Aegeline is a known constituent of the bael leaf and consumed as a dietary supplement with the intent to produce weight loss.
In 2013, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), the Department of Defense Armed Forces Health Surveillance Center, and Hawaii state and local health officials identified an outbreak of 97 persons with acute non-viral hepatitis that first emerged in Hawaii.
Seventy-two of these persons had reported using the dietary supplement containing aegeline, called OxyElite Pro which was manufactured by the Dallas company, USPlabs.
FDA had previously taken action against an earlier formulation of OxyElite Pro because it contained dimethylamylamine, a stimulant that FDA had determined to be an adulterant when included in dietary supplements and could cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders, and death.
USPlabs subsequently reformulated this product without informing FDA or submitting the required safety data for a new dietary ingredient.

Doctors at the Liver Center at The Queen's Medical Center investigating the first cases in Hawaii reported that between May and September 2013, eight previously healthy individuals presented themselves at their center suffering from a drug-induced liver injury.
All of these patients had been using the reformulated OxyElite Pro, which they had purchased from different sources, and which had different lot numbers and expiration dates, at doses within the manufacturer's recommendation.
Three of these patients developed fulminant liver failure, two underwent urgent liver transplantation, and one died.
The number of such cases would ultimately rise to 44 in Hawaii.
In January 2014, leaders from the Queen's Liver Center informed state lawmakers that they were almost certain that aegeline was the agent responsible for these cases, but the mechanism of how aegeline may damage the liver has not been isolated.
Aegeline is a known constituent of the bael leaf and consumed as a dietary supplement with the intent to produce weight loss. In 2013, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), the Department of Defense Armed Forces Health Surveillance Center, and Hawaii state and local health officials identified an outbreak of 97 persons with acute non-viral hepatitis that first emerged in Hawaii. Seventy-two of these persons had reported using the dietary supplement containing aegeline, called OxyElite Pro which was manufactured by the Dallas company, USPlabs. FDA had previously taken action against an earlier formulation of OxyElite Pro because it contained dimethylamylamine, a stimulant that FDA had determined to be an adulterant when included in dietary supplements and could cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders, and death. USPlabs subsequently reformulated this product without informing FDA or submitting the required safety data for a new dietary ingredient.
Doctors at the Liver Center at The Queen's Medical Center investigating the first cases in Hawaii reported that between May and September 2013, eight previously healthy individuals presented themselves at their center suffering from a drug-induced liver injury. All of these patients had been using the reformulated OxyElite Pro, which they had purchased from different sources, and which had different lot numbers and expiration dates, at doses within the manufacturer's recommendation. Three of these patients developed fulminant liver failure, two underwent urgent liver transplantation, and one died. The number of such cases would ultimately rise to 44 in Hawaii. In January 2014, leaders from the Queen's Liver Center informed state lawmakers that they were almost certain that aegeline was the agent responsible for these cases, but the mechanism of how aegeline may damage the liver has not been isolated.
Aegle marmelos