Agency Response Letter GRAS Notice No. GRN 000599
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
February 17, 2016
Donald Schmitt, M.P.H.
739 Thornapple Drive
Naperville, IL 60540
Re: GRAS Notice No. GRN 000599
Dear Mr. Schmitt:
The Food and Drug Administration (FDA) is responding to the notice, dated September 3, 2015, that you submitted on behalf of Cargill, Inc. (Cargill) 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 4, 2015, filed it on September 11, 2015, and designated it as GRAS Notice No. GRN 000599.
The subject of the notice is citrus fiber. The notice informs FDA of Cargill’s view that citrus fiber is GRAS, through scientific procedures, for use as a texturizer and moisture retention agent in yogurt, low-fat mayonnaise, ice cream, ice pops, and sorbet at a maximum level of 4%, and in whole muscle and comminuted meat and poultry products and ready-to-eat (RTE) meat and poultry products at a maximum level of 5%.
As part of its notice, Cargill includes the report of a panel of individuals (Cargill’s GRAS panel) that evaluated the data and information that are the basis for Cargill’s GRAS determination. 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 evaluated information describing the identity and composition, manufacturing process and specifications, and estimated dietary exposure, as well as published studies supporting the safety of citrus fiber. Based on this review, Cargill’s GRAS panel concluded that citrus fiber produced in accordance with current good manufacturing practices (cGMP) that meets its established food grade specifications is GRAS under the conditions of its intended use.
Cargill provides information on the identity and composition of citrus fiber. Citrus fiber is a fine, white-colored powder that contains greater than 50% fiber (i.e., cellulose, hemicellulose, and pectin) obtained from the peels of lemons, limes, sweet oranges, and bitter oranges.
Cargill describes the method of manufacture for citrus fiber. The raw materials used in the production of citrus fiber are partially depectinized peels of lemons, limes, or oranges, which Cargill refers to as “spent peels.” Spent peels are first hydrated; any remaining seeds are removed and discarded. Cargill states that the hydrated spent peels may then be subjected to optional decolorization using sodium carbonate, sodium bisulfite, nitric acid, and a safe and suitable oxidizing agent. The spent peels are wet milled to reduce particle size and are then homogenized at high pressure. Homogenized citrus fiber is then subjected to several dissolution and precipitation steps using water and isopropanol. Sucrose is added to the wet precipitated citrus fiber and the mixture is then heated to remove isopropanol. The remaining solids are dried. The dried product is milled and the final product is classified by particle size. This final product is then blended with sucrose. Cargill states that all flavonoids are removed from citrus fiber when the pectin is removed from the peels and during subsequent precipitation and washing steps. Cargill states that citrus fiber is produced in accordance with cGMP for food ingredients.
Cargill provides specifications for citrus fiber that include a minimum content of fiber (≥ 50%), typical content of sucrose (25-40%), and limits on moisture (≤ 10%), isopropanol (≤ 0.3%), fat (≤ 0.5%), ash (≤ 5%), lead (≤ 1 milligram per kilogram (mg/kg)), arsenic (≤ 0.2 mg/kg), and microbial contaminants. Cargill also specifies that ≤ 10% of citrus fiber particles are >250 micrometers (μm) in size. Cargill provides the results of three batch analyses to demonstrate that citrus fiber meets these specifications.
Cargill provides an estimate of the dietary exposure to citrus fiber from the intended uses. Cargill used food consumption data from the National Health and Nutrition Examination Survey (NHANES, 2009-2010 and 2011-2012). Cargill reports that the estimated mean and 90th percentile dietary exposures (users-only) for the U.S. population, aged 2 years and older, are 6.40 grams per person per day (g/p/d) (0.11 g/kg body weight (bw)/d) and 9.76 g/p/d (0.18 g/kg bw/d), respectively. Cargill notes that citrus fiber will substitute for other citrus and dietary fibers used in the intended foods.
Cargill discusses data and information supporting the safety of citrus fiber. Cargill describes the long history of human consumption of citrus fibers through their presence in citrus fruits, and incorporates by reference the safety data for similar citrus fiber products provided in GRNs 000154, 000487, and 000541, which all resulted in “No questions” letters from FDA. The subjects of these previous notices are fibers (>70%) derived from either the peel and/or pulp of citrus fruits and are, therefore, similar to the fiber in the current notice. Additionally, Cargill reports that no recent studies raising new safety concerns related to citrus fiber consumption have appeared in the published literature subsequent to FDA’s evaluations of these notices. Cargill also cites published safety studies in previous GRAS notices describing the intended uses of dietary fibers from other sources, such as vegetable and grain-based fibers, and cellulose and modified-cellulose ingredients. Cargill considers that these studies further support the safety of citrus fiber consumption.
Based on the totality of the available data and information, Cargill concludes that citrus fiber is GRAS under the conditions of its intended use.
Standards of Identity
In the notice, Cargill states its intention to use citrus fiber in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. 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.
Products under USDA Jurisdiction
During its evaluation of GRN 000599, FDA consulted with the Risk, Innovations, and Management Staff (RIMS) of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). 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.
FSIS states that it does not object to the use of citrus fiber in meat and poultry products where binders are permitted. The Federal meat inspection regulations list specific binding additives for use below 3.5% of product formulation. In most cases, FSIS has viewed the use of binders and extenders at levels greater than 3.5% as re-characterizing products. Currently, the use of binders in standardized meat and poultry products are limited to a maximum of 3.5% of total product formulation with a few exceptions (e.g., meatloaf, meatballs, and chili). Therefore, FSIS has no objection to the use of citrus fiber used as a binder in various whole muscle and comminuted meat and poultry products and RTE meat and poultry products where binders are permitted at a level not exceeding the product’s standard of identity limits with a maximum of 5% of total product formulation.
Cargill indicates that citrus fiber is approximately 60-70% fiber, with the remainder being sucrose. Therefore, FSIS states that the product will need to be listed as “isolated citrus product,” which would also include the residual sucrose without the need to label it separately, since it does not contain a minimum of 85% dietary fiber based on the appropriate AOAC method of analysis.
Any additional questions regarding guidance from FSIS should be directed to: Valeria Jefferson, Deputy Director, RIMS, OPPD, FSIS, via email at Valeria.Jefferson@fsis.usda.gov.
Potential Labeling Issues
In describing the intended use of citrus fiber and in describing the information that Cargill relies on to conclude that citrus fiber is GRAS under the conditions of its intended use, Cargill raises a potential issue under the labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This issue consists of Cargill describing citrus fiber based on the percentage of fiber it contains. Under section 403(a) of the FD&C Act, a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FD&C Act lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-related condition. If products that contain citrus fiber bear any claims on the label or in labeling, such claims are the purview of the Office of Nutrition and Food Labeling (ONFL) in the Center for Food Safety and Applied Nutrition (CFSAN). The Office of Food Additive Safety (OFAS) neither consulted with ONFL on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about citrus fiber on the label or in labeling.
Section 301(ll) of the FD&C Act
Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, 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 citrus fiber is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing citrus fiber. Accordingly, this response should not be construed to be a statement that foods that contain citrus 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 citrus 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 citrus 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 000599, 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 at www.fda.gov/grasnoticeinventory .
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition