Inspections, Compliance, Enforcement, and Criminal Investigations
Ever Cat Fuels, LLC 12/22/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
December 22, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 12 - 17
Larry C. McNeff
Ever Cat Fuels, LLC
617 Pierce Street, P.O. Box 665
Anoka, Minnesota 55303
Dear Mr. McNeff:
An inspection of your facility located at 100 Isanti Parkway NE, Isanti, Minnesota, was conducted by investigators from the Food and Drug Administration (FDA) and Minnesota Department of Agriculture (MDA) on February 22 and 25, 2011. The inspection followed a report made to FDA’s reportable food registry (RFR) regarding an animal feed product manufactured and distributed by your firm that you labeled as “Vegetable Bottoms.” Additional information was collected on February 23 and March 11, 2011, by inspection of (b)(4) , a marketing firm/commodity trader you worked with in the manufacture and marketing of this product.
This product was adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(2)(C)(i), in that it contains deodorizer distillates, a food additive that is unsafe within the meaning of section 409 of the Act, 21 U.S.C. § 348. The product was also misbranded under section 403(i) of the Act, 21 U.S.C. § 343(i), in that the product was fabricated from two or more ingredients but its label did not bear the common or usual name of each ingredient.
Any animal food ingredient that is not generally recognized as safe (GRAS) or subject to a prior sanction requires a food additive regulation promulgated under section 409 of the Act before it may be directly or indirectly added to food (see Title 21, Code of Federal Regulations (21 CFR), section 570.30(e)). Otherwise, the substance is an unsafe food additive within the meaning of section 409 of the Act. Food is adulterated under section 402(a)(2)(C)(i) of the Act if it is or bears or contains any food additive that is unsafe within the meaning of section 409 of the Act. There is no food additive regulation that authorizes the use of deodorizer distillates in animal food. We are not aware of any information to indicate that deodorizer distillates are the subject of a prior sanction. Furthermore, we are not aware of any basis to conclude that deodorizer distillates are GRAS for use in animal food. (See FDA’s regulation in 21 CFR 570.30 for a description of criteria for eligibility for classification of a food substance as GRAS.) Therefore, because “Vegetable Bottoms” contained deodorizer distillates, it was adulterated under section 402(a)(2)(C)(i) of the Act.
The product was also misbranded within the meaning of section 403(i) of the Act, 21 U.S.C. § 343(i). Under section 403(i) of the Act, a food shall be deemed misbranded unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient. “Vegetable Bottoms” is a multi-ingredient food and its label did not bear the common or usual name of each ingredient.
The introduction or delivery for introduction into interstate commerce of a food that is adulterated or misbranded, the adulteration or misbranding of any food in interstate commerce, and the receipt in interstate commerce of any food that is adulterated or misbranded and the delivery thereof for pay are prohibited acts within the meaning of section 301 of the Act, 21 U.S.C. § 331. You may find the Act and its implementing regulations through links on the internet at www.fda.gov.
We also note that section 415 of the Act, 21 U.S.C. § 350d, requires that all facilities engaged in the manufacture, processing, packing or holding of food for consumption in the United States register with the FDA. Our inspection determined that you have not registered your facility with FDA. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act, 21 U.S.C. § 331(dd).
We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates your corrections, if applicable. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
During the inspection discussed above, via Form FDA 483, your representative (Steven J. Rupp, Vice President) was advised of the registration requirement and the lack of controls in place to ensure that your products are suitable for use in animal feed. In a signed affidavit, dated February 25, 2011, Mr. Rupp stated that your firm is a biodiesel fuel manufacturer and does not plan to be in the feed business. He also stated that you do not plan to register with FDA as a food facility and that any products that you sell will be labeled as “Not for food or feed use.” In your written response to this Warning Letter, please address whether Mr. Rupp’s statements accurately describe your firm’s intentions and identify any additional actions you will take to prevent your distribution of misbranded or adulterated animal food in the future.
Failure to make prompt corrections may result in enforcement action, including seizure or injunction. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with the products manufactured by your facility. It is your responsibility to ensure that all animal feed or food products manufactured or distributed by your firm are in compliance with the Act and its implementing regulations. For example, it is your responsibility to ensure that the other ingredients in “Vegetable Bottoms” (e.g., “centrifuge dumping” and waste oil/free fatty acids) are approved food additives, subject to prior sanctions, or GRAS.
Your reply should be directed to Compliance Officer Timothy G. Philips at the address indicated in the letterhead. Mr. Philips may be reached at (612) 758-7133.
Elizabeth A. Waltrip