Food

Agency Response Letter GRAS Notice No. GRN 000154

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CFSAN/Office of Food Additive Safety

December 13, 2004

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

Re: GRAS Notice No. GRN 000154

Dear Ms. McColl:

The Food and Drug Administration (FDA) is responding to the notice, dated June 15, 2004, 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 June 17, 2004, filed it on June 21, 2004, and designated it as GRAS Notice No. GRN 000154.

The subject of the notice is dried orange pulp. The notice informs FDA of the view of Fiberstar that dried orange pulp 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, such as frozen doughs, frozen meat products, frozen baked goods, frozen desserts, and frozen dairy products at a maximum use level up to 5 percent; for use as a flavor enhancing agent in non-carbonated beverages and fruit drinks at a maximum use level up to 2 percent; and for use as a moisture retention agent in processed meat and poultry products and in seasoning brines and solutions for meat and poultry products at maximum use level of 3 percent.

Fiberstar describes the identity, composition, and method of manufacture of dried orange pulp. Dried orange pulp is manufactured from orange juice pulp cells that have been washed, dewatered, sheared, stabilized/dried and ground to a particle size between 10 to 200 mesh. Fiberstar notes that no chemical extraction or treatment is involved in the manufacturing process, and that the product's final form is a yellowish light and fluffy powder. Fiberstar states that the dried orange pulp final product has a pH of 5.5 to 7.5. The product is 36 percent soluble fiber and 37.4 percent insoluble fiber for a total dietary fiber content of 73.4 percent. Fiberstar provides specifications for the manufactured product.

Fiberstar notes that dried orange pulp has self-limiting levels of use due to the high water-retention capacity of the product. When used above the self-limiting levels of use there is a loss of desirable eating qualities. Such limiting levels are 5 percent for baked goods, pastas, salad dressings, confectionery, processed cheese spreads, and frozen food entrees, such as frozen doughs, frozen meat products, frozen baked goods, frozen desserts, and frozen dairy products; 2 percent for non-carbonated beverages and juice drinks; and 3 percent for processed meat products and in seasoning brines and solutions for meat and poultry products.

Fiberstar estimates the current dietary intake of dried orange pulp consumed from fresh oranges and orange juice and then calculates the additional consumption of dried orange pulp from a proposed additional use. Based on published estimates of fresh orange and orange juice consumption, the annual consumption of pulp at 8 percent moisture per capita would be approximately 0.3 pounds (137 grams). Based on the amount of dried orange pulp that could be added to flour, Fiberstar estimates that approximately 63.7 million pounds of dried orange pulp as added to flour would be consumed per year, resulting in an additional annual per capita consumption of 0.219 pounds (99.4 grams).

Standards of Identity

In its notice, Fiberstar states its intention to use dried orange pulp in several food categories, including foods for which standards of identity exist (i.e., certain bakery products), 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. If Fiberstar has any questions about the use of dried orange pulp in standardized foods, other than meat or poultry products, that would be marketed in the United States, Fiberstar should contact the staff in the Office of Nutritional Products, Labeling and Dietary Supplements, Division of Standards and Labeling Regulations, HFS-820, 5100 Paint Branch Parkway, College Park, MD 20740. Fiberstar can reach this division by telephone at (301) 436-2371.

Use in Meat and Poultry Products

During its evaluation of GRN 000154, OFAS consulted with the Labeling and Consumer Protection Staff of the Food Safety and Inspection Service (FSIS) of USDA. Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat and poultry 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 Fiberstar has provided sufficient data to support their assertion that this ingredient is suitable as a moisture retention agent or as a binder in ground meat and poultry products. Therefore, FSIS would not object to the use of this ingredient as a binder in ground meat and poultry products provided it does not exceed 3.5 percent of the product formulation.

FSIS advises that binders are regulated under the Federal Meat Inspection Act based on efficacy of use in meat products, including standardized meat products. The Federal meat inspection regulations list specific binding additives for use below 3.5 percent of meat product formulation. FSIS has viewed the use of binders and extenders at levels greater than 3.5 percent as recharacterizing products. FSIS would not object to the use of dried orange pulp as a binder in various non-standardized meat and poultry products provided it does not exceed 3.5 percent of the product formulation. Currently, there are no allowances for the use of dried orange pulp as a binder in standardized meat and poultry products.

FSIS also advises that the ingredient will need to be declared on the labeling of meat and poultry products containing it as citrus flour or dried orange pulp.

FSIS requested that FDA advise Fiberstar to seek regulatory guidance from FSIS, Labeling and Consumer Protection staff, about the use of the ingredient in emulsified meat and emulsified poultry products. Fiberstar should direct such an inquiry to Dr. Robert Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program and Employee Development, Food Safety and Inspection Service, 1400 Independence Ave., S.W., Suite 602, Annex, Washington, DC 20250-3700. The telephone number for that office is (202) 205-0279 and the facsimile number is (202) 205-3625.

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 dried orange 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 orange 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, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).

Sincerely,
Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

cc: Dr. Robert Post, Director
Labeling and Consumer Protection Staff
Office of Policy, Program and Employee Development
Food Safety and Inspection Service
1400 Independence Ave., SW, Suite 602, Annex
Washington, DC 20250-3700

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