October 15, 2015

 

 Banned in one name, allowed under another

Posted Sept. 30, 2015

A supplement maker accused of selling an unapproved kidney disease drug for pets is allowed to continue selling the product as a supplement with a new product name and different marketing.

Nevada-based Bio Health Solutions and company co-founder Mark Garrison consented, without admission of guilt, to a federal court order prohibiting sales of RenAvast in the U.S. as well as requiring a recall of stock sold and submission to unannounced inspections by the Food and Drug Administration. Department of Justice spokeswoman Nicole Navas said that, under the court order, RenAvast still can be made in the U.S. if it is sold overseas, and the same product can be made and sold in the U.S. under a different name and with different marketing.

A DOJ complaint filed on behalf of the Food and Drug Administration states that Bio Health and Garrison had claimed RenAvast could treat or prevent kidney disease in cats and dogs, despite two warnings from the FDA in 2012.

In the complaint, the agencies said Bio Health responded to the warnings by removing some product claims from public portions of the RenAvast website. But the complaint states that the company was marketing RenAvast to veterinarians for prevention and treatment of chronic renal failure, hosting websites discussing chronic renal failure in dogs and cats and linking to the RenAvast site, and making kidney disease–related claims in a password-protected area of the RenAvast site.

The complaint also indicates FDA agents confirmed while buying the product that the company was making drug claims.

Bio Health Solutions’ website and those of its distributors provide indications RenAvast, listed by the company as available in eight countries in Europe and Asia, is at least related to another product, AminAvast, sold in the U.S. Company officials confirmed in a message that RenAvast is unavailable in the U.S. but did not respond to a question about the relationship between RenAvast and AminAvast.

In addition to sharing similar logos and identical tag lines of “promotes healthy kidney function,” the two appear to be based on the same ingredient: “AB070597,” described by Bio Health as a “patent pending ingredient created through a proprietary process using amino acids and a peptide.”

Patterson Veterinary Supply, for example, lists the substance in connection with RenAvast in a 2013 material safety data sheet and in a sales listing for AminAvast. The MSDS indicates the product contains L-aspartic acid, L-carnosine, L-glutamic acid, L-glutamine, glycine, L-arginine, and L-histidine as well as maltodextrin, gelatin from capsules, magnesium stearate, and stearic acid.