Bimeda Incorporated – FDA Warning Letter, Apr 9, 2019

This FDA Warning Letter, dated April 9, 2019, addresses Bimeda, Inc. regarding their products Polyglycan®, Polyglycan®–SA, Polyglycan®–HV, and A-CYST®. The FDA reviewed the Polyglycan® product label and the company's website (www.bimedaus.com) in October 2018.

The FDA determined that the product labels and website claims establish these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, and/or to affect the structure or function of the body of animals. This classification makes them "drugs" under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(B) and (C)]. Although promoted as devices, they achieve their primary intended purposes through chemical action, not meeting the device definition.

These products are cited as "new animal drugs" under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are not generally recognized as safe and effective by experts. They lack an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and