Lawmakers Probe DMAA, USPlabs, GNC

WASHINGTONMembers of the House Committee on Energy and Commerce are investigating the safety of an amphetamine derivative FDA believes is an illegal substance in dietary supplements and that is the subject of a wrongful-death lawsuit.

The leaders of the House's Subcommittee on Oversight and Investigations have asked FDA for documents and communications related to dimethylamylamine (DMAA), which is commonly promoted for building muscle and improving performance.

FDA has received 86 "adverse event reports" that associate DMAA-laden products with death and illnesses including heart problems and psychiatric disorders, according to a consumer safety alert.

Although FDA has cautioned the reports don't prove the stimulant caused the health problems, the agency has warned companies using DMAA it believes the substance is illegal. All but one of the companies that have received the warning letters agreed to stop distributing dietary supplements containing DMAA.

The only exception was USPlabs, which submitted published studies that challenged FDA's conclusions, the agency said in the consumer alert.

In a letter to FDA Commissioner Margaret Hamburg, lawmakers said USPlabs continues to market its product Jack3d, which contains DMAA, and General Nutrition Centers, Inc. (GNC) is still selling it.

Last month, USPlabs announced plans to remove DMAA from its products.  In a press release, the company maintained the substance is legal and safe as a dietary supplement but noted it was making the change for business reasons.

"Despite being among the most studied ingredients ever with 11 published peer-reviewed clinical and analytical studies," USPlabs declared, "the FDA has urged the industry to discontinue the use of 1, 3 DMAA in dietary supplements." 

Laura Brophy, a spokeswoman for GNC, on Thursday reitterated what it has previously noted: "pending a recall order on the products from the FDA, GNC will continue selling what inventory we have left of the USPlabs product."

"GNC has no reason to believe that DMAA is unsafe," she said in an emailed statement. "GNC, as a responsible retailer, does not sell products that contain substances banned by the FDA or that have been recalled by the FDA."

Brophy also said GNC will respond to the lawmakers' letters.

Jack Deschauer, a spokesman for USPlabs, did not immediately respond Thursday to an emailed request for comment.

Earlier this year, the parents of a deceased soldier who ingested Jack3d filed a wrongful-death lawsuit in California state court against USPlabs and GNC. The lawsuit said 22-year-old Michael Sparling collapsed in 2011 during a moderate workout with his unit and died several hours later of respiratory failure and cardiac arrest, according to The New York Times.

USPlabs and GNC have been accused of deceptively marketing Jack3d as safe and effective, failing to warn consumers of the potential health risks. Andrews & Thornton, a law firm handling the matter on behalf of the plaintiffs, was not immediately available Thursday to comment on the status of the case. GNC said it doesn't comment on pending litigation, and USPlabs hasn't responded to requests for comment.

More than a year ago, the Times reported that the U.S. Army was investigating whether DMAA played a role in the deaths of two soldiers. The article referenced the deaths of a 32-year-old and a 22-year-old who collapsed during a training runpossibly referring to Sparling. In December 2011, the Department of Defense implemented a temporary moratorium on sales of products containing DMAA, citing the deaths of two soldiers and other medical problems linked to the substance.