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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pet Kiss Inc.

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


WIL 17-09


June 2, 2009


Mr. Orlando Miguel, President
Pet Kiss, Inc.
3053 Rancho Vista Blvd.; Suite #H-155
Palmdale, CA 93551


Dear Mr: Miguel:


This letter concerns your film's marketing of "Arthritis & Joint Formula". Based on statements made on your website at the Internet address
http://www.petkiss.com/Arthritis_and_JointFormula.html.this product is a drug under section 20l(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the "Act") [21 U.S.C. § 321(g)(1)(B)] and is a new animal drug under section 20l(v) of the Act [21 U.S.C. § 321(v)]
because the product is 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 product includes, but are not limited to, the following statements that your product is intended to:


• Treat arthritis (based on product name ''Arthritis & Joint Formula")
"Help Lubricate and Rebuild Joint Tissue"
"Alleviate Pain While Joint Tissue Rebuilds"


In addition, your web site contains a testimonial statement "My dog was hit by a car several years ago, and unfortunately lost a lot of his ability to move around. Just a couple of weeks after trying this product, he was actually running. I couldn't believe it!"


Your "Arthritis & Joint Formula" is a drug as defined by 20l(g)(1) of the Act [21 U.S.C. § 321(g)(1)(B)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, this product is a "new animal drug" because it is "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 "Arthritis & Joint Formula" is unsafe within the meaning of section 512(a) of the Act [21 U.S.C. § 360b(a)] because it is not the subject of an approved New Animal Drug Application. As such, it is 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 "Arthritis & Joint Formula" without an approved NADA 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 fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that your 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 can not be completed within fifteen (15) working days, state the reason for the delay & the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.


Your response should be sent to:


Dennis Farley
Acting Director of Compliance Branch
U.S. Food & Drug Administration
19701 Fairchild
Irvine, CA 92612-2506


If you have any questions about this letter, please contact either Scott Goff (Los Angeles District Compliance Officer) at telephone number 949-608-2900.

 

Sincerely,

/S/

Alonza Cruse
District Director
Los Angeles District

 


Cc: Jeff Farrar, DVM, PhD, MPH
Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue-MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413