The U.S. Food and Drug Administration is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health. The FDA approves new animal drugs with requirements, including a specified time period to withdraw an animal from treatment prior to slaughter, to assure that a drug has been depleted from edible tissue to a level safe for humans. The order also prohibits the sale of milk until compliance is met.
The court order follows a civil complaint filed against the defendants on Sept. 19, 2006, based upon FDA's investigations into the dairies and their practices. The dairies produce milk for human consumption and sell dairy cows for slaughter for human consumption.
The injunction is based, in part, on five illegal residues in the edible tissue of three dairy cows sampled by the U.S. Department of Agriculture's Food Safety Inspection Service (FSIS) between August 2003 and September 2005. The drug residues found by FSIS included antibiotics such as sulfamethazine, sulfathiazole, sulfadimethoxine, and penicillin at levels not permitted by FDA. More recent FDA inspections confirmed that the dairies continued to use animal drugs in a manner contrary to the label directions, without the benefit of a veterinarian's oversight, and failed to maintain record-keeping systems to ensure that they did not sell milk or animals for slaughter for human food with illegal new drug residues.
Under the terms of the Aug. 8, 2007 order, the defendants must implement record-keeping systems to ensure that their use of drugs conforms to FDA regulations and that no milk or animals for slaughter for human food enters into interstate commerce with illegal new drug residues.
The defendants may only resume selling or delivering food—milk or animals for slaughter for human food—in interstate commerce after they are notified by FDA that they are in compliance with the terms of the order.