Posted 02 March 2015
By Alexander Gaffney, RAC
A dietary supplement firm long on the US Food and Drug Administration's (FDA) enforcement radar is again in the agency's sights after regulators claim they found fluoxetine, the active ingredient in Prozac, in one of the company's former fitness products.
The company, USPlabs, has been linked to several FDA enforcement actions in recent years.
In December 2012, FDA sent the company a Warning Letter regarding three of its products: Jack3D, Super Cissus and Oxy Elite Pro. The company's manufacturing operations did not meet federal regulations for good manufacturing practices (GMPs), FDA said. In addition, the company's Super Cissus product was cited by regulators as being marketed for claims restricted for approved pharmaceuticals, and was therefore misbranded.
In April 2013, the company's Jack3D and Oxy Elite Pro supplements were again the target of an FDA Warning Letter after the agency said they contained dimethylamylamine (DMAA), an ingredient linked to cardiovascular adverse events.
"Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack," FDA wrote in its warning. "Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market. FDA has issued warning letters to companies notifying them products with DMAA need to be taken off the market or reformulated to remove this substance."
Despite initially defending its right to use DMAA in its products, USPlabs ultimately agreed to destroy $8 million in dietary supplements containing DMAA, according to USA Today.
Then, in early October 2013, FDA issued a statement saying that it was coordinating with the Centers for Disease Control and Prevention (CDC) to investigate 29 cases of acute non-viral hepatitis associated with use of Oxy Elite Pro, which the company had since reformulated to remove DMAA.
FDA explained that at the time of its statement, one patient had already died from liver-related issues, while another two had received liver transplants and 11 had been hospitalized with acute hepatitis. As a result, FDA said it was in the process of re-inspecting USPlabs' manufacturing facility and distribution records to determine if the outbreak was caused by Oxy Elite Pro or by counterfeit versions of the product.
USPlabs would subsequently agree to recall its Oxy Elite Pro product, but not before FDA issued the company a third Warning Letter regarding the episode.
Now USPlabs is again facing FDA scrutiny after agency regulators said they found an undeclared drug ingredient in the since-discontinued product.
On 28 February 2015, FDA issued a "public notification" that USPlabs' Oxy Elite Pro containing fluoxetine, the active ingredient in Prozac, and should not be used by consumers.
"This product was identified by FDA during an examination of international mail shipments," FDA wrote in its notice.
In a statement, USPlabs said the product in question was counterfeit, and that, “Media reports saying that a company product contains Prozac are false.
"A USPlabs investigation determined that the product shown in the Public Notification and tested by FDA was not manufactured or distributed by or for the Company. It is a counterfeit," it explained. The company said that, in addition to not having manufactured the product since its October 2013 recall, it also manufactured its products using markedly different lot numbers than those contained on the product intercepted by FDA.
"Neither USPlabs nor its contract manufacturers has ever ordered or in any way handled fluoxetine for any purpose of any kind," USPlabs added.
That explanation should be familiar to longtime watchers of USPlabs. When the company's Oxy Elite Pro product was implicated in the outbreak of non-viral hepatitis, it also claimed to FDA that the associated products were counterfeit.
That FDA ultimately forced the company to recall its Oxy Elite Pro product may well mean either of two things: That FDA will exercise its enforcement powers vigorously, even in cases where a clear link between product and harm cannot be definitely established; or that FDA has little reason to believe the explanations of a company long-accused of regulatory noncompliance.
Either way, USPlabs might want to prepare itself for more agency scrutiny.
FDA Notice on Oxy Elite Pro