On Thursday, Chief Judge Marc Treadwell of the Middle District of Georgia ordered BioAnue Laboratories Inc. and two individuals to submit documentation
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May 7, 2021 On Thursday, Chief Judge Marc Treadwell of the Middle District of Georgia ordered BioAnue Laboratories Inc. and two individuals to submit documentation detailing how they will comply with Food and Drug Administration (FDA) regulations that the court found they were circumventing.
The United States’ 2013 complaint against BioAnue, CEO Gloria Raber, and her husband, Kelly Raber, sought a permanent injunction under the Food, Drug, and Cosmetic Act (FDCA) to restrict the defendants from marketing and selling products through their website that the U.S. characterized as drugs. Products with a drug classification are subject to the FDA’s standards that require approval to be circulated, the U.S. noted; however, these are standards that BioAnue did not meet.