IOWA
A federal court entered into an agreement with an Iowa dietary supplement company to stop the distribution of adulterated dietary supplements that were advertised as being able to treat and prevent such diseases cancer, malaria and heart disease, according to officials
A U.S. District Court today issued the 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, officials announced.
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 consent decree 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 firm also produces a product called “Cold BeGone,” which purports to be a complex of natural ingredients. Officials claim that 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 federal court at the request of the U.S. Food and Drug Administration alleging that the company’s dietary supplements are manufactured under conditions that are inadequate to ensure the quality of its products, officials said.
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, according to federal officials.
On Aug. 13, officials said the parties filed a consent decree of permanent injunction by which the defendants agreed to settle the litigation.