Agency Response Letter GRAS Notice No. GRN 000373
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CFSAN/Office of Food Additive Safety
August 19, 2011
Susan Cho, Ph.D.
6309 Morning Dew Court
Clarksville, MD 21029
Re: GRAS Notice No. GRN 000373
Dear Dr. Cho:
The Food and Drug Administration (FDA) is responding to the notice, dated February 23, 2011, that you submitted on behalf of CJ America, Inc. (CJ America) 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 February 25, 2011, filed it on February 28, 2011, and designated it as GRAS Notice No. GRN 000373.
The subject of the notice is rice bran fiber. The notice informs FDA of the view of CJ America that rice bran fiber is GRAS, through scientific procedures, for use as an ingredient in food, excluding meat and poultry, at levels consistent with current good manufacturing practice.
Our use of “rice bran fiber” 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. Title 21 CFR 101.4 states that each ingredient must be declared by its 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 Nutrition, Labeling, and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition.
As part of its notice, CJ America includes the report of a panel of individuals (CJ America’s GRAS panel) who evaluated the data and information that are the basis for CJ America’s GRAS determination. CJ America considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. CJ America’s GRAS panel evaluated estimates of dietary exposure, method of manufacture, and product specifications as well as published studies. Based on this review, CJ America’s GRAS panel concluded that rice bran fiber meeting its established food grade specifications is GRAS under the conditions of its intended use.
CJ America provides information about the identity and composition of rice bran fiber. Rice bran fiber is a fine, cream-colored powder with a particle size of < 100 microns. CJ America states that rice bran fiber is a beta-linked fiber, composed of glucose (42.3%), lignin (26.9%), arabinose (11.5%), xylose (11.5%), mannose (3.8%), and galactose (3.8%). CJ America notes that rice bran fiber has ≥ 40% total dietary fiber (TDF), with ≥ 90% as insoluble dietary fiber.
CJ America provides information about the method of manufacture of rice bran fiber from defatted rice bran. Defatted rice bran is mechanically cleaned to separate rice bran from rice fragments and to remove any residual impurities. The defatted rice bran is suspended in water and the pH adjusted with sodium hydroxide to extract rice protein and starch. Rice bran fiber is then separated from the aqueous solution and washed with water to neutralize the pH. The separated rice bran fiber is dried and roasted to control microbes. After cooling, rice bran fiber is pulverized, packaged, and stored at room temperature. CJ America states that rice bran fiber is produced under current good manufacturing practice.
CJ America provides specifications for rice bran fiber. Specifications include target levels for TDF (> 40%), moisture (< 8%), protein (< 15%), and fat (1.5%). The limits for heavy metals are: lead (< 1 milligram per kilogram (mg/kg)) and arsenic (< 1 mg/kg). The microbial limits are: yeast and mold (< 200 colony forming units/gram (cfu/g)), E. coli (negative cfu/g), and Salmonella (negative cfu/g).
CJ America discusses a potential estimate of dietary intake for rice bran fiber. CJ America states that rice bran fiber will be used as a replacement for conventional fiber products, and is unlikely to significantly increase fiber intake in Americans. CJ America notes that the Institute of Medicine recommends a daily intake of 14 g per 1,000 calories for Americans. The 2003-2006 National Health and Nutrition Examination Survey shows an average estimated daily intake of 14.8 g/day (d), which is approximately one half the daily recommended intake for fiber. Based on the recommended daily intake for fiber, CJ America states that the consumption of rice bran fiber will not exceed 25-28 g/d.
CJ America discusses published safety data on rice bran fiber including metabolism, mutagenicity, carcinogenicity, and human clinical studies. CJ America states that rice bran fiber, like other beta-linked fibers, is not digested by brush border or human pancreatic enzymes and is not expected to be absorbed intact. Rice bran fiber is not hydrolyzed by human alimentary enzymes, but is fermented by the colonic microflora to short chain fatty acids (e.g., acetate, propionate, butyrate) that can be used as a caloric source by the intestinal microflora. CJ America states that published human clinical studies showed no adverse effects when administered a maximum dose of 28 g/d of rice bran fiber for 6 weeks.
To corroborate the safety of rice bran fiber, CJ America discusses toxicity, mutagenicity, genotoxicity, carcinogenicity, and human clinical studies of other fibers (e.g., rice bran, brown rice, wild brown rice, wheat bran, buckwheat, purified cellulose, and other cereal brans) having similar composition to rice bran fiber. The results of these studies indicated no adverse effects.
CJ America discusses the allergenic potential of rice bran fiber. Based on CJ America’s submission, there have been no known reports of allergenicity with rice bran or rice bran fiber. Additionally, in support of the non-allergenicity of rice bran fiber, extracts of pigmented black rice brans were shown to inhibit proinflammatory cytokine expression in vitro. CJ America concludes that there are no safety concerns for the use of rice bran fiber.
Standards of Identity
In the notice, CJ America states its intention to use rice bran fiber in several food categories, including foods for which standards of identity exist, located in Title 21 of the CFR. 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.
Potential Labeling Issues
In describing antioxidant effects of rice bran fiber, CJ America raises potential issues under the labeling provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 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 rice bran fiber bear any claims on the label or in labeling, such claims are the purview of ONLDS. The Office of Food Additive Safety neither consulted with ONLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about rice bran fiber on the label or in labeling.
Section 301(ll) of the FD&C Act
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FD&C Act to, among other things, add section 301(ll). 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 CJ America’s notice that rice bran fiber is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing rice bran fiber. Accordingly, this response should not be construed to be a statement that foods that contain rice bran fiber, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by CJ America, as well as other information available to FDA, the agency has no questions at this time regarding CJ America’s conclusion that rice bran 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 rice bran fiber. As always, it is the continuing responsibility of CJ America 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 000373, 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.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition