The Department of Justice and its federal partners is announcing a nationwide sweep and enforcement actions against some dietary supplement makers. More than 100 of those facilities have been investigated in the past year. One of the main reasons for these recalls is that the products contain drugs that have been removed from U.S. markets. Why are these products being sold with unapproved drugs?
This year-long effort focused resources on facilities that sold supplements that contain ingredients other than those listed on the label, or the sale of products that make health claims unsupported by scientific evidence. One of the criminal cases announced charges against USPlabs LLC, maker of OxyElite Pro and Jack3d, along with several of its officers. In 2013, OxyElite Pro was recalled by the FDA because it included Angeline, a synthesized version of a natural extract from the Bael tree, which can cause hepatitis, liver damage, and liver failure. One person died after taking this supplement, and others have needed liver transplants.
The 11-count indictment against USPlabs LLC charges the company and its officers with various counts associated with the unlawful sale of dietary supplements. Other charges include obstruction of an FDA proceeding and conspiracy to commit money laundering.
The indictment 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.” USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called OxyElite Pro and Jack3d, when it was using a synthetic stimulant manufactured in a Chinese chemical factory.
It is also alleged that the defendants sold some of their products without determining whether or not they are safe for human consumption. The indictment notes that the defendants knew of studies that linked the products to liver toxicity.
In October 2013, USPlabs told the FDA it would stop distribution of OxyELite Pro after an outbreak of liver injuries were connected to the product. But, USPlabs “engaged in a surreptitious, all-hands-on-deck effort” to sell as much of that product as they could, according to the indictment.
This is not the first company to have problems with selling dietary supplements that contain undeclared drugs. Food Poisoning Bulletin has told you about these recalls. Most of the recalls of dietary supplements have been for undeclared, unapproved drugs that have been removed from the market and used illegally in these products.
In 1962, Congress passed a law that all manufacturers showed that their drug products were effective and safe. But dietary supplement makers are not regulated by the FDA and their products are only removed from the market after a problem is discovered.
Five civil cases were also filed last week against some businesses and individuals who allegedly sold supplements as disease cures or that were in violation of law. They are against Vibrant Life, Viruxo, Optimum Health, Bethel Nutritional Consulting, Sunrise Nutraceuticals, Health Nutrition Products, NPB Advertising, Inc., and Regency Worldwide.