Product labeled as OxyElite Pro has been linked to liver damage in Hawaii, and the FDA says that, “several findings suggest a causal connection may exist between ingestion of a product labeled as Oxy Elite Pro and the illnesses reported in Hawaii”.
While doubts still remain as to whether the product labeled as OxyElite Pro is actually OxyElite Pro because of reports of counterfeit product in the market, the FDA has gone one step further and raised questions and concerns about the safety of an ingredient in OxyElite Pro called aegeline, which it alleges may not be a lawful dietary ingredient.
The Bael connection
Aegeline, however, is an alkaloid from the leaves of the bael tree, and questions about it being lawfully marketed as a dietary ingredient in the United States before October 15, 1994 have been dismissed by the company behind OxyElite Pro: USPLabs.
In a statement from USPLabs sent to NutraIngredients-USA, the company claimed: “The citrus fruit tree Bael, along with its major alkaloids such as aegeline, have a long documented history in the food supply. Also known as the ‘Wood Apple’, Bael fruit, leaves and extracts are commonly used around the world in food, tea, and as natural remedies. A famous drink known as sherbet is made from the bael fruit and it has been known for its use since 1500 BC. There are scores of Bael and Bael extract and alkaloid products on the US market today.
“Bael is as safe as its long history demonstrates. Not only has Bael been used in foods around the world for thousands of years, but more recent scientific studies of aegeline show no adverse health effects, including any harm to liver functions.”
In a wide-ranging article in today's USA Today on USPLabs, the newspaper quotes Philip Guzelian, a retired medical professor from the University of Colorado hired as an adviser by USPlabs, as saying: "If I had to pick a culprit [for the liver damage seen in Hawaii], it would not be aegeline."
Botanical materials vs pure compounds
Ed Wyszumiala, General Manager of NSF International’s Dietary Supplement Certification programs, told NutraIngredients-USA: "If there are concerns with the alkaloids and liver function, then there would need to be more research than we have currently available to be able to make any definitive response on this.
“The issues with the tox studies we found were they were performed on the leaf extract as a whole and not for the aegeline alone, so it was hard to draw any conclusions on the ingredient with the data that we found that was available.”
Commenting independently on the issue, James Neal-Kababick, Director of Flora Research Laboratories, told us that there is a listing for Bael tree, aka Bengal quince, in Herbs of Commerce.
“Thus, the use of this botanical technically is allowed under the cGMPs from what I understand since it was listed in commerce providing it is free from reasonably anticipated contaminants and not subsequently banned for safety reasons like ephedra was. However, there is a big difference between including a botanical material and including a nearly pure compound obtained from such a botanical or obtained as a synthetic botanical identical compound.
“The compound aegeline is found in this botanical in the leaf material. It is the main alkaloid in the family of alkaloids of this class,” explained Kababick. “However, the question I would have is how does the level detected in the product compare to the level detected in the plant material? In addition, the same goes for norcoclaurine (higenamine) which is also found in various plants. What is the relative concentration of the dosage taken by use of the plant compared to the level in the product?
“There can be long ethnobotanical historical uses of all sorts of botanicals but that does not necessarily mean you can take a compound found in one of those botanicals, purify it and use it in large doses far beyond what would be consumed by someone taking the plant material in the traditional manner.
“I am not sure how much of this compound or norcoclaurine is in the product compared to the botanical sources but that would be the big question I would have.”
A search on the PubMed database showed that eight papers have been published related to aegeline since 1965, with the majority being published since 2011 and referring to potential anti-adipogenic properties, as well as potential activity to control blood sugar and blood lipid levels.