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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities: August–November 2008

FDA Veterinarian Newsletter 2008 Volume XXIII, No IV

Warning Letters

Jerald D. and Jeremy D. Visser, co-owners of Viacres LLC and Natural Milk, LLC, Sumas, WA, have received a Warning Letter for violations of the adulteration provision of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, the dairies sold three dairy cows for slaughter as food that were found to contain excess levels of the drug sulfadimethoxine in the edible tissues. In the first instance, an analysis of tissue samples revealed the presence of sulfadimethoxine at 6.47 parts per million (ppm) in the muscle tissue and 5.40 ppm in the liver tissue. In the second instance, the dairy cow in question was found to contain residues of the same drug in the muscle tissue at 7.73 ppm and in the liver tissue at 4.12 ppm. In the third instance, the dairy cow was found to contain sulfadimethoxine in the muscle tissue at 0.41 ppm and in the liver tissue at 0.42 ppm. FDA has established a tolerance of 0.1 ppm for residues of this drug in the edible tissues of cattle. In addition, the firms’ treatment records were found to be so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. The dairy operation failed to maintain complete treatment records, the Warning Letter said.

A Warning Letter has been issued to John E. Shrock, owner of a dairy farm in Middlefield, OH, for violations of the adulteration provision of the FFDCA. Specifically, Mr. Shrock sold a bob veal calf that was subsequently found to contain residues of the drug sulfamethazine in the liver tissue at 19.94 ppm and in the muscle tissue at 22.94 ppm. FDA has established a tolerance for this drug in the edible tissues of cattle at 0.1 ppm. Mr. Shrock was also found to have violated the extralabel use provision of the FFDCA and implementing regulations because the dairy operation did not use sulfamethazine as directed by its approved labeling.

Violations of the new animal drug provisions of the FFDCA were cited in a Warning Letter issued to Dr. Race L. Foster and Dr. Martin R. Smith, of Drs. Foster and Smith, Inc., of Rhinelander, WI. The two men marketed via the Internet such products as “Joint Care Primary 1,” “Joint Care Primary Plus 1,” “Joint Care-Advanced 2 with MSM,” “Joint Care Premium 3, “ “Joint Guard Treats,” and “Premium Plus Omega-3, Gel Caps.” Based on statements made on the company’s Web site, the products were found to be drugs under Section 201(g) of FFDCA and new animal drugs under Section 201(v) of FFDCA because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in dogs and cats without being the subject of approved new animal drug applications. Samples of the statements included, “help manage the crippling effects of osteoarthritis,” “work by actually healing the damage that has been done,” “builds cartilage,” “reduce pain,” “reduce the signs of feline arthritis,” “treat arthritis in dogs,” and “decrease inflammation in arthritic dogs and cats.”

FDA has issued a Warning Letter to Douglas L. Richards, a dairy farmer in Rome, NY, stating that he offered for sale an animal for slaughter as food that was adulterated. A U.S. Department of Agriculture Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal found levels of sulfamethazine at 9.58 ppm in liver tissue and 8.79 ppm in muscle tissue. FDA has not established a tolerance for residues of sulfamethazine in lactating dairy cattle. The presence of sulfamethazine in edible tissues from this animal in these amounts causes the food to be adulterated under FFDCA. The investigation also found that the animals were held under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Mr. Richards had failed to maintain complete treatment records, according to the Warning Letter. Food from such animals is considered adulterated under FFDCA. The letter also said that Mr. Richards administered a sulfa drug to the dairy cows as directed by approved labeling.

FDA has sent a Warning Letter to Rudolf P. DeJong, Jr., president, Red Arrow Dairy, LLC, Coopersville, MI, for sale of an animal for slaughter as food that was adulterated under FFDCA. An investigation revealed that Mr. DeJong sold a bob veal calf and told the buyer that it was intended to be raised as a steer by the purchaser, but did not tell the purchaser that it should not be slaughtered for use as food. The animal was subsequently slaughtered for use as food, and a USDA/FSIS inspection found 0.13 ppm penicillin in the kidney and 0.151 ppm flunixin in the liver. FDA has not set a tolerance for residues of those drugs in edible tissues of calves to be processed as veal. The presence of the residues in edible tissues causes food from the animal to be considered adulterated under FFDCA. The investigation also found that the animals were held under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Mr. DeJong had failed to maintain complete treatment records.

FDA has sent a Warning Letter to Paul W. Rothermel, owner, Paul Rothermel Livestock, Hartville, OH, because an investigation found that Mr. Rothermel sold an animal for slaughter as food that was adulterated under FFDCA. He had sold a bob veal calf as food that was adulterated. A USDA/FSIS analysis of tissue samples from the animal found the presence of flunixin at 0.425 ppm in liver tissues and 0.035 ppm in muscle tissue. FDA has not established a tolerance for residues of flunixin in edible tissues of calves. The presence of the drug in edible tissues from the animal in the amounts cited causes the food to be adulterated within the meaning of FFDCA. FDA’s investigation also found that Mr. Rothermel held animals under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The Warning Letter said his operation lacks a system to ensure that the animals he buys and sells for slaughter for food have not been medicated or have been properly withheld from slaughter long enough to deplete the potentially hazardous drug residues in edible tissue.

FDA has sent a Warning Letter to Andrew J. Miller, owner of a dairy operation in Big Prairie, OH, because an investigation found that he offered for sale an animal for slaughter as food that was adulterated under FFDCA. An investigation revealed that he had sold a bob veal calf for slaughter for food that a USDA/FSIS analysis revealed the presence of 26.27 ppm of penicillin in the muscle tissue, 0.86 ppm in the liver tissue, and 0.42 ppm in the kidney tissue. FDA has established a tolerance of 0.05 ppm residues of penicillin in edible tissues of cattle. The presence of this drug in edible tissues from the animal in amounts found causes the food to be adulterated within the meaning of FFDCA. In addition, the FDA investigation found that Mr. Miller held animals under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The letter said that Mr. Miller failed to maintain treatment records, failed to establish a system to control the administration of drug treatments to his animals, failed to establish an adequate inventory system for determining the quantities of drugs used to medicate the animals, and fed milk from treated cows to calves intended for slaughter. Food from such animals is considered adulterated.

FDA has sent a Warning Letter to Bradley D. Bouma, senior partner, Legacy Dairy Farms LP, Plainview, TX, because an investigation found that animals the dairy operation had offered for sale for slaughter as food were adulterated. The investigation revealed that the dairy operation sold a dairy cow for slaughter as food, and tissues from that animal that were tested by USDA/FSIS were found to have the presence of oxytetracycline at 14.30 ppm in the kidney tissue and the presence of flunixin at 0.184 ppm in the liver. The tolerance level set by FDA is 12 ppm for residues of oxytetracycline in the kidney of cattle and 125 parts per billion for residues of flunixin in the liver of cattle. Also, the Warning Letter said, the operation sold another dairy cow for slaughter as food that a USDA/FSIS analysis of tissue samples from the animal revealed that the tissue had flunixin at 3.427 ppm in the liver tissue. The presence of oxytetracycline and flunixin in edible tissues from these animals in these amounts causes the food to be adulterated under the FFDCA. The investigation also found that the dairy operation held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The operation, for example, failed to maintain complete treatment records. Food from animals held under such conditions is adulterated under the FFDCA. The investigation also found that the operation adulterated the new animal drug oxytetracycline, because the operation did not used it as directed by its approved labeling.