Posted October 27, 2013

Ingredient In Workout Supplements May Be Unsafe, FDA Warns

On October 11, 2013, the FDA directed USP Labs, LLC to cease distribution of workout supplement OxyElite Pro and and muscle-building supplement VERSA-1, which are labeled as containing the ingredient aegeline, or N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide.

The FDA stated that USP Labs failed to notify the agency of the new dietary ingredient, and expressed concern that the safety of aegeline has not been established through history of use or scientific evidence. The agency stated that aegeline was "a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury."

The letter was issued three days after the FDA warned consumers not to use OxyElit Pro as it investigates a link between use of OxyElite Pro supplements and 24 cases of acute non-viral hepatitis in Hawaii. OxyElite Pro products being investigated include the original OxyElite Pro with DMAA, OxyElite Pro with the "Purple Top" and OxyElite Pro Super Thermo Powder.

USPLabs countered in a statement that the ingredients in OxyElite Pro supplements "have been studied for safety, are consumed in the food supply and widely used in dietary supplements," and that "the studies and consumption history show no negative liver issues."

The company also said it would cease domestic distribution of OxyElite Pro with the Purple Top and OxyElite Pro Super Thermo Powder "out of an abundance of caution," but that it "believes these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii."

OxyElite Pro was pulled from shelves and inventory was destroyed in July 2013 because it contained the illegal ingredient DMAA, which is associated with an increased risk of cardiovascular events like stroke and heart attack.

(See's Reviews of Energy Supplements and Muscle Enhancers for tests of related products.)

See Related Warnings:

FDA Warns Consumers Not to Use OxyElite Pro As It Investigates Link With Hepatitis

USPLabs Settles Class Action Lawsuit Over Controversial DMAA Ingredient

USPLabs Destroys $8 Million Worth of Supplements Containing DMAA

FDA Warns Consumers About The Dangers Of DMAA

FDA Warns USPLabs For Adulteration and Drug Claims

To read the FDA's warning, use the link below.