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Infant Formula Regulation

Role of the FDA

The FDA has the overarching responsibility for food safety in the United States. The  work the FDA does to over see the safe manufacture of infant formula is succinctly summarized on the Frequently Asked Questions about FDA's Regulation of Infant Formula page of the FDA's website. The site is geared to infant formula manufacturers and reviews topics such as:
  • the definition of infant formula
  • who regulates infant formula
  • what substances can be used in infant formula
  • rules of marketing infant formula
  • infant formula monitoring processes


The pages under this tab are as follows:
  • Guidance and Regulatory Information- here you will find links to agencies that play a role in the manufacture of infant formula, and an explanation of the work they do. You will also find specific regulations and how they are monitored. 
  • The Proposed Rule for Good Manufacturing is detailed on this page.
  • The work of the Live Science Research Office (LSRO) is explained on this page.
  • Food Safety and Recall History is found on this page.




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