Regulatory Activities for August and September 2006

FDA Veterinarian Newsletter 2006 Volume XVII, No IV

The offering for sale of animals adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA) has led to the issuance of a WARNING LETTER to Todd R. Meech of Sebeka, MN. The action follows an investigation that also revealed the new animal drugs penicillin G procaine, tylosin, oxytetracycline, and lincomycin were adulterated and unsafe, pursuant to provisions in the FFDCA. The adulteration was caused by the presence of neomycin in amounts that exceeded the established tolerance of 7.2 ppm by as much as 100 percent. The investigation revealed that animals were being held under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. The animal drugs mentioned above were being used “extralabel” in that they were not being used in accordance with the approved labeling. Specifically, the drugs were not administered by a licensed veterinarian.

The identical provisions of the FFDCA were cited in a WARNING LETTER issued to Steven L. VanderHoff, member/owner of Vreba-Hoff Dairy, LLC, Hudson, MI. An inspection of this dairy operation revealed that a dairy cow that was offered for slaughter for human food contained residues of penicillin in kidney tissue that exceeded the established tolerance as set forth in Title 21, Code of Federal Regulations, Part 556 (21 CFR 556.510). Similarly, another dairy cow had been offered for slaughter for use in human food bearing residues of oxytetracycline in the liver and the muscles in excess of the established tolerance as set forth in 21 CFR 556.500. In addition, an approved animal drug was administered via a route—intrauterine—that was not indicated in the labeling, without benefit of a valid veterinarian-client-patient relationship, and adequate treatment records were not maintained.

Significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds (21 CFR 225) were noted in a WARNING LETTER issued to Steve J. VanRoekel, president & CEO of Ridley, Inc., the parent company of Hubbard Feeds, Mankato, MN. These deviations caused the feeds being manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the FFDCA. The investigation found that the firm’s continued use of the Type A medicated article, oxytetracycline, in the manufacture of medicated feeds after the drug had reached its labeled expiration date caused the drug to be deemed unsafe within the meaning of section 512(a)(1) of the FFDCA and adulterated within the meaning of section 501(a)(5) of the FFDCA. Additionally, the use of oxytetracycline to produce medicated feed caused the product to be unsafe under section 512(a)(2) of the FFDCA.

A WARNING LETTER was issued to Kent W. Pulfer, DVM, managing partner of MPM Farms, Wayne, NE, because an investigation of the dairy operation confirmed that animals being offered for sale for slaughter as food were adulterated under section 402 of the FFDCA. In addition, the investigation revealed that MPM Farms caused Quartermaster^® Dry Cow Treatment brand of penicillin and dihydrostreptomycin to become adulterated and unsafe under sections 501 and 512, respectively, of the FFDCA. Specifically, one dairy cow contained residues of ampicillin in the kidney tissue exceeding the established tolerance set forth in 21 CFR 556.40. A second dairy cow offered for slaughter and use as food was found to contain residues of dihydrostreptomycin in the kidney tissue exceeding the established tolerance set forth in 21 CFR 556.200. In both instances, the firm failed to maintain treatment records. The Quartermaster^® Dry Cow Treatment brand of penicillin was found to be adulterated because it was being used extralabel in a manner that did not comply with specific provisions of the FFDCA that address the appropriate withdrawal period.

An adulterated slaughter dairy cow that was offered for sale as food in violation of sections 402 and 512 of the FFDCA was cited as the basis for a WARNING LETTER issued to Calvin and Mike Berwald, partners in Berwald Dairy, Toronto, SD. Specifically, the cow in question contained residues of tilmicosin in liver and muscle tissue exceeding the established tolerance set forth in 21 CFR 556.735. In addition, the firm was cited for holding medicated animals under conditions that could have resulted in potentially harmful drug residues entering the food supply; treatment records were also lacking. The firm was also in violation of section 512 of the Act in that tilmicosin was being used extralabel because a licensed veterinarian was not administering the drug.

