"As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately began an investigation with state officials and the Centers for Disease Control and Prevention," Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs, said in a statement.
"Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace."
The dietary supplement was advertised as an aid to losing weight and building muscles.
In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials it would destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA would oversee the destruction of the product, officials said.
The FDA warned the company Oct. 11 certain OxyElite Pro products and another supplement, VERSA-1, were considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
The FDA's investigation is ongoing and the agency warned consumers to avoid using OxyElite Pro and VERSA-1.
Earlier this year, a stockpile of another formulation of OxyElite Pro was destroyed after being held through an FDA administrative detention order. A stimulant included in those products, DMAA, or dimethylamylamine, can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.
After removing DMAA from its products, USPLabs substituted aegeline, among other ingredients, in certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree.
"Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law," Fabricant said. "Losses to the company should also serve as a reminder that FDA's laws and regulations serve a purpose and must be followed."
On Sept. 13, 2013, FDA learned of a cluster of seven Hawaii residents with acute liver failure/non-viral hepatitis.
A joint investigation by the Hawaii Department of Health and CDC revealed the patients all had consumed OxyElite Pro products. FDA meanwhile identified patients outside Hawaii with similar liver dysfunction after using OxyElite Pro, the agency said.
The FDA urged the public to avoid using products labeled as OxyElite Pro or VERSA-1 while it investigates further.
The FDA warned the company Oct. 11 certain OxyElite Pro and VERSA-1 products were deemed adulterated and failure to immediately cease distribution of both products could lead to enforcement actions.
At the end of October, there were 56 cases of acute liver failure or acute hepatitis linked to OxyPro Elite, 43 in Hawaii.
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