Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm162121.htm
Timestamp: 2016-12-05 20:37:12
Document Index: 766672347

Matched Legal Cases: ['§ 321', '§ 321', '§ 321', '§ 321', '§ 360', '§ 351', '§ 331']

PETMED EXPRESS, INC 2/18/09 Quick Links: Skip to main page content
PETMED EXPRESS, INC 2/18/09
55 Winderley Pl., Ste 200
FLA-09-09
Mr. Menderes Akdag, CEO, President
1441 S.W. 29th Avenue
Dear Mr. Akdag:
This letter concerns your firm's marketing of "Super Joint Enhancer" and "Super Joint Omega." Based on statements made on your website at the Internet address http://www.1800petmeds.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 201(v) of the Act [21 U.S.C. § 321(v)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in dogs, cats, and horses.
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:
• Ease joint pain.
• Improve joint function.
• Help "reduce the tenderness and swelling of arthritis."
• Reduce swelling and joint tenderness.
These statements are supplemented by metatag keywords that you use to direct consumers to your web site through Internet searches. The metatag keywords include "pain," "inflammation," and "arthritis."
Your "Super Joint Enhancer" and "Super Joint Omega" are drugs as defined by 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], 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 "Super Joint Enhancer" and "Super Joint Omega" 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 "Super Joint Enhancer" and "Super Joint Omega" 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 fifteen (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 fifteen (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 Brant M. Schroeder, Compliance Officer, Florida District, Food and Drug Administration, 555 Winderley Place, Ste. 200, Maitland, Florida 32751. If you have any questions about this letter, please contact Mr. Schroeder at (407) 475-4763.
Director, Florida District -