OxyElite Pro Supplements Recalled
Following actions by the Food and Drug Administration (FDA), a Texas-based company has agreed to recall and destroy a dietary supplement linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants.
In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials that it will destroy warehouse stocks of the supplement.
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 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 (Agele marmelos).
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.
As of the end of October 2013, there were 56 cases of acute liver failure or acute hepatitis linked to OxyPro Elite, 43 of them in Hawaii. The investigation continues.
Following the Law
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. A new dietary ingredient is defined as one not marketed in the United States before Oct. 15, 1994.
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.
The fact that the FDA clearly states “manufacturers of dietary supplements are not required to provide proof of safety and effectiveness prior to marketing” should put a lot of doubt in the consumer’s mind regarding the safety of all over the counter supplements.
At Heal n Cure, we remove this doubt by providing only the highest quality Nutraceuticals to our patients. Nutraceuticals are premium supplements that provide medical health benefits in the form of treating and preventing disease.
Our clinic only accepts Nutraceuticals that have undergone quality testing by a 3rd party to guarantee accuracy of dosage and wholesome ingredients. Heal n Cure physicians hand pick which Nutraceuticals to offer our patients based on effectiveness, purity, and usage.
