Animal & Veterinary
Regulatory Activities - March-April 2006
FDA Veterinarian Newsletter 2006 Volume XXI, No I
The following individuals and firms received Warning Letters for offering animals for slaughter as food that were adulterated because of the presence of illegal tissue residues:
- Daniel J. Petrie, owner, Petrie Farms, Arcade, NY
- William Boman, Susquehanna, PA
- Ronald A. Lamarche and Yvette Lamarche, owners, Windy Ridge Farm, Charleston, ME
- Pete Tuls and Brian Hemann, co-owners, Lost Trail Dairy, LLC, Liberal, KS
Animals at these facilities were held under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. For example, each operation lacked an adequate system to ensure that animals medicated by the operation were withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. In addition, new animal drugs were adulterated when each of the operations failed to use a drug in conformance with its approved labeling. “Extralabel use,” i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, 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. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 530. FDA investigations found that the extralabel use of new animal drugs at these operations failed to comply with these requirements and resulted in illegal drug residues. Because the extralabel use of the drugs was not in compliance with Part 530, the drugs were caused to be unsafe and adulterated. The above violations involved Penicillin G Procaine Injectable Suspension, Flunixin Meglumine, Dihydrostreptomycin Sulfate, and Sulfamethazine in dairy cows.
A Warning Letter was issued to Joseph Valentine, Union Dale, PA, because an investigation of Mr. Valentine’s dairy operation revealed that he offered an animal for sale for slaughter as food that was adulterated because of the presence of illegal tissue residues. The investigation also found that animals were held under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The operation lacks an adequate system to ensure that animals medicated by the facility are withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.
A Warning Letter was issued to Stephen J. Palladino, partner, Hardie Farms, Inc., Lansing, NY, because an investigation of the dairy operation confirmed that the new animal drug Agricillin Procaine Penicillin G was caused to become adulterated. Specifically, the illegal extralabel use of the drug rendered the drug unsafe and, therefore, adulterated. The dairy operation treated a dairy cow with the drug in a manner contrary to the drug’s approved labeling. Extra-label 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. Agricillin was administered to a dairy cow in an extralabel manner, without following the daily dosage level, duration of treatment, or dosage level per injection site requirements set forth in the approved labeling, and was done without the supervision of a licensed veterinarian.
A Warning Letter was issued to Chris P. Hytrek, DVM, owner, Willow Creek Veterinary Service, Cortland, NE, because an investigation of his veterinary practice revealed that Dr. Hytrek caused animal drugs used in his practice to be unsafe and adulterated because they were used in a manner that did not conform with their approved use or the regulations for Extralabel Drug Use in Animals, 21 CFR Part 530. The investigation revealed that Dr. Hytrek prescribed the drugs kanamycin and amikacin to Wil Mar Sen Dairy. A U.S. Department of Agriculture analysis of tissue samples identified the presence of these two drugs in the kidney tissue of a cow offered for sale for slaughter as food from Wil Mar Sen Dairy. Neither kanamycin nor amikacin is approved for use in cattle. No tolerance levels have been established for these drugs in edible tissues from cattle. The detectable presence of kanamycin and amikacin in the edible tissues of the animal caused the food to be adulterated. The extra-label use of approved veterinary or human drugs is permitted only if it complies with the Act and 21 CFR Part 530. Dr. Hytrek failed to comply in that he did not establish substantially extended withdrawal periods supported by appropriate scientific information for the extralabel use of these two drugs in food producing animals; he failed to institute procedures to assure that the identity of treated animals was carefully maintained; and he did not take appropriate measures to ensure that there were no illegal residues in the dairy cows for which he prescribed the extralabel use of kanamycin and amikacin.
A Warning Letter was issued to Donald R. Pilegard, president, Jensen & Pilegard, Fresno, CA, because an investigation of the licensed medicated feed mill found significant deviations from the current Good Manufacturing Practice (cGMP) regulations for medicated feeds. Such deviations cause feeds manufactured at this facility to be adulterated under of the Act. In addition, the investigation revealed deviations from labeling requirements that cause the medicated feeds manufactured at this facility to be misbranded. The deviations from the label requirements also cause the medicated feed to be unsafe and, therefore adulterated. The following deviations from cGMP requirements were found:
- Failure to have adequate cleanout procedures for all equipment used in the manufacture and distribution of medicated feeds to avoid unsafe contamination of feed with drugs;
- Failure to maintain a Master Record File, which includes the correct name of each drug ingredient to be used in the manufacture of the medicated feed. In addition, the Master Record File had not been prepared, checked, dated, and signed or initialed by a qualified person;
- Failure to maintain a Master Record File, which includes a copy or description of the label or labeling that will accompany the medicated feed;
- Failure to accurately test all scales used in the manufacture of medicated feeds at least once per year or more frequently as may be necessary to insure their accuracy; and
- Failure to have suitable construction to minimize access by rodents, birds, insects, and other pests, to maintain the building in a reasonably clean and orderly manner, and to maintain the building grounds so that they are reasonably free from waste and refuse.
The medicated feeds were misbranded due to the mill’s practice of using a page from the Feed Additive Compendium as labeling. This practice does not provide sufficient information to allow the purchaser of the medicated feed to use the feed in a safe manner. In addition, there are serious concerns over the mill’s drug inventory and reconciliation practices. Specifically, the mill has a practice of rounding drug usage amounts up or down to simplify calculations and had failed to take corrective action to reconcile drug discrepancies and accurately weigh drug ingredients. FDA’s regulations require that drug inventory be maintained by means of a daily comparison of the actual amount of drug used with the theoretical drug usage and to investigate any significant discrepancy and take corrective action.
