Agency Response Letter GRAS Notice No. GRN 000487
Diane B. McColl
Hyman, Phelps & McNamara, P.C.
700 Thirteenth Street, N.W.
Washington, DC 20005
Re: GRAS Notice No. GRN 000487
Dear Ms. McColl:
The Food and Drug Administration (FDA) is responding to the notice, dated September 5, 2013, that you submitted on behalf of Fiberstar, Inc. (Fiberstar) 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 9, 2013, filed it on October 28, 2013, and designated it as GRAS Notice No. GRN 000487.
The subject of the notice is dried citrus pulp. The notice informs FDA of the view of Fiberstar that dried citrus pulp is GRAS, through scientific procedures, for use as a moisture retention agent in baked goods, pastas, salad dressings, confectionery, processed cheese spreads, frozen food entrees, and comminuted and whole muscle meat and poultry products at a maximum level of 5%; and, as a flavor enhancer in non-carbonated beverages and fruit drinks; as seasoning in brine and in comminuted and whole muscle meat and poultry products, and as an ingredient in salads, sauces, meats, fillings, dips, baked goods, dairy products, fruit- and vegetable-based products, and pizza products at a maximum level of 5%.
Fiberstar provides information on the identity and composition of dried citrus pulp. Dried citrus pulp is a light yellow powder that is made from the following: juice cells, peels, rag or segment membranes, and cores from mandarin oranges (excluding bitter oranges), lemons, limes, grapefruits, and tangerines that have been dried, mechanically sheared, and ground. Fiberstar states that dried citrus pulp contains carbohydrates, fiber (total dietary, soluble, and insoluble), protein, and ash.
Fiberstar describes the method of manufacture for dried citrus pulp. Dried citrus pulp is manufactured by separating the fibrous material from the juice by squeezing and then washing the solids to remove sugars and oils. Further processing of the fibrous material includes shearing, heat-stabilization, and drying to a moisture content suitable for shelf life at ambient temperatures. The dried product is milled and packaged and then formulated into three commercial products. Fiberstar states that dried citrus pulp is produced in accordance with current good manufacturing practices for foods.
Fiberstar provides specifications for dried citrus pulp, including moisture content (<10%), particle size (>30%), and water-holding capacity (4-10.5 grams (g) water per g dry material). Specifications also include limits for lead (<0.5 milligrams per kilogram (kg)) and microbiological contaminants. Fiberstar provides analytical data from six batches (two batches for heavy metals) of dried citrus pulp to demonstrate compliance with these specifications. Fiberstar also provides batch data for the three formulations of dried citrus pulp to demonstrate stability for up to 30 months.
Fiberstar estimates the dietary exposure to dried citrus pulp using data from the National Health and Nutrition Examination Survey (NHANES, 2003-2008) and the National Center for Health Statistics (2007-2009). Based on these data, Fiberstar calculates the cumulative mean and 90th percentile dietary exposures to dried citrus pulp from all intended uses for the U. S. population ages 2+ years to be 0.4 g per kg body weight per day (g/kg bw/d) and 0.8 g/kg bw/d, respectively.
Fiberstar discusses data and information supporting the safety of dried citrus pulp. Fiberstar states that a thorough review of the publicly available scientific literature failed to reveal evidence of any adverse effects associated with consumption of dried citrus pulp. Fiberstar cites a published study in which male rats received 8 g/kg bw/d dried citrus pulp in the diet for 27 weeks. The results of this study showed that there were no adverse effects.
Fiberstar also discusses published data on the safety of flavonoids, which are components of dried citrus pulp. Fiberstar concludes that flavonoids are not anticipated to produce adverse effects at the estimated level of consumption of dried citrus pulp.
Based on the information summarized above, Fiberstar concludes that dried citrus pulp is GRAS for the intended uses in foods.
Standards of Identity
In the notice, Fiberstar states its intention to use dried citrus pulp 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 000487, 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 (FMIA), Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA), FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry, and egg products. 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 the consumer.
FSIS states that dried citrus pulp may be combined with other permissible food ingredients, e.g., guar gum, prior to addition to poultry or meat products and is intended to be used in both comminuted and whole muscle meat and poultry products at a level of up to 3.0% of total product formulation. Dried citrus pulp would act as a binder (moisture retention agent) and as a flavor enhancing agent. FSIS would not object to the use of dried citrus pulp in whole muscle meat and poultry products where binders are permitted at a level of up to 3.0% of total product formulation provided the ingredient is labeled in products in which it is used. FSIS states that dried citrus pulp may also be used in various ground meat and poultry products where binders are permitted, at a level of up to 3.0% of total product formulation provided the ingredient is labeled in the products in which it is used.
FSIS states that in order to qualify as a processing aid and not require listing on the ingredients statement of finished products, the ingredient must meet the definition of FDA' s 21 CFR 101.100(a)(3) (ii). FSIS states that Fiberstar did not provide sufficient information that supports their request for processing aid status that would not require labeling in meat and poultry products.
Regarding labeling, FSIS states that dried citrus pulp would be listed as "Citrus Flour" in the ingredients statement, and dried citrus pulp formulations would be listed as "Citrus Flour, [permissible food ingredient]". FSIS Directive 7120.1, "Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products," will be amended to include the aforementioned dried citrus pulp in the next scheduled revision. Please contact Ms. Rosalyn Murphy-Jenkins, Labeling and Program Delivery Division Staff, Office of Policy and Program Development (OPPD), FSIS, via telephone at (301) 504-0879 or via email at firstname.lastname@example.org if you have questions regarding labeling.
Any additional questions regarding regulatory guidance from FSIS should be directed to: Dr. William Shaw, Jr., Director, RIMS, OPPD, FSIS, 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 Fiberstar’s notice that dried citrus pulp is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing dried citrus pulp. Accordingly, this response should not be construed to be a statement that foods that contain dried citrus pulp, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Fiberstar, as well as other information available to FDA, the agency has no questions at this time regarding Fiberstar’s conclusion that dried citrus pulp 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 dried citrus pulp. As always, it is the continuing responsibility of Fiberstar 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 000487, 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