Supplement industry lauds DOJ action against false claims, unlisted ingredients

WASHINGTON — The Department of Justice on Tuesday indicted more than 100 manufacturers of illegal supplements masquerading as dietary supplements in a move welcomed by the mainstream dietary supplement industry. In each case, the DOJ or one of its partners allege that companies sold supplements with ingredients not listed on the label or sold supplements making scientifically unsupported health or treatment claims.

 

The efforts that led to the indictments began in November 2014, according to the DOJ, and in May of this year, the Council for Responsible Nutrition reached out to the agency with concerns that companies breaking the law were damaging the credibility of reputable companies and presenting a risk to public health.

 

“We are grateful to the Department of Justice, the U.S. Food and Drug Administration, the Federal Trade Commission and other government agencies for taking an important step today toward protecting consumers and responsible dietary supplement companies by taking strong enforcement actions against companies that do not follow the laws and put consumers at risk,” CRN president and CEO Steve Mister said.

 

Other industry organizations were also appreciative of the DOJ’s efforts. 

 

“These illegal products are a major threat to public health and hurt the credibility of the legitimate dietary supplements industry,” Scott Melville, president and CEO of the Consumer Healthcare Products Association, said. “CHPA has long supported efforts of law enforcement and regulators to crack down on rogue manufacturers who threaten public health and defraud consumers," he said. 

 

One of the cases announced today was an 11-count indictment against Dallas-based USPLabs — known for its workout and weight loss supplements, which it sold under such names as Jack3d and OxyElite Pro — and several of its top executives. 

 

Indictments include USPLabs’ CEO Jacobo Geissler, president Jonathan Doyle and packaging designer Matthew Herbert — all of whom are charged with obstruction of an FDA proceeding and conspiracy to commit money laundering. Those charges are in addition to various others that affect USPLabs, one of the company’s quality assurance executives and a consultant, as well as S.K. Laboratories’ VP Sitesh Patel. 

 

The indictment alleges that USPlabs conspired to import ingredients from China using false certificates of analysis and false labeling, and then lied about the source and nature of those ingredients once they were in the products.  According to the indictment, USPlabs told some of its retailers and wholesalers that Jack3d and OxyElite Pro used natural plant extracts despite actually 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.  In fact, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity. Additionally, the DOJ 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, but actually engaged in a surreptitious effort to sell as much OxyElite Pro as it could as quickly as possible, selling it at dietary supplement stores nationwide.

 

Four of the defendants were arrested earlier today and the other two will self-surrender, the DOJ reported.  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.

 

As part of the sweep, the DOJ is working with the Department of Defense and the U.S. Anti-Doping Agency. The joint efforts are aimed at assisting service members targeted by illegitimate athletic supplements and unveiling new tools to increase awareness of the risks posed by unlawful dietary supplements. 

 

As part of these efforts, the Uniformed Services University of the Health Sciences’ Consortium for Health and Military Performance partnered with the USADA to develop educational resources for service members to protect them from risky dietary supplements. The tools include an online educational module and two mobile apps — HPRC’s Operation Supplement Safety High-Risk Supplement List mobile application for Service members and USADA’s Supplement 411 mobile application for athletes.

 

“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 Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy 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.”

 

Beyond USPLabs, the DOJ, U.S. Attorney’s Offices and the FTC have brought 25 civil actions since November 2014. Courts have entered judicial orders requiring supplement makers to change their practices and ensure their products are compliant with the law. 

 

To read about some of the cases brought by the DOJ, click here.