Dietary supplement manufacturers and distributors are not required to obtain FDA approval prior to marketing dietary supplements. The FDA establishes stringent regulations for the manufacture, distribution and sale of dietary supplements. These help ensure the quality, purity and safety of supplements sold in the United States. PURE adheres to these FDA established regulations to help ensure that our customers are receiving the best products available. All manufacturers of products by PURE are in the United States and are registered with the Food and Drug Administration.