The Food and Drug Administration (FDA) in the USA has issued a final rule to establish requirements that manufacturers show that their infant formulas support normal physical growth and meet quality standards (Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors). These requirements, which manufacturers must comply with from 8th September 2014, improve the protection of infants consuming infant formulas by establishing greater regulatory control over the formulation and production of infant formula.Many infant formula manufacturers that sell their products in the USA have voluntarily applied many of the good manufacturing practices and quality control procedures included in the final rule, but the new rule establishes legally enforceable requirements.