Dallas' USP Labs Is Recalling a Bodybuilding Supplement Linked to Hepatitis Outbreak

Categories: Biz, Drugs

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At this point, it's probably wise, even if you can't bring yourself to forego shady workout supplements completely, to at least steer clear of stuff produced by Dallas-based USP Labs. Over the summer, the Food and Drug Administration forced the company to destroy $8 million worth of product containing dimethlyamylamine, or DMAA, a compound that had been linked to 86 reports of illness and death nationwide. Then, last month, the agency issued a warning that two other USP Labs product, OxyElite Pro and VERSA-1, might be behind an outbreak of non-viral hepatitis in Hawaii.

According to the FDA, 27 of 46 patients hospitalized with acute hepatitis in the state in recent months reported taking OxyElite Pro. Several patients are currently awaiting liver transplants, and one has died. The suspected culprit is a compound called aegeline, a relatively untested ingredient supplement makers have begun using in recent years.

See also: FDA Makes Dallas Supplement Maker Destroy $8 Million Worth of Bodybuilding Powder

USP Labs has steadfastly denied that its products are to blame.

"The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been on the market," it said in October.

Nevertheless, the company stopped distributing the product and, as the FDA announced on Saturday, has agreed to pull OxyElite Pro products from the shelves or face sanctions.

USP Labs has also agreed to reformulate its product and destroy its remaining inventory of aegeline-containing supplements. It explained those decisions in a letter to the FDA last week, which was obtained by USA Today.

See also: The FDA Says a Dallas-Made Bodybuilding Supplement May Be Causing Hepatitis

"Although the company knows of no valid concern about the safety of aegiline or OxyElite Pro, the Company has made the business decision, in light of adverse publicity, to reformulate the product and to discontinue the use of aegeline in The United States," its chief compliance officer wrote.

The FDA's evidence is admittedly circumstantial, but any concerns about couple of dozen people taking the same dietary supplement and mysteriously contracting hepatitis would seem to be quite valid indeed.

Send your story tips to the author, Eric Nicholson.

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2 comments
poppymann
poppymann

The actual costs of that $8m stash probably cost around $150.

TheCredibleHulk
TheCredibleHulk topcommenter

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