Agency Response Letter GRAS Notice No. GRN 000430
CFSAN/Office of Food Additive Safety
March 6, 2013
Dr. Clyde Takeguchi
Phoenix Regulatory Associates, Ltd.
21525 Ridgetop Circle, Suite 240
Sterling, VA 20166
Re: GRAS Notice No. GRN 000430
Dear Dr. Takeguchi:
The Food and Drug Administration (FDA) is responding to the notice, dated May 1, 2012, that you submitted on behalf of Nordic Sugar A/S (Nordic Sugar) 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 May 2, 2012, filed it on May 15, 2012, and designated it as GRAS Notice No. GRN 000430.
The subject of the notice is sugar beet fiber. The notice informs FDA of the view of Nordic Sugar that sugar beet fiber is GRAS, through scientific procedures, for use in various non-standardized meat and poultry products as a binder and texturizing agent, in bakery products as a binder and source of fiber, in cereals and muesli as a texturizing agent and source of fiber, in sauces as a thickening agent, and in cheese as an anti-caking and/or dispersing agent.
Our use of "sugar beet 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.
Nordic Sugar describes the identity, composition and method of manufacture of sugar beet fiber. Nordic Sugar states that sugar beet fiber is produced from the pulp that remains following the aqueous extraction of sugar from sugar beets. The pulp is then mechanically pressed to remove the remaining water. The beet pulp is dried and milled to specific grades. Nordic Sugar states that the product meets the specifications in the monograph on sugar beet fiber in the Food Chemicals Codex. These include specifications for total fiber (not less than (NLT) 62%), soluble fiber (NLT 20%), ash (≤6.0%), loss on drying (not more than 10%), pH (between 4.0 and 5.0) and lead (≤1 milligram/kilogram).
Nordic Sugar provides an estimate of dietary exposure to sugar beet fiber based on a typical level of 1% in specified food categories. The mean exposure for the total population was estimated at 2.5 grams/person/day (g/p/d) and the 90th percentile at 5.5 g/p/d. For specific food groups, the use levels will be 1–5% for bread products, 1–10% for cereals and muesli and 1–5% for non-standardized meat and poultry products. Nordic Sugar notes that the estimate using a 1% level exceeds current total sugar beet fiber production by 70-fold. Nordic Sugar explains that the use of sugar beet fiber is self-limiting based on quality considerations and consumer acceptability of the taste and texture of the products.
Nordic Sugar describes published studies on sugar beet fiber that include absorption, distribution, metabolism and excretion studies, a sub-acute oral toxicity study, and several functional and application studies. Nordic Sugar describes the in vitro fermentation profile of sugar beet fiber by human fecal bacteria and fate of the metabolic products. Nordic Sugar concludes that sugar beet fiber is fermented rapidly and the end products of fermentation are short chain fatty acids. They further describe factors that affect the fermentability of sugar beet fiber including particle size, porosity, hydration properties, and monosaccharide composition. Nordic Sugar provides a summary statement for a pending GRAS affirmation petition (GRASP 2G0378), submitted by Delta Fibre Foods. Nordic Sugar summarizes information in GRASP 2G0378, reporting that when rats were fed 33% sugar beet fiber for 8 weeks or pigs were fed up to 30% sugar beet fiber in the diet, there were no safety concerns. Nordic Sugar also summarizes a published 4-week oral toxicity study conducted in male Wistar rats that were fed diets containing 0, 2.5, 5.0, or 10% sugar beet fiber. Nordic Sugar notes that no adverse effects or any differences in urinary, hematological, or serum parameters were observed. There was no reduction in food consumption, body weight, or in organ weights. The notifier states that sugar beet fiber levels up to 10% were well-tolerated. Nordic Sugar also summarizes the published literature on the clinical, physiological, and nutritional effects of sugar beet fiber in animals and humans. Nordic Sugar states that sugar beet fiber does not contain any known allergens and the vegetable proteins that it contains are safe to consume.
Standards of Identity
In the notice, Nordic Sugar states its intention to use sugar beet 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.
Potential Labeling Issues
In describing the effects of sugar beet fiber on LDL-cholesterol and triglycerides in the blood, increased stool bulk and laxation, and possible delayed glucose absorption and gastric emptying, Nordic Sugar raises potential issues under the labeling provisions of the Federal Food, Drug, and Cosmetic Act (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 sugar beet 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 sugar beet fiber on the label or in labeling.
Use in Products under USDA Jurisdiction
During its evaluation of GRN 000430, 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 advises that Nordic Sugar has provided sufficient data to support their assertion that sugar beet fiber is suitable as a binder and/or thickener in various non-standardized meat and poultry products. Therefore, FSIS would not object to the use of sugar beet fiber as a binder and/or thickener in various non-standardized comminuted meat and poultry products, provided that it does not exceed 5% of the product formulation. FSIS advises that the quantity of sugar beet fiber added to non-standardized meat and poultry products should not exceed the amount necessary to achieve the desired technical effect in that meat and poultry food product.
FSIS advises that binders are regulated under the Federal Meat Inspection Act based on efficacy of use in meat products, including standardized meat products. Currently, there are no allowances for the use of sugar beet fiber as a binder in standardized meat and poultry products.
With regard to labeling, FSIS does not permit the term “fiber” to be used as nomenclature for ingredients used in meat and poultry products. FSIS suggests “Sugar Beet Pulp,” “Sugar Beet Powder,” or "Sugar Beet Pulp Powder” as a suitable name for the ingredient.
FSIS requested that FDA advise Nordic Sugar to seek regulatory guidance from RIMD/OPPD/FSIS/USDA about the use of sugar beet fiber in meat and poultry products. Nordic Sugar should direct such an inquiry to William Shaw, Jr., Director, Risk, Innovations, and Management Division, Office of Policy and Program Development, Food Safety and Inspection Service, Stop Code 3782, Patriots Plaza III, 8-163A, 1400 Independence Ave., SW., Washington, DC 20250-3700.
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 Nordic Sugar’s notice that sugar beet fiber is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing sugar beet fiber. Accordingly, this response should not be construed to be a statement that foods that contain sugar beet fiber, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Nordic Sugar, as well as other information available to FDA, the agency has no questions at this time regarding Nordic Sugar’s conclusion that sugar beet 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 sugar beet fiber. As always, it is the continuing responsibility of Nordic Sugar 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 000430, 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, Cubicle 8-163A
1400 Independence Ave. SW
Washington, DC 20250-3700