USPlabs LLC of Texas is recalling some OxyElite Pro dietary supplements products because they have been linked to liver illnesses. The FDA states that there is a “reasonable probability” that the products are adulterated. FDA also said that if the company didn’t initiate a voluntary recall, FDA could be law order the company to stop distributing the supplements.
This is the second time FDA has exercised its recall authority under the Food Safety Modernization Act of 2011. A warning letter was sent to the company in October 2013.
You can see details of the recalled products at the FDA web site. The products include OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, and OxyElite Pro Super Thermo Powder in many sizes. The products are linked to a number of liver illnesses reported among consumers in Hawaii. Cases of liver damage linked to those products have been found in other states.
The Hawaii Department of Health reviewed 46 medical reports and forwarded them to the FDA. They found that 27 patients, or 58%, had taken OxyElite Pro before becoming ill. Seventeen of the 27 patients (63%) reported that OxyElite Pro was the only dietary supplement they were taking. One person has died among this group. One person had a liver transplant; others are waiting for liver transplants.
The products contain aegeline, a new dietary ingredient that does not have a history of use or other safety evidence. Aegeline is an ingredient that was not marketed in the U.S. before October 15, 1994, so its inclusion in the supplement violates federal law. That is the date of the Dietary Supplement Health and Education Act, which removed supplements from the same regulatory requirements as other foods. That Act means that dietary supplements don’t need approval from the FDA before they are marketed as long as they include ingredients sold before October 15, 1994.
