Hi-Tech Lawsuit Calls FDA DMAA Enforcement “Bullying Tactics”
This article was originally published in The Tan Sheet
Executive Summary
Hi-Tech Pharmaceuticals files a lawsuit in federal court after receiving an administrative detention order from FDA to stop distributing its DMAA-containing products. The firm argues FDA should conduct a rulemaking to propose banning DMAA rather than ordering firms to stop using it.
You may also be interested in...
As Hi-Tech Argues For DMHA Use, DMAA Seizure Falls In FDA's Criminal Case, Contempt Stands In FTC Complaint
Hi-Tech Pharmaceuticals granted motion in federal court to have $19m in seized DMAA products returned, though the order noted sales of the products are prohibited. As Hi-Tech seeks court order that FDA is wrong about DMAA, an appellate court upholds $40m contempt fine against firm in FTC complaint.
Hi-Tech Tangles With FDA Again: Plans Litigation To Keep DMHA Available
Hi-Tech Pharmaceuticals says it will "continue to supply its customers with DMHA-containing products until there is a final, judicial determination." Firm, currently appealing a ruling upholding a previous FDA action, says DMHA "is a stimulant compound naturally found in Walnut Bark extract" and walnuts "are the oldest tree food known to man."
Hi-Tech CEO Wheat Arrested In FDA Investigation Of Steroid-Spiked Supplements
Hi-Tech Pharmaceuticals CEO Jared Wheat and an associate face 18 criminal charges in federal court alleging they falsified FDA documents and distributed as supplements products containing steroid ingredient. Wheat is appealing the indictment to federal circuit court.