A Warning Letter was issued to Raymond Kastendieck, president, FRM Chemical, Inc., Washington, MO, because inspections of the animal drug manufacturing facility found significant deviations from the cGMP regulations for finished pharmaceuticals. Such deviations cause animal drug products manufactured at this facility to be adulterated under the Act. The investigation found the following deviations:
- Failure to perform at least one specific identity test on each drug component received, in lieu of testing each component for conformity with all appropriate written specifications for purity, strength, and quality;
- Failure to establish and follow a written program for calibration of instruments, apparatus, gauges, and recording devices used to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- Failure to conduct cGMP training on a continuing basis;
- Failure to establish written procedures describing the in-process controls and tests, or examinations to be conducted on appropriate samples of in-process controls and tests, or examinations to be conducted with appropriate samples of in-process materials of each batch;
- Failure to establish written procedures designed to prevent objectionable microorganisms in drug products;
- Failure to establish written control procedures for the issuance of labeling;
- Failure to establish written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; an
- Failure to establish written procedures for evaluation, at least annually, of the quality standards of each drug product.
Warning Letters were issued to Herbert B. Tully, president, Wilbur Ellis Company, San Francisco, CA, regarding the company’s licensed medicated feed mill known as Knox McDaniel Company in Ogden, UT, and to Bryan K. Draper, owner, Western Ag Industries, Genola, UT, regarding the company’s medicated feed distribution business because investigations of both establishments revealed that on several occasions they sold a Category II, Type A medicated article (Amprolium 25%) to a firm that does not have a Medicated Feed Mill License. A new animal drug is deemed unsafe, and, therefore, adulterated if it is removed from a distributor’s establishment for use in the manufacture of animal feed, unless at the time of such removal the distributor has an unrevoked written statement from the consignee of the drug, or notice from the Secretary of the Health and Human Services, to the effect that, with respect to the use of such drug in animal feed, such consignee (1) holds a license issued under section 512(m) [21 U.S.C. § 360(m)] and possesses current approved labeling for such drug in animal feed, or (2) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under 512(m) [21 U.S.C. § 360(m)]. The firms had no such written statement on file from the feed mills to which the Amprolium 25% was sold. In addition, Western Ag Industries’ own-label medicated feed “Western Ag Industries Amprolium Crumbles” is being manufactured by a firm without a Medicated Feed Mill License, and is unsafe under the Act, and therefore, adulterated.
A Warning Letter was issued to Greta Armstrong, Risingsun Health Alternatives and Herbs, Division of McAdam Health Enterprises, Livingston, MT, concerning products marketed on its Internet websites. One of the products, Bla-Cansema Type Black Salve For Pets, is intended for use in cats and dogs; the other products are intended for use in humans. According to the websites, the salves, capsules, and tonics are sold as topical and oral treatments for various forms of cancers, heart disease, high blood pressure, diabetes, and numerous other life threatening diseases. Ordering instructions and a price list for the products are provided on the website. Consumers are directed to select the desired products and are provided with a secure payment processor to facilitate payment by credit card to Risingsun Health Alternatives. Based on the claims cited, the products are “drugs” as defined by 21 U.S.C. § 321(g). Moreover, all the products are either “new drugs” or “new animal drugs” as defined by 21 U.S.C. § 321(p) and 21 U.S.C. § 321(v), respectively, because there is no evidence that they are generally recognized as safe and effective for the intended uses conveyed in their labeling. Furthermore, the salves are topical products and cannot be dietary supplements because they are not intended for ingestion, but rather to bypass the alimentary canal by direct absorption through the skin. The Act defines the term “dietary supplement” to mean a product that is “intended for ingestion….” Consequently, topical products intended to enter the body directly through the skin or mucosal tissues are not “dietary supplements.” For these products, both disease and structure/function claims cause them to be new drugs. Under 21 U.S.C. § 355(a), a “new drug” may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved drug application is in effect for the drug. The distribution of the products intended for humans are in violation of 21 U.S.C. § 355 and prohibited by 21 U.S.C. § 331(d). The Bla-Cansema Type Black Salve For Pets is adulterated under 21 U.S.C. § 351(a)(5), because it is unsafe under 21 CFR U.S.C. § 360b, because it is a new animal drug, and there is no FDA-approved new animal drug application in effect for the drug.
A Warning Letter was issued to Gary Schell, president, Schell and Kampeter, Inc., Meta, MO, because an inspection of the company’s pet food manufacturing facility located in Gaston, SC, revealed significant deviations from the Act. The investigation determined that the facility manufactures various dog and cat food products under several labels including Diamond, Country Value, and Professional. The FDA investigator documented that the facility manufactured a number of lots of dog food between September 1 and November 30, 2005, which were released for distribution in interstate commerce, that were adulterated under section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] because they contained a poisonous or deleterious substance (aflatoxin), which may render them injurious to health. In addition, these lots of pet food were adulterated under section 402(a)(4) [21 U.S.C. § 342(a)(4)]. The inspection revealed that the facility failed to implement appropriate controls to prevent the adulteration of the pet food, and that the plant personnel failed to follow established procedures, which, if followed, could have prevented these violative lots from being distributed. The inspection also revealed that the waste or salvaged materials from pet food production (scrapes) were being sold to a local hog farmer in bulk. Some of the pet food manufactured at the plant contains protein derived from mammalian tissues. The scrape product, which may contain prohibited material, was not labeled with the statement “Do not feed to cattle or other ruminants” as required by 21 CFR 589.2000. This regulation is intended to help prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). This labeling deviation causes the distributed pet food scrapes to be misbranded within the meaning of section 403(a)(1) [21 U.S.C. § 343(a)(1)] of the Act.