FDA Allows Oxaloacetate CFS Structure/Function Claim for ME/CFS
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Based on the results of peer-reviewed clinical trials, doctor and patient reports and the existing body of research investigating Oxaloacetate, the U.S. Food and Drug Administration has allowed the following structure/function claim for Oxaloacetate CFS:
“Oxaloacetate may help alleviate the physical and mental fatigue associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).”
Data supporting this structure/function claim include the recent 3-month, randomized, placebo-controlled clinical trial of Oxaloacetate CFS peer-reviewed and published by Frontiers in Neurology. This study found:
- Oxaloacetate CFS significantly reduced fatigue in ME/CFS patients by greater than 25% (on average).
- 40.5% of clinical trial patients, labeled by researchers as “enhanced responders,” experienced an average fatigue improvement of 63%.
- Improvements spanned both mental and physical aspects of fatigue and the improvement in fatigue lasted at least the length of the 3-month study.
In addition, submitted data included a 2022 study peer-reviewed and published by the Springer-Nature Journal of Translational Medicine. This six-week study used a dose-escalating methodology ranging from 500 mg oxaloacetate daily to 1,000 mg twice daily. The study found fatigue reduction up to 33% in ME/CFS patients and fatigue reduction up to 46.8% in Long COVID patients.
More research of Oxaloacetate medical food therapy is underway for both ME/CFS and Long COVID patients at research institutions including Stanford University and the University of Melbourne. Oxaloacetate CFS is recommended by doctors in more than 26 countries for thousands of ME/CFS patients worldwide.
At the 2025 International ME/CFS Conference in Berlin, Oxaloacetate CFS Chief Science Officer Alan Cash gave a featured lecture summarizing the history, scientific background and clinical trial data that lead the FDA to allow the Oxaloacetate CFS structure/function claim for ME/CFS.