Agency Response Letter
GRAS Notice No. GRN 000084
Richard Lamb
Larex, Inc
4815 White Bear Parkway
White Bear Lake, MN 55110-3325
Re: GRAS Notice No. GRN 000084
Dear Mr. Lamb:
The Food and Drug Administration (FDA) is responding to the notice, dated September 5, 2001, 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); the GRAS proposal). FDA received the notice on September 6, 2001, and designated it as GRAS Notice No. GRN 000084.
The subject of the notice is arabinogalactan from the Eastern Larch tree (Larix laricina). The notice informs FDA of the view of Larex, Inc. (Larex) that arabinogalactan from the Eastern Larch tree (Eastern Larch) is GRAS, through scientific procedures, for use in foods in general, including meat and poultry products, for multiple technical effects in accordance with current good manufacturing practice. These technical effects include use as an emulsifier, formulation aid (including use as a binder), humectant, nutrient supplement, processing aid, stabilizer and thickener, synergist, and texturizer.
Larex describes generally available information about the identity and structure of arabinogalactan from Eastern Larch. Arabinogalactan (CAS Reg. No. 9036-66-2) is a polysaccharide that occurs naturally in the cell walls of higher plants and the wood of species of the genus Larix. It is composed of galactose and arabinose units consisting of a highly substituted backbone of 1-3 linked beta-D-galactopyranose units with side chains of galactose and arabinose.
Larex considers that arabinogalactan from Eastern Larch is chemically equivalent to arabinogalactan from the Western Larch tree (Western Larch). FDA has approved arabinogalactan from Western Larch for use as an emulsifier, stabilizer, binder or bodying agent in essential oils, non-nutritive sweeteners, flavor bases, nonstandardized dressings, and pudding mixes in the minimum quantity required to produce its intended technical effect (February 25, 1964, 30 FR 2430; 21 CFR 172.610). Within the context of a GRAS notice previously submitted by Larex (GRN 000047), FDA had no questions about Larex’s determination that arabinogalactan from Western Larch is GRAS for use as a multiple-use ingredient in foods, including meat products, with expected applications as an emulsifier, formulation aid (including use as a binder), humectant, nutrient supplement, processing aid, stabilizer, thickener, synergist, and texturizer in food categories such as baked goods and non-alcoholic beverages.
Arabinogalactan is manufactured from Eastern Larch logs. The butt cut of large Larch logs are debarked, split, and chipped. The resulting wood chips are then heated in a steam bin. The steamed chips are fed via a plug screw feeder, extracted, and fed through a hot water impregnator. A second plug screw feeder further extracts the arabinogalactan, which is then filtered with a screen to remove any cellulosic particles. Purified water is then added to the screened pressate. The extract is then further heated with steam before being sent through a pall separator. The permeate from this separation contains 7 percent arabinogalactan by weight. This dilute solution is then sent to an evaporator. The product of the evaporator contains 50-55 percent arabinogalactan, and is ready for drumming and shipping as either a food material or an industrial processing aid. A small quantity of potassium sorbate is added to some products at this time as a preservative. Depending upon the product being manufactured, this liquid product from the evaporator can be sent through an ion exchange step to further purify it before it is spray dried, or the liquid product can be decolorized, and further processed to reduce color, odor, and flavor. The decolorization is accomplished by treating the product with specified quantities of 45 percent potassium hydroxide and 35 percent hydrogen peroxide solutions; alternatively various concentrations of calcium hydroxide may be substituted for potassium hydroxide. After decolorization, the product is then cooled via cooling water. Following cooling, the concentration of the bulk arabinogalactan in solution is 35 percent. Depending upon the product being manufactured, this solution may enter one of several streams following decolorization and cooling: 1) it may be directly spray agglomerated; 2) it may be sent through a carbon filter followed by spray agglomeration; 3) it may be sent through a carbon filter and an ion exchange step prior to being spray agglomerated; or 4) it may go through an ion exchange step and a spray drying step and then be agglomerated.
Larex provides individual specifications for each of the various arabinogalactan products. The specification for the lead content of all arabinogalactan products is less than 0.1 milligram per kilogram (mg/kg). The specifications for individual products containing arabinogalactan from Eastern Larch mimic those for products containing arabinogalactan from Western Larch.
Larex 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. Larex predicts that persons who consume arabinogalactan as a dietary supplement would consume approximately 4.5 grams of arabinogalactan per day. Larex considers that the use of arabinogalactan from Eastern Larch would be a substitute for the use of arabinogalactan from Western Larch.
