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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities for June and July 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No III

Warnings Letters

WARNING LETTER was issued to Janet Cunningham, regulatory affairs consultant at Bayer Health Care LLC (Animal Health Division), Shawnee Mission, KS, for a violation of the misbranding provisions of section 502(n) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, the firm’s 60-second direct-to-consumer TV ad entitled, “Field Trip” for its Advantage Multi™ (imidacloprid/moxidectin) for Dogs, NADA 141-251, minimizes risks associated with use of the drug and fails to reveal material facts about the product in violation of the FFDCA and its implementing regulations (21 CFR 202.1(e)). By omitting and minimizing the risks associated with Advantage Multi™ for Dogs, the TV ad misleadingly suggests that Advantage Multi™ for Dogs is safer than has been demonstrated by substantial evidence or substantial clinical experience. FDA also reviewed certain conference exhibit booth materials for the company’s Advantage Multi™ (imidacloprid/moxidectin) products for dogs and cats. The promotional piece for the products, produced by Bayer Health Care LLC, was located in the exhibit booth at the conference. FDA considers the exhibit booth materials to be misleading because they fail to reveal relevant risk information. Therefore, the Agency determined that the drugs are misbranded within the meaning of sections 502(a) and 201(n) of the FFDCA.

Steve M. Hand of Ocilla, GA, received a WARNING LETTER from FDA because dairy cows offered by him for slaughter as food were found to be adulterated within the meaning of section 402(a) of the FFDCA. Specifically, tissue samples taken of one animal revealed the presence of gentamicin in the liver and kidney, although the level was not quantified. Nevertheless, there is no tolerance established for residues of this drug in the edible tissues of cows (21 CFR 300). Tissue samples taken from another cow revealed the presence of penicillin at 18 parts per million (ppm) in the kidney tissue and 12 ppm in the liver. A tolerance of 0.5 ppm has been established for residues of this drug in the edible tissues of cows (21 CFR 556.510).

FDA has sent a WARNING LETTER to Dr. Marilyn M. Porter, regulatory affairs associate/animal testing, Heska Corporation of Des Moines, IA, and to Nancy Thompson-Brown, senior regulatory compliance specialist, Schering-Plough Animal Health Corporation, Union, NJ, regarding their Web site for Tri-Heart® Plus (ivermectin/pyrantel) that was deemed to cause the drug to be misbranded under sections 502(n) and 201(n) of the FFDCA. Specifically, the promotional piece on the Web site was misleading because it presented an unsubstantiated claim about how Tri-Heart® Plus is effective in treating whipworm infections in dogs; however, this product was not approved for removing or controlling whipworms. Both officials were advised to correct the promotional materials on the Web site concerning Tri-Heart® Plus and any other materials that may contain similar information. They were also warned that future promotional materials should adequately address the claims of heartworm and other intestinal parasite prevention, described in the currently approved labeling, without overstating the effectiveness.

Adulterated medicated feed has led to the issuance of a WARNING LETTER by FDA to Gary L. Grossnickle, president of Southern States Frederick Cooperative, Inc., of Richmond, VA. An inspection of the firm revealed that it was manufacturing and distributing an animal feed mixed with a liquid supplement that contained lasalocid sodium, which is neither approved as a food additive nor considered generally recognized as safe. As a result, the animal feed is considered adulterated under section 402(a) of the FFDCA. Mr. Grossnickle was also cited for re-distributing animal feed without a label that had been returned because it contained lasalocid sodium; this amounted to misbranding under section 403 of the FFDCA.

A WARNING LETTER was sent by FDA to Kevin A. Sharpe, owner of Kevin Sharpe Farm of Cortland, NY, for violations of the adulteration provisions in sections 402(a) and 501(a) of the FFDCA. Specifically, the dairy operation had offered for slaughter as food one dairy cow that was found to have residues of penicillin in the kidney tissue at 0.15 ppm and another animal that was found to have residues of the same drug at 0.33 ppm in the kidney tissue. A tolerance of 0.05 ppm has been established by regulation (21 CFR 556.510(a)) for penicillin in kidney tissue. Therefore, both animals are considered adulterated under section 402(a). In addition, Sterile Penicillin G Procaine Injectable Suspension was found to be adulterated under section 501(a) because it was administered without following the dosage level and it was done so without the supervision of a licensed veterinarian in violation of 21 CFR 530.11.

