As Deaths Mounted, the FDA Dithered in its Probe of Dallas' USPlab's Diet Supplement

If you want nice arm muscles like this man, you should probably just do some old-fashioned exercise.
If you want nice arm muscles like this man, you should probably just do some old-fashioned exercise.

It was over four years ago when agents from the Food and Drug Administration began hearing disturbing complaints about USPLabs, the corporation headquartered in Dallas that sells "nutrition" powder, dietary supplements and other products to bros trying to beef up their builds.

Customers complaining of bad reactions included a 16-year-old who had to go to the emergency room after feeling numb and dizzy. So the FDA did what any powerful government agency would do: They showed up to the company's lab on Manana Drive and investigated, er, "inspected" it, according to an FDA search warrant. (Already not a good sign -- inspections are the friendlier, less hostile cousin of investigations).

The inspection would set off an extremely slow, passive FDA investigation into a company that's made millions in sales. Eventually, three years later, the FDA would recall the company's OxyElite Pro product, worth about $50 million. Then late last year, the FDA's criminal division finally raided the business, seizing more than $1 million from its bank accounts. The criminal investigation into allegations of mail fraud continues.

The raid happened in November 2013, but the search warrant affidavits describing it were made public by the Department of Justice only recently. While the unsealed search warrants attempt to show how hard the FDA has been cracking down on USPLabs, the documents actually tell a different story.

"As a result of the [2010] inspection, USP Labs was cited for failure to comply with FDA's regulations for the legal manufacture of dietary supplements," the FDA's search warrant says. And what exactly happens when a lab is cited for failing to comply with something? Not much, it appears. "During and following the inspection, the firm promised corrective action," the FDA's search warrant says, "but ultimately failed to provide evidence of adequate compliance with FDA manufacturing requirements for dietary supplements." And that was that. USPLabs stayed in business.

See also: Dallas' USPLabs Is Recalling a Bodybuilding Supplement Linked to Hepatitis Outbreak

Two years later, the FDA was on USPLab's case again. A 21-year-old had died from cardiac arrest after taking a USP supplement. So the FDA returned to the lab and conducted another inspection. Sure enough, the FDA found that the company still wasn't complying with its dietary supplement rules. But it still got to stay in business, because, as the FDA explained in its search warrant: "Following inspection, USP promised corrective action on several occasions." It's almost as if dietary supplement companies make promises they don't intend to keep.

There was one substance in particular the FDA was concerned about -- methylhexanamine, or DMAA, a chemical often found in dietary supplements that is illegal because of terrible health risks. The FDA was so concerned about DMAA, in fact, that it sent yet another "warning letter" to USP about it, later in 2012. That didn't seem to scare USPLabs. The following year, the FDA notes, USP continued to market products that contained DMAA, "despite this letter and continued FDA warnings, including another warning letter..."

In late 2013, the FDA finally got the company to destroy its remaining stock of DMAA-containing products, issued a recall and got search warrants for the criminal raid. But that all didn't happen until state officials in Hawaii told the FDA about a cluster of liver failure cases that seemed to be caused by USP's products. "At the time this affidavit was drafted," wrote FDA special agent Chad Medaris in November 2013, over three years since the FDA first looked into the company, "at least 18 individuals have been hospitalized, one individual has received a liver transplant, two more are awaiting transplants, and one individual had died." Great work, everyone.

Send your story tips to the author, Amy Silverstein.


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