Is SOMADERM registered with the Food and Drug Administration (FDA)? Yes, SOMADERM is registered with the FDA. New U Life exclusively uses an FDA registered manufacturing facility and complies with all FDA regulations. With our extensive experience in regulatory compliance of over-the-counter (OTC) products, we adhere to all requirements for FDA product indications, label copy, and ingredient listings. We also file the appropriate drug product listing with the FDA for all drug products manufactured for U.S. sales.