Food

Agency Response Letter GRAS Notice No. GRN 000487

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CFSAN/Office of Food Additive Safety

September 24, 2014

Diane B. McColl
Hyman, Phelps & McNamara, P.C.
700 Thirteenth Street, N.W.
Suite 1200
Washington, DC  20005

Re: GRAS Notice No. GRN 000487

Dear Ms. McColl:

This letter corrects our letter dated June 6, 2014, sent in response to GRAS Notice No. GRN 000487. The purpose of this revised letter is to correct information regarding the particle size and stability of the subject of the notice, and to clarify its use in products containing liquid, frozen, and dried whole egg products. Also, in this revised letter FDA uses the name citrus flour to be consistent with the name used by the United States Department of Agriculture.

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 citrus flour, also known as dried citrus pulp. The notice informs FDA of the view of Fiberstar that citrus flour is GRAS, through scientific procedures, for use as a moisture retention agent in baked goods, pastas, salad dressings, confectionery, processed cheese spreads, and frozen food entrees at a maximum level of 5%, and in comminuted and whole muscle meat and poultry products at a maximum level of 3%; as a flavor enhancer in non-carbonated beverages and fruit drinks at a maximum level of 2%; as seasoning in brine and in comminuted and whole muscle meat and poultry products at a maximum level of 3%; and as a formulation aid in salads, sauces, meats, fillings, dips, baked goods, dairy products, fruit- and vegetable-based products, and pizza products at a maximum level of 1%. When used as a moisture retention agent or a formulation aid, the citrus flour may be premixed with liquid, frozen, or dried whole egg products in amounts that result in no more than the maximum proposed levels in a finished product.

Fiberstar provides information on the identity and composition of citrus flour. Citrus flour 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 citrus flour contains carbohydrates, fiber (total dietary, soluble, and insoluble), protein, and ash.

Fiberstar describes the method of manufacture for citrus flour. Citrus flour 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 reduce the moisture content to that suitable for shelf life at ambient temperatures. The dried product is milled and packaged, then be formulated for use in different food categories. Fiberstar also states that citrus flour is produced in accordance with current good manufacturing practices for foods.

Fiberstar provides specifications for citrus flour, including moisture content (<10%), particle size (>90%, passes through 30 mesh sieve), and water-holding capacity (4-10.5 grams (g) water per g dry material). The specifications also include limits for lead (<0.5 milligrams per kilogram (mg/kg)) and microbiological contaminants. Fiberstar provides analytical data from six batches (two batches for lead) of citrus flour to demonstrate compliance with these specifications. Fiberstar also provides batch data for citrus flour to demonstrate stability for at least 36 months.

Fiberstar estimates the dietary exposure to citrus flour 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 citrus flour 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 citrus flour. Fiberstar cites a published study in which male rats received 8 g/kg bw/d of citrus flour in the diet for 27 weeks. Fiberstar states that no adverse effects were reported.

Fiberstar also discusses published data on the safety of flavonoids, which are components of citrus flour. Fiberstar states that the total flavonoid intake from the highest estimated intake (90th percentile per user) resulting from the intended food uses of citrus flour is 12.9 mg/kg bw/d. Fiberstar also discusses published studies on overall flavonoid consumption. Fiberstar states that the authors of these studies did not report any adverse events. Based on these studies, Fiberstar concludes that flavonoids will not produce adverse effects at the estimated level of consumption of citrus flour.

Based on the information summarized above, Fiberstar concludes that citrus flour is GRAS for the intended uses in foods.

Standards of Identity

In the notice, Fiberstar states its intention to use citrus flour 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 citrus flour may be combined with other permissible food ingredients, e.g., guar gum, prior to addition to meat or poultry 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. Citrus flour would act as a binder (moisture retention agent) and as a flavor enhancing agent. FSIS would not object to the use of citrus flour in whole muscle meat and poultry products where binders are permitted at a level of up to 3% of total product formulation provided the ingredient is labeled in products in which it is used. FSIS states that citrus flour may also be used in various comminuted meat and poultry products where binders are permitted, at a level of up to 3% 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 of citrus flour in meat and poultry products.

Regarding labeling, FSIS states that citrus flour would be listed as "Citrus Flour" in the ingredients statement, and citrus flour 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 citrus flour 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 rosalyn.murphy-jenkins@fsis.usda.gov 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 citrus flour is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing citrus flour. Accordingly, this response should not be construed to be a statement that foods that contain citrus flour, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

Conclusions

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 citrus flour 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 flour. 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.

Sincerely,

Michael A. Adams

Dennis M. Keefe, Ph.D. 
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

cc:  William K. Shaw Jr., Ph.D.
Director
USDA/FSIS/OPPD/RIMS
Stop Code 3782, Patriots Plaza III
1400 Independence Ave. SW
Washington, DC 20250-3700

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