What is OxyElite?
OxyElite Pro is sold as a “dietary supplement” used to lose weight and build muscle. It is available at large diet supplement stores, such as GNC, as well as on the Internet. The product has been “reformulated” at least twice by the manufacturer, USPlabs, because of safety and other concerns. Prior to the early part of 2013, the OxyElite Pro label indicated that the product contained a stimulant-like substance called DMAA (1,3-dimethylamylamine). However, USPlabs “reformulated” OxyElite Pro in 2013, removing DMAA and adding a substance known as Aegeline, which is supposedly extracted from parts of the Bael (Aegle marmelos) tree.
Is OxyElite Pro Safe and Effective?
No one knows for sure, because the FDA does not closely regulate dietary supplements. Many people wrongly assume that dietary supplements don’t have serious side effects because they are “natural.” In fact, many plants and herbs can be toxic to humans. In addition, supplement manufacturers may use potent extracts of plants and herbs, which can expose people to much higher quantities of toxins than are present in the plant as it exists in nature. With regard to OxyElite Pro, there is increasing evidence that the current formulation of the product, which contains Aegeline (now recalled), may be linked to cases of serious liver dysfunction, including acute hepatitis resulting in the possibility of liver transplant surgery and even death. There may be other side effects as well.
Is OxyElite Pro Regulated by the FDA?
While the FDA regulates dietary supplements such as OxyElite Pro, the agency’s authority is quite limited in comparison to its power to regulate other products such as drugs and medical devices. New drugs may not be marketed until the FDA approves them. The drug approval process may take years, and requires numerous tests in the laboratory, and also very comprehensive studies in humans called placebo-controlled, double blind clinical trials. In these trials, subjects are given either the new drug or a placebo (sugar pill) for weeks or even months. The subjects are carefully monitored and studied to determine (1) whether the drug works, and (2) whether there are any significant side effects. FDA only approves drugs that are shown to be safe and effective before they are marketed to the general population. This is not usually the case with dietary supplements like OxyElite Pro. Federal law provides a huge loophole that allows the manufacturers of these products to market them without clinical trials.
What is the Evidence Supporting a Link between OxyElite Pro and Liver Damage?
As of November 2013, evidence gathered by the FDA and Centers for Disease Control (CDC) has documented several dozen reported cases of liver dysfunction among people who have a history of taking OxyElite Pro. FDA and the CDC, as well as state and local health services, are continuing to review and accumulate additional data. Although some investigators have focused on the Aegeline in the reformulated version of OxyElite Pro, it is not clear whether that ingredient is causing liver damage, and prior versions of the product may also be implicated.
What Steps has FDA Taken to Protect Consumers from the Health Problems Associated with OxyElite Pro?
FDA initially sent letters to USPlabs in which the agency (1) informed the manufacturer about the growing evidence of liver damage associated with OxyElite Pro, and (2) demanded that USPlabs provide FDA with evidence demonstrating the safety of the ingredient Aegeline as a food extract. Also, FDA notified USPlabs that unless it proved to FDA that the Aegeline in OxyElite Pro met certain federal requirements, the product would be considered “adulterated” and subject to FDA enforcement action. FDA and CDC have also issued “important health alerts” advising consumers not to ingest any product called OxyElite Pro. FDA advises against using another product made by USPlabs, VERSA-1, which also contains Aegeline.
Has OxyElite Pro be Recalled?
Yes. In November 2013, USPlabs announce that it would “voluntarily” cease the production of current versions of the product and recall the following:
- OxyElite Pro Super Thermo capsules
- OxyElite Pro Ultra-Intense Thermo capsules
- OxyElite Pro Super Thermo Powder
For the latest information concerning product recalls, as well as current FDA recommendations, go to www.fda.gov.
What should I do if I believe I was Injured by OxyElite Pro?
FDA recommends that individuals who believe they have been injured by OxyElite Pro, VERSA-1, or any product, should contact their health care providers. There are a number of symptoms associated with acute hepatitis and other liver disorders that may be linked to OxyElite Pro, although liver injury may occur in the absence of obvious sign. Those include:
- Nausea
- Vomiting
- Abdominal pain
- Loss of appetite
- Clay- or gray-colored bowel movements
- Dark urine
- Fever
- Yellow eyes
- Fatigue
- Joint pain
- Jaundice
Contact An OxyElite Pro and VERSA-1 Lawyer From The Senators Firm
If you believe you or loved one has been injured by OxyElite Pro, VERSA-1, or any dietary supplement product, and you are interested in finding out if you are eligible to receive compensation, contact The Senators Firm. Our OxyElite Pro recall lawyers have helped hundreds of clients who were injured by defective dietary supplements as well as drugs and medical devices. Call us 24 hours a day, toll-free at (949) 557-5800. Or, contact us through this website.