“I write to express concern that the products manufactured by UPSLabs, LLC, endanger human health and are adulterated,” Durbin wrote.
As of late October, the Hawaii Department of Health has reported 41 cases of liver illness associated with the use of OxyElite Pro including several cases that required liver transplants and one death. Earlier this month the agency advised consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues.
In addition, Durbin mentioned USPLabs’ used of aegeline in two of its products, OxyElite Pro and VERSA-1. This ingredient was the subject of a FDA warning letter sent to the company over the use of this ingredient. FDA maintains that the products are adulterated because in its opinion aegeline is a New Dietary Ingredient for which the company has not filed a NDI notification.
In the letter Durbin asks for all of the serious adverse events reports USPLabs has received on its products manufactured from 2010 to the present and requested a total number on all reports. He also requested a description of any new ingredients in these products and their function. Also, he specifically asked whether the company had ceased to produce products containing aegeline. Durbin put a Nov. 18 deadline on his request.
The letter is similar in tone the letters that Durbin and Sen. Richard Blumenthal, D-CT sent to energy drink manufacturers last year seeking information on their marketing practices and their policies regarding the labeling of caffeine content. In both cases actions arose from a legitmate conern and were also perhaps driven in part by an underlying agenda, said Marc Ullman, a Garden City, NY-based attorney with the firm Ullman, Shapiro & Ullman.
“Members of Congress, where they feel that there is a public health issue that they think FDA is not adequately addressing, can get involved directly,” Ullman told NutraIngedients-USA. “In this case we know that Sen. Durbin has an agenda with regards to supplements and I’m sure he believes that he can use these circumstances to further his agenda.”
While USPLabs is not under any statutory obligation to respond to Durbin, Ullman confirmed it would be a bad idea to ignore the request.
Company claims ingredient has long history of use
As far as aegeline is concerned USPLabs disputes the assumption that it is a NDI.
In a statement given at to NutraIngredients-USA at the time of the warning letter, the company said, “The citrus fruit tree Bael, along with its major alkaloids such as aegeline, have a long documented history in the food supply. Also known as the ‘Wood Apple’, Bael fruit, leaves and extracts are commonly used around the world in food, tea, and as natural remedies. A famous drink known as sherbet is made from the bael fruit and it has been known for its use since 1500 BC. There are scores of Bael and Bael extract and alkaloid products on the US market today.
“Bael is as safe as its long history demonstrates. Not only has Bael been used in foods around the world for thousands of years, but more recent scientific studies of aegeline show no adverse health effects, including any harm to liver functions.”
USPLabs has also been under pressure from class action lawsuits filed over DMAA which was contained in some of the company's products that have since been reformulated. The company recently set aside $2 million to settle those cases.