US Publishes Guidance for Industries on Infant Formula Enforcement Discretion Policy

On May 18^th, 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 14^th, 2022 until further notice.

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