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Monday, August 17, 2015

District Court Enters Permanent Injunction against Iowa Dietary Supplement Company and its Principals to Stop Distribution of Adulterated Dietary Supplements

The U.S. District Court for the Northern District of Iowa today entered a consent decree of permanent injunction against Iowa Select Herbs LLC, of Cedar Rapids, Iowa, its president and CEO, Gordon L. Freeman, and a partial owner, Lois A. Dotterweich, to prevent the distribution of adulterated dietary supplements, announced Principal Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.

Iowa Select Herbs manufactures and distributes a variety of 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 company and its owners marketed their products online and through online marketplace websites, such as eBay Inc., Amazon.com Inc. and buy.com.  They also sold their products through a retail location in Cedar Rapids. 

The department filed a complaint in the Northern District of Iowa at the request of the U.S. Food and Drug Administration (FDA) alleging that the company’s dietary supplements are manufactured under conditions that are inadequate to ensure the quality of its products.  The complaint also alleged that 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 FDA for approval, and have never been found safe and effective for those purposes. 

On Aug. 13, the parties filed a consent decree of permanent injunction by which the defendants agreed to settle the litigation.  The consent decree was entered by the court today and requires the defendants to cease all production and distribution of the adulterated, unapproved and misbranded products, and to recall their drugs and dietary supplements.  Further, the defendants have agreed to cease the manufacture and distribution of any dietary supplement or drug and will not be allowed to resume such activities without FDA approval.

The government is represented by Trial Attorney Heide L. Herrmann of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel for Enforcement Laura Akowuah of the Department of Health and Human Services’ Office of General Counsel-Food and Drug Division and Assistant U.S. Attorney Jacob Schunk of the Northern District of Iowa.

Consumer Protection
Updated August 18, 2015