Consumer Alert: FDA Investigates Causes of Deaths and Injuries Linked to Jack3d and OxyELITE Pro

The line between “dietary supplement” and “drug” is a fine one. Drugs are subject to FDA approval and regulations; dietary supplements are not. That’s an important distinction when it comes to the health and safety of individuals who opt to take a given substance. And it’s a distinction that often is blurred when it comes to performance enhancing substances that are so appealing to athletes or anyone trying to get in shape. Two of those substances—Jack3d and OxyELITE Pro—have recently come under close scrutiny, bringing to light the inadequacy of the Dietary Supplement Health and Education Act (DSHEA) as well as FDA oversight.

According to an article in the New York Times, the United States Army is investigating whether these types of “dietary supplements” played a role in the death of two soldiers last year. Both died from heart attacks and toxicology reports reveal the presence of dimethylamylamine (DMAA)—the active ingredient in these products—in their blood. Aside from those two deaths, there are also reports of liver and kidney failures, seizures, loss of consciousness and rapid heartbeat from users of DMAA. The evaluation is still ongoing, but In the meantime, the Defense Department has removed all products containing DMAA from stores on military bases. And the FDA is now launching an investigation into both Jack3d and OxyELITE Pro.

Whether DMAA is a supplement or a drug is a debate with manufacturers and retailers on one side and safety advocates on the other. The maker of USPlabs describes the products as supplements derived from naturally-occurring compounds found in plants, producing an effect similar to caffeine. At the same time, organizations like the World Anti-Doping Authority which regulates drug use by Olympic athletes, and several professional sports leagues list DMAA as a banned stimulant. Health experts as well describe DMAA as a powerful stimulant drug similar to amphetamines.

The take-away lesson from all of this is that until the regulatory agencies get their act together, consumers of these products need to be on alert. For now, safety in using DMAA-containing products unfortunately falls on the shoulders of the consumer.