Animal & Veterinary
Regulatory Activities - July/August 2005
FDA Veterinarian Newsletter July/August 2005 Volume XX, No IV
The following individuals and firms received Warning Letters for offering animals for slaughter that contained illegal tissue residues:
- Phillip V. Banks, co-owner, Phillip and Vincent Banks Dairy Farm, Normandy, TN
- Mike D Griffith, partner, G & G Dairy, Twin Falls, ID
- Charles F. Luchsinger and Susan B. Luchsinger, co-owners, Silver Spring Farm, Syracuse, NY
- Kevin R. Martin, owner, Martin-Vue Farms, Goshen, IN
- Marlen L. Martin, owner, Marlen Martin Farm, Goshen, IN
- Melvin Medeiros, owner, Maria Medeiros Dairy, Laton, CA
- Donald N. Pope, owner, Donald Pope Veal Farm, Whitewater, WI
- Samuel O. Smith, owner, Smith Dairy, Cornersville, TN
- George E. Vander Dussen, owner, Providence Dairy, Texico, NM
The above violations involved gentamicin in dairy cows, penicillin in dairy cows, dihydrostreptomycin in a dairy cow, neomycin in a veal calf, and sulfadimethoxine in dairy cows.
A Warning Letter was issued to Eugene R. Anderson, DVM, owner, Morris Veterinary Center, PSC, Morris, MN, because an investigation revealed that the practices of the veterinary center caused animal drugs to be unsafe under Section 512(a) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 360b, and adulterated within the meaning of Section 501(a)(5) of the Act, because drugs were prescribed for use in a manner that did not conform with their approved uses or with regulations for Extralabel Drug Use in Animals, 21 CFR Part 530. The above violations involved sulfadimethoxine and oxytetracycline in lactating dairy cattle.
A Warning Letter was issued to Gary D. Daniels, DVM; Dale A. Timm, DVM; Myron A. Cyphers, DVM; Henry Peeters, DVM, Chosen Valley Veterinary Clinic, Chatfield, MN. An investigation confirmed that the new animal drugs sulfadimethoxine and gentamicin sulfate were caused to be unsafe under -Section 512(a) of the Act, 21 U.S.C. 360b, and adulterated within the meaning of Section 501(a)(5) of the Act because the drugs were used in a manner that did not conform with their approved uses or with the regulations for Extralabel Drug Use in Animals, 21 CFR Part 530. In addition, the investigation found that the clinic was compounding and distributing the unapproved new animal drug GM 100. The GM 100 drug product is a new animal drug as defined under Section 201(v) of the Act. The composition is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The drug is adulterated under Section 501(a)(5) of the Act because it is unsafe within the meaning of Section 512 of the Act. Section 512 in part deems a new animal drug to be unsafe unless an approved new animal drug application (NADA) is in effect for the specific product in question. The Chosen Valley Veterinary Clinic holds no FDA approval of an application for its GM 100 drug product.
A Warning Letter was issued to Wendy J. Raak, president, Xtreme Design, Inc., Rosemount, MN, because an inspection revealed that this veterinary product distributing facility is marketing and distributing Xtreme Shampoo and Xtreme Spray. Section 201(g) of the Act defines a drug as an article intended in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals or intended to affect the structure or function of the body of man or other animals. The representations made for the Xtreme products indicate that they are intended for use, among other things, in the cure, prevention, and treatment of disease in horses and/or to affect the structure or function of their bodies. These include statements such as, “Helps on all skin fungus, ringworm, rainrot, girth itch, thrush, proud flesh, greasy heel, cankers and scratches.” These products are therefore drugs under the Act. Because they are not the subject of approved new animal applications (NADAs), they are unsafe under Section 512(a) of the Act, and thus adulterated under Section 501(a)(5) of the Act.