Seven federal agencies, led by the U.S. Department of Justice (DOJ), have announced joint civil and criminal actions against more than 100 makers and marketers of potentially dangerous dietary supplements, which one official compared to modern-day versions of “snake oil salesman and medical quacks.” The agencies went public Tuesday, Nov. 17, 2015, with some unsealed federal court indictments, with the top among them being the bestselling supplement manufacturer USPlabs LLC. The Dallas-based company is known for muscle and weight loss supplements, such as Jack3d and OxyElite Pro. “As alleged in the indictment unsealed today, the defendants were on a perpetual search for the next miracle ingredient,” said Benjamin C. Mizer, principal deputy assistant attorney general. “That search generally focused on Chinese chemical manufacturers.” Mizer said that when USPlabs found a promising ingredient, it would doctor the packaging, labeling, and other paperwork in order to defraud the public. “Much of the alleged fraud focused on the defendant’s claims that their products were made from natural plant extracts,” Mizer said in a press conference on Tuesday. “In truth, as one defendant put it, ‘LOL, [the] stuff is completely, 100% synthethic.’” Actions the agencies announced Tuesday have generated federal court cases in 18 states and involve criminal and civil litigation against at least 117 individuals and entities. The “sweep,” as DOJ calls it, involves personnel from the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), U.S. Postal Inspection Service (USPIS), Internal Revenue Service (IRS), Department of Defense (DOD), and the U.S. Anti-Doping Agency. USPlabs is named in an 11-count indictment, along with Anaheim, CA-based S.K. Laboratories Inc. Arrests warrants or self-surrender arrangements have occurred for Jacobo Geissler, 39, of University Park, TX, the CEO of USPlabs; Jonathan Doyle, 37, of Dallas, the president of USPlabs; Matthew Hebert, 37, of Dallas, responsible for product packaging design at USPlabs; Kenneth Miles, 69, of Panama City, FL, the quality assurance executive in charge of compliance at USPlabs; S.K. Laboratories Inc.; Sitesh Patel, 32, of Irvine, CA, the vice president of S.K. Laboratories, and Cyril Willson, 34, of Gretna, NE, a consultant to USPlabs. They are all charged with various counts associated with the unlawful sale of dietary supplements. Additionally, USPlabs, Geissler, Doyle and Hebert are charged with obstruction of a FDA proceeding and conspiracy to commit money laundering. FDA and IRS special agents seized assets in dozens of investment accounts, real estate in Texas, and a number of luxury and sports cars, DOJ stated. 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 putting them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products, such as Jack3d and OxyElite Pro, when it was actually using a synthetic stimulant manufactured in a Chinese chemical factory. Charges are also being made that the defendants sold some of their products without determining whether they would be safe to use and that the defendants knew of studies linking their products to liver toxicity. The indictment further alleges that, in October 2013, USPlabs and its principals told FDA that it would stop distribution of OxyElite Pro after the product had been implicated in an outbreak of liver problems. However, 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, according to the indictment. FDA stated Tuesday that the agency had warned consumers not to use certain USPlabs products found to contain a new dietary ingredient not shown to be safe. That ingredient, aegeline, is a synthetic version of an alkaloid which comes from a tree that grows in Asia, the agency added. “In addition, the product had adverse events linked to acute liver failure or non-viral hepatitis so severe that several patients needed liver transplants, and one resulted in death,” FDA noted.
(To sign up for a free subscription to Food Safety News, click here.)