Adulterated pet treats were the subject of a WARNING LETTER issued to Ian W. McCauley, president of T.W. Enterprises, Inc., of Ferndale, WA. Specifically, an analysis of a sample of the firm’s American Bullie A. B. Dog Chew, 6” Medium, revealed the presence of Salmonella muenster. Salmonella, including Salmonella muenster, is a micro-organism that is known to be pathogenic to animals and humans. Dog chews bearing or containing Salmonella are adulterated within the meaning of section 402(a) of the FFDCA. FDA’s inspection also revealed the firm’s use of bleach in animal feeds, which was in violation of the agency’s food additive petition requirements (21 CFR 571).

Liubov Skibo, director of regulatory affairs at Merial Limited, Duluth, GA, received a WARNING LETTER for making unsubstantiated claims in the firm’s advertisement for the canine heartworm drug, Heartgard® Plus. The advertisement, which appeared in the Journal of the American Veterinary Medical Association, caused the product to be misbranded under section 502(n) of the FFDCA. Heartgard® Plus is an oral chewable formulation containing ivermectin and pyrantel and is approved for the prevention of canine heartworm disease by eliminating the tissue stage of heartworm larvae for a month after infection and for the treatment and control of ascarids and hookworms. Statements in the advertisements imply the drug is effective for controlling and treating zoonotic diseases generally, not only ascarids and hookworms. These statements thus overstate the demonstrated effectiveness of Heartgard® Plus. In addition, other statements in the ads accompanying a photo gave the overall impression that the use of Heartgard® Plus in dogs will prevent zoonotic transmission of toxocariasis and subsequent ocular larval migrans in humans. FDA is not aware of substantial evidence or substantial clinical experience to support the effectiveness of Heartgard® Plus for the prevention of toxocariasis, ocular larval migrans, or any other zoonotic disease in humans.

A WARNING LETTER was issued to Stanley H. Wilson, owner of S & W Farms, Cave City, KY, for violations of the adulteration provisions contained in section 402(a) of the FFDCA. Specifically, this dairy and beef operation offered one dairy cow for slaughter as food that was found to contain 0.10 ppm penicillin in the kidney tissue and 0.09 ppm penicillin in the liver tissue. A second dairy cow offered for slaughter as food was found to contain 0.19 ppm penicillin in the kidney tissue. A tolerance of 0.05 ppm has been established for residues of this drug in the edible tissues of cattle (21 CFR 556.510(a)). Other violations cited in the WARNING LETTER included inadequate treatment records and an inadequate drug inventory system.

Margaret Gillis, regulatory associate at Elanco Animal Health, Greenfield, IN, has received a WARNING LETTER because of various promotional items associated with the firm’s product, Reconcile™ (fluoxetine hydrochloride). Reconcile™ is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. The four items in question involved an article entitled, “Separation Anxiety: A Brief Overview,” the “reconcile.com” Web site, a consumer brochure, and a print advertisement in the May issue of Veterinary Forum Magazine. The pieces and the Web site suggested that the product was more effective than had been demonstrated. Therefore, the drug was found to be misbranded under sections 502(n) and 201(n) of the FFDCA.

