Hi-Tech Pharmaceuticals Moves Forward with DMAA Appeal After Failed Mediation

The owner of Hi-Tech Pharmaceuticals Inc. said he is moving forward with an appeal of a federal court’s decision in a years-long civil dispute with FDA after mediation talks failed to bear fruit.

By Josh Long

Jared Wheat, the owner of Hi-Tech Pharmaceuticals Inc., a manufacturer of dietary supplements recently indicted on criminal charges, said he is moving forward with an appeal of a federal court’s decision in a years-long civil dispute with FDA after mediation talks failed to bear fruit.

U.S. District Judge Willis B. Hunt Jr. ruled in April that DMAA is an illegal ingredient in dietary supplements. Wheat later filed a notice of appeal with the U.S. Court of Appeals for the Eleventh Circuit. Hi-Tech and the federal government held brief mediation talks early last week to try to resolve the years-long court battle, but the discussions may have been doomed from the get-go in light of recent developments in an unrelated criminal proceeding.

“Mediation was not fruitful, and we are speeding up the briefing schedule to get to a resolution one way or another,” Wheat advised INSIDER via email.

An 18-count criminal indictment filed against Wheat and his Georgia-based company likely frustrated efforts to reach a settlement with the federal government. Wheat noted mediation was held on the morning of Oct. 24 and only lasted 15 to 20 minutes by phone.

“[W]e had all preliminarily decided it was a waste of time due to” charges by the government related to red yeast rice and DHEA, Wheat explained.

In a phone interview with INSIDER following his arrest, Wheat described the criminal charges as “bogus.” For instance, he asserted products listed in the indictment contain only DHEA (dehydroepiandrosterone) compounds excluded from the Controlled Substances Act. He also noted his Choledrene product was labeled as containing monacolin K, the compound in red yeast rice that is chemically identical to lovastatin. Red yeast rice supplements, he added, are available widely, including through big box retailers.

None of the charges in the grand jury’s superseding indictment mention DMAA. The ingredient gained popularity in sports supplements before FDA cracked down on it amid reports of serious adverse events, including death, linked to products containing the substance.

DMAA’s controversial history dates to at least 2012, when FDA warned several companies in letters that the ingredient was illegally on the market in dietary supplements and hadn’t been shown to be safe.

“DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers,” FDA asserted in a 2013 online posting, linking to its warning letters. “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.”

All the companies that received a warning letter—including eventually USPlabs LLC, a dietary supplement manufacturer now facing criminal charges—withdrew their DMAA-containing supplements from the market.

Hi-Tech didn’t receive a warning letter. FDA, nonetheless, administratively detained the company’s DMAA-containing products in 2013. Hi-Tech sued FDA, claiming the agency unlawfully bypassed rulemaking procedures that were used by FDA to ban ephedra in dietary supplements.

“If they sent me a warning letter and they were correct, which they did … 15 years ago for using the term(s) 'erectile dysfunction' and 'obesity,' then I changed what I needed to,” Wheat observed during an interview in late September (see video above) at SupplySide West in Las Vegas before he was arrested on the criminal charges. “But if they send me a warning letter and they’re incorrect, then I’m going to push back, which we did. When we went to court [in the DMAA case] their first move was to try to dismiss the case by saying warning letters are not final agency action, so they don’t actually stand by their warning letters.”

In his April ruling, Hunt Jr. held DMAA doesn’t belong in supplements, and Hi-Tech’s products containing DMAA were adulterated. After Hi-Tech’s motion for reconsideration was denied by the judge, the company filed a notice of appeal with the Eleventh Circuit.

In an Oct. 24 email to INSIDER, Wheat said he anticipated the opening brief would be filed with the appeals court within two weeks. Then, the Department of Justice (DOJ) will have 30 days to file its response brief before Hi-Tech is afforded an opportunity to file a reply brief.

FDA and DOJ declined to comment.

Asked what he wanted to achieve by continuing to litigate the DMAA matter, Wheat expressed hope FDA would “actually get their evidence right” before sending a warning letter.

“I also hope to keep the consumers’ access to products that do help you lose weight like DMAA on the market,” he added during the SupplySide West interview.

Wheat insisted DMAA is safe. Hi-Tech has received no serious adverse event reports related to the ingredient, he said. He’s only aware of such adverse events as feelings of dizziness and being lightheaded, which he compared to a person who has consumed too much coffee.

Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP), declined to comment on the appeal. However, he said the agency’s position on DMAA has been consistent.

“FDA’s position is that DMAA is not a lawful dietary ingredient,” Tave said in an interview at SupplySide West. “It should not be in dietary supplements. Products that contain DMAA are in violation of the law.”

The sale of DMAA is on the radar of federal prosecutors. Last week, four Chinese companies and several of their employees were indicted by a Dallas grand jury for charges related to the intended sale of mislabeled DMAA, including fraud, smuggling and obstruction. And in a separate announcement in July by federal prosecutors, a judge sentenced a dietary supplement executive to prison in a case related to DMAA. According to the U.S. Attorney's Office for the Middle District of Florida, Derek Vest of Gentech Pharmaceutical authorized the use of DMAA in various supplements, but he failed to disclose the presence of the ingredient on the product labeling for the tablets. 

 

TAGS: Litigation
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