November 18, 2017

Permanent Injunction Closes Dietary Supplement Makers

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, to prevent the distribution of “adulterated and misbranded dietary supplements and unapproved and misbranded drugs.” The Department alleges that the defendants, who sell about 150 dietary supplement products, violated the Federal Food, Drug, and Cosmetic Act.

Gavels

Several of those products were labeled as dietary supplements, but were marketed as drugs. The company claimed that the product could help treat or prevent diseases such as “heart disease, diabetes, depression, hypertension, osteoporosis, and liver and kidney disorders.” According to the complaint, the defendants offered these claims to the public without FDA approval. Some of the specific products identified as unapproved drugs were 4NOx2, HGH Night Time, rHGH Drops Black Label, Primal Rage Levo 5 GH Mass and Deer Antler Velvet Extract. And the company sold those supplements without implementing procedures to validate their composition.

Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division said in a statement, “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. 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 alleges that the defendants marketed some of their products as drugs through disease-related treatment claims even though these products were not approved by the FDA. In addition, the FDA repeatedly warned the company, but they continued to post statements on their websites claiming that their products “cured, mitigated, treated, or prevented a number of serious diseases.” These claims were unsupported by any well-controlled clinical studies or other credible scientific substantiation.

The products also did not contain directions for these uses. The complaint also said 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.”

The complaint also alleges that the products were not manufactured in compliance with federal good manufacturing practice regulations. Dietary supplement manufacturers must ensure that their products meet specifications for identity, purity, strength, and composition. A 2016 FDA inspection of the manufacturing facility revealed that the defendants did not establish specifications for these products or the components in them, or prepare and follow their manufacturing plant.s Many of the labels on the supplements were deficient, according to the complaint, and caused the products to be misbranded. For example, some of the labels did not list all of the product’s 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. If they want to start manufacturing supplements in the future, they must implement remedial measures set forth in the consent decree, notify the FDA, and obtain written approval from the FDA that they are in compliance.

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