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Bogus Supplements Sold in Colorado
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Washington – A federal judge in Colorado has issued a permanent injunction against EonNutra LLC, its related companies CDSM LLC and HABW LLC, and their owner, Michael Floren, to stop the sale and distribution of adulterated and misbranded dietary supplements and unapproved and misbranded drugs, the Justice Department announced today.
The U.S. District Court for the District of Colorado entered the injunction after the Justice Department filed a complaint on March 10, alleging that the defendants, who sell some 150 dietary supplement products, violated the Federal Food, Drug, and Cosmetic Act (FDCA).
According to the complaint, the defendants marketed several of their products as drugs through a series of disease-related treatment claims, even though these same products had not received FDA approvals. The defendants continued to post statements on their websites claiming that their products cured, mitigated, treated, or prevented a number of serious diseases, despite repeated warnings from FDA.
The complaint alleged that the defendants’ products did not contain adequate directions for such uses, and that the directions for use, including dosages, warnings, and side effects, must be premised on clinical data derived from scientifically controlled investigation. However, the defendants persisted in making disease-related treatment claims about their products in the absence of any well-controlled scientific test data, rendering the products misbranded.
Additionally, the complaint alleged that the defendants’ products were adulterated dietary supplements because they were not manufactured in compliance with federal good manufacturing practice regulations. A 2016 FDA inspection of the defendants’ manufacturing facility revealed that the defendants failed to establish specifications for the identity, purity, strength, and composition of their finished products.
‘Lying to the public so you can make money is a bad idea,’ said Acting U.S. Attorney for the District of Colorado Bob Troyer. ‘Doing it in a way that jeopardizes their health and safety is a REALLY bad idea. We have a long history in the West of not tolerating snake-oil salesmen.’
The FDA and the Justice Department will continue to work together to ensure that consumers can be confident in the claims of sellers of drugs and dietary supplements. ‘Manufacturers need to ensure the quality and identity of the ingredients that go into their products, so that such products are safe for consumers and the public can rely on the integrity of those products,’ said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division.
Key Facts
- State: Colorado
- Category: Drug Trafficking|Fraud & Financial Crimes|White Collar Crime
- Source: DOJ Press Release â†â€â€
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