In response to dozens of acute hepatitis and liver failure cases associated with diet drug OxyELITE Pro, the FDA threatens to use its detention power and has issued warning letters to USPlabs, the Texas-based manufacturer of the dietary supplement. Threatened with federal enforcement action to stop distribution, USPlabs finally agreed to recall the entire OxyELITE Pro line on November 9, 2013.
The FDA’s authority to regulate dietary supplements like OxyELITE Pro is relatively limited because manufacturers do not need FDA approval to sell dietary supplements. Therefore, the FDA generally bears the burden of proving a supplement is unsafe before taking action to limit its use or remove it from the market. However, the law requires distributors or manufacturers of supplements with “new dietary ingredients” to provide the FDA with adequate safety information. Last month, the FDA issued a warning letter to USPlabs regarding OxyELITE Pro and VERSA-1, another dietary supplement used for weight loss and/or muscle gain. The FDA informed USPlabs that OxyELITE Pro and VERSA-1 are considered adulterated drugs because they contain aegeline, an ingredient for which USPlabs failed to provide evidence of safety. The FDA warned,
“Failure to immediately cease distribution of all products containing aegeline may result in enforcement action by FDA without further notice.”
The FDA will supervise the destruction of all lots of OxyELITE Pro products, including warehouse stock valued at over $20 million. Further, the Hawaiian Department of Health (DOH) continues to work with the FDA and CDC in its investigation of liver failure associated with OxyELITE Pro. The DOH has asked retailers with recalled OxyELITE Pro products to voluntarily surrender the inventory for proper disposal and destruction.
Daniel Fabricant, PhD, Director of the FDA’s Division of Dietary Supplement Programs, credits the new enforcement tools provided by the Food Safety Modernization Act with the prompt nationwide response to the liver failure outbreak. Fabricant and his colleagues strive to “continue to use our new authorities, as appropriate, to make sure that the supplements you take will not put you in the hospital.”
Andrews and Thornton encourages patients and loved ones who have been affected by OxyELITE Pro, VERSA-1, or any other dietary supplement to contact us for a free case evaluation at www.andrewsthornton.com or toll free at 1-800-644-1734.