Inspections, Compliance, Enforcement, and Criminal Investigations
Revival Animal Health, Inc. 21-Nov-05
Department of Health and Human Services
Public Health Service
Kansas City District
November 21, 2005
RETURN RECEIPT REQUESTED
Ref. KAN 2006-03
Mr. Roy Nielson III
President and CEO
Revival Animal Health, Inc.
1700 Albany Place, South East
P.O. Box 200
Orange City, IA 51041
Dear Mr. Nielson:
The Food and Drug Administration (FDA) conducted an investigation of the sale of Revival Animal Health, Inc . products and promotion of animal drug products on your firm's website, www.revivalanimal.com and in your firm's catalog. The investigation found that your promotional materials, including your firm's product catalog and website content, contain statements that represent or suggest that your products are intended to be used in the cure, mitigation, treatment, or prevention of disease. Such statements cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. In addition, this investigation revealed that your promotional materials contain unapproved new animal drug claims for approved drug products, causing these drugs to be adulterated under section 501(a)(5) of the Act [21 U.S.C. 351(a)(5). Finally, this investigation also revealed that your firm is selling and dispensing veterinary prescription drug products without a lawful order from a licensed veterinarian. Because you dispensed prescription new animal drug products without the lawful written or oral order of a licensed veterinarian, these products are misbranded within the meaning of section 503(f)(1)(C) of the Act [21 U.S.C. 353(f)(1)(C)].
Our investigation found that you are marketing unapproved new animal drugs. Section 201(g) of the Act defines "drugs" in part to be articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and articles (other than food) intended to affect the structure or any function of the body of man or other animals.
Your firm is marketing a line of products under the "Doc Roy's" label. For some of these products, your web site and catalog include claims that indicate the articles are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. For example, your web site states that "Doc Roy's Aches Away" "helps prevent and manage arthritic joints."
Our investigation also found that your firm is marketing various unapproved products with claims that they are replacements or substitutes for already approved products. For example, your web site markets the unapproved product BioCase V as "comparable to the [human] prescription product VioKaseV[®]." Such comparisons to approved drug products indicate that the unapproved products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.
Also, the investigation found that your firm is marketing epinephrine in 10 ml and 30 ml vials for the treatment of anaphylactic shock in cattle, horses, swine, dogs, and cat. Thus, the epinephrine is intended for use in the treatment of disease in animals.
Because the labeling and promotional materials for these products include statements which indicate that the products are intended to be used in the cure, mitigation, treatment or prevention of disease, or are intended to affect the structure or function of animals, these products are drugs within the meaning of Section 201(g) of the Act.
Under section 201(v) of the Act, a new animal drug is any drug intended for use for animals other than man that is not generally recognized, among experts qualified by scientific training and experience to evaluate safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
We have no evidence that these products are generally, recognized as safe and effective: therefore, they are new animal drugs. A new animal drug may not be legally marketed unless it is the subject of an Approved New Animal Drug Application (NADA). Because these products are not approved under a New Animal Drug Application (NADA), they are unsafe under Section 512 of the Act and thus adulterated under section 501(a)(5).
However, at this time, we would not object to the marketing of the epinephrine 10 MI, provided that its label bears appropriate warning statements in a prominent and conspicious manner, such as "For emergency use only in treating anaphylactic shock. Usual Dosage: Cattle, horses, sheep, and swine -- 1 cubic centimeter per 100 pounds of body weight. Inject subcutaneously", a description of the symptoms of anaphylatoid shock (glassy eyes, increased salivation, grinding of the teeth, rapid breathing, muscular tremors, staggering gait, and collapse with death following), and that symptoms may appear after injection of a bacterin, vaccine, or antibiotic.
The investigation also found that your promotional materials for approved drug products include intended uses in animals for which the drugs are not approved. Specifically, your promotional materials include drug products approved for human use that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. For example, your catalog and web site both include "Pyrantel 50mg, " which is described as "[l]abeled for humans to treat pinworms, but widely used in kennels & catteries to control round, hook & threadworms (type of roundworm). "
In addition, your web site and catalog descriptions of some approved animal drug products indicated that they are intended for uses other than the labeled use. For example, your catalog lists "Albon Soluble Powder, " and states that it is "[l]abeled for poultry & cattle, " but is '[u]sed to treat Cocci in dogs, respiratory infections & bacterial enteritis," though it is not "labeled for such use."
Because we have no evidence that these products are generally recognized as safe and effective for their intended uses in animals, they are new animal drugs under the Act, and the drugs, their labeling, and their use must conform to an approved new animal drug application. There is no approved NADA for the drug products approved only for human use, so the unapproved new animal drug claims cause these products to be unsafe under section 512 and thus adulterated under section 501(a)(5) of the Act . Similarly, new animal drug products for which you include labeling claims that do not conform to the approved NADA are unsafe under section 512 and thus adulterated under 501(a)(5).
The investigation also found that your firm sold prescription new animal drug products without requiring a prescription . For example, Lincomycin Injection 25/300 mg is approved for over the counter (OTC) use in swine and prescription use in dogs and cats (21 CFR 522.1260). However, your firm sold this product with labeling for the prescription use in dogs and cats but did not require a prescription.
The sale of prescription animal drugs without a prescription from a licensed veterinarian causes the drugs to be misbranded under sections 502(f)(1) and 503(f)(1)(C) of the Act. The Lincomycin you dispensed is misbranded because it does not bear adequate directions for use as required by section 502(f)(1) of the act, and it does not fall within an exception to that requirement. FDA has defined "adequate directions for use" as "directions under which the layman can use a drug safely and for the purpose for which it is intended." 21 CFR 201.5.
Under Section 503(f)(1)(A) of the Act, prescription, drugs may be used safely only under the supervision of a veterinarian. Directions under which a layperson can safely use prescription drugs cannot be written because such drugs can only be used safely under the supervision of a licensed veterinarian. Thus, adequate directions for lay use in cats or dogs cannot be written for the lincomycin dispensed by you. Moreover, you are not exempt from section 502(f)(1) because the drug fails to comply with the conditions set forth in section 503(f)(2)(A) and 21 CFR 201.105 in that you sold lincomycin with directions for prescription use in dogs and cats but without a lawful written or oral order of a licensed veterinarian in the course of the veterinarian's professional practice.
Your firm should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct the above referenced violations may result in regulatory action without further notice, including seizure and/or injunction.
The violations listed above are not intended to be all inclusive. As the owner of this firm, you have the responsibility to insure that all drugs intended for animal/veterinary use are promoted and sold in accordance with their approvals. Products which bear the prescription legend must be dispensed or sold by your firm on the lawful prescription or other order of an appropriately licensed veterinarian.
You should notify this office in writing within fifteen (15) working days of the receipt of this letter, of the specific steps that you have taken to correct the noted violations, including an explanation of each step to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed. Also include copies of any available documentation, including labels, labeling, catalog and website revisions that demonstrate that corrections have been made.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Joseph G. Kramer, Compliance Officer, at the address noted in the letterhead.
John W. Thorsky
Kansas City District