Hi-Tech Pharmaceuticals Inc. fails to convince a federal judge that FDA bullied it and other firms in ordering DMAA-containing products off the market, but its complaint gives the judge pause about the agency's finding that the stimulant is noncompliant for use in dietary supplements. Judge Willis Hunt in US District Court for the Northern Georgia District on April 3 approved FDA's motion for summary judgement dismissing Hi-Tech's complaint, which the firm filed in 2013 arguing the agency must conduct a rulemaking to ban the use of DMAA – 1,3 dimethylamylamine – in supplements but instead seized its products by exercising an administrative detention order without notice. In his order, the judge said he "credits Hi-Tech’s argument that a botanical can be synthesized in a laboratory without losing its status as a botanical under the Dietary Supplement Health and Education Act," and he is "inclined to find that the Government has failed to meet its burden of establishing that DMAA has not been found in geraniums," as some supplement industry stakeholders argue. However, the judge also said "it is inconceivable that in passing the DSHEA Congress intended for supplement manufacturers to take a chemical that heretofore had only been manufactured in a laboratory and to scour the globe in search of minuscule amounts of that chemical in obscure plants so that they could declare the substance a dietary ingredient under the statute." Norcross, Ga.-based Hi-Tech, which has faced additional regulatory enforcement from FDA and the Federal Trade Commission and including convictions on criminal charges prosecuted by the Department of Justice, said it will ask Judge Hunt to reconsider his decision and will appeal an unchanged decision to federal circuit court. (Also see "Hi-Tech Lawsuit Calls FDA DMAA Enforcement “Bullying Tactics”" - Pink Sheet, 25 November, 2013.)
Hi-Tech DMAA Ruling, Recalls: Health And Wellness Industry News
HiTech Pharmaceuticals will appeal ruling dismissing its complaint against FDA's seizure of its DMAA supplements; and Butala Emporium's Baidyanath brand products and McShare's Premark HS Vitamin RDA Premix are among recent recalls in the dietary supplement sector.
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