FDA WARNING_LETTER - Tri-Star Equine

This FDA Warning Letter, FLA-15-05, dated October 29, 2014, addresses Tri-Star Equine Marketing, LLC, regarding their product Gastrotec. The FDA reviewed the firm's website, tristarequine.com, and other promotional sites like ergogeniclabs.com and horseprerace.com.

The core violation is that Gastrotec is marketed as a drug intended for use in the mitigation, treatment, or prevention of disease in animals, specifically for "gastric and colonic ulcers in horses." This classification makes it a drug under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)].

As a new animal drug, defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(v)], Gastrotec requires an approved new animal drug application, conditionally approved application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Since Gastrotec lacks such approval or listing, it is deemed unsafe under section 512(a)(1)