Future Sale of Unapproved Pet Kidney Drug RenAvast Prevented by FDA
A district court in Nevada has issued a permanent injunction against Bio Health Solutions and its owner Mark Garrison for selling RenAvast.
RenAvast, a drug designed to benefit liver function for dogs and cats, had never received approval from the U.S. Food and Drug Administration (FDA). The decision, filed on the FDA's behalf, prevents the Las Vegas-based company from introducing RenAvast and any other unapproved animal drugs into interstate commerce.
It is illegal to market new animal drugs without first requesting FDA pre-market review and obtaining legal marketing status. The FDA pre-market review process evaluates whether products are safe and effective for their intended use, can be consistently manufactured, and are truthfully and completely labeled.
The FDA previously issued a warning letter to Garrison regarding Bio Health Solutions LLC's marketing of RenAvast in August 2012.
"The Federal Food, Drug, and Cosmetic Act's new animal drug approval requirements provide important protections for consumers and their animals," Bernadette Dunham, director of the FDA's Center for Veterinary Medicine said in a written statement. "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."