive, listed under section 172.695 in Title 21 of the Code of Federal Regulations (21 CFR 172.695).
The notice provides information about the chemical identity and properties of XGRP. XGRP is a high-molecular-weight extracellular polysaccharide gum comparable to xanthan gum, with the exception that XGRP contains less than 1.5% pyruvate. XGRP is produced by a pure-culture fermentation of a carbohydrate with a strain (ATCC 31313) of the bacterium Xanthomas campestris that is nontoxigenic and nonpathogenic to humans and animals. The notice states that the primary structure of XGRP is identical to that of xanthan gum with the exception of a reduced percentage of pyruvate groups contained in the polysaccharide molecule. The notice discusses the similarity of the two substances with respect to chemical characteristics and the manufacturing process. The notice states that the decreased pyruvate concentration of XGRP alters its pseudoplastic characteristics, making it more free flowing on application, but more viscous when stationary. The notice also states that this alteration of pseudoplastic characteristics is highly desirable in liquid food systems.
The notice considers that XGRP is a normal variant found in the production of xanthan gum and, as such, studies on xanthan gum may be reviewed for a safety determination of XGRP for its intended use. Published studies show that it passes through the digestive system relatively unchanged, and is not a macroconstituent of the diet, nor does it add nutritive value to the diet. The notice maintains that the lowering of pyruvate on the molecule would not affect the lack of digestibility of xanthan gum and its exclusive excretion in the feces unchanged. The notice includes published information to show that pyruvate is not an essential nutrient and concludes that lack of pyruvate is not associated with a deficiency state.
The notice discusses published animal and human studies conducted with xanthan gum. These studies include a two year feeding study in rats and dogs, a three generation reproduction study in rats, and feeding studies of up to 23 days in humans. No adverse effects were noted. Kelco concludes that in the unlikely event that XGRP replaces all currently used commercial xanthan gum for various food applications, XGRP would be consumed at a level of approximately 15 mg/kg/day, less than a tenth of the level of xanthan gum that is well tolerated in human clinical studies.
Standards of Identity
In the notice, Kelco states its intention to use XGRP in foods, except in meat and poultry, provided that food standards of identity, located in Title 21 of the Code of Federal Regulations do not preclude such use. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Kelco notes that xanthan gum is approved as a food additive for use as a stabilizer, emulsifier, thickener, suspending agent, bodying agent, and foam enhancer in foods (21 CFR 172.695). Under 21 CFR 172.695, xanthan gum must meet a specification for pyruvate content of greater than 1.5% measured as pyruvic acid. FDA notes that XGRP does not comply with 21 CFR 172.695, because Kelco describes XGRP as being a variant of xanthan gum with less than 1.5% pyruvate content. In order for XGRP to comply with 21 CFR 172.695, that food additive regulation would have to be amended to include XGRP. If Kelco wishes to submit a food additive petition to amend 21 CFR 172.695, the firm should contact the Division of Petition Review (HFS-265), Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. This division can be reached by telephone at (301) 436-1267.
Based on the information provided by Kelco, as well as other information available to FDA, the agency has no questions at this time regarding Kelco's conclusion that XGRP 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 XGRP. As always, it is the continuing responsibility of Kelco 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 GRN 000211, 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 on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition