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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities - December 2007 and January 2008

FDA Veterinarian Newsletter 2007 Volume XXII, No VI

Warning Letters

FDA has issued a WARNING LETTER to John Visser, owner of the Visser Ranch, Strathmore, CA, for violations of the adulteration provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, Mr. Visser sold a bob veal calf for slaughter as human food that, upon inspection by the U.S. Department of Agriculture (USDA), was found to contain residues of the drug neomycin in the kidney tissue at 14.95 parts per million (ppm) and sulfamethoxazole in the liver tis-sue at 0.91 ppm and in the muscle tissue at 0.58 ppm. A tolerance of 7.2 ppm has been established for residues of neo-mycin in the kidney tissue (21 CFR 556.430); no tolerance has been established for residues of sulfamethoxazole in the edible tissues of cattle. The presence of these drugs at the levels indicated rendered the animal adulterated under Section 402(a) of the FFDCA. In addition, other drugs at the Visser ranch were not used in conformance with their approved label-ing with respect to extralabel use parameters set forth in Section 512(a) of the FFDCA and 21 CFR Part 530.

A WARNING LETTER has been issued to William J. Behnken, CEO of American Nutrition, Inc., of Ogden, UT, for viola-tions of the misbranding provisions of the FFDCA. Specifically, an FDA inspection revealed that some of the baked, dry extruded, and canned pet food products manufactured by the firm under its own label are in violation of Section 403(i) of the FFDCA because they are made from two or more ingredients and their labels fail to declare the common or usual name of each ingredient. At issue was the addition of rice protein concentrate to certain dog food products. This ingredi-ent, however, is mentioned in the label, yet the label did not state “Grain and Gluten Free” and “No Rice.” Other pet food products made by the firm had similar labeling violations.

Violations of the adulteration provisions of the FFDCA were cited in a WARNING LETTER issued to Que Fullmer, owner of Fullmer Cattle Company New Mexico LLC of Muleshoe, TX. This cattle raising operation, which is actually lo-cated in New Mexico, offered animals for sale as food that were adulterated pursuant to Section 402(a) of the FFDCA. Two veal calves were found with the drug neomycin in the kidney tissue at 337.12 ppm, 1.28 ppm in the muscle tissue, sulfadimethoxine in the liver tissue at 0.49 ppm, and sulfadimethoxine in the muscle tissue at 0.60 ppm. A tolerance of 7.2 ppm has been established for residues of neomycin in the uncooked edible kidney tissue of cattle and 1.2 ppm in the un-cooked edible muscle tissues of cattle as codified in 21 CFR 560.430. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in 21 CFR 560.620. The firm was also cited for failing to maintain treatment records and failing to segregate treated animals to ensure that drugs had been used only as directed and that appropriate withdrawal times had been observed prior to offering an animal for slaughter for hu-man food.

Dennis D. Luce, owner of 4D Cattle, Fort Sumner, NM, has received a WARNING LETTER from FDA for violations of the adulteration provisions of the FFDCA. Specifically, the firm offered a Holstein steer for sale as food that contained 18.6 ppm tilmicosin in the liver tissue and 7.5 ppm of the drug in the muscle tissue. In addition, the USDA inspection also revealed the presence of phenylbutazone in the kidney tissue of the animal. FDA has set a tolerance for tilmicosin at 1.2 ppm in the liver tissue of cattle and 0.1 ppm in the muscle tissue of cattle (21 CFR 556.735). No tolerance has been es-tablished for residues of phenylbutazone in the edible tissues of cattle. The presence of these levels of these drugs ren-dered the animal adulterated under Section 402(a) of the FFDCA. In addition, the WARNING LETTER cited the firm for violation of the safety provision of Section 512(a) of the FFDCA and the adulteration provisions of Section 501(a)(5) of the FFDCA.

FDA issued a WARNING LETTER to Jerry A. Settles, majority owner and partner of the Del Oro Dairy, Anthony, NM, for violations of the adulteration provisions of the FFDCA. Specifically, the firm offered for sale as food a Holstein dairy cow that was found to contain 8.99 ppm sulfadimethoxine in the muscle tissue and 11.8 ppm of the drug in the liver tissue. FDA has set a tolerance of this drug at 0.1 ppm in the edible tissues of cattle (21 CFR 556.640). Exceeding the tolerances constituted a violation of Section 402(a). In addition, the firm was found to lack an adequate system to ensure that animals medicated by it have been withheld from slaughter for appropriate periods of time to permit depletion of potentially haz-ardous residues of drugs from edible tissues. For example, the firm failed to maintain and review complete treatment re-cords and it lacked an adequate inventory system for determining the quantities of drugs used to medicate its animals.

