Agency Response Letter GRAS Notice No. GRN 000344
CFSAN/Office of Food Additive Safety
May 23, 2011
15407 McGinty Road West
Wayzata, MN 55391
Re: GRAS Notice No. GRN 000344
Dear Ms. Kolberg:
The Food and Drug Administration (FDA) is responding to the notice, dated June 1, 2010, 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 June 14, 2010, filed it on June 22, 2010, and designated it as GRAS Notice No. GRN 000344.
The subject of the notice is barley fiber. The notice informs FDA of the view of Cargill, Inc. (Cargill) that barley fiber is GRAS, through scientific procedures, for use as a texturizer in sauces, soups, and gravies that may contain or be used with meat or poultry products.
Cargill previously submitted GRN 000207, for the use of barley fiber as an ingredient in food generally, except infant formula and meat and poultry products. In a letter dated December 19, 2006, FDA stated that the agency had no questions at that time about Cargill's determination that the intended uses described in GRN 000207 were GRAS. GRN 000344 includes the information submitted in GRN 000207 and also describes new information that has become publicly available since the submission of GRN 000207.
As part of its notice, Cargill includes the report of a panel of individuals (Cargill’s GRAS panel) who evaluated the data and information that are the basis for Cargill's GRAS determination, including the information contained in GRN 000207. Cargill considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Cargill's GRAS panel considered barley fiber’s identity, specifications, method of manufacture, estimated dietary intake, and various published studies on barley fiber. Based on this review, Cargill's GRAS panel concludes that barley fiber is GRAS, by scientific procedures, when used as an ingredient in certain meat and poultry products, at levels consistent with current good manufacturing practice.
Cargill describes the identity and method of manufacture of barley fiber, and provides information on its composition. Barley fiber is obtained from food grade barley by water extraction at an elevated temperature. Starch is removed during the extraction process by treatment with alpha-amylases that are safe and suitable for food use. The barley fiber is recovered by centrifugation after treatment with denatured food grade ethanol. The resulting fiber product has an average molecular weight of 50 to 400 kiloDaltons. Barley fiber is composed of about 91% carbohydrate, 3% protein, 3% inorganic salts, and less than 1% lipids. Cargill provides specifications for barley fiber including a specification for ≥70% beta-glucan.
In estimating the consumer intake of barley fiber, Cargill assumes that use levels of barley fiber are self-limiting for technological reasons. Excessive levels of barley fiber can alter flavor or texture. In most food applications, the concentration of barley fiber approaches a technically feasible maximum level of approximately 4.3 grams (g) of barley fiber per serving. Cargill estimates that the combined average intake of barley fiber by consumers from all uses of barley fiber in both GRN 000207 and GRN 000344 would be 12.4 g per day.1 Cargill estimates that barley fiber would be added at levels up to 4.3 g per serving, resulting in approximately 3 g of beta-glucan per serving.
Cargill concluded that there was no reason to conduct any classical absorption, disposition, metabolism and excretion studies since beta-glucan, the main component of barley fiber, is not digested by human digestive enzymes and its molecular size precludes absorption of significant amounts while passing through the small intestine. Nevertheless, in the notice Cargill described a number of published studies, including both those studies cited in GRN 000207 and studies published subsequent to FDA’s response to GRN 000207, to further support the safety of barley fiber and its constituent, beta-glucan. None of the studies cited by Cargill identified adverse reactions or toxicity correlated with beta-glucan exposure.
Cargill describes several published studies on barley derived beta-glucan and on barley fiber. Some of these studies show that beta-glucan, ingested with barley-based foods, is solubilized and extracted from the food matrix during the initial stages of digestion and then it is entirely utilized by the intestinal flora.
Use in Products under USDA Jurisdiction
During its evaluation of GRN 000344, FDA consulted with the Risk, Innovations, and Management Division of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture. Under the Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry, and egg products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient 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. Regarding suitability, FSIS has determined that Cargill has provided sufficient data to support their assertion that barley fiber is suitable as a texturizer in sauces, soups, and gravies. Data provided demonstrated that the addition of barley fiber enabled the final viscosity of sauces, soups, and gravies to increase, up to levels of 2.5%. Further, a summary was provided of the organoleptic testing done by the company. The summary stated that barley fiber containing products were found to be equivalent when compared against the control non-fiber formulations. Therefore, FSIS has no objection to the use of up to 2.5% barley fiber as a texturizer in sauces, soups, and gravies containing meat and poultry that are under FSIS jurisdiction.
FSIS does not permit the term "fiber" to be used as nomenclature for ingredients used in meat and poultry products because FDA has not yet defined the term fiber as it applies to ingredients and additives. FSIS suggests "isolated barley product" as a suitable name for this ingredient.
FSIS requested that FDA advise Cargill to seek regulatory guidance from FSIS, RIMD, about the use of barley fiber in meat products. Cargill should direct such an inquiry to Dr. William Shaw, Jr., Director, Risk, Innovations, and Management Division, Office of Policy and Program Development, Food Safety and Inspection Services, 5601 Sunnyside Ave., Mailstop 5272, Beltsville, MD 20705-5271.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the Federal Food, Drug, and Cosmetic Act (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 Cargill’s notice that barley fiber is GRAS under the intended conditions of use, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing barley fiber. Accordingly, this response should not be construed to be a statement that foods that contain barley fiber, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Cargill, as well as other information available to FDA, the agency has no questions at this time regarding Cargill’s conclusion that barley fiber 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 barley fiber. As always, it is the continuing responsibility of Cargill 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 000344, as well as a copy of the information in this notice that conforms to the information in the 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/grasnoticeinventory.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: William Shaw, Ph.D.
Risk, Innovations, and Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U.S. Department of Agriculture
George Washington Carver Center (GWCC)
5601 Sunnyside Avenue, Mailstop 5271
Beltsville, MD 20705-5271
1In GRN 000207, Cargill developed an exposure estimate using a number of food categories for which the firm considered the use of barley fiber most likely. Cargill subsequently revised this estimate to include the category of tomato-based sauces. The new “all uses” estimate provided in GRN 000344 encompasses both the new intended use in meat-containing soups, sauces, and gravies and the revised estimate of exposure from the intended uses described in GRN 000207.