Letter to the Honorable Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration - OxyPro Safety

Letter

Dear Commissioner Hamburg:

Given the U.S. Food and Drug Administration (FDA) finding of an undisclosed prescription drug in Oxy ELITE Pro Super Thermogenic products, we urge the agency to use its existing authority to ensure that all Oxy ELITE Pro Super Thermogenic products on the market pose no harm to human health, and if necessary, institute a full removal of the products from the market.

In February, an FDA laboratory analysis confirmed that international shipments of Oxy ELITE Pro Super Thermogenic contained hidden amounts of fluoxetine, a potentially harmful antidepressant. Oxy ELITE Pro touts its benefits as sustained weight loss, suppressed appetite, and a "strong yet smooth" boost in energy. But what consumers have secretly been getting is a hidden drug with life-threatening side effects. Fluoxetine, better known as Prozac, has been shown to be associated with suicidal thinking, abnormal bleeding, and seizures. For consumers on other medications such as aspirin or ibuprofen, Fluoxetine can even lead to ventricular arrhythmia and death. In response to the dangers of this drug, FDA issued a Public Notification Health Fraud Alert urging consumers not to purchase or use the product.

This is not the first time OxyElite, or the manufacturer USPlabs, has come under fire. In 2012, USPlab's OxyElite Pro was found to contain DMAA (1,3-dimethylamylamine), a powerful stimulant that has been linked to high blood pressure, cardiac arrest, and death. USPLabs in response then re-formulated OxyElite Pro with more hazardous ingredients, including aegeline which doctors suspect caused an outbreak of liver damage in Hawaii in 2013. By the time OxyElite Pro was recalled in November 2013, more than 97 people were injured, several required liver transplants, and one woman died.

FDA should follow Oxy ELITE Pro Super Thermogenic's Public Notification Health Fraud Alert by working with USPlabs to ensure the products currently on the market pose no risk to consumer health, and if necessary, remove these products from store shelves as soon as possible. Use the full extent of FDA's authority today to prevent a repeat of the needless harm USPlab products caused in 2013. Thank you for your attention to this important matter.

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