Efforts to crack down on unregulated drugs and dietary supplements are ongoing, with Iowa Select Herbs LLC the latest target of scrutiny by the US Food and Drug Administration (FDA).
A US district judge recently approved a consent decree of permanent injunction against the manufacturer and distributor of drugs and dietary supplements, effectively shutting the company down until it recalls its products, reforms a number of its practices and receives permission to continue operations from the FDA.
"The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations," explained 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."
According to an FDA press release, a warning letter was sent to Iowa Select Herbs in April 2014. This letter catalogued a number of infractions urgently requiring correction. As of August 2014, a further inspection revealed that needed changes had yet to be made.
"During the inspection, the FDA found Iowa Select Herbs manufacturing and distributing misbranded and unapproved new drugs," according to the FDA statement. "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' drugs for any use."
The Associated Press reported in July that Iowa Select Herbs manufactured and sold almost 200 different supplements at its own website and through other Web vendors like eBay and Amazon. Co-owners Lois A. Dotterweich and Gordon L. Freeman did not comment for the story.
A lack of testing and quality control were also cited among the company's violations in the complaint, which was filed by the US Department of Justice. The complaint alleges that Iowa Select Herbs unlawfully manufactured and distributed drugs that were unapproved, misbranded and adulterated. It's the FDA's responsibility to regulate dietary supplements, among many other drugs, vaccines and medical devices.
According to a 2011 report from the Centers for Disease Control and Prevention, about 50 percent of adults in the US used dietary supplements at some point between 2003 and 2006 — up from 40 percent between 1988 and 1994. Multivitamins and multiminerals were the most commonly used supplements.
