21 July 2015

FDA Takes Action Against Bio Health Solutions LLC

The company Bio Health Solutions LLC has reportedly been selling RenAvast to treat chronic renal failure in cats and dogs. On July 10th, 2015, the ‘United States District Court for the District of Nevada entered a consent decree of permanent injunction against Bio Health Solutions LLC, of Las Vegas and its manager and co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug.’1 The decree was filed by the U.S. Department of Justice’s Consumer Protection Branch and the U.S. Attorney’s Office for the District of Nevada and prohibits Bio Health Solutions LLC from marketing unapproved medications.

It is against the law to market medications without having a United States Food and Drug Administration (FDA) pre-market review and legal marketing status. These measures allow the FDA to examine the safety and effectiveness of medications for their intended use and examines whether or not products are properly labeled. In 2012 Bio Health Solutions LLC received a warning letter from the FDA about their marketing of RenAvast.

The FDA is tasked with protecting public health from dangerous or ineffective medications, vaccines, biological products, and medical devices. Director of the FDA’s Center for Veterinary Medicine, Bernadette Dunham, D.V.M., Ph.D. said, “The Federal Food, Drug, and Cosmetic Act’s new animal drug approval requirements provide important protections for consumers and their animals. We believe consumers should be able to trust that the drug products they administer to their pets have been proven to be safe and effective.”


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