116 3rd St SE
Cedar Rapids, Iowa 52401
FDA files lawsuit against dietary supplement store in Cedar Rapids
Trish Mehaffey Jul. 14, 2015 3:25 pm, Updated: Jul. 14, 2015 4:01 pm
CEDAR RAPIDS - A civil complaint was filed in federal court against Iowa Select Herbs LLC, in Cedar Rapids, claiming the company is misbranding dietary supplements that could be unsafe.
An injunction was filed Friday by the U.S. Justice Department, on behalf of the U.S. Food and Drug Administration in U.S. District Court, to stop the company and its president and CEO Gordon L. Freeman and partial owner Lois A. Dotterweich, from manufacturing and selling the supplements from their store at 2347 Blairs Ferry Road, Suite 2, as well as over the Internet.
According to the suit, the company manufactures and distributes a variety of dietary supplements, consisting primarily of extracts from various plants, including papaya leaf, Echinacea, elderberry and nettle leaf. Iowa Select also produces a product, 'Cold BeGone,” which claims to be a complex of natural ingredients. The owners told investigators they distribute 197 dietary supplements.
The complaint alleges the dietary supplements are manufactured under conditions that are 'inadequate to ensure the safety” of its products and also make claims to treat or prevent diseases.
According to the complaint, an FDA inspection performed in August 2014 showed that the company's supplements do not conform to federal law because of the way they are manufactured, prepared or packed. For example, the complaint claims the company repeatedly failed to test its dietary ingredients, in order to verify their identity, before using them.
The complaint also contends the dietary supplements qualify as 'unapproved and misbranded” drugs because they claim to treat or prevent a variety of diseases, including cancer, malaria and heart disease. However, none of them have been submitted to the FDA for approval, and have never been found safe and effective for those purposes.
Gavel. (MGN)

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