Yes, we are regulated by the FDA in that we must comply with FDA-mandated manufacturing standards. In addition, all of our product labels and all of our literature must comply with FDA regulations. OproCyn is made in the USA at a Natural Products Association GMP-certified Manufacturer, meeting the highest standards for supplement manufacturing.
Secondly, the actual contents of nutritional supplements on the market are not approved by the FDA because the FDA does not “approve” nutritional supplements – this is under the jurisdiction of the USDA. Under federal law, the FDA only approves pharmaceutical products, and nutritional supplements are categorized by federal law as food, and not as pharmaceuticals. The FDA is not required to “approve” supplements. But the FDA does inspect our manufacturing facility regularly – every other year – and it is because we successfully meet or exceed the FDA’s manufacturing standards that we maintain continued certifications of compliance.