Department of Health and Human Services January 7, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of letters containing FDA's initial determinations and feedback on safety and effectiveness data submitted to demonstrate that certain active ingredients are generally recognized as safe and effective (GRASE) and not misbranded for use in over-the-counter (OTC) sunscreen drug products (sunscreen feedback letters). We are taking this action under the Sunscreen Innovation Act (SIA).