In general, supplements aren't FDA approved, however we are GMP certified which means all of our ingredients are 3rd party tested for ingredient purity, quality & label accuracy. With all natural supplements, results vary person to person and we always recommend running S'moo by your doctor first to ensure it is the right fit for you. S'moo is not intended to diagnose, cure or prevent any disease. If you are pregnant, nursing or have a medical condition, please consult your physician before use. Results may vary person to person.