In addition to the arrests, FDA and IRS agents seized assets in numerous investment accounts, along with real estate in Texas as well as a number of sports and luxury cars, the agency said.
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During a November 17 press conference announcing the charges, Benjamin Mizer, principal deputy assistant attorney general, said, “Regulators, retailers and consumers trusted that the defendants were telling the truth about their products”.
The criminal indictment, which was unsealed this week, alleges an elaborate conspiracy by Dallas-based USPlabs, along with its California-based manufacturer SK Laboratories, to sell “natural” supplements that were actually laced with synthetic chemicals from China.
In 2012, the FDA told companies selling products containing DMAA to stop using the ingredient. The supplements had $400 million in sales between 2008 and 2013, according to the indictment. However, the indictment says that USPlabs engaged in an “all hands-on-deck effort” to sell as much OxyElite Pro as it could as quickly as possible.
The Defense Department removed products containing DMAA, including Jack3d, from base stores and on-base GNCs in 2013 after the supplements were implicated in the deaths of at least two soldiers who suffered heart attacks during physical training.
“While none of the recent allegations made against USPlabs relate to the current formulations of any of its products and we have no reason to believe that there are any health and safety issues with respect to any USPlabs products now sold by GNC, it is in the best interest of our customers to suspend the sale of the company’s products pending further review”, stated Michael Archbold, GNC CEO.
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 NY and New Jersey and the company’s president and vice-president.
The multibillion dollar herbal supplements industry is built on the promise that its products will improve the health and well-being of those who use them.
Manufacturers have to adhere to certain labeling requirements, such as including the name of the manufacturer, a list of ingredients and identifying the product as a “supplement”. Claire McCaskill of Missouri sent a letter to more than a dozen companies asking executives to explain how they vet dietary supplements and weed out products making false claims. Sibutramine was an active pharmaceutical ingredient in Meridia, a drug approved by the FDA in 1997 for prescription treatment of obesity. These include, but are not limited to, drugs commonly used to treat depression and migraine.
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The FDA continues to warn consumers about the risks associated with a few over-the-counter products, falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful. These products are most frequently marketed for sexual enhancement, weight loss, and body building. This latest round of enforcement represents inter-agency action in conjunction with the FDA, FTC and the U.S. Anti-Doping Agency and the joint agency crack down on the sale of illegal, misbranded or tainted dietary supplements.
