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Monday, June 24, 2024 | Back issues
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Supplement Maker Accuses FDA of Bullying

WASHINGTON (CN) - A diet supplement maker sued the U.S. Food and Drug Administration, claiming the FDA is intimidating the industry to try to stamp out the stimulant DMAA.

Hi-Tech Pharmaceuticals sued the FDA in Federal Court, claiming the agency bypassed standard rule-making procedures in favor of a bullying campaign to try to force companies to destroy their products containing dimethylamylamine, or DMAA.

DMAA was originally sold as a nasal decongestant. It has effects similar to speed, or methamphetamines, according to scientific literature. It has been blamed for several deaths, according to lawsuits, and for heart attacks, according to the FDA.

Hi-Tech Pharmaceuticals denies it.

"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 the drug 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.

But the FDA calls DMAA a dangerous stimulant, particularly when combined with caffeine.

"DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers," the agency said in a statement in June. "Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack. Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market."

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 evidence regarding DMAA and its safety."

According to both the FDA and Hi-Tech, multiple companies are acquiescing to the agency's demands, destroying millions of dollars worth of their products. USPLabs destroyed its DMAA products such as OxyElite Pro and Jack3d - worth more than $8 million - according to the FDA.

Hi-Tech says it responded to an FDA warning letter with scientific studies supporting the safety of DMAA, only to receive a detention order from the agency.

"In July of 2013, under continuing FDA pressure, USPLabs 'voluntarily' destroyed $8 million worth of DMAA containing products," Hi-Tech says in the lawsuit.

Hi-Tech says it wants the "FDA's campaign of intimidation" stopped by the court, and that "if the agency has scientific evidence which brings the safety of DMAA into question, that it disclose same and engage in the formal rule making process to ban the ingredient."

Hi-Tech is represented by Jack Wenik of Sills Cummis & Gross in Newark, N.J.

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