Pharmaceutical

Colorado dietary supplement companies ordered to stop selling unapproved drugs

dietary supplements pills probiotics Colorado dietary supplement companies ordered to stop selling unapproved drugsA group of dietary supplement manufacturers based in Colorado were found in violation of federal laws and ordered to cease operations by U.S. District Judge Marcia S. Krieger for the U.S. District Court of Colorado.

EonNutra LLC, CDSM LLC, and HABW LLC, , and their owner, Michael Floren, were hit with a decree of permanent injunction for manufacturing and distributing unapproved drugs and dietary supplements and selling them through numerous websites including www.sotosupplements.com, www.deerantlermax.com, www.warhorselabs.com, www.primalragenutrition.com and www.dnnutrition.com. The products were also sold in a retail store in Colorado Springs, Colorado.

The complaint was filed by the U.S. Department of Justice on behalf of the Food and Drug Administration (FDA).

“Companies that market their products with unproven health claims and also continue to violate manufacturing regulations put consumers’ health in jeopardy,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “The FDA will take the enforcement actions necessary to protect consumers from this undue risk.”

FDA officials inspected Floren’s businesses four times since 2012, noting deficiencies in following current Good Manufacturing Practices as well as violations of the Federal Food, Drug and Cosmetic Act. The company said it would correct the deficiencies but repeatedly failed to do so.

During inspections, the FDA found that the companies did not establish specifications for dietary supplement components and failed to test or verify that components and finished products met specifications for identity, purity, strength or composition, rendering the supplements adulterated. Some of the products were misbranded because they failed to properly list on the products’ label each ingredient contained in the dietary supplement and identify the part of the plant each botanical dietary ingredient was derived from.

Source: FDA