The FDA does not specifically approve any supplements. The FDA works to ensure that products are compliant with their rules on what can be claimed on a label in order to protect public safety. We have reviewed our label and consulted with third party experts to ensure that our label remains compliant. As with all supplements, our product label contains the required statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."