U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Food Additive Safety
March 20, 2003

Nancy J. Rachman, Ph.D.
Exponent
1730 Rhode Island Avenue, NW
Suite 1100
Washington, DC 20036

Re: GRAS Notice No. GRN 000116

Dear Dr. Rachman:

The Food and Drug Administration (FDA) is responding to the notice, dated September 6, 2002, that you submitted on behalf of Wm. Bolthouse Farms, Inc. (Bolthouse) 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 13, 2002, filed it on October 3, 2002, and designated it as GRAS Notice No. GRN 000116.

The subject of the notice is carrot fiber. The notice informs FDA of the view of Bolthouse that carrot fiber is GRAS, through scientific procedures, for use in baked goods as a texturizer at a maximum level of 5 percent by weight of flour, for use in meat substitutes (e.g., meatless sausages and meatless patties) at a maximum level of 5 percent, and for use in meat and poultry products as a binder/extender and to reduce water purging/gelling at a maximum level of 5 percent. The notice includes the findings of a panel of individuals who evaluated the data and information that are the basis for Bolthouse's GRAS determination. Bolthouse considers these individuals to be qualified by scientific training and experience to evaluate the safety of substances added to food.

Bolthouse describes the identity, composition, and method of manufacture of carrot fiber. Carrot fiber is manufactured from fresh carrots through a series of physical processes that renders a free flowing, bland tasting, off-white powder. Bolthouse notes that there is no chemical extraction or treatment involved, and that the final form of the ingredient is unbleached. Carrot fiber has a pH of 5.0 at 1 percent solution and is slightly soluble in water. On a dry solids basis, the ingredient is approximately 27 percent soluble fiber and 65 percent insoluble fiber (for a total dietary fiber content of approximately 92 percent). Bolthouse notes that carrot fiber has the ability to absorb at least 10 times its weight in water but only 4 times its weight in oil. Bolthouse provides specifications for the manufactured ingredient, including specifications for appearance and proximate composition.

Bolthouse notes that the use of carrot fiber is self-limiting in that use levels that exceed 5 percent of flour weight in bakery products or 5 percent in meat products result in poor texture and flavor that render the products undesirable to consumers. Bolthouse estimates dietary intake of carrot fiber using several methods and, thus, provides a range of estimated intakes. Based on per capita consumption of carrots, Bolthouse estimates that dietary intake of carrot fiber would be 0.3 grams/person/day (g/p/d) at the mean and 0.9 g/p/d at the 90th percentile. Based on the intake of carrot fiber in a single serving of franks/sausages or meat patties/canned meat, Bolthouse estimates that dietary intake of carrot fiber would be 2.5 grams/serving (g/s) for franks/sausages or 4.2 g/s for meat patties/canned meat.⁽¹⁾

Bolthouse discusses the historical consumption of carrots, both fresh and cooked, including the fiber portion. Bolthouse cites published articles that carrots, including their fiber, have been consumed for centuries.⁽²⁾

Standards of Identity

In the notice, Bolthouse states its intention to use carrot fiber 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 Bolthouse has any questions about the use of carrot fiber in standardized foods, other than meat or poultry products, that would be marketed in the United States, Bolthouse should contact the staff in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS), Division of Standards and Labeling Regulations, HFS-820, 5100 Paint Branch Parkway, College Park, MD 20740. Bolthouse can reach this division by telephone at (301) 436-2371.

Use in Meat and Poultry Products

During its evaluation of GRN 000116, FDA consulted with the Labeling and Consumer Protection Staff of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (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 Bolthouse has provided sufficient data to support their assertion that this ingredient is suitable as a binder in various comminuted meat and poultry products. Therefore, FSIS would not object to the use of this ingredient as a binder in various non-standardized comminuted meat and poultry products, provided that it does not exceed 3.5 percent of the product formulation.

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 re-characterizing products. The ingredient can be used at levels higher than 3.5 percent (not to exceed 5 percent) if the non-standardized comminuted meat and poultry products are appropriately named to reflect the presence of the ingredient (e.g., beef, water, and binder product). Currently, there are no allowances for the use of the ingredient as a binder in standardized meat products.

FSIS also advises that the ingredient will need to be declared on the labeling of meat and poultry products containing it as "isolated carrot product."

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

Conclusions

Based on the information provided by Bolthouse, as well as other information available to FDA, the agency has no questions at this time regarding Bolthouse's conclusion that carrot 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 carrot fiber. As always, it is the continuing responsibility of Bolthouse 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 Bolthouse's 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).

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

⁽¹⁾FDA does not concur with the methods used by Bolthouse to estimate dietary intake of carrot fiber. FDA's own estimate of the daily intake for carrot fiber under the conditions of use proposed by Bolthouse is 4 g/p/d at the mean and 7.5 g/p/d at the 90th percentile.

⁽²⁾FDA is aware of a publicly available database that lists the fiber content of carrots.