Iowa Select Herbs LLC, a Cedar Rapids, Iowa-based dietary supplement company, and its principals are facing a federal enforcement action for allegedly distributing adulterated and misbranded dietary supplements.
According to a complaint filed in the Northern District of Iowa, 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 company 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 also make unlawful claims to treat or prevent diseases.
Principal Deputy Assistant Attorney General Benjamin C. Mizer stated, ?The Department of Justice is committed to ensuring that dietary supplements are manufactured and distributed in compliance with the law.? We will pursue actions against manufacturers who do not manufacture their products under proper conditions or who make unlawful claims about them.?
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 that the company repeatedly failed to test its dietary ingredients, in order 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.
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.
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.
Mandatory Facts:
- Defendant: Iowa Select Herbs LLC
- Criminal Charges: Distribution of Adulterated and Misbranded Dietary Supplements
- City and State: Cedar Rapids, Iowa
- Exact Date: August 2014
- Sentence or Outcome: Ongoing case
- Dollar Amounts: No amounts mentioned
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Key Facts
- State: Iowa
- Category: Drug Trafficking|Fraud & Financial Crimes|Violent Crime
- Source: DOJ Press Release â†â€â€
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