The U.S. Food and Drug Administration (FDA) announced its continuing probe of acute hepatitis illness associated with products labeled as OxyElite Pro and VERSA-1. The agency indicated that consumers should not use products labeled either OxyElite Pro or VERSA-1 as they may contain aegeline, an ingredient for which the manufacturer has not provided adequate safety evidence.
In a warning letter the agency sent USP Labs LLC on October 11, 2013, the firm was advised that OxyElite Pro and VERSA-1, both supplements, have been deemed adulterated, and that failure to immediately cease distribution of OxyElite Pro and VERSA-1 may lead to FDA enforcement action.
The letter also explains that the supplements have been deemed adulterated because of a new dietary ingredient that has not been in the food supply previously and for which no history of use or other evidence of safety has been determined. There is also insufficient evidence for the ingredient, which is a component of these supplements, that provides a reasonable assurance of safety when the product is used as suggested in the labeling.
Also according to the letter, USP Labs has not provided the FDA with legally mandated evidence that the ingredient, aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, is safe for use in its dietary supplements. The warning letter notes that a causal connection may exist between use of a product labeled OxyElite Pro and the liver illnesses that have been reported in Hawaii.
The FDA is working with the U.S. Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) on the mounting, acute, non-viral hepatitis cases in Hawaii.
To date, 29 cases of acute non-viral hepatitis, with an unknown cause, have been identified. The Hawaii DOH reported that 24 cases all share a common link to a dietary supplement product labeled OxyElite Pro. Of the 29 cases, 11 people required hospitalization for acute hepatitis, two people underwent received liver transplant, and one person died. The CDC is investigating other liver injury cases nationwide that may be tied to the supplements.
The CDC issued recommendations, including that, as part of a thorough examination, clinicians with patients diagnosed with acute hepatitis be asked about their use of dietary supplements.
Hepatitis symptoms, regardless of type, are similar and can include fever, fatigue, nausea, vomiting, abdominal pain, joint pain, and yellow eyes,
On October 8, 2013, USP Labs LLC advised the FDA that it would voluntarily stop distributing OxyElite Pro and advised that it believes counterfeit versions of OxyElite Pro are being marketed in the U.S. and have been on the U.S. market for some time. The FDA is investigating if counterfeit product is associated with any cases of acute hepatitis.