Noncompliance with the current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210 and 211) for the manufacture of finished pharmaceuticals was the basis of a WARNING LETTER issued to Lawrence F. Schneider, president of First Priority, Inc., of Elgin, IL. The firm’s noncompliance caused the finished products to be adulterated under section 501(a)(2)(B) of the FFDCA. An FDA inspection also revealed that the firm’s “Purple Lotion Wound Dressing” was adulterated because it contained gentian violet and was, therefore, unsafe within the meaning of section 512(a) of the FFDCA. Gentian violet is not generally recognized as safe and effective for any veterinary drug use in food animals. The WARNING LETTER followed the issuance by FDA of a Form 483 (findings of inspection) and a subsequent response to those findings by First Priority, Inc. FDA maintained that many of the firm’s explanations and data submissions were incomplete or insufficient. Among the products covered by the FDA inspection were Pyrantel Pamoate Suspension Canine-2X, Povidone Iodine Shampoo, Ivermectin Equine Oral Liquid, Povidone Iodine Shampoo, Iodine Tincture, Cort-Astrin (Hydrocortisone Solution 1%, 1 oz.), Phenylbutazone raw material, and Levoxine Powder. FDA urged prompt corrective action with respect to all of the violations outlined in the letter.

A WARNING LETTER was issued to John M. Nauta, owner of the J & T Dairy, Buhl, ID, for violations of the adulteration provisions of section 402(a) of the FFDCA. Specifically, the firm sold a dairy cow for slaughter as human food that contained sulfadimethoxine in both the liver at 3.53 ppm and the muscle at 1.38 ppm. A tolerance of 1.0 ppm has been established for residues of this drug in the edible tissues of cattle, as codified in 21 CFR 556. 640. In addition, the firm adulterated sulfadimethoxine within the meaning of section 501(a) of the FFDCA when it failed to use the drug in conformance with its label, in that it was used extralabel. The extralabel use of this drug in lactating dairy cattle is prohibited by 21 CFR 530.41(a)(9). The WARNING LETTER also listed a variety of administrative violations.

Nancy Thompson-Brown, senior regulatory compliance specialist with Schering-Plough Animal Health Corporation, Union, NJ, has received a WARNING LETTER regarding a promotional piece (product bulletin) for Nuflor® (florfenicol) Type A Medicated Article for Swine. This piece makes unsubstantiated claims of effectiveness and thus misbrands the drug within the meaning of sections 502(a) and 201(n) of the FFDCA. Additionally, the piece promotes Nuflor® for a new intended use that is not the subject of an approved NADA. When promoted for this new, unapproved intended use, Nuflor® is unsafe within the meaning of section 512(a)(1). Specifically, the promotional piece presents six bulleted points under the heading “Advantages.” Three of them are false or misleading because they present claims that go beyond those approved and have not otherwise been substantiated. These three bullet points are: (1) “Fast acting – Reaches therapeutic concentrations in serum and lungs within 4-5 hours”; (2) “Highly palatable – Ensures intake of full dose”; and (3) “VFD status ensures long-term effectiveness.” An additional bullet in the promotional piece claims the drug “(s)ignificantly…increased average daily gain compared to untreated controls.” Nuflor® is not approved to increase average daily gain.

Offering an adulterated animal for slaughter as food in violation of section 402(a) of the FFDCA was the basis for a WARNING LETTER issued to Robert C. Zieroth, co-owner of KZ Dairy of Raymond, WA. Specifically, an analysis of tissues by the U.S. Department of Agriculture revealed the presence of 23.56 ppm of the drug sulfamethazine in the liver and 48.27 ppm in the muscle tissue of the cow in question. A tolerance of 0.1 ppm has been established by FDA for residues of this drug in the uncooked edible tissues of cattle (21 CFR 556.670). The dairy was also advised that complete treatment records were not being maintained as required by section 402(a) of the FFDCA. In addition, FDA’s investigation revealed that the firm failed to use sulfamethazine and lincomycin hydrochloride in conformance with their approved labeling and approved drug applications. The dairy was also warned that both drugs were being used extralabel in violation of 21 CFR Part 530 and were, therefore, unsafe within section 512(a) of the FFDCA and adulterated under section 501(a) of the Act.

