FDA Sweeps Dietary Supplements to Protect Consumers

FDA Announces Results of Nationwide Sweep of Dietary Supplements

On November 17, 2015, FDA published a news release, announcing “the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements.”

Background

In partnership with five other agencies, FDA participated in the government’s dietary supplement search. Led by the Department of Justice (DOJ), this was an effort to protect consumers against dietary supplements that could be dangerous. In addition to the DOJ and FDA, the Agencies involved include:

  1. Internal Revenue Service’s (IRS) Criminal Investigation Division
  2. Federal Trade Commission (FTC)
  3. U.S. Postal Inspection Service
  4. Department of Defense (DOD)
  5. U.S. Anti-Doping Agency (USADA)

The outcome of the sweep was announced last week, stating that “the sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.”

Indictment of USPlabs LLC

In its press release, FDA announced a criminal case charging USPlabs LLC and several of its corporate officers with a number of charges related to the sale of the company’s products.

USPlabs is a Dallas, Texas-based company, known for its popular workout and weight loss supplements, such as Jack3d and OxyElite Pro. According to the press release, on the same day that the Agency made its announcement, “FDA and IRS special agents seized assets in dozens of investment accounts, real estate in Texas, and a number of luxury and sports cars.” Also on that day, the defendants were arrested by (or surrendered to) the U.S. Marshal’s Service.

The indictment includes 11 counts and 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.
  • “Sold some of their products without determining whether they would be safe to use.”
    • The indictment also notes that the defendants were aware of studies linking the company’s products to liver toxicity.
  • “Told the FDA in October 2013 that it would stop distribution of OxyElite Pro, once the product had been implicated in an outbreak of liver injuries.”
    • The indictment states that, despite the company’s promise, it continued to engage in an “all-hands-on-deck effort” to sell as much of the product as quickly as possible.

FDA Warning Letters

Over the past year, FDA has warned consumers about the risks associated with more than 100 over-the-counter (OTC) products that contain hidden active ingredients and are being falsely marketed as dietary supplements. Including the product ingested by Lamar Odom prior to his recent collapse (details in our FDA News article here), a majority of these products are marketed for sexual enhancement, weight loss, and body building. A full list of these products/ingredients is available here.

In addition, FDA has also issued warning letters to companies selling dietary supplements that contain BMPEA and 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.”

For more details on the dietary supplement sweep, view FDA’s press release here.

Are you in the process of developing a dietary supplement? Do you have a supplement that you’re looking to verify is compliant with all FDA regulations? We can help. Using our proprietary approach, which combines deep scientific knowledge with extensive regulatory expertise, we have helped numerous clients achieve successful outcomes with FDA. To learn more about our services and how we can help you, contact us today.