Update: GNC to Pay $2.25 Million in OxyElite Pro Settlement
December 8, 2016 – GNC Holdings Inc. has agreed to pay $2.25 million and take steps to ensure potentially unlawful ingredients are not included in its supplements, according to the U.S. Justice Department. The announcement follows a federal investigation into how a misbranded version of OxyElite Pro Advanced Formula reached the company’s shelves in 2013.
OxyElite Pro Linked to Liver Damage Epidemic
In October 2013, the Hawaii Department of Health reported that OxyElite Pro was associated with a cluster of 24 cases of acute hepatitis (liver inflammation). The U.S. Food and Drug Administration (FDA) published a Safety Communication and began investigating the outbreak.
Soon afterward, the FDA sent USPLabs a Warning Letter after finding that OxyElite Pro contained aegeline, an unapproved ingredient with questionable safety. In November, the Centers for Disease Control (CDC) confirmed 56 cases of liver damage from OxyElite Pro, including several people who needed liver transplants and one woman who died.
Liver Side Effects of OxyElite Pro
- Acute non-viral hepatitis (liver inflammation)
- Elevated liver enzymes
- Jaundice (yellowing of skin, eyes)
- Liver damage (hepatotoxicity)
- Liver failure
- Liver transplant
- Hospitalization and surgery
- Brain damage (hepatic encephalopathy)
OxyElite Pro Recall
November 10, 2013 — USPLabs has agreed to voluntarily recall OxyElite Pro. In addition to the recall, FDA officials will oversee the destruction of $22 million worth of the supplement in warehouse stockpiles.
Recalled OxyElite Pro products include:
- OxyElite Pro Super Thermo Powder
- OxyElite Pro Super Thermo Capsules
- OxyElite Pro Ultra-Intense Thermo Capsules
$2 Million Settlement in OxyElite Pro Class Action Lawsuit
In 2012, USPLabs agreed to pay $2 million to settle an OxyElite Pro class action lawsuit. The action consolidated several claims accusing USPLabs of violating laws in California that prohibit false and misleading statements on dietary supplements. Individuals who purchased Jack3D or OxyElite Pro between January 1, 2008 and August 17, 2012 could be eligible for a refund up to $300. Since this lawsuit settled, three additional class action lawsuits have been filed by plaintiffs who allege that OxyElite Pro contains unsafe ingredients that are “adulterated,” as defined by the FDA.
OxyElite Pro and DMAA
The original formula of OxyElite Pro contained DMAA (1,3-dimethylamylamine), which USPLabs claimed was an extract of the geranium plant. In fact, DMAA was a synthetic stimulant drug with amphetamine-like effects and severe cardiovascular side effects.
Where did DMAA come from?
DMAA was listed on the ingredient label for OxyElite Pro as “1,3-Dimethylamylamine (Geranium [stem]),” despite the fact that there is no credible evidence linking DMAA to the geranium plant or any natural source.
According to a Washington Post investigation in 2006, DMAA was first popularized in the bodybuilding community after ephedrine was banned in the mid 2000s. It was sold online under the trademark “Geranamine” by Patrick Arnold, a sports-doping chemist who served federal prison time for his role in the BALCO scandal.
Military Bans OxyElite Pro
Numerous organizations quickly sounded the alarm. In 2011, the U.S. Department of Defense (DOD) banned sales of OxyElite Pro on military bases following the deaths of several soldiers who suffered cardiac arrests during routine training. Although DMAA was ultimately cleared in the soldiers’ deaths, the DOD concluded that the supplement could have serious cardiovascular risks. The military banned OxyElite Pro in 2013 after it was associated with liver injuries in Hawaii.
OxyElite Pro Manufacturers Face Criminal Charges
November 17, 2015 – USPlabs, which sold the controversial workout supplements OxyElite Pro and Jack3D, faces criminal charges filed today by the U.S. Justice Department, according to Reuters. The indictment says the company used a synthetic Chinese-made stimulant to manufacture the supplements, but told retailers they were made from plant extracts. OxyElite Pro and Jack3D generated about $400 million in sales from 2008 to 2013, according to the indictment.
FDA Issues First Warning Letter for OxyElite Pro
By 2012, DMAA was an ingredient in over 200 bodybuilding supplements, and USPLabs’ OxyElite Pro and Jack3D were the most popular. In April, the FDA started cracking down. In Warning Letters to nearly a dozen manufacturers, the FDA stated:
“Synthetically-produced DMAA is not a ‘dietary ingredient’ and, therefore, is not eligible to be used as an active ingredient in a dietary supplement.”
USPLabs Fights FDA to Keep OxyElite Pro on Market
Although most of the manufacturers quickly complied with the FDA, USPLabs — the largest manufacturer of DMAA supplements — fought the FDA for one year. During this time, they presented studies that the FDA called contradictory, unreliable, deficient, and inconsistent.
$8 Million Worth of OxyElite Pro, Jack3D Destroyed
The FDA was ultimately forced to order U.S. marshals to seize 3,200 cases of OxyElite Pro and other DMAA supplements from GNC warehouses in Pennsylvania and South Carolina. In July 2013, the FDA announced that about $8 million worth of OxyElite Pro and Jack3D were destroyed at a USPLabs warehouse in Texas.
Side Effects of OxyElite Pro with DMAA
- Elevated blood pressure
- Increased heart rate
- Irregular heart rhythm
- Hyperthermia (dangerously elevated body temperature)
- Cardiac arrest
- Heart attack
- Sudden cardiac death
- Heart failure
- Kidney failure
- Nervous system disorders
- Psychiatric disorders
Do I have an OxyElite Pro Class Action Lawsuit?
The Product Liability & Dietary Supplement Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OxyElite Pro lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free OxyElite Pro Class Action Lawsuit Evaluation: Again, if you or a loved one was injured by OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by joining an OxyElite Pro class action, or by filing an OxyElite Pro lawsuit and we can help.