US Publishes Guidance for Industries on Infant Formula Enforcement Discretion Policy

Posted By: Baviya Priyadharshini

On May 18th, 2022, the Center for Food Safety and Applied Nutrition of the United States issued a document on the “Guidance for the Industry: Infant Formula Enforcement Discretion Policy” to increase Infant Formula supply.


The guidance document highlights the following key points:

  • FDA to seek information from manufacturers regarding their products' safety and nutritional adequacy;
  • Explains factors on enforcement discretion to allow safe and nutritionally adequate infant formula that may not comply with all statutory and regulatory requirements;
  • Advises infant formula manufacturers about the type of information to provide to the FDA;
  • The regulation on Infant formula also establishes labeling requirements of nutrient information (21 CFR 107.10) and directions for use (107.20).


The Guidance document will remain in effect until November 14th, 2022 until further notice.

To view the complete document, check out the Food News Monitoring System.