For the second time this year, diet pills produced by USPLabs of Texas have been linked to illness and death, and the company has agreed to recall and destroy all of its supplies of those products.
OxyElite Pro products were advertised as weight loss and muscle building supplements, and sold nationwide through retail stores, mail order, online and direct from the manufacturer. In October these products were linked to 29 cases of acute hepatitis and liver failure in Hawaii. . Those cases included 11 hospitalizations, two liver transplants and one death, according to the Centers for Disease Control and Prevention.
By late October, there were 56 cases of acute liver failure or acute hepatitis linked to OxyPro Elite, with 43 of them in Hawaii. Authorities suspect the problems were caused by the presence of a compound called aegeline, a relatively untested ingredient that supplement makers have begun using in recent years. It may appear on product ingredient labels as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide.
On Nov. 9 USPLabs announced a voluntary recall of specific OxyElite products. Under the supervision of the Food and Drug Administration, the company will destroy all of its supplies of those items, which have an estimated retail value of about $22 million.
USPLabs did not return calls for comment, but a statement on its website said, "The Company agrees with FDA that a national recall is appropriate as a precautionary measure."
Earlier this year, USPLabs destroyed a different formulation of OxyElite Pro. That version of the product contained the stimulant DMAA (dimethylamylamine), which can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.
There is no pre-approval requirement for dietary supplements, but manufacturers must notify the FDA before adding a new ingredient (anything not marketed in the United State before 1994).
"Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law," said Daniel Fabricant, director of the FDA's division of dietary supplement programs, in a statement to consumers. "Losses to the company should also serve as a reminder that FDA's laws and regulations serve a purpose and must be followed."
The FDA provides a list of the specific products recalled. Consumers are advised to stop taking these, and should contact their doctor if they think they might have been harmed by these products.