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                Infant Formula Guidance Documents & Regulatory Information

Infant Formula Guidance Documents & Regulatory Information

                        Regulations and Information on the Manufacture and Distribution of Infant Formula
          Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
          Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
          Status Update on FDA’s Infant Formula Response Activities
          Progress Update on FDA’s Evaluation of the Infant Formula Response Home
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          Infant Formula Guidance Documents & Regulatory Information
          Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula MarketInfant Formula Guidance Documents & Regulatory Information Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
  
  	
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    PrintImmediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
The Food and Drug Omnibus Reform Act of 2022 directed the U.S. Food and Drug Administration, in consultation with other federal government partners, to develop an immediate national strategy to increase the resiliency of the U.S. infant formula supply chain, protect against future contamination and other potential causes of shortages, and ensure parents and caregivers have access to infant formula and the information they need.

The strategy describes immediate actions the FDA took to address the shortage and details the agency’s plans for improving the resiliency of the infant formula market, while noting multiple issues that are beyond the purview of the FDA. It also traces the events that led up to and followed the voluntary recall of infant formula by Abbott Nutrition in February 2022, the temporary pause in production at the facility in Sturgis, Michigan, and pantry loading that peaked in May 2022, likely driven in part by an overemphasis on other shortages being reported in the media, as well as numerous other factors that contributed to and exacerbated the shortage.

The immediate strategy represents a first step toward issuing, with input from the National Academy of Science, Engineering and Medicine (NASEM), a long-term national strategy in 2024 to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination. The longer-term strategy will explore new approaches to help facilitate entry of new infant formula manufacturers to increase supply and mitigate future shortages and recommend necessary authorities to gain insight into the supply chain and risks for shortages.

**Download the Strategy**(PDF)

Status Update on FDA’s Infant Formula Response Activities

For more information

Constituent Update: FDA Publishes Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
	Strategy to Help Prevent *Cronobacter sakazakii* Illnesses Associated with Consumption of Powdered Infant Formula
	Letter to the Infant Formula Industry
	Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
	Infant Formula
	*Cronobacter sakazakii*

                                                                                  Content current as of:
      03/28/2023
              
              
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Infant Formula & FoodsInfant Formula Guidance Documents & Regulatory Information

          
                        Regulations and Information on the Manufacture and Distribution of Infant Formula
          Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
          Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
          Status Update on FDA’s Infant Formula Response Activities
          Progress Update on FDA’s Evaluation of the Infant Formula Response
 
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