November 8, 2013 — USPLabs, the manufacturer of OxyElite Pro supplements, says it will stop using the ingredient aegeline and re-formulate OxyElite Pro. The company was hit with an avalanche of negative publicity in October, after OxyElite Pro was linked to dozens of cases of hepatitis (liver damage).
USPLabs has agreed to destroy its remaining inventory of OxyElite Pro with aegeline and will re-formulate it without aegeline.
In a Warning Letter issued October 11, the FDA warned USPLabs that aegeline was an unapproved ingredient that is illegal to use in dietary supplements. The FDA also recommended that consumers stop using OxyElite Pro and VERSA-1, another supplement from USPLabs that contained aegeline.
Federal law requires dietary supplement companies to notify the FDA when they introduce a new ingredient. Although supplement companies do not have to provide safety studies for the ingredient, they do need to show evidence that it is reasonably expected to be safe.
USPLabs responded to the FDA warning letter by defending the safety of aegeline, saying that it does not present an unreasonable risk of illness or injury to consumers:
“Although the company knows of no valid concern about the safety of aegeline or OxyElite Pro, the company has made the business decision, in light of the adverse publicity, to reformulate the product and to discontinue the use of aegeline in the United States.”
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