The FDA indicates that new regulatory authority provided by lawmakers in recent years was used to force a recall of OxyElite Pro, after the weight loss and dietary supplement was linked to reports of hepatitis, liver damage and liver failure among dozens of people throughout the United States.
Nearly 60 cases of liver damage from OxyElite Pro have been identified by state and federal health officials in recent weeks, leading to an investigation by the U.S. Centers for Disease Control (CDC) and the FDA.
Although USPLabs, LLC initially resisted removing OxyElite Pro from the market entirely, the FDA used regulatory authority under the Food Safety Modernization Act (FSMA), which was passed into law in 2011, to force the manufacturer to recall the product after it was found to contain a new and unapproved ingredient, agegeline.
OxyElite Pro is a dietary supplement that was marketed by USPlabs for weight loss and body building. The FDA does not approve dietary supplements before they are sold, like it does with drugs and medical devices. It falls to the FDA to establish that a product is unsafe, unless the manufacturer is using a previously unapproved ingredient.
If a new ingredient is being used, it is the manufacturer’s responsibility to provide the FDA with information concerning the product’s safety before it can be sold. If that was not done, there are certain actions available to the FDA under the FSMA that can be taken to ensure the safety of the product in question, including enforcing a mandatory recall and administrative detention actions.
Under the FSMA, the FDA was able to take steps to protect the public after the connection between the liver problems and OxyElite Pro was made, since a new ingredient was used without proper notification and approval. The FDA indicates that the regulatory authority provided under FSMA was crucial in mitigating the effects of the recent OxyElite Pro injury outbreak.
OxyElite Recall Issued After Reports of Hepatitis, Liver Failure
The OxyElite Pro problems first surfaced in Hawaii in early September, after Hawaii’s Department of Health (DOH) was notified of at least 7 patients with acute hepatitis and sudden liver failure.
On October 8, the FDA and CDC issued warnings about a potential link between OxyElite Pro supplements and the hepatitis outbreak, indicating that at least 24 cases had been identified involving individuals who experienced liver problems within 60 days of using the product. There are now at least 56 reports of liver illnesses across the country, including several cases where individuals required a liver transplant and at least one death.
In response to the illnesses, the Hawaii Department of Health forced retailers in the state to remove OxyElite Pro from the shelves and embargoed shipments of the supplement.
Although USPLabs ceased sales of OxyElite Pro on their website, an official recall was not issued until November 10, after the FDA sent the manufacturer a letter indicating that the product was considered adulterated because it contains aegeline, an Asian compound derived from a tree. Aegeline is considered a new dietary ingredient that has no safety history in the United States before 1994.
USPlabs has indicated that it disagrees with the assessment of aegeline, maintaining that the ingredient has a long history of safe use. However, the company agreed to recall OxyElite Pro and to destroy the current inventory in their distribution center that contains aegeline, a move that will reportedly cost the company nearly $22 million.
FSMA in Action
This is at least the third time in more than a year that the FDA has exerted its authority under FSMA to divert impending harm to the general public.
Earlier this month the FDA imposed FSMA regulation to prompt the voluntary recall of Rhino 5 Plus, Maxtremezen, and Extenzone which were marketed as supplements.
These three supplements also contained unapproved ingredients, which were causing harmful side effects to consumers. The drugs were marketed as erectile dysfunction supplements, but affected blood pressure at dangerous levels and acted on depression, causing severe side effects.
Last year, the FDA also imposed administrative regulation under FSMA to stop manufacture of OxyElite Pro and Jack3D after officials found a key ingredient, dimethylamylamine (DMAA), caused more than 100 illness and six deaths. USPLabs later replaced that ingredient with aegeline, which caused the current outbreak of illnesses.
“FSMA has been instrumental in the FDA’s enforcement actions regarding the OxyPro dietary supplements,” stated the FDA in a consumer update concerning the recall.