October 14, 2013 — USPLabs, the manufacturer of OxyElite Pro and VERSA-1, has received a Warning Letter from the U.S. Food and Drug Administration (FDA) because the pre-workout supplements contain aegeline, an illegal ingredient.
At least 24 people reported using OxyElite Pro before developing liver damage, including 2 people who required liver transplants and one woman who died. It is unusual for the FDA to blame illnesses on a product without issuing a recall.
Evidence linking OxyElite Pro and liver injuries in Hawaii:
- FDA reviewed medical records on 20 people who got sick, of whom 14 (70%) reported using OxyElite Pro.
- OxyElite Pro was the only common risk-factor among the victims.
- OxyElite Pro was the only supplement used by 8 victims.
- Before liver injuries occurred, most of the victims were perfectly healthy.
- After discontinuing OxyElite Pro, most patients recovered, implying that OxyElite Pro was causing the problem.
In October 1994, Congress passed the Dietary Supplement Health and Education Act. It requires manufacturers to tell the FDA when they introduce new ingredients 75 days before they start selling the product. Manufacturers must be able to prove that the ingredient is not chemically altered and is “reasonably expected to be safe.”
USPLabs, the manufacturer of OxyElite Pro and VERSA-1, has never submitted a notification for aegeline. This makes the ingredient adulterated and illegal to use in dietary supplements.
The warning letter is déjà vu for USPLabs. It is nearly identical to the OxyElite Pro Warning Letter the FDA sent in April 2012. At the time, OxyElite Pro contained DMAA, a synthetic stimulant “designer drug.”
In both Warning Letters, the FDA told USPLabs to stop selling the products or face enforcement action without further notice. Last time, USPLabs argued with the FDA for months about whether DMAA was a natural botanical from the geranium plant. It took the FDA over a year to seize the products.
Do I have an OxyElite Pro Lawsuit?
The Schmidt Firm, PLLC is currently accepting OxyElite Pro induced injury cases in all 50 states. If you or somebody you know has been injured by OxyElite Pro, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.