Agency Response Letter GRAS Notice No. GRN 000427
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CFSAN/Office of Food Additive Safety
September 12, 2012
Robert S. McQuate, Ph.D.
GRAS Associates, LLC
20482 Jacklight Lane
Bend, OR 97702-3074
Re: GRAS Notice No. GRN 000427
Dear Dr. McQuate:
The Food and Drug Administration (FDA) is responding to the notice, dated March 5, 2012, that you submitted on behalf of Z Trim Holdings, Inc. (ZTH) 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 March 19, 2012, filed it on March 21, 2012, and designated it as GRAS Notice No. GRN 000427.
The subject of the notice is corn hull fiber. The notice informs FDA of the view of ZTH that corn hull fiber is GRAS, through scientific procedures, for use as a formulation aid and/or as a source of fiber in baked goods and cereal products; coatings and breading; dairy products; egg products; meat, poultry and seafood products; dressings and dips; sauces, soups, and gravies; snacks; and fillings, toppings, and icings, at levels ranging from 0.25 to 3.0%.
As part of its notice, ZTH includes the report of a panel of individuals (ZTH’s GRAS panel) who evaluated the data and information that are the basis for ZTH’s GRAS determination. ZTH considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. ZTH’s GRAS panel evaluated the method of manufacture, product specifications, estimates of dietary exposure as well as published studies. Based on this review, ZTH’s GRAS panel concluded that corn hull fiber that meets its established food grade specifications is GRAS under the conditions of its intended use.
ZTH describes the identity and composition of corn hull fiber. Corn hull fiber, obtained from corn bran, is an off-white powder that has a neutral taste and odor. Corn hull fiber contains 87-92% total dietary fiber, consisting of cellulose (49-52%), hemicellulose (22.5-37%) and lignin (maximum 0.2%).
ZTH discusses the method of manufacture for corn hull fiber. Corn hull fiber is made in accordance with current good manufacturing practices from the bran of the corn kernel. Corn hull fiber is unbleached to retain its natural off-white color. Corn bran is first hydrated using hot water to form a slurry. If necessary, the pH is adjusted with sodium hydroxide to reach a pH value ranging from 5 to 6. Following starch hydrolysis, a second addition of sodium hydroxide is made and the resulting mixture is then allowed to react until a designated viscosity is achieved. The mixture is then washed with hot water and the pH adjusted with citric acid to 6 to 7. The suspension is dried and milled. The moisture in the final product is tested to ensure that it is within product specifications.
ZTH provides specifications for food grade corn hull fiber. The specifications include target levels for total dietary fiber (87-92%) and limits for moisture (≤8%), ash (<3.5%), arsenic (<0.2 milligram per kilogram (mg/kg)), cadmium (<0.2 mg/kg), lead (<0.2 mg/kg), mercury (<0.2 mg/kg), and sodium (1500 mg/100 gram (g)). The microbial limits are: aerobic plate count (<1000 colony-forming units (cfu)/g), coliform (<10 cfu/g), yeast and mold (<100 cfu/g), Escherichia coli (<10 cfu/g), and Salmonella (negative/25g).
Based on FDA guidelines and USDA survey data, ZTH estimates a 90th percentile total consumption of 27 g per person per day (d) (450 mg/kg body weight (bw)/d) for their intended uses. ZTH considers this estimate to be an overestimate, given that the average consumer will likely consume corn hull fiber in some, but not all, of their daily fiber-based food selections.
ZTH discusses studies on corn hull fiber including the metabolism of fibers. Corn hull fiber is expected to be metabolized in a similar manner as other dietary fibers. Published clinical studies on corn hull fiber and corn bran, showed that corn hull fiber and corn bran consumed at levels up to 26 g of fiber a day for a time period of 4 weeks, showed no adverse effects.
Standards of Identity
In the notice, ZTH states its intention to use corn hull 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.
Use in Products under USDA Jurisdiction
During its evaluation of GRN 000427, FDA consulted with the Risk and Innovations Management Division 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 has determined that ZTH has provided sufficient data to support that corn hull fiber is suitable for use in ground, emulsified, and processed meat and poultry products as a binder, where binders are permitted, and as a texturizer. Therefore, FSIS would not object to the use of corn hull fiber as a binder in ground, emulsified, and processed meat and poultry products in which binders are permitted and as a texturizer, provided that it does not exceed 2% (notified level) of the product formulation.
FSIS also advised that the ingredient will need to be declared on the label of meat and poultry products containing it as “isolated corn bran product,” “corn bran product,” or “isolated corn product.”
FSIS requested that FDA advise ZTH to seek regulatory guidance from FSIS, Labeling and Program Delivery Division, about labeling the use of corn hull fiber in meat and poultry products. Any additional questions should be directed to Dr. William Shaw, Risk, Innovation, and Management Division, Office of Policy, Program, and Development, Food Safety and Inspection Service, via email at William.Shaw@fsis.usda.gov.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (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 ZTH’s notice that corn hull fiber is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing corn hull fiber. Accordingly, this response should not be construed to be a statement that foods that contain corn hull fiber, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by ZTH, as well as other information available to FDA, the agency has no questions at this time regarding ZTH’s conclusion that corn hull 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 corn hull fiber. As always, it is the continuing responsibility of ZTH 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 000427, 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
cc: William K. Shaw Jr., Ph.D.
Stop Code 3782, Patriots Plaza III
1400 Independence Ave. SW
Washington, DC 20250-3700