Iowa Select Herbs manufactures its dietary supplements in conditions that cannot ensure safety and promotes them as medical cures even though they have never been found safe and effective for such purposes, the U.S. Department of Justice alleged in a civil complaint.
The enforcement action asks a judge to block the Cedar Rapids-based company from introducing adulterated and misbranded drugs into interstate commerce.
Iowa Select Herbs makes nearly 200 supplements that it sells to consumers and wholesalers across the U.S., mainly through its website and others such as eBay and Amazon. It also has a retail store at its headquarters in Cedar Rapids. Most of its supplements are extracts from plants — such as papaya leaf, elderberry and echinacea — and are sold under names such as Cold BeGone and Holy Basil Extract.
Co-owner Lois Dotterweich declined to comment on the Justice Department's allegations. She referred questions to her husband, co-owner Gordon Freeman, who wasn't immediately available. Both are named as defendants along with the company.
The company advertises their products as curing or treating diseases such as cancer, malaria, heart disease, migraines and herpes. But the U.S. Food and Drug Administration says they haven't been submitted for testing by experts to evaluate whether they are effective and therefore cannot be promoted that way.
FDA inspections at the company in 2013 and 2014 also revealed a number of safety violations and resulted in the company receiving warnings. Company officials repeatedly failed to test the products' ingredients to verify their identities, didn't have specifications for their products and didn't have any quality control procedures, among other things, according to the complaint.
The company promised improvements in April 2014, but hasn't responded to the most recent FDA findings, the complaint alleged. Instead, Iowa Select Herbs has continued to make disease-treatment claims, demonstrating an "unwillingness to comply" with federal law, the complaint said.