District Court Enters Permanent Injunction against Nevada Animal Drug Manufacturer to Prevent Distribution of Adulterated Drug
The U.S. District Court for the District of Nevada entered a consent decree of permanent injunction against Bio Health Solutions LLC, of Reno, Nevada, and Mark Garrison, its manager, to prevent the distribution of RenAvast, an animal drug that is adulterated, the Department of Justice announced today.
“The department will not hesitate to bring enforcement actions against animal drug producers who do not follow the necessary procedures to comply with our nation’s animal drug laws,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division.
On July 9, the department filed a complaint in U.S. District Court at the request of the U.S. Food and Drug Administration (FDA) alleging that Bio Health Solutions and Garrison caused the shipment of RenAvast in interstate commerce in violation of federal law. The complaint alleged that Bio Health Solutions markets, sells and distributes RenAvast, which the company describes as an animal supplement, and that the company intended that RenAvast be used to treat and prevent kidney disease and chronic renal failure in cats and dogs.
Under the federal Food, Drug and Cosmetic Act (FDCA), a new animal drug includes any drug intended for use for animals, the composition of which is such that it is not generally recognized as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling. A new animal drug that lacks FDA approval or otherwise fails to meet an exception under the law is deemed to be unsafe, and a new animal drug that is unsafe under the law is deemed to be adulterated. The complaint alleged that defendants caused the shipment of RenAvast, an adulterated animal drug, into interstate commerce.
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from introducing or delivering for introduction into interstate commerce, manufacturing, processing, packaging, labeling, holding, selling or distributing RenAvast. In addition, these same restrictions apply to any other product intended to diagnose, cure, mitigate, treat or prevent disease, unless and until a new animal drug application has been approved, or the product meets the requirements for an investigational new animal drug exemption in the law.
According to the complaint, the FDA issued a warning letter to Garrison on Aug. 1, 2012. The letter cited numerous statements throughout the defendants’ website and other promotional materials that showed the intended use of RenAvast was to prevent and/or treat kidney disease and chronic renal failure in cats. The FDA’s letter warned Garrison that RenAvast could not be legally marketed because it was a new animal drug that was not approved by the FDA.
The complaint further alleged that in November 2012, a representative for the company informed the FDA that the company had complied with FDA requests to remove statements on its website and in other promotional materials that showed its intent that RenAvast be used to mitigate, treat and prevent chronic renal failure in cats and in dogs. Nevertheless, the complaint alleged that after these assurances, Bio Health Solutions created a password-protected section on its website that contained numerous express disease claims. In addition, as alleged in the complaint, the FDA conducted undercover purchases of RenAvast, and such purchases confirmed that the defendants continued to make claims about RenAvast that caused it to be an adulterated drug under the FDCA.
The government is represented by Trial Attorney David A. Frank of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel Steven J. Tave of the Department of Health and Human Services’ Office of General Counsel-Food and Drug Division and Assistant U.S. Attorney Greg Addington of the District of Nevada.