Larex incorporates GRN 000047 by reference to describe studies conducted with arabinogalactan from Western Larch. These include a published 30-day preliminary toxicity study in rats, published studies regarding the fermentation of arabinogalactan by human microflora, published studies regarding the utilization of arabinogalactan by growing pigs, an unpublished 6-month chronic toxicity study in beagle dogs, an unpublished 8-week feeding study in rats, and an unpublished bacterial mutagenicity assay.
Larex reports the results of studies conducted in animals and humans with arabinogalactan from Eastern Larch. Larex considers that the results of these studies demonstrate that the physiological effects of arabinogalactan from Eastern Larch are identical to those of arabinogalactan from Western Larch. These studies include an unpublished acute study in rats and an unpublished six-month, randomized, double-blind human trial to determine the long-term effects of ingestion of arabinogalactan on blood lipids, glucose, and insulin.
As part of its notice, Larex includes the report of a 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. Larex’s GRAS panel discusses the chemical equivalence of arabinogalactan from Eastern Larch and Western Larch and considers that the arabinogalactan produced by Larex from Eastern Larch and Western Larch are equivalent. Larex’s GRAS panel considers that arabinogalactan is a constituent of cell walls and that arabinogalactans have previously been consumed by humans in products such as maple syrup, carrots, tomatoes, soy beans, radishes, and wheat flour. Larex’s GRAS panel considers that arabinogalactan from Eastern Larch, which is manufactured by the Larex process in accordance with current good manufacturing practices and meets the specifications described, is GRAS for use in foods in the minimum quantity required to produce its intended technical effects.
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 Eastern Larch 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 Eastern Larch. 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.
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 homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Under section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FFDCA lays out the statutory framework for a health claim. In describing the intended use of arabinogalactan from Eastern Larch and in describing the information that Larex relies on to conclude that this ingredient is GRAS under the conditions of its intended use, Larex raises potential labeling issues under these provisions of the FFDCA. These labeling issues include the purported physiological effects of arabinogalactan from Eastern Larch, such as increasing the population of beneficial bacteria in the colon. If products that contain arabinogalactan bear any claims about such benefits on the label or in labeling, such claims would be the purview of the Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) in the Center for Food Safety and Applied Nutrition (CFSAN). The Office of Food Additive Safety (OFAS) neither consulted with ONPLDS on these potential labeling issues nor evaluated the information in your notice to determine whether it would support any claims made about arabinogalactan on the label or in labeling.
During its evaluation of GRN 000084, FDA consulted with the Labeling and Consumer Protection Staff of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture. FSIS advised that one of Larex’s commercial arabinogalactan products (i.e., L’Extra F 100) contains potassium sorbate as a preservative. FSIS pointed out that potassium sorbate is allowed as an external mold inhibitor for dried sausage, but is not otherwise allowed in meat and poultry products. However, FSIS has permitted the use of potassium sorbate in sauces that may be lawfully added to meat and poultry products. The small amount of potassium sorbate added to the meat or poultry as a result of the use of arabinogalactan as a binder would not be sufficient to have any technical effect on the meat or poultry. Consequently, FSIS would not object to the use of potassium sorbate as a preservative in arabinogalactan.
FSIS advised that binders are regulated under the Federal Meat Inspection Act based on efficacy of use in meat products, including standardized meat products. The Federal meat inspection regulations list specific binding additives for use below 3.5 percent of meat product formulation. FSIS has viewed the use of binders and extenders at levels greater than 3.5 percent as recharacterizing products. FSIS would not object to the use of arabinogalactan as a binder in various non-standardized meat and poultry products provided it does not exceed 3.5 percent of the product formulation. Currently, there are no allowances for the use of arabinogalactan as a binder in standardized meat and poultry products.
Under the tenets of the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients and additives in meat and poultry products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the additive in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product or one that misleads consumers. FSIS advised that Larex’s notice does not provide any data to support Larex’s assertion that arabinogalactan is suitable for use as a binder in meat and poultry products. Specifically, FSIS pointed out that Larex does not provide data establishing that arabinogalactan is being used at the lowest level necessary to achieve the intended functional effects in the specific meat and poultry products to which application is desired. FSIS requested that FDA advise Larex to seek regulatory guidance from FSIS, Labeling and Consumer Protection Staff, about the use of arabinogalactan in meat and poultry products. Larex should direct such an inquiry to Dr. Robert Post, Director, Labeling and Consumer Protection Staff, 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 of his office is (202) 205-0279 and the telefax number is (202)205-3625.
| Sincerely, /s/ Alan M. Rulis, Ph.D. Director Office of Food Additive Safety Center for Food Safety and Applied Nutrition |
| cc: | Dr. Robert Post, Director Labeling and Consumer Protection Staff Office of Policy, Program Development and Evaluation Food Safety and Inspection Service 300 12th Street, SW, Room 602 Washington, DC 20250-3700 |
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