Yes. Orchid Lens is made using FDA approved materials only and by an FDA-certified medical manufacturer. The manufacturing process is a sandwich process, where the color pigments are safely sealed within the lens. We are based in Malaysia and our lenses are certified in the following countries and regions: Australia, Europe (European CE), Singapore, UAE, and United Kingdom. We are constantly seeking to register our products in more countries to provide assurance of the safety of our products to our customers.