Products found to contain undeclared medicines
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| The United States: FDA takes action to protect consumers from potentially dangerous dietary supplements, including Jack3d and OxyElite Pro |
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The U.S. Food and Drug Administration, in partnership with other government agencies, announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro.
An 11-count indictment was unsealed earlier against USPlabs, a Dallas, Texas company that formerly manufactured highly popular workout and weight loss supplements. The indictment charges USPlabs, S.K. Laboratories Inc. and their operators with a variety of charges related to the sale of those products. The indictment alleges that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleges that USPlabs and its principals told the FDA in October 2013 that it would stop distribution of OxyElite Pro, once the product had been implicated in an outbreak of liver injuries. The indictment alleges that, despite this promise, USPLabs engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible. It was sold at dietary supplement stores across the nation.
Also as part of the sweep, the DOJ announced it filed a complaint in federal court in the District of New Jersey, on behalf of the FDA, against Bethel Nutritional Consulting Inc. of New York and New Jersey and the company’s president and vice-president. According to the complaint, Bethel and its officers distributed adulterated and misbranded dietary supplements and unapproved new drugs throughout the United States. Additionally, certain tainted products falsely marketed as dietary supplements by Bethel contained potentially harmful active pharmaceutical ingredients, including sibutramine and lorcaserin.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm473099.htm
In Hong Kong, Jack3d and OxyElite Pro are not registered pharmaceutical products, and there is no registered pharmaceutical product manufactured by USPLabs, S.K. Laboratories Inc or Bethel Nutritional Consulting Inc. Related news on OxyElite Pro has been issued by various overseas drug regulatory authorities, and was posted on the Drug Office website between 2011 and 2013.
Ends/ Wednesday, November 18, 2015
Issued at HKT 13:00
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