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Hi-Tech Pharmaceuticals Sues The FDA For "Bullying Tactics"
Date:11/18/2013

ATLANTA, Nov. 18, 2013 /PRNewswire/ -- Hi-Tech Pharmaceuticals sued the FDA November 5th, 2013 in Federal Court- Case 1:13-cv-01747, claiming the agency bypassed standard rule-making procedures in favor of a bullying campaign to try to force companies to destroy their products containing 1,3 dimethylamylamine, or DMAA.  "DMAA has existed in the food supply for many years," the complaint states. "Hi-Tech has sold over a million bottles of dietary supplement products containing this ingredient without any adverse event reports."

Hi-Tech calls DMAA a natural constituent of the geranium plant. It claims that geraniums are used in salads and its oil as a flavoring. "No less than four published, peer-reviewed scientific studies have confirmed the presence of DMAA in the geranium plant. Large, established reputable laboratories such as Cantox Health Sciences International have confirmed the presence of DMAA in the geranium plant," the complaint states.

Hi-Tech claims the FDA's efforts to eradicate DMAA from the market exceeds its authority and violates the Administrative Procedures Act.  "Under the pretext that DMAA-containing products pose a danger to consumers, the FDA has engaged in a campaign of intimidation against dietary supplement companies like Hi-Tech who include this ingredient in their products," Hi-Tech says in its lawsuit. "For some companies this has taken the form of warning letters and pressure by the FDA to remove and destroy DMAA containing products. In the case of Hi-Tech, the FDA has issued an administrative detention order against numerous proprietary dietary supplement products without notice, essentially removing millions of dollars in goods from the marketplace."

Hi-Tech adds: "By its own admission, the FDA has declined to engage in the rule making process necessary to formally ban DMAA. Thus there has been no public discussion or comment regarding the scientific e
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SOURCE Hi-Tech Pharmaceuticals, Inc.
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