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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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American Nutrition, Inc 11-Sep-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Denver District Office
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000


September 11, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. William J. Behnken
CEO
American Nutrition, Inc.
2813 Wall Avenue
Ogden, Utah 84401

Ref. # - DEN-07-08 W L

Dear Mr. Behnken:

An inspection of your firm located at 2813 Wall Avenue, Ogden, Utah was conducted between April 19 and May 24, 2007, by the Food and Drug Administration (FDA). This inspection determined that your firm manufactures baked, dry extruded and canned pet food products under your own label, as well as under contract for various national pet food brands. These products are foods under section 201(f) [21 U.S.C. § 321(f)] of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection revealed that some of these pet foods are misbranded within the meaning of section 403(i)(2) [21 U.S.C. 343(i)(2)] of the Act because the products are fabricated from two or more ingredients and their labels fail to declare the common or usual name of each ingredient.

Our inspection found that your firm received rice protein concentrate from Wilbur-Ellis Company of Canada. In reviewing the formulations and labels of the products you manufactured, our investigators found that rice protein concentrate was used in the products but that many of the labels did not list it as an ingredient as required by section 403(i)(2) [21 U.S.C. 343(i)(2)] of the Act and Title 21, Code of Federal Regulations, sections 501.4(a) and 501.4(b) [21 C.F.R. 501.4(a) and 501.4(b)].

Specifically, your firm manufactures two pet foods for Canine Caviar Pet Foods, Inc. You admitted adding rice protein concentrate to Canine Caviar's Gourmet Turkey Canned Dog Food and Canine Caviar's Gourmet Beaver Canned Dog Food. However, the labeling does not declare the presence of rice protein concentrate in these products. Moreover, the front panel of the product labels specifically state that the products are "Grain and Gluten Free," and the side panels state that the products contain "No Rice."

Your firm also manufactures pet foods for the Blue Buffalo Company, Harmony Farms, Natural Balance, Mulligan Stew Pet Food, and Diamond Pet Foods, Inc. You admitted adding rice protein concentrate to foods manufactured for each of these companies. Specifically, your firm added rice protein concentrate to canned foods under the names Blue Buffalo Company, Harmony Farms, and Mulligan Stew Pet Food. The labels on these foods list brown rice as an ingredient, but do not list rice protein concentrate as an ingredient. Similarly, your firm added rice protein concentrate to one canned food product under the name Natural Balance that lists brown rice flour, but not rice protein concentrate, as an ingredient. Your firm also added rice protein concentrate to three Diamond Pet Foods, Inc. products. Two of these products list whole grain brown rice and white rice as ingredients. The third product lists rice flour as an ingredient. However, none of these three products lists rice protein concentrate as an ingredient.

Section 403(i)(2) [21 U.S.C. 343(i)(2)] of the Act states "[a] food shall be deemed misbranded. . . unless the label bears. . .in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient. . ." 21 C.F.R. 501.4(a) specifies that "ingredients. . . shall be listed by common or usual name in descending order of prominence. . .," and 21 C.F.R. 501.4(b) further clarifies that "[t]he name of an ingredient shall be a specific name and not a collective (generic) name. . ." The products to which your firm added rice protein concentrate all contain two or more ingredients, and rice protein concentrate is a specific and common name that does not fall under the names brown rice, whole. grain brown rice, brown rice flour, rice flour, or white rice.

This letter may not be an all inclusive list of violations at your facility. It is your responsibility to ensure that your establishment is in compliance with all requirements of the Federal Food, Drug and Cosmetic Act and all applicable regulations . Failure to promptly correct violations may result in regulatory action being initiated by the Food and Drug Administration without further notice, such as seizure and/or injunction.

You should notify this office in writing within fifteen (15) working days of receiving this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your reply should be sent to the Food and Drug Administration, Denver District Office, P.O. Box 25087, Denver, Colorado 80225-008, Attention: Regina A. Barrell, Compliance Officer. If you have any further questions, please feel free to contact Ms. Barrell at (303) 236-3043.

Sincerely,

/S/

B. Belinda Collins
District Director