The Department of Justice today announced that the U.S. District Court for the Northern District of Iowa handed down a consent decree [PDF] preventing Iowa Select Herbs from introducing adulterated and misbranded drugs into interstate commerce.
Back in July, the Dept. of Justice filed a civil complaint [PDF] against the Cedar Rapids, IA-based company alleging that its dietary supplements are manufactured under conditions that are inadequate to ensure the safety of its products.
Iowa Select Herbs manufactures and distributes more than 200 dietary supplements, consisting primarily of extracts from various plants, including papaya leaf, echinacea, elderberry and nettle leaf. The firm also produces a product called “Cold BeGone,” which purports to be a complex of natural ingredients.
The products were marketed online and through online marketplaces such as eBay, Amazon and Buy.com, as well as in retail locations.
According to the complaint, the firm’s dietary supplements qualify as unapproved and misbranded drugs in that they claim to treat or prevent a variety of diseases, including cancer, malaria and heart disease, but have never been submitted to the Food & Drug Administration for approval, and have never been found safe and effective for those purposes.
The Star Tribune reported last month that FDA inspections in 2013 and 2014 found 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 issues, according to the complaint.
Last year, the company promised it would make improvements, but the earlier complaint alleges no changes have been made.
Under the terms of the consent decree, the company and its operators – Gordon L. Freeman and Lois A. Dotterweich – are required to cease all production and distribution of the adulterated, unapproved and misbranded products, and to recall their drugs and dietary supplements.
They must also stop the manufacturing and distribution of any dietary supplement or drug and will not be allowed to resume such activities without FDA approval.
District court enters permanent injection against Iowa dietary supplement company and its principals to stop distribution of adulterated dietary supplements [Dept. of Justice]
by Ashlee Kieler via Consumerist
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