In a letter dated October 11, 2013, William Correll Jr, acting director at the Office of Compliance at the FDA’s Center for Food Safety and Applied Nutrition, stated that there is no evidence that the ingredient aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. The ingredient has also not been the subject of a new dietary ingredient (NDI) notification. This would cause the products to be classed as adulterated, said Correll.
However, 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.”
Referring to the 29 cases of acute non-viral hepatitis recently reported in Hawaii linked to a product labeled as Oxy Elite Pro, Correll said, “several findings suggest a causal connection may exist between ingestion of a product labeled as Oxy Elite Pro and the illnesses reported in Hawaii”.
Correl continued: “First, in a review of twenty (20) medical records submitted to FDA by the Hawaii Department of Health, the records indicated that fourteen (14) patients (70%) had ingested a product labeled as Oxy Elite Pro prior to becoming ill. There were no other consistent commonalities among the fourteen (14) patients other than exposure to Oxy Elite Pro. Importantly, eight (8) patients reported Oxy Elite Pro as the sole dietary supplement they took prior to becoming ill, and most of these patients had been entirely healthy before they became ill. Second, upon discontinuing Oxy Elite Pro following onset of illness, most patients recovered from their illness, implying Oxy Elite Pro was the cause of the illness.
“[…] rigorous clinical protocols were followed in the care of the patients to exclude and/or rule out known causes of liver disease (e.g., viral causes of hepatitis, autoimmune conditions, hemochromatosis, Wilson’s disease, excess alcohol or acetaminophen ingestion, and alpha-1-antityrpsin deficiency). The absence of these causes of liver disease increases the likelihood that Oxy Elite Pro played a hepatotoxic role in these patients.
“Therefore, in the absence of a history of use or other evidence of safety establishing that aegeline is reasonably expected to be safe under the conditions recommended or suggested in the labeling of Oxy Elite Pro and VERSA-1, your products are deemed to be adulterated under 21 U.S.C. 342(f).
“We request that you take prompt action to correct these and any other violations associated with Oxy Elite Pro and VERSA-1 and any other products marketed by your firm that contain aegeline.
“Failure to immediately cease distribution of all products containing aegeline may result in enforcement action by FDA without further notice.”
In its statement, USPLabs said that the cause of the outbreak of liver issues in Hawaii remains a mystery.
“There is no objective evidence to link OxyELITE Pro to these cases of illness. At this point, speculation and unscientific theories only hurt the ability to identify the cause of the injuries in question and risks skewing the investigation away from the actual causes of injury, which is not helpful for the people of Hawaii.”
According to the FDA, the company has informed the Agency that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time. FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.
The product is sold nationwide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. The CDC is reportedly investigating other cases of liver injury nationwide that may be related.