For Immediate Release
August 17, 2015
Today, U.S. District Judge Edward J. McManus for the U.S. District 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, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.
The company and its owners marketed their products online at http://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,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “But when a company refuses to comply, we will take aggressive enforcement action.”
The FDA most recently inspected Iowa Select Herbs in August 2014. During the inspection, the FDA found Iowa Select Herbs manufacturing and distributing misbranded and unapproved new drugs. The defendants marketed their products with claims that they could treat medical conditions such as cancer, malaria, herpes and heart disease. The FDA has not approved Iowa Select Herbs’s drugs for any use.
During the inspection, FDA investigators also found numerous violations of the agency’s current Good Manufacturing Practice (cGMP) regulations for dietary supplements, including failing to establish specifications for any of their products and failing to test dietary ingredient components. Because the defendants failed to follow cGMP regulations, their dietary supplements are adulterated under the Federal Food, Drug, and Cosmetic Act.
In April 2014, the FDA issued a Warning Letter to Iowa Select Herbs for similar violations. Despite assurances from Iowa Select Herbs that the violations noted in the Warning Letter would be corrected, the August 2014 follow-up FDA inspection revealed that the company failed to make the necessary corrections.
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 cGMP experts and receive written permission from the FDA to resume operations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is 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.