The FDA regulates dental bleaching systems as cosmetics instead of medical products and procedures.  This means that manufacturers of dental whitening products are not required to get FDA approval on their products, however they can submit their products to the FDA for review if they wish. All of our products have been submitted to the FDA for review and have been released by the FDA for sale.  Very few, if any other manufacturers of dental whitening gels and systems submit their products to the FDA for review and release. Since our products are reviewed by the FDA, you can be confident that the dental whitening products you are using have been properly formulated and labeled.