Permanent Injunction Closes Two Dietary Supplement Makers

The U.S. District Court for the District of Colorado has entered a permanent injunction against EonNutra LLC, two associated businesses, CDSM LLC and also HABW LLC, along with their proprietor to avoid the supply of “adulterated and misbranded nutritional supplements and unapproved and misbranded drugs.” The Department alleges the defendants, who sell about 150 nutritional supplements, violated the Federal Food, Drug, and Cosmetic Act.

A few of the products were labeled as dietary supplements, but have been marketed as drugs. The company asserted that the product could help cure or prevent ailments such as “cardiovascular disease, diabetes, obesity, hypertension, depression, hypertension, and liver and kidney disorders.” According to the complaint, the defendants offered these claims to the general 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 also the firm sold those nutritional supplements without implementing procedures to confirm 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 to ensure consumers can be sure from the claims of vendors of drugs and nutritional supplements.   Manufacturers need to guarantee the high quality and identity of these ingredients that go into their products, so that these products are safe for both consumers and the people can depend on the integrity of these products.”

The complaint claims that the defendants marketed some of the products as drugs via disease-related treatment claims although these products weren’t accepted by the FDA. Additionally, the FDA repeatedly warned the company, but they chose to post statements on their own sites claiming that their products “treated, falsified, treated, or prevented a number of serious ailments.” These claims were unsupported with any well-controlled clinical trials or other plausible scientific substantiation.

The products also did not include directions for these uses. The complaint also stated the “directions for usage, including doses, warnings, and side effects, must be premised on clinical data derived from scientifically controlled evaluation, and because the defendants persisted in creating disease-related treatment claims regarding their products in the absence of any well-controlled scientific evaluation data, the products were misbranded.”

The complaint also alleges that the products weren’t manufactured in compliance with federal good manufacturing practice regulations. Dietary supplement manufacturers have to ensure that their products meet specifications for identity, purity, potency, and composition. A 2016 FDA review of the manufacturing facility revealed that the defendants did not establish specifications for these products or the elements inside them prepare and follow their manufacturing plant.s a lot of the labels about the nutritional supplements were deficient, according to the complaint, also caused the products to be misbranded. By way of instance, a few 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 begin manufacturing supplements in the future, they have to implement remedial measures set forth in the consent decree, notify the FDA, and obtain written approval from the FDA that they’re in compliance.

source http://revivelifesupplements.com/permanent-injunction-closes-two-dietary-supplement-makers/