FDA WARNING_LETTER - Canine Care

On October 23, 2014, the FDA issued a Warning Letter to CanineCare.us, LLC, and Dr. Jonathan Nyce, concerning the marketing of Tumexal Capsules, Tumexal Liquid, and Tumexal Transdermal. An FDA review of the firm's product labeling and website (www.caninecare.us) revealed that these products are promoted with claims indicating their use in the mitigation, treatment, or prevention of disease in animals, such as being "effective against a wide array of canine cancers." Consequently, the FDA classified these products as "drugs" under section 201(g)(1)(B) of the FD&C Act. Furthermore, they are deemed "new animal drugs" under section 201(v) because they are not generally recognized as safe and effective. Since these products lack the required FDA approval, conditional approval, or index listing under sections 512, 571, and 572, they are considered unsafe under section 512(a) and adulterated under section 501(a)(5) of the Act. The introduction of such adulterated drugs into interstate commerce is prohibited by section 301(a). CanineCare.us, LLC, is required to respond within fifteen working days, detailing corrective actions taken to achieve compliance, with potential enforcement actions like product seizure or injunction if violations persist.