FDA accuses Colorado Springs dietary supplement maker of … – Colorado Springs Gazette

EonNutra shared this location in the 3500 block of North El Paso Street in central Colorado Springs. Image via Google Maps.

A Colorado Springs manufacturer and distributor of dietary supplements has agreed to cease operations after being accused by the U.S. Food and Drug Administration of marketing products as drugs without the agency's approval.

Michael Floren, the owner of EonNutra LLC, CDSM LLC and HABW LLC, sold numerous products on several websites, and also in a Colorado Springs retail location, according to court filings and an FDA news release.

Products sold by Floren's companies were marketed with claims that they could address health problems such as high cholesterol levels and high blood pressure, diabetes, depression and muscle pain. But by making such claims, Floren's companies effectively were marketing their products as drugs because they establish "that the products are intended to cure, mitigate, treat, or prevent diseases," the FDA said.

"Legally speaking, only drugs can make those claims and they have to go through the FDA approval process," said Lyndsay Meyer, an FDA spokeswoman. That process includes numerous steps such as clinical trials and evidence of safety and efficacy for the problem being targeted for treatment, she said.

The FDA inspected Floren's businesses - which shared a location in the 3500 block of North El Paso Street in central Colorado Springs - four times since 2012.

"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," the FDA said in a news release.

Also, the FDA said Floren's companies committed "numerous violations of the agency's current Good Manufacturing Practice regulations for dietary supplements," 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."

Some supplements also were 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."

Despite Floren's assurances that he would resolve the problems, FDA follow-up inspections revealed that he "repeatedly failed to make the necessary corrections," according to the agency.

Last week, the FDA sued Floren and his companies in U.S. District Court in Denver, seeking to shut down his businesses. On Monday, U.S. District Judge Marcia S. Krieger entered a court order, in which the FDA and Floren agreed that his businesses "would immediately cease operations until they come into compliance with federal laws."

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

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FDA accuses Colorado Springs dietary supplement maker of ... - Colorado Springs Gazette