Update: Feds ask Judge to Reject Hi-Tech’s Motion in DMAA Lawsuit
May 3, 2017 – The U.S. Justice Department has asked a federal judge to deny a request by Hi-Tech Pharmaceuticals Inc. to vacate an order stating that the manufacturer’s DMAA supplements are adulterated. In a summary order issued last month, U.S. District Judge Willis B. Hunt, Jr., ruled in favor of the FDA and against Hi-Tech and its CEO and principal owner Jared Wheat when he declared that DMAA is not a dietary ingredient, and that Hi-Tech’s DMAA-containing supplements are adulterated and subject to seizure.
What is DMAA?
DMAA is an amphetamine-like stimulant drug that was an ingredient in over 200 supplements used for bodybuilding and weight-loss. The most popular products are Jack3d and OxyElite Pro, which were manufactured by USPLabs, LLC, in Dallas, Texas.
DMAA may be listed on product labels as:
- Geranium extract, leaf, stem, or other part of geranium plant
- Perlargonium graveolens extract
- 4-methyl- (9CI)
Is DMAA Safe?
No, the FDA does not have information demonstrating that DMAA is safe. Because it was sold as a “dietary supplement,” manufacturers were never required to provide evidence of safety or efficacy before it was allowed on the market.
Drug-makers like USPLabs, LLC cite many studies that supposedly demonstrate safety, but all of these studies were conducted on small patient populations — less than 100 people total, many of whom were taking placebos — and most patients were only monitored for a few hours. After reviewing “evidence” linking DMAA to the geranium plant, the FDA called the studies contradictory, unreliable, deficient, and inconsistent.
Where Did DMAA Come From?
DMAA (methylhexanamine) was originally approved as a nasal decongestant drug in the 1940s by Eli Lilly & Co., but no medical use is approved today. According to a Washington Post investigation in 2006, DMAA was re-introduced by Patrick Arnold, a chemist convicted of trafficking steroids and making “designer drugs” for professional athletes in the BALCO sports-doping scandal. He trademarked DMAA as “Geranamine” and sparked a craze in the bodybuilding scene for a new stimulant drug.
FDA Cracks Down on DMAA
The U.S. Food and Drug Administration (FDA) has concluded that DMAA is a synthetic drug that has no link to the geranium plant and is illegal in dietary supplements. They started cracking down on supplements in 2012, shortly after the Department of Defense banned DMAA on military bases. The FDA sent Warning Letters to several manufacturers. The largest manufacturer, USPLabs, continued selling OxyElite Pro and Jack3d in stores like GNC and online for another year. In June 2013, the FDA announced that $8 million worth of Jack3d and OxyElite Pro were destroyed.
DMAA Side Effects
- Elevated blood pressure
- Increased heart rate
- Irregular heart rhythm
- Hyperthermia (dangerously elevated body temperature)
- Cardiac arrest
- Heart attack
- Sudden cardiac death
- Heart failure
- Kidney failure
- Nervous system disorders
- Psychiatric disorders
Do I have a DMAA Class Action Lawsuit?
The Product Liability & Dietary Supplement 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 cases in all 50 states.
Free DMAA Class Action Lawsuit Evaluation: Again, if you or a loved one was injured by DMAA, you should contact our law firm immediately. You may be entitled to compensation by joining a DMAA class action lawsuit or by filing a DMAA personal injury lawsuit, and we can help.