Takes enforcement action against Bio Health Solutions LLC
According to the complaint filed with the consent decree, the defendants have marketed RenAvast to treat diseases, including chronic renal failure, in cats and dogs. 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 decree, filed on FDA’s behalf by the U.S. Department of Justice’s Consumer Protection Branch and the U.S. Attorney’s Office for the District of Nevada, prevents Bio Health Solutions LLC and Garrison from introducing RenAvast and any other unapproved new animal drugs into interstate commerce. The firm would not be able to market the drug unless and until it obtains an approved new animal drug application or meets the requirements for an investigational new animal drug exemption.
“The Federal Food, Drug, and Cosmetic Act’s new animal drug approval requirements provide important protections for consumers and their animals,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine. “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.”
The FDA previously issued a Warning Letter to Garrison regarding Bio Health Solutions LLC’s marketing of RenAvast in August 2012.
Unapproved animal drugs are animal drugs that do not have legal marketing status. They have not been approved, conditionally approved, or indexed by the FDA. In addition, unapproved animal drugs may not meet the agency’s strict standards for safety and effectiveness and may not be properly manufactured or properly labeled. The FDA can take enforcement actions such as issuing Warning Letters to and seeking injunctions against companies that are in violation of the FD&C Act.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products