A permanent injunction was entered against drug and dietary supplement manufacturers and distributors, EonNutra LLC, CDSM LLC, and HABW LLC, requiring the businesses to immediately cease operations until they come into compliance with federal laws.
The businesses are all owned by Michael Floren, who sold the products in a retail location in Colorado Springs, CO, and on multiple websites. Over the course of 4 visits to Mr. Floren’s businesses, the Food and Drug Administration (FDA) determined that the dietary supplement products were misbranded and unapproved new drugs, as they were being marketed with drug claims despite receiving any such approvals. Some of the products chad claims of treating high cholesterol, hypertension, diabetes, depression, and muscle pain.
The FDA also found the supplements to be adulterated with no specifications for supplement components and failure to test or verify that components and finished products met product specifications for identity, purity, strength or composition—violating the agency’s Good Manufacturing Practice (cGMP) regulations.
“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.”
The injunction was entered by U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado. For Mr. Floren to resume business operations, he must, among other things, recall the company’s dietary supplements, hire labeling and good manufacturing practices experts and receive written permission from the FDA to resume operations.
For more information visit FDA.gov.