USFDA Extends Enforcement Discretion for Infant Formula with Regulatory Compliance Guidance

September 30, 2022

To protect public health by stabilizing the supply of a variety of infant formula products, FDA issued a guidance document on temporary basis which will remain in effect until October 18, 2025. This will help infant formula manufacturers meet applicable regulatory requirements for introduction into interstate commerce of infant formula products that may not comply with certain statutory and regulatory requirements if| (1) such manufacturers can market these products consistent with a letter of enforcement discretion relating to information given under “Infant Formula Enforcement Discretion Policy: Guidance for Industry”.|(2) such manufacturers take specific actions to achieve compliance with the statutory and regulatory requirements applicable to their products. 

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