Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal viola

Dietary supplement products "misbranded" and unapproved new drugs being marketed with drug claims despite not being approved for any use.

US District Judge Marcia S. Krieger for the US District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring Floren's businesses to immediately cease operations until they come into compliance with federal laws.

"Companies that market their products with unproven health claims and 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 FDA inspected Floren's businesses, which shared a location, four times since 2012. Despite assurances from Floren that the deficiencies noted during the inspections would be corrected, follow-up FDA inspections revealed that Floren repeatedly failed to make the necessary corrections.

Over the course of the inspections, the FDA determined Floren's dietary supplement products to be misbranded and unapproved new drugs because they were being marketed with drug claims despite not being approved for any use. Some of the claims Floren's dietary supplement products were marketed with included the treatment of high cholesterol, hypertension, diabetes, depression and muscle pain.

During the inspections, FDA investigators also found Floren's businesses were manufacturing and distributing misbranded and adulterated dietary supplements. Numerous violations of the agency's current Good Manufacturing Practice (cGMP) regulations for dietary supplements were found, including failure to establish specifications for dietary supplement components and failure to test or verify that components and finished products meet product specifications for identity, purity, strength or composition. Because Floren's businesses failed to follow cGMP regulations, their dietary supplements are adulterated under the Federal Food, Drug, and Cosmetic Act. Some of the supplements were also misbranded because Floren's businesses failed to properly list on the products' label the number of servings per container and the correct serving size per container. Additionally, they failed to list each ingredient contained in the dietary supplements and identify the part of the plant each botanical dietary ingredient was derived from.

The consent decree prohibits Floren and his businesses from marketing misbranded or unapproved new drugs and adulterated or misbranded dietary supplements. Before Floren and his businesses can resume operations, they must, among other things, recall their dietary supplements, hire labelling and good manufacturing practices experts and receive written permission from the FDA to resume operations.