Medical foods must contain ingredients generally regarded as safe (GRAS) or be FDA approved, and Metagenics continually evaluates formula ingredients in concert with current nutritional research for optimal safety and effectiveness. Plus, Metagenics' manufacturing facility has 3 certifications for good manufacturing practices to ensure the highest quality. Key active ingredients in this formula were developed through the ExpresSyn Process® that sets a new standard in clinical certainty for natural products via demonstrated efficacy, bioavailability, and a high level of predicted safety. (This product is not recommended for those taking anti-coagulant medications. UltraGlycemX® Medical Food may be an excellent alternative.)