The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter.
“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”
By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of several OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.
In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58%, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63%) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.
In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the U.S. before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.
In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.
Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.
If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, their healthcare provider can submit a report by calling the FDA’s MedWatch hotline at 1-800-FDA-1088 or by reporting it online. The MedWatch program allows healthcare providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.
Consumers can contact USPlabs at 800-890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or email@example.com.