FDA Sends Warning Letters to DMAA Manufacturers

April 28, 2012 – On Friday, the U.S. Food & Drug Administration (FDA) issued warning letters to 10 manufacturers and distributors of dietary supplements containing dimethylamylamine (DMAA) for failing to submit evidence of the safety of their products. Popular with fitness buffs seeking an edge or weight loss, DMAA has recently been linked to serious side effects including hyperthermia, irregular heartbeats, seizures, heart attacks and strokes. To date, the FDA has received at least 42 adverse event reports associated with DMAA-containing dietary supplements including cases of cardiac disorders, nervous system disorders, psychiatric disorders, and death.

If you or a loved one has been injured by DMAA, you should contact our DMAA lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.

In its warning letters, the FDA stated that it was not aware of any credible scientific evidence to indicate that DMAA is safe to use as directed. Commonly referred to as ‘geranium extract,’ DMAA is often marketed as a ‘natural’ stimulant that provides safe and effective energy. However, the administration warned the companies that synthetically-produced DMAA is not classified as a ‘dietary ingredient,’ and therefore cannot be legally eligible for use as an active ingredient in dietary supplements.

“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated,” said Daniel Fabricant, director of the FDA’s Dietary Supplement Program.

Additionally, the FDA raised concerns that DMAA has been found to narrow blood vessels and arteries, which can lead to side effects such as shortness of breath, hyperthermia, strokes, seizures, and heart attacks. To date, the administration has received at least 42 adverse event reports involving DMAA, including severe psychiatric disorders and even death.

In December, the Army Times reported that the Department of Defense had banned all DMA-containing products on military bases pending a safety review of the controversial ingredient. The action came following the deaths of two soldiers who had heart attacks during routine physical exercises after using DMAA dietary supplements.

According to the FDA, the following firms have 15 business days to respond with specific steps they will take to address the issues in the warning letters:

  • Exclusive Supplements
  • Fahrenheit Nutrition
  • Gaspari Nutrition
  • iSatori Global Technologies
  • Muscle Warfare
  • MuscleMeds Performance Technologies
  • Nutrex Research
  • SEI Pharmaceuticals
  • SNI
  • USP Labs

Do I Have a DMAA or OxyElite Pro Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation.

Our firm is investigating cases involving consumers who suffered liver damage after using OxyElite Pro and USPLabs products containing DMAA or aegeline. We are currently accepting new cases in all 50 states.

Call toll free 1-(949) 557-5800 for a free consultation. You may be entitled to compensation for your injuries and we can help.