Iowa Pharmacy Shut Down for Manufacture of Unapproved Drugs
An Iowa supplement manufacturer is under fire for selling unapproved drugs.
This week, U.S. District Judge Edward J. McManus for the Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements. The injunction also lists co-owners Gordon L. Freeman and Lois A. Dotterweich.
The complaint, filed by the U.S. Department of Justice, alleges that the company and its owners unlawfully manufactured and distributed unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.
The company and its owners marketed their products online at Stores.IowaSelectHerbs.com and through online marketplace websites, such as eBay, Amazon and buy.com. They also sold their products through a retail location in Cedar Rapids, Iowa.
"The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations," Melinda Plaisier, FDA associate commissioner for regulatory affairs, said in a written statement. "But when a company refuses to comply, we will take aggressive enforcement action."
The U.S. Food and Drug Administration (FDA) most recently inspected Iowa Select Herbs in August 2014. The inspection uncovered manufacture and distribution of items marketed as treatments for cancer, malaria, herpes, and heart disease. None of these products were approved for any use.
The consent decree prohibits the company and its owners from marketing misbranded or unapproved new drugs and adulterated or misbranded dietary supplements. Before the company and its owners can resume operations, they must, among other things, recall their drugs and dietary supplements, hire labeling and current Good Manufacturing Practice (cGMP) experts and receive written permission from the FDA to resume operations.