Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted October 27, 2013
Ingredient In Workout Supplements May Be Unsafe, FDA Warns
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 Related Warnings:
To read the FDA's warning, use the link below.