FDA Extends Infant Formula Enforcement Discretion with Guidance for Regulatory Compliance
The U.S. Food and Drug Administration (FDA) has issued a guidance announcing the agency’s plans to allow manufacturers who are producing infant formula under enforcement discretion to market products that may not currently comply with specific FDA requirements, while working toward meeting those requirements. The decision aims to stabilize the U.S. infant formula supply while providing manufacturers a pathway to ensuring their infant formula products are safe and quality.
The present guidance follows FDA’s May 2022 guidance granting enforcement discretion for certain requirements that apply to infant formula on a case-by-case basis. Since the publication of the May 2022 guidance, many manufacturers have provided FDA with detailed information pertaining to particular infant formulas, and FDA has reviewed such information, including details about the products’ nutritional adequacy and safety, microbiological testing results, labeling information, and details about manufacturing facilities’ food safety production practices and inspection histories.