USPlabs Initiates Recall of OxyElite Pro

DALLASUSPlabs LLC initiated a recall of certain OxyElite Pro dietary supplement products, after the FDA exercised its recall authority under the Food Safety Modernization Act (FSMA), notifying the company that the products are suspected to be adulterated. If USPlabs did not voluntarily recall the products, FDA stated in its Nov. 6 letter that it could order a stop to all distribution.

"We took this step to ensure that adulterated and harmful products do not reach the American public," said Michael R. Taylor, deputy commissioner for foods and veterinary medicine. "We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public."

Products involved in the recall include different SKUs of OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder. The complete list of affected products is available on the FDA website.

FDA's Nov. 6 letter to USPlabs explained the agency has reviewed medical records submitted by the Hawaii Department of Health, indicating 27 patients had taken an OxyElite Pro supplement prior to diagnoses with liver illnesses; one death has occurred among those patients, another has had a liver transplant and others are awaiting liver transplants. Hawaii's health department first raised the red flag on OxyElite Pro in September, publicly stating it was investigating a possible connection between use of the supplements and liver illnesses. While the majority of cases have been seen in Hawaii, FDA added other cases of liver damage after use of OxyElite Pro products have been reported from other states.

Concerns with OxyElite Pro have been high profile for many months. In July, the company voluntarily destroyed more than $8 million in OxyElite Pro and Jack3d supplements that contained DMAA (1,3-dimethylamylamine); USPlabs said it had not produced the DMAA-containing version since early 2013. In October, FDA sent a warning letter to USPlabs regarding OxyElite Pro and VERSA-1, which the agency considered to be adulterated as they contain aegeline, a new dietary ingredient (NDI) with no history of use or safety. In that letter, the agency noted failure to cease distribution of supplements containing aegeline could result in enforcement action.