FDA Sweep of Dietary Supplements Spurs Criminal Charges

More than 100 dietary supplement manufacturers and distributors are facing civil injunctions and criminal actions following an FDA sweep of potentially unsafe or tainted supplements.

One of the 117 companies involved in the year-long sweep is USPlabs LLC, which pharmacists and consumers may recognize for its workout and weight-loss products called Jack3d and OxyElite Pro, for example.

The Texas-based company was indicted on 11 counts on November 17, 2015, and the defendants were arrested, according to a FDA press release. In addition to the arrests, agents seized investment accounts, real estate, and several luxury cars.

The indictment accuses USPlabs of importing ingredients from China and using fake certificates of analysis and false labeling. The company is also accused of false information about the source and ingredients on labels. For example, USPlabs allegedly referred to a synthetic stimulant manufactured in a Chinese chemical factory as “natural plant extracts” to some retailers and wholesalers.

The FDA press release also noted that USPlabs is accused of distributing products while knowing that some of their products were linked with liver toxicity.

Despite the fact that USPlabs told the FDA that it would stop production back in October 2013, the indictment alleged that the company instead focused its efforts in selling as much product as soon as possible.

In the past, the FDA told consumers not to use some USPlabs products that contained aegeline, because the ingredient has been linked to severe cases of acute liver failure or non-viral hepatitis.

“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, FDA’s deputy commissioner for global regulatory operations and policy, in a press release. “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 protect Americans and bring justice.”

In addition to USPlabs, the sweep also involved complaints against Bethel Nutritional Consulting Inc, which is accused of distributing adulterated and misbranded dietary supplements and unapproved new drugs.

Some of the dietary supplements contained harmful ingredients such as sibutramine and locaserin.

Bethel Nutritional Consulting will cease operations due to a consent decree of permanent injunction.

In the past year, the FDA has issued warnings about more than 100 products, often promoted for sexual enhancement, weight loss, and bodybuilding.

The investigations were led by the US Department of Justice and involved the FDA, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the US Postal Inspection Service, the Department of Defense, and the US Anti-Doping Agency.