Engredea News  Analysis

Iowa Select Herbs accused of selling adulterated, misbranded supplements

Justice Department files civil complaint after FDA inspection finds Iowa Select Herbs doesn't follow manufacturing standards and falsely claims supplements treat or prevent diseases.

The United States Justice Department on Friday filed a civil complaint in federal court 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 and misbranded dietary supplements, announced principal deputy assistant attorney general Benjamin C. Mizer, head of the Justice Department’s civil division.

Iowa Select Herbs LLC 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 complaint alleges that the company’s dietary supplements are manufactured under conditions that are inadequate to ensure the safety of its products and that the company makes unlawful claims to treat or prevent diseases. The department filed the injunction action in the Northern District of Iowa on behalf of the U.S. Food and Drug Administration (FDA).

“The Department of Justice is committed to ensuring that dietary supplements are manufactured and distributed in compliance with the law,” Mizer said. “We will pursue actions against manufacturers who do not manufacture their products under proper conditions or who make unlawful claims about them.”

According to the complaint, an FDA inspection performed in August 2014 revealed that the company’s dietary supplements are adulterated within the meaning of the federal Food, Drug and Cosmetic Act because they are manufactured, prepared, packed or held in a manner that does not conform to Dietary Supplement Current Good Manufacturing Practices. The complaint alleges, for example, that the company repeatedly failed to test its dietary ingredients to verify their identity before using them. The complaint also alleges 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 the FDA for approval, and have never been found safe and effective for those purposes.

The government is represented by 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.

A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.

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