Durbin Calls on Dietary Supplement Manufacturer to Prove Compliance with Federal Law Regulating New Ingredients
Senator raises concerns about safety of products manufactured by USPLabs
[WASHINGTON, D.C.] – U.S. Senator Dick Durbin (D-IL) today called on USPLabs to provide information showing it has complied with federal law requiring dietary supplement manufacturers to report new dietary ingredients and evidence of their safety to the Food and Drug Administration (FDA). In a letter to the CEO and Co-Owner of USPLabs, Durbin raised concerns about OxyElite Pro, a diet supplement that may be linked to 48 cases of liver injury including death. The product contains 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.
“I am concerned about the mounting evidence that products manufactured by USPLabs endanger consumer health and contain adulterated ingredients,” said Durbin. “The recent cases of adverse events – including liver injury and even death – surrounding yet another USPLabs product raise serious questions about the company’s practices and commitment to consumer safety.”
An October 25, 2013 USA Today investigation reported that a USPLabs product is likely linked to serious adverse events and has been found to contain an illegal ingredient. According to the report, Hawaii’s Department of Health had confirmed 41 cases of liver injury linked to OxyElite Pro, including one death and several cases that required liver transplants. Additionally, in 2003, the company’s CEO, Jacob Geissler, was indicted on a controlled substance charge involving possession of thousands of pills containing anabolic steroids.
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.
On October 8, 2013, the FDA issued a health advisory for OxyElite Pro warning consumers to stop taking any supplement while FDA investigates the cases of acute hepatitis illness and liver injury. USPLabs has voluntarily ceased domestic distribution of OxyElite Pro while FDA investigates, but maintains that the product is safe.
Recent investigative reports by USA Today, Rock Center and Chicago Tribune have exposed the lack of information about dietary supplement products while they are on store shelves. With no authority to require a dietary supplements to be registered with the before it is put on the market, the first FDA often learns about a product is when a consumer becomes sick or worse.
In August 2013, Durbin joined with U.S. Senator Richard Blumenthal (D-CT) to introduce the Dietary Supplement Labeling Act which would improve the information available to consumers by requiring more information on product labels, give more authority to the FDA to require manufacturers to register their products and ingredients and provide proof of any health benefit claims, 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.
Text of today’s letter is below.
October 29, 2013
Chief Executive Officer and Co-Owner
10761 King William Drive
Dallas, TX 75220-2445
Dear Mr. Geissler:
I write to express concern regarding mounting evidence that products manufactured by USPLabs, LLC, endanger consumer health and are adulterated.
On October 8, 2013, the U.S. Food and Drug Administration (FDA) issued a health advisory for OxyElite Pro, a diet supplement manufactured by your company. In the safety alert, FDA warns consumers to stop taking any supplement labeled as OxyElite Pro while the product is under investigation for cases of acute hepatitis illness and liver injury. Further, a USA Today article published on October 25, 2013, reported that Hawaii’s Department of Health had confirmed 41 cases of liver injury linked to OxyElite Pro, including one death and several cases that required liver transplants.
The consumer advisory letter was followed by a warning letter to your company from FDA on October 11, 2013, stating that USPLabs is marketing two adulterated products, OxyElite Pro and VERSA-1, which contain aegeline. The letter cites that these products are adulterated, because FDA is not aware of a history of use for aegeline in the United States before October 1994 and USPLabs did not submit the requisite notification and assurance that this new ingredient did not present a significant risk of injury. In the warning, FDA urges your company to cease distribution and take prompt action to correct violations associated with OxyElite Pro, VERSA-1, and any other products containing aegeline.
These letters follow a consumer advisory issued by FDA on April 11, 2013, for dimethylamylamine (DMAA), a stimulant found in two sport supplements manufactured by your company, Jack3D and OxyElite. In the warning, FDA cites receiving 86 adverse event reports of psychiatric disorders, heart problems, and even death involving products containing DMAA.
While your company has committed to cease the manufacturing and distribution of products containing DMAA, the recent health advisory, warning letter, and cases of liver injury raise questions regarding your company’s practices and commitment to consumer safety. I respectfully request that you provide a written response to the following questions.
1.) Specify the number of serious adverse event reports your company has received for all dietary supplement products manufactured from 2010 to present, including products no longer manufactured. Please distinguish between reformulated versions of products with the same name.
2.) Provide documentation for any serious adverse event report involving hospitalization, death, liver injury, cardiovascular problems, and nervous system disorders.
3.) Specify all new dietary ingredient notifications submitted to FDA as required under 21.U.S.C. 350(a)(2) and 21 CFR 190.6. Describe the function of each the new ingredients.
4.) List all USPLabs products that contain aegeline. Has your company ceased manufacturing and distributing products containing aegeline?
Please provide a written response to these questions by November 18, 2013. Thank you for your assistance and cooperation in response to this request.
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