FDA WARNING_LETTER - Bio Health Solutions

This FDA Warning Letter, dated August 1, 2012, addresses Mark Garrison, DC, regarding the marketing of the product RenAvast. The FDA reviewed the website www.renavast.com and determined that RenAvast is intended for use in the mitigation, treatment, or prevention of disease in animals, classifying it as a drug under section 201(g)(1)(B) of the FD&C Act.

Violations include promoting RenAvast with claims such as "can halt the progression of chronic renal failure," "may reverse the effects of chronic renal failure," and "treats the cause" of renal failure. These statements establish the product's intended use as a drug.

RenAvast is cited as an unapproved new animal drug under section 201(v) of the FD&C Act because it is not generally recognized as safe and effective. To be legally marketed, a new animal drug requires an approved new animal drug application, conditional approval, or index listing under sections 512, 571, and 572. Since RenAvast lacks such approval or listing, it is considered unsafe under section 512(a) and adulterated under section 501(a)(5). Introducing an adulterated drug into interstate commerce is prohibited by section 301(a).

The letter requires a written response within fifteen working days detailing corrective actions taken to