The U.S. Justice Department has brought an 11-count indictment against Dallas -based supplement maker USPlabs LLC, and filed five civil suits against other supplement makers. The lawsuits are part of a nationwide sweep of more than 100 supplement makers conducted by DOJ and its federal partners.
Supplements are regulated by the U.S. Food and Drug Administration (FDA) but, unlike drugs, they do not require pre-market approval. Manufacturers are responsible for ensuring that their products are safe, but not all of them do. In fact, many of these products contain undeclared ingredients that pose health hazards for those with certain medical conditions and interfere with prescription medications. And others have been found to contain banned drugs.
These supplements have been linked to dozens adverse health events reported to the FDA such as increased blood pressure, racing heart, liver damage, stroke, seizure and death. During 2014, the agency issued seven recalls and more than 30 public notifications about these products. It also maintains an online list of tainted weight-loss products.
FDA officials say consumers should be wary of products promising a quick fix such as “lose 10 pounds in one week;” those that use the words “guaranteed” or “scientific breakthrough,” those that are marketed in a foreign language or through mass e-mails; and those marketed as herbal or natural alternatives to an FDA-approved drug.
The DOJ’s actions are the result of a year-long effort that began in November 2014. Since then, criminal and civil enforcement actions have been brought against 117 individuals and entities. USPlabs, which makes Jack3d and OxyElite Pro, and several of its corporate officers face criminal charges.
“The Justice Department and its federal partners have joined forces to bringing to justice companies and individuals who profit from products that threaten consumer health,” said Principal Deputy Assistant Attorney General Mizer. “The USPlabs case and others brought as part of this sweep illustrate alarming practices the department found—practices that must be brought to the public’s attention so consumers know the serious health risks of untested products.”
The indictment alleges that by using false certificates of analysis and false labeling and lying about the source of its ingredients, USPlabs engaged in conspiracy. It also alleges that the company sold some of their products without determining if they would be safe to use and with the knowledge that studies had linked the products to liver toxicity.
The indictment further alleges that after OxyElite Pro had been implicated in an outbreak of liver injuriesi n October 2013, USPlabs told the FDA that it would stop distribution of the product but instead tried to sell as much OxyElite Pro as it could as quickly as possible.
“This joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements and products falsely marketed as dietary supplements,” said Deputy Commissioner Sklamberg. “The criminal charges against USPlabs should serve as notice to industry that if products are a threat to public health, the FDA will exercise its full authority under the law to bring justice.”