FDA Prevents Two Dairies From Adulterating Animal Drugs And Food

Main Category: Veterinary
Also Included In: Regulatory Affairs / Drug Approvals;  Nutrition / Diet
Article Date: 07 Jan 2009 - 6:00 PDT

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The U.S. Food and Drug Administration announced that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M.

FDA has cited the defendants on multiple occasions, most recently following inspections of the dairies from June 24 to July 1, 2008. During these inspections the FDA investigator noted that the defendants were not keeping adequate medication records to prevent unsafe drug residues in cattle offered for slaughter, that they failed to review treatment records prior to offering an animal for slaughter, and that they were using medications for unapproved indications not specified on the drug label. Although using drugs in this "extralabel" manner is legal with a valid veterinarian-client-patient relationship, the defendants did not have such a relationship.

FDA previously inspected Do-Rene Dairy on Feb. 1-5, 2005, and subsequently sent the owners a Warning Letter summarizing the deviations, which were similar to those found in the 2008 inspection. The letter informed the owners that a failure to correct all violations may result in enforcement action, including seizure or injunction.

In tissue samples collected since 2003, FDA determined that Do-Rene and Clover Knolls Dairies offered 12 animals for slaughter with illegal drug residues. The animals included dairy cows that tested positive for illegal levels of the drugs flunixin, penicillin, neomycin and sulfadimethoxine, a drug expressly prohibited from extra-label use in lactating cows. In addition, four bob veal calves tested positive for sulfamethoxazole. (Bob veal calves are calves less than 30 days old and may be as young as two days at slaughter.) These residues may cause allergic reactions in extremely sensitive individuals, and they may contribute to forming antibiotic-resistance in bacteria.

Under the terms of the consent decree, the defendants and their employees cannot introduce any adulterated food into commerce, use animal drugs in an "extralabel" manner without a valid veterinarian-client-patient relationship, or use drugs in animals in which such drugs are expressly forbidden. Failure to obey the terms of the consent decree could result in civil or criminal penalties.

U.S. Food and Drug Administration