FDA has issued a WARNING LETTER to Michael F. Stubbs, owner of the Diamond S Dairy, Hazelton, ID. Specifically, the dairy offered for slaughter as food a dairy cow that contained 0.69 ppm of the drug tilmicosin in the muscle. A tolerance of 0.1 ppm has been established for residues of this drug in the muscle tissue of cattle (21 CFR 556.735(b)(ii)). The presence of the drug in the muscle tissue exceeding the tolerance rendered the animal adulterated within the meaning of section 402(a) of the FFDCA. Furthermore, the firm administered tilmicosin to a lactating dairy cow when the drug is indicated for use in cattle, withdrawal periods set forth in the approved labeling were not followed, and administration of the drug was not done with the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). In addition, complete treatment records were lacking.

Mitchell K. Visser, owner of the Par 5 Dairy, Dexter, NM, received a WARNING LETTER from FDA for a violation of section 402(a) of the FFDCA. Specifically, the firm offered for slaughter as food a cow that contained 14.0 ppm of the drug sulfadimethoxine in the liver and 11.34 ppm in the muscle. A tolerance of 0.1 ppm has been established by FDA for residues of this drug in the uncooked edible tissues of cattle, as codified in 21 CFR 556.640. FDA’s investigation also revealed that the firm administered sulfadiemethoxine without following the dosage level and withdrawal period set forth in the approved labeling and without the supervision of a licensed veterinarian in violation of 21 CFR 530.11(a). As a result, the drug was found to be unsafe under section 512 of the FFDCA and adulterated under section 501(a)(5) of the Act.

Similar violations were cited in a WARNING LETTER from FDA to Michael W. Copeland, owner of the Madera Calf Ranch, Madera, CA. Specifically, an analysis by USDA of tissue samples collected from an animal raised by the firm as a calf identified the presence of gentamicin (amount not quantified) in the kidney. There is no tolerance for gentamicin in the tissues of cattle (21 CFR 556.300), thus the animal was adulterated within the meaning of section 402(a) of the FFDCA. The firm was also warned that it lacked treatment records for the calves raised on its ranch, as well as an adequate inventory system for determining the quantities of drugs used to medicate the animals in the ranch’s care. The WARNING LETTER also noted that the facility adulterated the drugs gentamicin sulfate, penicillin G procaine, tylosin, and ceftiofur hydrochloride within the meaning of section 501(a) of the FFDCA when the facility failed to use these drugs in conformance with their approved labeling.

Recalls

A Class II firm-initiated recall is ongoing by the Springer Magrath Co. of McCook, NE, for approximately 13,255 bottles of “O-NO-MORE” Calf Claimer Powder, packaged in 11-oz. bottles. The recall was undertaken because the finished product was manufactured with bovine blood meal that contained an excess of hair and bone and did not bear the cautionary BSE statement that the product should not be fed to ruminants. Distribution of the recalled product was nationwide.

Altana, Inc., of Meville, NY, is carrying out a Class III recall of 7,092 units of its Muricin (mupirocin) Ointment 2% for dermatologic use on dogs. The reason for the recall is that the product in question is subpotent. Altana had out-of-specification results in three lots of a similar product, Mupirocin Ointment USP, 2%, for human use. The product was also distributed for use on dogs under the trade name Muricin Ointment 2%, sold under Altana’s Pharmaderm Animal Health label. Distribution occurred in Massachusetts, Pennsylvania, South Carolina, Alabama, Indiana, Mississippi, Missouri, Texas, Colorado, Arizona, and Washington.

A nationwide, Class III firm-initiated recall is ongoing by Fort Dodge Laboratories, Inc., of Fort Dodge, IA, for more than 33,500 tubes of its Fort Doge Panolog Cream, Nystatin-Neomycin Sulfate-Thiostrepton-Triamcinolone Acetonide Cream USP, for topical use on dogs and cats. The affected products are packaged in 7.5- and 15-g aluminum tubes. The reason for the recall is that one of the active ingredients in the product (triamcinolone acetonide) was from an unapproved manufacturer.

Darling International, Inc., of Irving, TX, has completed a firm-initiated Class II (three different codes) recall and a Class III recall (four different codes) of 682,600 lbs. of its dry rendered tankage (also known as Crax), because the product contained melamine. Distribution was limited to Kansas and Nebraska.