The U.S. Justice Department has asked a federal judge to reject a request by Hi-Tech Pharmaceuticals Inc. to vacate an order stating that the manufacturer’s DMAA supplements are adulterated.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by DMAA side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the problem?
May 3, 2017 – In a summary order issued last month, U.S. District Judge Willis B. Hunt, Jr., ruled in favor of the U.S. Food & Drug Administration (FDA) and against Hi-Tech when he declared that 1, 3-dimethylamylamine (DMAA) is not a dietary ingredient, and that Hi-Tech’s DMAA-containing supplements are adulterated and subject to seizure.
Jared Wheat, President and principal owner of Hi-Tech, has vowed to file an appeal if Judge Hunt declines to vacate his judgment. Under procedural rules, Hi-Tech and Wheat must file a reply to the Justice Department’s May 1 memorandum before Hunt rules on the company’s motion for reconsideration.
Hi-Tech objected to the U.S. 11th Circuit Court of Appeals’ interpretation of the term “botanical” and what comprises a “constituent” of a botanical under the 1994 Dietary Supplement Health and Education Act (DSHEA); however, the Justice Department argued that the “court applied the canons of statutory construction to give the statutory terms their ordinary meaning.”
First introduced as a nasal decongestant in 1948, DMAA was withdrawn as an approved drug in the 1970s after tests found that the substance was structurally similar to ephedra. Often touted as a ‘natural stimulant,’ supplement manufacturers base this assertion on a highly questionable study from a now-defunct journal claiming it was a derivative of geranium oil.
In 2012, FDA warned supplement manufacturers to remove DMAA from their products. However, Hi-Tech and Wheat have challenged the agency’s position in a drawn out court case that could continue through 2018.
Courts cannot rule in favor of a party on summary judgment unless there are no genuine disputes regarding a material fact. But Hi-Tech’s argument, according to the feds, represents an attempt to put new evidence into the record.
Do I Have a DMAA Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in DMAA lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you were harmed by the effects of DMAA supplement, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.