Great Lakes Nutrition is regulated by the U.S. Food and Drug Administration. We must comply with the FDA’s regulations for manufacturing our products. In addition, all of our product labels and all of our product literature must comply with FDA regulations. Allergen labeling and adverse event reporting are also required to be performed. Our products are not pre-approved by the FDA because the FDA does not “approve” nutritional supplement products. Under the federal food and drug law, the FDA is only required to approve drug products. Because nutritional supplements are categorized by the federal food and drug law as food, and not as drugs, the FDA is not required to pre-approve them before sale, just as the FDA does not approve traditional foods before sale. However, the FDA inspects our manufacturing facility on a regular basis.