Pet Pill Maker Dinged for Unapproved Drug

     RENO, Nev. (CN) – A federal judge on Friday banned the maker of pet supplements from selling a product to treat kidney failure in cats and dogs until it is approved by the Food and Drug Administration.
     Federal prosecutors filed and settled a complaint against Reno-based Bio Health Solutions, LLC, and its manager Mark Garrison on Thursday, alleging the company has been marketing and selling its RenAvast supplement to treat kidney disease and chronic renal failure in cats and dogs without FDA approval.
     The FDA issued a warning letter to Garrison in 2012, citing numerous statements on Bio Health’s website touting RenAvast’s ability to treat and prevent kidney disease in pets. The letter warned Garrison that RenAvast could not be marketed because the agency considered it a new drug under the federal Food, Drug and Cosmetic Act and therefore needed FDA approval.
     Prosecutors said a Bio Health Solutions representative told the FDA months later that the offending statements had been removed. Instead, the company put its claims about RenAvast on a password-protected webpage and continued selling the product – including to undercover FDA officers, according to the 9-page complaint.
     Bio Health Solutions and Garrison agreed to settle the action, which involved violations of the FDCA. Under the terms of the agreement, the company will stop making and selling RenAvast until – if – it receives approval from the FDA.
     The company will also pay all present and future FDA costs for inspections, travel and litigation and $5,000 for each violation of the FDCA.
     Failure to abide by the terms of the settlement could result in a contempt action brought by the Justice Department, the settlement said.
     Bio Health Solutions can petition the court to end the restrictions after five years of “continuous compliance.”

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