The Department of Justice, in concert with the Food and Drug Administration (FDA) and several other federal agencies, have begun a series of civil and criminal charges against 117 makers and sellers of muscle-building and fat-burning supplements. Many of the charges involve fraud or conspiracy with claims that the ostensibly “natural” products were in fact synthetic and, in some cases, toxic.
One of the largest single cases was an 11-count indictment against Texas-based USPLabs and S.K. Laboratories, its manufacturing and marketing arm, which were charged with conspiracy to commit wire fraud, obstruction of an agency proceeding, and conspiracy to introduce misbranded food, among other offenses. Both current and former executives of the companies have been indicted.
Specifically, the indictments of USPLabs revolved around its bestselling “Jack3d” and “OxyElite Pro” workout and weight loss supplements. The criminal charges claim that USPLabs told retailers that the products were made from plant extracts when in fact the company was importing synthetic ingredients from China to produce them and used false certificates of analysis, false labeling, and outright lying to hide the origin and nature of the components.
Among the more lurid elements of the Department of Justice’s claims is the description of a reckless and almost freewheeling atmosphere in which defendants from S.K. Laboratories self-tested products and sold the ones that made them feel good without performing any safety or efficacy tests.
More concerning is how USPLabs is accused of handling its OxyElite Pro. Charges claim that this product was sold despite testing for safety and in face of evidence that it was potentially toxic. OxyElite Pro was heavily implicated in a 2013 outbreak of liver failure and non-viral hepatitis that saw 56 people sickened, one killed, and others requiring liver transplants. At the time, USPLabs had agreed to stop distributing the product but the recent charges claim they did just the opposite. The FDA asserts that the company instead engaged in an “all-hands-on-deck” effort to sell as much OxyElite Pro as fast as possible.
If convictions result from these charges, it will be a huge blow to the $40 billion nutritional and diet supplement industry. These products are not technically considered drugs and so the FDA has limited power to regulate them. The ease of which supplement manufacturers can evade FDA oversight is one of the reasons behind multiple agencies becoming involved with the charges.
Other companies targeted by the joint-agency action include Bethel Nutritional Consulting Inc., which is accused of distributing unapproved drugs and adulterated dietary supplements with unapproved ingredients known to cause events ranging from strokes to heart attacks.
Sources for Today’s Article:
Bartz, D., “U.S. Files Criminal Charges against Sellers of Jack3d, Other Supplements,” Reuters web site, November 17, 2015; http://www.reuters.com/article/2015/11/18/us-doj-investigation-dietarysupplements-idUSKCN0T628320151118#O7iqywOgS24iArp2.97.
“FDA Takes Action to Protect Consumers from Potentially Dangerous Dietary Supplements,” U.S. Food and Drug Administration, November 17, 2015; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473099.htm.
Gibson, K., “U.S. Says Supplements Billed as Natural Can Be Toxic,” CBSNews web site, November 17, 2015; http://www.cbsnews.com/news/dietary-supplement-stocks-fall-before-u-s-crackdown/.
Golshan, T., “USPlabs Charged in Money Laundering, Wire Fraud Case,” USA Today web site, November 18, 2015; http://www.usatoday.com/story/news/2015/11/17/supplements-charges-justice-investigation/75943252/.
O’Keefe, M., et al., “Feds Flex Muscle with Indictment of Supplement Makers,” NY Daily News web site, November 18, 2015; http://www.nydailynews.com/sports/i-team/feds-flex-muscle-indictment-supplement-makers-article-1.2438645.
Young, A., “Firm Reformulates Sports Supplement in Wake of Outbreak,” USA Today web site, November 6, 2013; http://www.usatoday.com/story/news/nation/2013/11/06/usplabs-reformulating-oxyelite-pro-and-discontinuing-use-of-aegeline/3459235/.