Three Dietary Supplement Manufacturers Ordered to Halt Operations
Officials with the FDA noted that in past inspections, dating back as far as 2012, they have noticed the dietary supplement products were misbranded because they were being marketed with drug claims despite not being approved for any use.
A US district judge in Colorado has entered a permanent injunction against 3 dietary supplement manufactuers, EonNutra LLC, CDSM LLC, and HABW LLC and their owner, Michael Floren, until they come into compliance with federal laws.
In addition, the products were sold in a retail location in Colorado Springs, Colorado.
Officials with the FDA noted that in past inspections, dating back as far as 2012, they have noticed the dietary supplement products were misbranded because they were being marketed with drug claims despite not being approved for any use. FDA officials noted in a statement that "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."
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 labeling and good manufacturing practices experts, and receive written permission from the FDA to resume operations.
The complaint was filed by the US Department of Justice on behalf of the FDA.
Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations [news release]. Gaithersburg, MD. FDA press office. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm546620.htm. Accessed March 14, 2017.