The makers of dietary supplements Jack3d and OxyElite Pro face criminal charges following a Justice Department investigation that alleges key ingredients in the workout boosters were made in a Chinese lab rather than extracted from natural ingredients as claimed.
The 11-count indictment, filed in U.S. District Court for the Northern District of Texas, charges USPlabs, S.K. Laboratory and five company executives with unlawful sale of dietary supplements. It also charges several defendants with conspiracy to commit money laundering, obstructing an FDA proceeding, wire fraud and food mislabeling.
"Regulators, retailers and consumers trusted that the defendants were telling the truth about their products. All of these people were deceived. The deception put lives at risk," said Benjamin Mizer, principal deputy assistant attorney general, at a Nov. 17 press conference announcing the charges.
Touted as workout boosters and weight loss products, the supplements Jack3d and OxyElite Pro contained 1,3 dimethylamylamine, or DMAA, or other ingredients the company claimed were naturally derived from plants, including geraniums or bael, a fruit that grows commonly in India.
But the Justice Department said the two companies conspired with Chinese manufacturers to create a paper trail claiming the ingredients were natural in an effort to ensure U.S. retailers would sell the products, while the substances actually were chemical compounds synthesized in laboratories.
According to court documents, Sitesh Patel, vice president of manufacturing S.K. Laboratory, even joked with USPlabs executives Jacobo Geissler and Jonathan Doyle about the obfuscation in an email.
"Lol. Stuff is completely 100% synthethic [sic]," Patel wrote.
Both products were sold widely online and in retail stores, including at GNC and in military exchanges.
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.
A follow-on investigation found insufficient evidence to prove the supplements caused the deaths, but investigators still decided that the ingredient posed enough of a health risk to keep it off the shelves of military stores.
In 2012, the FDA told companies selling products containing DMAA to stop using the ingredient.
USPlabs voluntarily destroyed $8 million worth of Jack3d and OxyElite Pro after the FDA move. But it then reformulated OxyElite Pro using aegeline, which the company claimed was a natural extract but which court documents say is also a synthetic stimulant.
The company also added another ingredient, labeled as cynanchum auriculatum root extract, to OxyElite Pro to promote weight loss.
Court documents say Geissler and others knew that substance could cause liver damage but believed there wouldn't be enough of the ingredient in the product to cause harm to those who used it.
When the new formula went on the market in October 2013, more than 50 residents of Hawaii, including some military family members, developed acute hepatitis and liver failure. At least one person died and three required liver transplants.
As CDC and FDA began investigating the cause of the hepatitis outbreak, USPlabs sought to sell off its existing supplies of OxyElite Pro, according to the indictments.
"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," Mizer said.
Proponents of stimulants and dietary supplements for workouts often defend their safety, blaming any illnesses or related deaths on failure to follow recommended dosages.
But Dr. Pieter Cohen, a dietary supplements researcher and Harvard Medical School professor who has lobbied for tighter regulations on such products, said USPlabs and S.K. Laboratory are not alone in putting synthetic chemicals in their products that have not been tested on humans.
"It's extremely important that the Department of Justice is moving forcefully to pursue criminal charges against a company that has placed profit ahead of our troops' safety," Cohen said. "Troops should understand that this is typical in the industry, and until the law is changed, there's no way to know if any weight loss or pre-workout supplement is safe."
Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., have pressed for tighter regulation of the supplements industry. On Nov. 17, they vowed to reintroduce legislation to address loopholes that largely allows the industry to self-regulate.
"We will … continue working with all agencies to ensure consumers are better protected," the senators said in a statement. "We commend the Department of Defense for taking meaningful action to educate military personnel, but more needs to be done to protect them from the riskiest dietary supplements — many of which should not be sold on military installations at all."