Durbin, Feinstein, Blumenthal To FDA: Use Existing Authority To Protect Consumers From Contaminated Dietary Supplement
Senators raise concerns about the safety of a product manufactured by company responsible for 2013 dietary supplement-related injuries and death
[WASHINGTON, D.C.] – In response to confirmed reports that international shipments of a popular dietary supplement contained hidden and potentially harmful contaminants, U.S. Senators Dick Durbin (D-IL), Dianne Feinstein (D-CA), and Richard Blumenthal (D-CT) called on the Food and Drug Administration (FDA) to conduct a full investigation into all Oxy ELITE Pro Super Thermogenic products on the market and – if necessary – ensure that they are removed from store shelves.
In February, the FDA confirmed that international shipments of Oxy ELITE Pro Super Thermogenic – manufactured by USPlabs – contained hidden amounts of fluoxetine, a potentially harmful antidepressant that has been shown to be associated with suicidal thinking, abnormal bleeding, and seizures. Just two years ago, the same manufacturer was forced to recall the product OxyElite Pro after more than 97 people were injured, several required liver transplants, and one woman died.
“This is not the first time OxyElite, or the manufacturer USPlabs, has come under fire,” the Members wrote. “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.”
In October 2013, the FDA issued a health advisory warning consumers to stop taking OxyElite Pro while FDA investigated cases of acute hepatitis illness and liver injury associated with the supplement. Later that month, a USA Today investigation found that not only was OxyElite Pro likely linked to serious adverse events, it had also been found to contain aegeline – a new ingredient in possible violation of federal law which requires a company to report new dietary ingredients and evidence of their safety to the FDA. Following the report, Durbin called on USPLabs to provide information showing it had complied with federal law requiring dietary supplement manufacturers to report new dietary ingredients and evidence of their safety to the FDA.
In 2012, FDA warned 11 companies that the stimulant, dimethylamylamine (DMAA), was an illegal and dangerous ingredient that should be removed from supplements. Of the warned companies, only USPLabs continued to use DMAA in its products – Jack3D and OxyElite. After the FDA issued another warning and seized products with a retail value of roughly $8.5 million in early 2013, USPLabs agreed to destroy supplements containing DMAA. In the warning, FDA cited receiving 86 adverse event reports of psychiatric disorders, heart problems, and even death involving products containing DMAA.
Recent investigative reports have exposed the lack of information about dietary supplement products while they are on store shelves. Although FDA has the authority to regulate the safety and effectiveness of drugs and medical devices, under current law, the agency cannot take action against dietary supplements or foods currently on the market until the product makes a consumer sick or worse.
In August 2013, Durbin and Blumenthal introduced the Dietary Supplement Labeling Act which would give more authority to the FDA to require manufacturers to register their products and ingredients and provide proof of any health benefit claims. The legislation would also improve the information available to consumers by requiring more information on product labels and curb the prevalence of drinks and foods that are masquerading as dietary supplements as a means of avoiding reviews and regulation by the FDA. More information on this legislation is available here.
A March 2013, Government Accountability Office (GAO) report found that between 2008 and 2011, the FDA received an average of 2,100 dietary supplement adverse event reports a year compared to less than 400 in 2007. The report also suggested that there is underreporting of adverse events to the FDA because consumers and health care practitioners are more likely to call poison control centers than they are to report a problem to the FDA or manufacturer.
Text of today’s letter is below.
March 17, 2015
The Honorable Margaret Hamburg
U.S. Food and Drug Administration
10903 Hampshire Avenue
Silver Spring, MD 20093
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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