The voluntary recall highlights quality control issues, but Marc Ullman, legal counsel for the marketer, Balanced Health, said the blame should fall at least in part on its supplier, in this case a Peruvian company that produced the pre-mixed formula.
“The problem lies in the fact that companies don’t test for this substance because it is only a problem in the professional sports arena,” Ullman told NutraIngredients-USA.com.
“We are considering legal action against them. We may be looking at a situation where there has been a fraud committed against Balanced Health through this adulteration. At the same time Balanced Health acknowledges its responsibilities under the Food and Drug Act which is why they have undertaken these recalls.”
Ullman said it was the first time Balanced Health had encountered contamination problems. It was in the process of locating a new domestic supplier of the weight loss pre-mix blend.
The recall was sparked by professional football players testing positive to the diuretic, bumetanide, which then prompted Balanced Health to conduct further testing. When these tests also came back positive the company recalled the products.
In conjunction with the Food and Drug Administration (FDA) it has subsequently recalled two batches dating as far back as March, 2006, as well as quarantining a batch of raw materials yet to see the manufacturing process.
Quality control
Ullman said it was not necessarily a failing of quality control for contaminated batches more than two-years-old to go undetected.
“Look at how long melamine was in the food supply for before it was detected,” he said. “Unless you are specifically testing for an ingredient you are not going to find it. There was no need to be screening for bumetanide. It wasn’t a sports product, it was a weight loss product for women.”
However the National Football League said it had warned front officers, trainers and players unions in December 2006 about the supplements and had added Balanced Health to its list of prohibited dietary supplement companies.
At least one the NFL players banned because of consuming StarCaps was suing Balanced Health, and the case was due to be heard early in 2009.
Bumetanide was found in the StarCaps dietary supplements at a level 0.8mg per capsule.
Bumetanide can have the side effect of fluid and electrolyte loss and raised uric acid concentrations. Other symptoms include hypotension (low blood pressure) and fainting (syncope).
Ullman speculated it was used by suppliers because it was cheaper than “materials that were meant to be supplied”.
NutraIngredients-USA.com was unable to determine the name of the Peruvian supplier by the time of publication.