Colorado supplement firm shut down over repeated GMP failures
The injunction was entered in the US District Court for Colorado on a consent decree with EonNutra LLC, CDSM LLC, and HABW LLC, manufacturers and distributors of what the Food and Drug Administration (FDA) maintains are unapproved drugs and dietary supplements, and their owner, Michael Floren. Floren was required to immediately cease operations. Attempts to contact to Floren to see if he intends to take the steps necessary to come into compliance with federal laws and resume business were unsuccessful.
"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."
Pattern of noncompliance
According to the FDA statement that announced the injunction, Floren’s businesses were inspected four times starting in 2012. Floren sold what appear to have been primarily sports nutrition products on four websites and at a retail location in Colorado Springs, CO. Each time inspectors found deficiencies in the inspections and, despite assurances that these deficiencies would be corrected, they never were, according to the agency. The injunction announcement made no mention of any warning letters having been issued to Floren or his businesses, and no warning letters connected could be located on FDA’s database.
During the course of the inspections, FDA said it 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 said its 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.
Ignoring FDA gets agency’s attention
Observers in the dietary supplement industry often remark that enforcement actions like this involve fringe companies they’ve never even heard of. That would most likely be the case here. Attorney Ivan Wasserman, a partner in the firm Amin Talati Upadhye LLC, said that it’s not necessarily a case that FDA only goes after the small players who don’t have big war chests with which to defend themselves. Like many law enforcement officials, FDA officers don’t like to be lied to.
“I think they will go after companies of any size that won’t do what they are told,” Wasserman told NutraIngredients-USA. “FDA doesn’t like to be ignored or disobeyed.”
Wasserman said an injunction is a relatively rare step when taken as a subset of the thousands of companies in the industry. It's one the agency resorts to when it becomes apparent the company (or companies, as in this case) doesn’t intend to comply, he said.
“It’s almost always because they didn’t clean up their act. If they think you are not going to comply then they go get a court involved,” he said.
Among the things Floren would have to do if he intended to re-enter the dietary supplement industry would be to hire labeling and good manufacturing practices experts and receive written permission from the FDA to resume operations. It’s impossible to say how many of the relatively few companies that have received these type of permanent injunctions then do successfully come into compliance and resume business, but the number must be very small. In addition to the above steps, Floren would also have to recall all of the products that have been distributed thus far.
“I don’t think FDA believes that will happen, that he will recall those products. It’s more a case that he should not be able to continue to profit from his ill gotten gains,” Wasserman said.