Drug Maker's Operations Halted by Federal Judge

A federal judge has entered a consent decree of permanent injunction against a drug and dietary supplement manufacturer based in Iowa.

Iowa Select Herbs LLC and its co-owners, Gordon L. Freeman and Lois A. Dotterweich, are prohibited from manufacturing and distributing unapproved drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements, an FDA press release stated.

During an inspection in August 2014, the FDA discovered that the company was marketing their products as viable treatments for cancer, malaria, herpes, and heart disease. However, the FDA had not approved the company’s products for any use.

Investigators also found violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements, according to the FDA. For example, Iowa Select Herbs LLC did not test dietary ingredient components.

The manufacturing company had first been warned by the FDA back in April 2014 that it would have to make changes to its operations.

The company’s products were available on their website, through a retail location in Cedar Rapids, and via eBay, Amazon, and buy.com.

Before resuming operations, the company will be required to recall their drugs and supplements, hire labeling and cGMP experts, and receive permission from the FDA to being manufacturing and marketing products.

“The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs, in a press release. “But when a company refuses to comply, we will take aggressive enforcement action.”