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FDA Warning Letter for Aegeline in OxyElite Pro, VERSA-1

FDA Warning Letter for Aegeline in OxyElite Pro, VERSA-1

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.

An FDA investigation of medical records also found a possible “causal connection” between OxyElite Pro and dozens of cases of non-viral hepatitis (liver damage) in Hawaii earlier this year.

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.

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