Hi-Tech Lawsuit Calls FDA DMAA Enforcement “Bullying Tactics”
This article was originally published in The Tan Sheet
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.
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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 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.