Inspections, Compliance, Enforcement, and Criminal Investigations
Xtreme Design, Inc. 07-Sep-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
September 7, 2005
RETURN RECEIPT REQUESTED
Wendy J. Raak
Xtreme Design, Inc.
13429 South Robert Trail
Rosemount, Minnesota 55068
Dear Ms . Raak:
On March 2, 2005, the Food and Drug Administration (FDA) conducted an inspection of your veterinary product distributing facility in Rosemount, Minnesota. We also reviewed your website on July 7, 2005. Our investigation revealed that your firm is marketing and distributing Xtreme Shampoo and Xtreme Spray. These products are new animal drugs under the Federal Food, Drug, and Cosmetic Act (the Act). Because they are not the subject of approved new animal drug applications (NADAs), they are unsafe under Section 512(a) [21 U.S.C. 360b] of the Act and thus adulterated under Section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].
Section 201(g) of the Act [21 U.S.C. 321(g)] defines a drug as an article intended for use 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 you are making for these 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." Your products are therefore drugs under the Act.
Because we have no evidence that these products are recognized by scientific experts as safe and effective for their labeled intended uses, they are regarded as "new animal drugs" under Section 201(v) of the Act [21 U.S.C. 321(v)]. A new animal drug may not be legally marketed unless it is the subject of an approved NADA as required by Section 512(a)(1)(A) of the Act [21 U.S.C. 360b(a)(1)(A)]. An NADA may be approved by the FDA only on the basis of adequate scientific data that the applicant submits as evidence of the safety and effectiveness of the products.
The violations described above are not meant to be an all-inclusive list. It is your responsibility to ensure that all products distributed by your firm are in compliance with the Act.
We previously noted these violations in a letter to you dated February 19, 2004. We received your responses to this letter dated March 8, 2004, and May 4, 2004. We replied to these letters on March 24, 2004, and June 22, 2004, respectively. In our June 22, 2004, letter, we informed you that your revised labels still indicated that the products may be used for the treatment of skin fungus, ringworm, rainrot, girth itch, thrush, proud flesh, greasy heel, cankers and scratches. And therefore these products would still be considered drugs as defined in Section 201(g) of the Act and new animal drugs under Section 201(v) of the Act because we have no evidence that these products are recognized by scientific experts as safe and effective for their labeled intended uses. A copy of the. June 22, 2004, letter is enclosed.
Failure to promptly correct these violations may result in enforcement action without further notice. The Act provides for the seizure of illegal products, injunctions against the manufacturer and/or distributor of illegal products, and criminal sanctions against persons responsible for causing violations of the Act.
Please notify this office in writing within 15 working days of receiving this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If the 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 implemented.
Your reply should be directed to Compliance Officer Judy E. Heisick at the address indicated on the letterhead. Ms. Heisick may be reached at (612) 758-7118.
W. Charles Becoat