Federal officials announced this week a nationwide crackdown on more than 100 dietary supplemental manufacturers resulting in the filing of criminal and civil proceedings against these defendants after a year-long investigation.
The dietary supplement is causing concern among health officials throughout the country, officials said.
In each case, the department or one of its federal partners allege the following: “the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.”
Among the cases announced 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.
The sweep includes federal court cases in 18 states.
“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 Deputy Assistant Attorney General Benjamin 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.”
During the period of the sweep, 117 individuals and entities were served with criminal and civil enforcement actions. Of these, 89 cases were filed in November 2014.
The FDA continues to warn consumers about the risks associated with some over-the-counter products, falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful, officials said.
In the last year, the agency has warned of more than 100 products found to contain hidden active ingredients. These products are most frequently marketed for sexual enhancement, weight loss and body building, according to authorities
“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 for Global Regulatory Operations and Policy Howard Sklamberg of the Food and Drug Administration “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.”
Within the last year, officials said the FDA also sent warning letters to manufacturers selling dietary supplements that contain BMPEAand DMBA, two ingredients that do not meet the statutory definition of a dietary ingredient as well as to several companies selling pure powdered caffeine products that the agency determined to be dangerous and present a significant or unreasonable risk of illness or injury to consumers.
Criminal Matters
- An 11-count indictment was unsealed Tuesday against USPlabs LLC, a Dallas firm, which formerly manufactured highly popular workout and weight loss supplements.
- The indictment charges USPlabs, S.K. Laboratories Inc., based in Anaheim, California, and their operators with a variety of charges related to the sale of those products.
- Jacobo Geissler, 39, of University Park, Texas, 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, Florida, the quality assurance executive in charge of compliance at USPlabs S.K. Laboratories Inc
- Sitesh Patel, 32, of Irvine, California, the vice president of S.K. Laboratories
- Cyril Willson, 34, of Gretna, Nebraska, a consultant to USPlabs, are charged with various counts associated with the unlawful sale of dietary supplements.
- Additionally, USPlabs, Geissler, Doyle and Hebert are charged with obstruction of an FDA proceeding and conspiracy to commit money laundering.
Four of the defendants were arrested Tuesday and the other two will self-surrender. Along with the arrests, FDA and IRS-CI special agents seized assets in dozens of investment accounts, real estate in Texas and a number of luxury and sports cars, according to officials.
The defendants are presumed innocent until proven guilty.
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 it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use.
The indictmen notes that the defendants knew of studies that linked the products to liver toxicity.
The indictment also alleges that in October 2013, USPlabs and its principals told the FDA that it would stop distribution of OxyElite Pro after the product had been implicated in an outbreak of liver injuries.
The indictment alleges that 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.
The charges and allegations in the indictments are merely accusations, and the defendants are presumed innocent unless and until proven guilty.
Civil Cases
The Department of Justice also filed in the past week five civil cases seeking injunctive relief against a number of businesses and individuals that allegedly sold supplements as disease cures or that were otherwise in violation of the law.