- Crackdown on Dietary Supplement Industry Continues as FDA, Other Agencies Take Action against 117 Companies
- December 9, 2015
- Law Firm: Loeb Loeb LLP - Los Angeles Office
- After a yearlong sweep, the FDA, along with several other government agencies, took action against more than 100 dietary supplement makers for tainting or falsely marketing their products. The FDA says the actions should serve as a warning to the rest of the industry that the agency will continue to crack down on manufacturers as it looks to protect consumers.
The FDA, along with other agencies, filed civil injunctions or took criminal actions against 117 dietary supplement makers for falsely marketing dietary supplements, as the result of a yearlong investigation. The investigation was spearheaded by the Department of Justice, with help from the Internal Revenue Service's Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency, as well as the FDA.
Among the charges is a criminal case against USPlabs, a manufacturer of weight loss and workout supplements Jack3d and OxyElite Pro, and several of its corporate officers. The Dallas-based company was served with an 11-count indictment, contending that it took part in a conspiracy to import ingredients from China using false certificates of analysis and false labeling. The indictment states that the company lied about the source and nature of the ingredients after adding them to its products. The company also told retailers and wholesalers that it used natural plant extracts, despite the fact that it was using a synthetic stimulant from China, the indictment states.
The indictment further finds that USPlabs sold some products despite the fact that it knew research had linked the products to liver toxicity. After its product OxyElite Pro was implicated in an outbreak of liver injuries, USPlabs told the FDA it would stop distributing the product, but instead engaged in what the indictment calls "a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible."
In addition to the action taken against USPlabs, the DOJ filed a complaint on behalf of the FDA against Bethel Nutritional Consulting and the company's president and vice president. The complaint, filed in federal court in the District of New Jersey, contends that Bethel and its officers distributed adulterated and misbranded supplements, as well as unapproved new drugs. Under a consent decree of permanent injunction, the company agreed to cease operations until it is in compliance with dietary supplement manufacturing, labeling and distribution laws.
The FDA's deputy commissioner for global regulatory operations and policy, Howard Sklamberg, said the actions should serve as a message to the industry that the agency will continue to crack down on products that are a threat to public health. In the past year, the agency has warned of more than 100 products containing hidden ingredients and has sent warning letters to manufacturers selling BMPEA- and DMBA-containing supplements as well as to makers of pure powdered caffeine products.
Despite the crackdown, experts say stricter controls of the market are needed. Dr. David S. Seres, director of medical nutrition and associate professor of medicine at Columbia University Medical Center, went so far as to call the Dietary Supplement Health and Education Act "one of the worst frauds ever perpetrated on Americans under the guise of protecting their health." Although they disagree on what's needed, experts seem to agree that more tools are needed to bolster DSHEA and the FDA's ability to regulate the market.