The Texas-based company that manufactures OxyElite has agreed to recall and destroy a dietary supplement linked to several hundred cases of acute liver failure and hepatitis, including deaths and cases where several patients required liver transplants.
According to the FDA,”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 launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC).”
On October 11, 2013, the FDA issued a warning letter to USPlabs LLC of Dallas, Texas, informing the company that the dietary supplements OxyElite Pro and VERSA-1 were adulterated, and that failure to immediately cease distribution of these products could result in enforcement action.
The supplement was advertised as an aid to losing weight and building muscles. FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
Earlier in 2013, 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 (Agele marmelos).
FDA Evidence of Danger
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 that the patients all had consumed OxyElite Pro products. FDA meanwhile identified patients outside of Hawaii with similar liver dysfunction after using OxyElite Pro.
On Oct. 11, 2013, FDA warned the company that certain OxyElite Pro and VERSA-1 products were deemed adulterated and that failure to immediately cease distribution of both products could lead to enforcement actions.
Dietary Supplements Not Regulated
While manufacturers of dietary supplements are not required to provide proof of safety and effectiveness prior to marketing, they are required to notify the FDA of plans to include a new dietary ingredient.
They are also required to submit evidence that the dietary ingredient would reasonably be expected to be safe under the conditions of use recommended or suggested in the supplement labeling.
Companies are required to provide evidence of safety of the new dietary ingredient 75 days before the product goes to market.
This notification was not made by USPLabs before it began using DMAA, a new dietary ingredient, in OxyElite Pro. FDA was likewise not informed when the company, no longer formulating with DMAA, began using the new dietary ingredient aegeline.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.