November 8, 2013 — After an avalanche of negative publicity, USPLabs has agreed to remove a controversial ingredient from OxyElite Pro, re-formulate it without aegeline, and destroy their remaining stock of OxyElite Pro. Earlier this year, OxyElite Pro with aegeline was associated with dozens of cases of acute non-viral hepatitis (liver inflammation), including one fatal liver failure.
The controversy surrounding OxyElite Pro began when health officials in Hawaii linked OxyElite Pro to 24 liver injuries. After the U.S. Food and Drug Administration (FDA) investigated, they found that OxyElite Pro contained aegeline, an unapproved ingredient that is illegal to use in dietary supplements without notification.
Federal law requires dietary supplement companies to provide a New Dietary Ingredient notification to the FDA before introducing a new ingredient. Although the FDA does not require safety studies, the ingredient must be reasonably expected to be safe.
USPLabs provided no notification for aegeline, and the FDA issued a Warning Letter on October 11. They recommended that consumers should not use OxyElite Pro or other supplements containing aegeline, such as VERSA-1.
USPLabs defended the safety of OxyElite Pro:
“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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