FDA WARNING_LETTER - Amber Technology, LLC - May 16, 2013

The FDA issued a Warning Letter to Amber Technology, LLC following a May 14-16, 2013 inspection and website review. The agency determined that numerous products marketed as "nutraceuticals for pets," including Parvaid, Vibactra, Kitty Distempaid, HWF, and Canine Distempaid, are intended for use in the mitigation, treatment, or prevention of animal diseases. This intent, evidenced by claims such as "help puppies overcome the Parvo virus" and "aid to help animals fight heartworms," classifies them as drugs under section 201(g)(1)(B) of the FD&C Act. Furthermore, these products are considered "new animal drugs" under section 201(v) because they are not generally recognized as safe and effective. The firm lacks approved new animal drug applications, conditional approvals, or index listings as required by sections 512, 571, and 572. Consequently, these products are deemed unsafe (section 512(a)) and adulterated (section 501(a)(5)), and their introduction into interstate commerce is prohibited by section 301(a). Amber Technology, LLC must respond within fifteen working days, outlining corrective actions taken and providing supporting documentation, or explain any delays. Failure to comply may lead to enforcement actions, including product seizure or injunction.