Residues of sulfadimethoxine in a dairy cow’s liver and muscle tissues exceeding established tolerances have led to the issuance of a WARNING LETTER to Timothy M. Potter, owner of John Potter Farm, LLC, Washington, CT, because the cow was offered for sale as human food. The high levels of the drug in the animal’s tissues caused it to be adulterated within section 402 of the FFDCA. FDA investigators determined that the firm: (1) failed to maintain an adequate recordkeeping system for determining the medication status of animals offered for slaughter; (2) failed to maintain an adequate record system for ensuring that animals receiving medication were withheld from slaughter for appropriate periods of time; and (3) failed to maintain an adequate system for ensuring that drugs were used in a manner not contrary to the directions contained in the labeling.

Flunixin residues in a dairy cow offered for slaughter as food exceeding established tolerances set forth in 21 CFR 556.286 served as the basis for a WARNING LETTER issued to Louis and Carol Calcagno, co-owners of Moon Glow Dairy, Moss Landing, CA. The presence of flunixin at inappropriate levels caused the animal to be adulterated within the meaning of section 402 of the FFDCA. The investigation also revealed that medicated animals were being held under conditions that would likely lead to the drug residues entering the food supply. Complete treatment records and an adequate inventory system for determining the quantities of drugs to medicate the dairy’s animals were lacking. In addition, flunixin was being used extralabel in violation of 21 CFR 530 and section 501(a)(5) of the FFDCA. Other violations revealed in the investigation included the routine, extralabel administration of penicillin G procaine and the use of the drug Baytril 100 (enrofloxacin); enrofloxacin is not approved for use in cattle intended for dairy production of calves to be processed for veal, and its use by the firm was in violation of 21 CFR 530.41.

A WARNING LETTER was issued to Lloyd North, Stanley, NY, for offering a dairy cow for slaughter as food in violation of section 402 of the FFDCA because it contained residues of flunixin in the liver tissue that exceeded the established tolerance set forth in 21 CFR 556.286. In addition, the operation lacked complete written treatment records and documentation showing route of administration and withdrawal times for milk and beef. In addition, the flunixin used was found to be adulterated under section 501(a)(5) of the Act because it was used extralabel; specifically, the wrong route of administration was used, and it was not administered under the supervision of a licensed veterinarian as required by 21 CFR 530. Because of this extralabel use, the drug was also found to be unsafe under section 512(a) of the FFDCA.

Neomycin residues in the tissues of a bull calf offered for sale as human food exceeding the established tolerances set forth in 21 CFR 556.430 resulted in the issuance of a WARNING LETTER to William W. and Barbara L. Young, majority partners and Principal Operators of Will-O-Crest Farms, LP, Clifton Springs, NY. The presence of neomycin at higher levels than authorized caused the animal to be adulterated under section 402 of the FFDCA. The firm used a calf milk replacer (medicated feed) that contained neomycin and oxytetracycline in calves to be processed for veal, contrary to the warning on the label. The extralabel use of the drugs caused the medicated feeds to be unsafe under section 512 and adulterated under section 501 of the FFDCA. Earlier violations included the use of flunixin in a slaughter cow destined for food use at a level exceeding the established tolerance set forth in 21 CFR 556.286. In addition, the drug was not used in conformance with approved labeling. 

False and misleading claims in promotional materials for Heartgard^® Plus (ivermectin/pyrantel) products for dogs and cats led to the issuance of a WARNING LETTER to Liubov Skibo, Director of Regulatory Affairs at Merial Limited, Duluth, GA. Heartgard^® Plus is an oral chewable formulation approved for the prevention of canine heartworm disease and the treatment and control of ascarids and hookworms. In previous letters, FDA had requested that the firm stop claiming 100 percent effectiveness for heartworm prevention. This request was based on the post-approval adverse drug event reports received concerning lack of effectiveness for heartworm prevention. However, the requests were ignored by the firm and the claim continued to be made. As a result, the promotion of the products bearing this claim rendered them false, misleading, and misbranded under section 502(a) of the FFDCA. The Warning Letter requested that the firm immediately cease disseminating the violative promotional materials.