Final defendant pleads guilty in Hawaii liver injuries case

The case involved now defunct sports supplement manufacturer USP Labs.  The company sold a product called OxyElite Pro that contained an illegal ingredient called aegeline.  The ingredient was linked to 29 cases of acute non-viral hepatitis in Hawaii in 2013​​.  There were a reported 11 hospitalizations, two cases that required liver transplants and one death associated with the sale of the product.

Final tally of injuries topped 50, NIH says

According to the LiverTox database​​ maintained by the National Institutes of Health, OxyElite Pro has been associated with more than 50 cases of liver damage. 

“Aegeline is a derivative of the fruit and other components of the bael tree and is a commonly used herbal agent in Southeast Asia, employed in Ayurvedic medicine for digestive complains.  The ingredient responsible for liver injury is unknown and cases of acute liver injury have not been previously reported with aegeline use.  The aegeline used in OxyELITE Pro implicated in liver injury, however, was a synthetic product produced in China and may have included contaminants, synthetic precursors or metabolic derivatives or racemic forms of the chemical that are toxic or immunogenic,”​ the LiverTox entry states.

Citing a legal resource called Westlaw Next Practitioner Insights, Reuters reported that federal prosecutors on Wednesday secured a guilty plea from the final defendant in the long-running case.

Matthew Hebert, one of the company’s owners who was also responsible for product packaging design at USPlabs, pleaded guilty in federal court in Dallas to a charge related to his role in shipping a supplement whose label falsely described a key ingredient.

Final disposition welcomed

Natural Products Association chief Dan Fabricant, PhD, was head of the Division (now Office) of Dietary Supplement Programs at FDA at the time of the Hawaii outbreak.

“It was my case when I was at FDA.  It took a while but I’m happy with the final disposition,” ​Fabricant told NutraIngredients-USA.

“Anyone who says the laws aren’t there or that they don’t work, they just need to look at this. FDA used a lot of authorities in this case,”​ he said.