Hi-Tech Challenges FDA's Ban on Ephedra, Opposes Motion to Dismiss

ATLANTA - Hi-Tech Pharmaceuticals recently replied to the FDA's motion to dismiss its lawsuit challenging the agency's ban on ephedra, saying that because a Utah judge previously reversed and remanded the Final Rule back to the FDA for further rulemaking, it is currently invalid and does not apply to Hi-Tech. Hi-Tech Pharmaceuticals Inc. v. FDA, et al. No. 05-cv-2083 (N.D. Ga.).

Hi-Tech - a manufacturer of ephedra-containing dietary supplements such as Lipodrene - alleges that the FDA's Feb. 11, 2004, 'Final Rule Declaring Dietary Supplement Containing Ephedrine Alkaloids Adulterated Because They Present An Unreasonable Risk' became invalid on April 13, …