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CFSAN/Office of Premarket Approval
June 6, 2000
Lee B. Dexter
Lee B. Dexter & Assoc.
15704 Webberville Rd.
Austin, TX 78724
Re: GRAS Notice No. GRN 000047
Dear Ms. Dexter:
The Food and Drug Administration (FDA) is responding to the notice, dated May 26, 2000, that you submitted on behalf of Larex, Inc. (Larex) 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 the notice on May 30, 2000 and designated it as GRAS Notice No. GRN 000047.
The subject of the notice is arabinogalactan from Larix occidentalis (also known as Western Larch). The notice informs FDA of the view of Larex that arabinogalactan is GRAS, through scientific procedures, for general use in food, including meat products. The notice incorporates by reference a notice dated October 15, 1998, that you previously submitted on behalf of Larex. FDA received that notice on March 11, 1999, and designated it as GRAS Notice No. GRN 000017. On December 15 and 16, 1999, FDA received supplemental information that you submitted regarding GRN 000017. In a letter dated April 6, 2000, you informed FDA that Larex was withdrawing GRN 000017 and intended to resubmit a GRAS notice for arabinogalactan with a revised estimate of dietary exposure and a revised set of specifications. On May 22, 2000, representatives of Larex presented a revised estimate of dietary exposure and set of specifications to representatives of the Office of Premarket Approval in FDA's Center for Food Safety and Applied Nutrition.
In GRN 000017, Larex describes (1) published information pertaining to arabinogalactan's chemical structure, (2) the manufacturing process for this food ingredient, including published information pertaining to arabinogalactan's water extractability from larch wood, (3) a published 30-day preliminary toxicity study conducted with arabinogalactan, (4) published studies regarding the fermentation of arabinogalactan by human microflora, (5) published studies regarding the utilization of arabinogalactan by growing pigs, (6) unpublished animal toxicity studies conducted with arabinogalactan, including a 6-month chronic toxicity study and an 8-week feeding study, and (7) an unpublished bacterial mutagenicity assay.
In GRN 000017, Larex provides a report of a specially convened panel of individuals (Larex's GRAS panel) who evaluated the data and information that are the basis for Larex's GRAS determination. Larex considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. In GRN 000017, Larex notes that FDA has previously approved arabinogalactan derived from Western larch wood for use as an emulsifier, stabilizer, binder, or bodying agent in essential oils, nonnutritive sweeteners, flavor bases, nonstandardized dressings, and pudding mixes in the minimum quantity required to produce its intended technical effect (21 CFR 172.610).
In GRN 000047, Larex (1) provides updated specifications for arabinogalactan, including a lead specification of less than 0.1 parts per million; (2) clarifies that the intended use of arabinogalactan is as a multiple-use ingredient in foods, including meat products, and identifies expected applications for arabinogalactan as an emulsifier, formulation aid, humectant, nutrient supplement, processing aid, stabilizer, thickener, synergist, and texturizer in food categories such as baked goods and non-alcoholic beverages; (3) estimates that the mean intake of arabinogalactan from its general use in food would be approximately 10.5 grams per person per day, and that the 90th percentile intake would be approximately 21 grams per person per day; and (4) provides information relevant to the cumulative dietary intake of arabinogalactan, i.e., that persons who consume arabinogalactan as a dietary supplement would consume approximately 4.5 grams of arabinogalactan per day.
Based on the information provided by Larex as well as other information available to FDA, the agency has no questions at this time regarding Larex's conclusion that arabinogalactan from Larix occidentalis 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 arabinogalactan from Larix occidentalis. As always, it is the continuing responsibility of Larex to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
During its evaluation of GRN 000017, OPA consulted with the Labeling and Additives Policy Division (LAPD) of the Food Safety and Inspection Service of the United States Department of Agriculture (FSIS) regarding the use of arabinogalactan as a binder and extender in meat products. FSIS advises that the Federal meat inspection regulations list specific binding additives for use below 3.5% of meat product formulation. FSIS also advises that it has viewed the use of binders and extenders at levels of greater than 3.5% as recharacterizing products, and as such, the product would no longer be considered a standardized traditional food. Based on the information submitted by Larex, FSIS concludes that arabinogalactan, when used at a level not to exceed 3.5% of the products, would be acceptable for binding and purge control in various meat and poultry products that are not subject to a standard of identity. Currently, there are no allowances for the use of arabinogalactan as a binder in standardized meat and poultry products. Therefore, FSIS would have to consider rulemaking to amend the Federal meat and poultry inspections regulations to permit such use. LAPD requested that FDA advise Larex to seek regulatory guidance from LAPD about the use of arabinogalactan in meat and poultry products. 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