|Company:||Drs. Foster and Smith, Inc.|
|Subject:||New Animal Drug/Adulterated|
|Issuer:||Minneapolis District Office|
|Issued:||Sept. 5, 2008||Closed:||
Department of Health and Human Services
Public Health Service
Minneapolis District Office
September 5, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 08-1 7
Dr. Race L. Foster
Dr. Martin R.Smith
Drs. Foster and Smith, Inc.
2253 Air Park Road
P.O. Box 100
Rhinelander, Wisconsin 54501
Dear Dr. Foster and Dr. Smith:
This letter concerns your firm's marketing of "Joint are Primary 1," "Joint Care Primary Plus 1," "Joint Care~Advanced 2 with MSM," "Joint Care Premium 3, " "Joint Guard Treats," and "Premium Plus Omega-3, Gel Caps." Based on statements made on your web site at the Internet address
hitp://www.DrsFosterSmith.com these products are 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)], and are new animal drugs under section ,20I(v) of the Act [21 U.S.C. § 32i(v)] because they are intended for use in the diagnosis; cure; mitigation, treatment. or prevention of disease in dogs and cats.
Some examples of statements on your web site that establish these intended uses for your products include, but are not limited to, the following statements that your products are intended to:
• Help "manage the crippling effects of osteoarthritis."
• "work by actually healing the damage that has been done"
• Builds cartilage.
• Reduce pain
• "Reduc[e] the signs of feline arthritis."
• Treat arthritis in dogs.
• Decrease inflammation in arthritic dogs and cats.
These statements are supplemented by metatag keywords that you use to direct consumers to your web site through Internet searches. The metatag keywords include "arthritis dog," "arthritis dog treatment," "arthritis dog remedy," "arthritis dog glucosamine," "arthritis dog medication mild," "arthritis dog medication pain," "arthritis dog drug," "arthritis canine dog treatment," "canine arthritis treatment," "cat arthritis," "arthritis cat treatment," and "medication for cats with mild arthritis."
Your "Joint Care Primary 1," "Joint Care Primary Plus1," "Joint Care Advanced 2 with MSM," '"Joint Care Premium 3," "Joint Guard Treats," and "Premium Plus Omega-3 Gel Caps" are drugs as defined by section 201(g)(1) of the Act [21 U.S.C. §321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, these products are "new animal drugs" because they are "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 the labeling" [21 U.S.C. §321(v)].
Your "Joint Care Primary 1," "Joint Care Primary Plus 1," "Joint Care Advanced 2 with MSM," "Joint Care Premium 3," "Joint Guard Treats," and "Premium Plus Omega-3 Gel Caps" are unsafe within the meaning of section 512(a) of the Act [21 U.S.C. §360b(a)] because they are not the subject of approved New Animal Drug Applications (NADAs). As such, they are adulterated under section 501(a)(5) of the Act [21 U.S.C. §351(a)(5)]. Under section 301(a) of the Act [21 U.S.C. §331(a)], it is unlawful to introduce any adulterated drug into interstate commerce. Your sale of "Joint Care Primary 1," "Joint Care Primary Plus 1," "Joint Care Advanced 2 with MSM," "Joint Care Premium 3," "Joint Guard Treats," and "Premium Plus Omega-3 Gel Caps" without approved NADAs violates the law.
The issues and violations mentioned above are not intended to be an all-inclusive list of violations that exist with respect to your marketing of new animal drugs. You are responsible for investigating and for preventing recurrence of these, or other violations, to ensure that you comply with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations. Your response should include each step,that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Brian D. Garthwaite, Ph.D., Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.