District Court Enters Permanent Injunction Against Colorado Companies to Stop Distribution of Adulterated And Misbranded Dietary Supplements and Unapproved and Misbranded Drugs
The U.S. District Court for the District of Colorado has entered a permanent injunction against EonNutra LLC, two related companies, CDSM LLC and HABW LLC, and their owner, Michael Floren, to prevent the sale and distribution of adulterated and misbranded dietary supplements and unapproved and misbranded drugs, the Justice Department announced today.
The Department filed a complaint on March 10 in the U.S. District Court for the District of Colorado, alleging that the defendants, who sell some 150 dietary supplement products, violated the Federal Food, Drug, and Cosmetic Act (FDCA). Although labelled as dietary supplements, several of the defendants’ products were, according to the complaint, marketed as drugs, with claims that the products could help treat or prevent a host of serious conditions or diseases, including heart disease, diabetes, depression, hypertension, osteoporosis, and liver and kidney disorders. But, according to the complaint, the defendants offered these claims to the consuming public, notwithstanding the absence of FDA approval. Some of the specific products identified in the complaint as unapproved drugs were 4NOx2, HGH Night Time, rHGH Drops Black Label, Primal Rage Levo 5 GH Mass and Deer Antler Velvet Extract. Additionally, as the complaint alleges, the defendants sold these supplements without implementing the requisite procedures to validate the supplements’ composition.
“The Department of Justice will continue to work cooperatively with FDA so that consumers can be confident in the claims of sellers of drugs and dietary supplements,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “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.”
The complaint alleged that 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 complaint further alleges that, despite repeated warnings from FDA, the defendants continued to post statements on their websites claiming that their products cured, mitigated, treated, or prevented a number of serious diseases. According to the complaint, these claims were unsupported by any well-controlled clinical studies or other credible scientific substantiation. In addition, the complaint alleges that the defendants’ products did not contain adequate directions for such uses. The complaint continued that directions for use, including dosages, warnings, and side effects, must be premised on clinical data derived from scientifically controlled investigation, and since the defendants persisted in making disease-related treatment claims about their products in the absence of any well-controlled scientific test data, the products were misbranded.
In addition to claims related to sales of unapproved drugs, the complaint further alleges that the defendants’ products were adulterated dietary supplements because they were not manufactured in compliance with federal good manufacturing practice regulations. Under the FDCA, dietary supplement manufacturers are required to have systems in place to ensure that their products meet specifications for identity, purity, strength and composition. According to the complaint, a 2016 FDA inspection of the defendants’ manufacturing facility revealed, among other things, that the defendants failed to establish specifications for the identity, purity, strength, and composition of their finished products or the components in their products, or prepare and follow their manufacturing plans. The complaint also alleges that many of the labels on the defendants’ supplements were deficient, and caused the products to be misbranded under the FDCA. The complaint alleges, for example, that some of the defendants’ supplement labels did not list all of the products’ ingredients, indicate the correct serving size, or indicate the number of servings in a bottle.
The defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction. The consent decree requires that if the defendants wish to resume manufacturing drugs or dietary supplements in the future, they must implement the remedial measures set forth in the consent decree, notify the FDA of the measures they have taken, and obtain written approval from the FDA that they appear to be in compliance with both the terms of the consent decree and the provisions of the FDCA.
“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.”
This matter was handled by Trial Attorney Christopher O’Connell of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant U.S. Attorney Jacob Licht-Steenfat of the U.S. Attorney’s Office for the District of Colorado and Senior Counsel Michele Svonkin of the U.S. Department of Health and Human Services’ Office of General Counsel.
For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of Colorado, visit its website at https://www.justice.gov/usao-co.