Jason Flores, owner of the Dan Dee Dairy, LLC, in Dexter, NM, also received a WARNING LETTER from FDA for viola-tions of Section 402(a) of the FFDCA. The firm sold a dairy cow for slaughter as food that contained the drug flunixin at 1.06 ppm in the liver tissue of the animal. FDA has set a tolerance for flunixin at 0.125 ppm in such tissue (21 CFR 556.286). In addition, the firm adulterated flunixin within the meaning of section 501(a) of the FFDCA when it failed to use the drug in conformance with the approved labeling. Extralabel use is permitted only if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship and in compliance with the requirements of 21 CFR Part 530. The firm administered flunixin without following the withdrawal period set forth in the approved labeling and did so without the supervision of a licensed veterinarian, in violation of 21 CFR Part 530. Because the extralabel use of this drug did not comply, the drug was unsafe under section 512(a) of the FFDCA and adulterated within the meaning of section 501(a).

Daniel VanGrouw and Sam Adams, owner and manger, respectively, of the Simco Dairy in Boise, ID, have received a WARNING LETTER from FDA for violations of the adulteration provisions of the FFDCA involving four cows. Specifically, the dairy sold a cow for slaughter as food that was found to have residues of penicillin at 1.36 ppm in the kidney and 0.07 ppm in the liver. A second cow contained residues of penicillin at 0.29 ppm in the kidney, and a third cow contained peni-cillin residues of 1.34 ppm in the kidney and 0.09 ppm in the liver. A tolerance of 0.05 ppm has been established by FDA for residues of this drug in the uncooked edible tissues of cattle (21 CFR 556.510). A fourth cow contained residues of the drug flunixin at 0.163 ppm in the liver. FDA has set a tolerance of 0.125 ppm for flunixin in the liver tissue of cattle (21 CFR 556.286(b)(1)(i)). Violations of FDA’s extralabel use provisions for drugs were also cited in the WARNING LETTER.

A WARNING LETTER was issued by FDA to Donald J. Moisan, owner of the Moisan Dairy, Salem, OR, for violations of the adulteration provisions of the FFDCA. Specifically, an animal was offered for slaughter as food that contained residues of the drug sulfadimethoxine in the liver tissue at 7.27 ppm and in the muscle tissue at 1.60 ppm. The kidney tissue was found to contain residues of penicillin at 2.22 ppm. A tolerance of 0.1 ppm has been established for residues of sulfadi-methoxine (21 CFR 556.640(b)(1)) in the uncooked edible tissues of cattle, and a tolerance of 0.05 ppm has been estab-lished for residues of penicillin in the uncooked edible tissues of cattle (21 CFR 556.510(a)). The excess drug levels ren-dered the food adulterated under Section 402(a) of the FFDCA. Among other violations, the firm was also found to have provided a false guaranty in violation of Section 301(h) of the FFDCA.

Recalls

A Class I firm-initiated recall is ongoing by Hartz Mountain Corp., Secaucus, NJ, for 2,772 bottles (231 cases) Hartz Vi-tamin Care for Cats and Kittens distributed nationwide. Surveillance samples collected and analyzed by FDA tested posi-tive for Salmonella.

PetEdge, Inc., of Beverly, MA, is carrying out a Class II firm-initiated recall of 25,440 units of its Top Performance ProDental Toothpaste that was marketed nationally and internationally. The reason for the recall is that the toothpaste, which was manufactured in mainland China, was contaminated with diethylene glycol.

A Class II firm-initiated recall of 2,168 cases of cat food under the “Lick Your Chops Healthy Pet Food” label has been completed by Menu Foods, Inc., of Pennsauken, NJ. The products, which were distributed in Pennsylvania and Canada may contain “non-protein nitrogen compounds.”

Sergeant’s Pet Cat Products, Inc., of Omaha, NE, is conducting a Class III firm-initiated recall of 18,791 of its tropical fish food under the “Atlantis” label. The finished tropical fish food products, which were distributed nationwide and interna-tionally, were found by the Georgia Department of Agriculture and Sergeant’s to contain melamine, an unapproved feed additive. The manufacturer was Five Eels Industry Corp. of Taipei, Taiwan.

A Class III firm-initiated recall is ongoing by United Pet Group, Inc., of Cincinnati, OH, for 54,178 units of several pet treats that were imported from China. FDA sampled the treats, and they were positive for melamine. The shipments were placed on hold for redelivery but were erroneously shipped into commerce. Distribution took place in Arizona, California, Florida, Michigan, New Jersey, Texas, and Washington.