On May 13, 2016, the U.S. Food and Drug Administration (FDA) released draft guidance for industry on Qualified Facilities under the Food Safety Modernization Act (FSMA) Preventive Controls Rules for Human and Animal Food (“Preventive Controls Rules”). Qualified Facilities enjoy less stringent regulatory obligations under the Preventive Controls Rules. Certain Qualified Facilities however are subject to a mandatory labeling/signage requirement that retailers, wholesalers and the facilities themselves should be aware of. The draft guidance will be available for public comment for 180 days. The draft guidance is in the form of questions and answers. This Lieberman PLLC regulatory alert summarizes the key points. Please contact Erik Lieberman at firstname.lastname@example.org or 202.830.0300 if you have questions or would like additional information.