FDA Takes Action Against Maryland Veal Calf Dealer

Main Category: Litigation / Medical Malpractice
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Nov 2009 - 4:00 PDT

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The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.

The complaint, filed Nov. 13, 2009, in the U.S. District Court for the District of Maryland, also alleges that Mr. Nickle caused drugs to become adulterated while held for sale after shipment in interstate commerce, used animal drugs in an "extralabel" manner without a valid veterinarian-client-patient relationship, and used drugs in animals in which such drugs are expressly forbidden.

Mr. Nickle is a dealer and hauler of calves and the sole owner and employee of a private unincorporated business. He buys and sells more than 1,200 calves a year for human consumption. The complaint is based, in part, on illegal flunixin drug residues in the edible tissue of Mr. Nickle's veal calves sampled by the U.S. Department of Agriculture.

Flunixin is a non-steroidal anti-inflammatory drug approved for injection into cattle to control abnormal rise in body temperature associated with bovine respiratory disease and endotoxemia. It also is indicated for the control of inflammation in endotoxemia.

The sale of animals for human food that may contain illegal levels of drugs is a concern because of the potential for adverse effects on human health. The FDA requirements for animal drugs include a specified time to withdraw an animal from treatment prior to slaughter, so that a drug is depleted from edible tissue to levels safe for humans.

Mr. Nickle has a long history with both the FDA and the USDA. He has received numerous oral and written warnings from both agencies. Most recently, the FDA conducted an inspection of Mr. Nickle's operations between February and April of 2009. In June 2004, the FDA issued a warning letter to Mr. Nickle. Despite these warnings, Mr. Nickle failed to comply with the law.

Source
U.S. Food and Drug Administration

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