Josh Long from Natural Product Insider has the scoop on a dietary supplement manufacturer heading to court to defend the safety of its supplement. USPlabs’ tale begins in 2013 after a physician at a hospital in Honolulu filed a report with the Food and Drug Administration’s MedWatch adverse event reporting program (AER).
Six patients that had used a dietary supplement had suffered liver injuries – enough to necessitate the need for liver transplants – and doctors were alarmed. Half of the patients were first seen by doctors at The Queen’s Medical Center as early as May/June 2013 but the FDA did not learn of the illnesses until early fall, documents filed reported.
The FDA announced USPlabs LLC was recalling OxyElite Pro products sixty-five days after the illnesses were reported to MedWatch. OxyElite Pro was a weight loss dietary supplement and has been linked to an outbreak of hepatitis, causing liver damage.
Another MedWatch report shows OxyElite Pro being referenced in an even earlier report by a physician indicating a patient had been hospitalized for acute liver failure and needed an urgent transplant. The patient had no history of liver problems.
MedWatch’s effectiveness came under fire after the US Centers for Disease Control (CDC) noted that the outbreak tied to OxyElitePro was one of the largest outbreaks of liver disease in the dietary supplements industry to date. MedWatch was launched by the FDA in 1993 in an effort to keep track of supplements once they hit the market.
But MedWatch is a different debate for another post, and it’s time to return to USPlabs.
Now in court following the hepatitis outbreak in 2013, USPlabs seeks to introduce experts to testify that OxyElite Pro was safe for consumers. Their lawyers noted that USPlabs is free to present multiple experts to show that their product was safe and their labels clearly outlined conditions of use.
An earlier 11-count indictment unsealed reports that USPlabs circulated fake documents to hide the source of synethetic chemicals in its dietary supplements. The indictment also cited the use of DMAA (dimethylamylamine), which is a highly-controversial ingredient. DMAA is an amphetamine derivative that shouldn’t be used in dietary supplements, but products containing DMAA are still widely available for purchase in the United States.
USPlabs, their contract manufacturer, S.K. Laboratories, executives, and a Nebraska-based consultant that worked with USPlabs are all named in the indictment.
Lawyers for the defendants are looking to use experts to show that OxyElite Pro was safe. They intend to call several experts to support this position, including medical clinicians; medical records; and the treatment history of patients that were affected.
Earlier this year, USPlabs was named in a wrongful death lawsuit but the suit was dismissed with predjudice after the testimony of experts from the plantiff that wanted to show the dangers of DMAA after a soldier died from taking another USPlabs supplement, Jack3d.
Manufacturers of Dietary Supplements can avoid regulation penalties and woes by instituting a quality assurance system to ensure that their products are manufactured using quality ingredients from qualified vendors. InstantGMP™ MES was designed by ex-Pharmaceutical industry veterans to provide a solution for manufacturers to better understand Good Manufacturing Practices. Be sure to check out the online demo for more information and sign up for a personalized demonstration today! We’ll show you how InstantGMP™ MES can integrate with your existing manufacturing process.