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        Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

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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          Guidance & Regulation (Food and Dietary Supplements)
          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Infant Formula Guidance Documents & Regulatory InformationGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Infant Formula Guidance Documents & Regulatory Information
  	
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    PrintPersons responsible for the manufacture or distribution of infant formula that will be introduced into interstate commerce in the United States must comply with the requirements of the Federal Food, Drug, and Cosmetic Act ( the act), 21 USC 321 et seq., and FDA's regulations implementing the act. All of FDA's regulations are published in Title 21 of the Code of Federal Regulations (CFR).

The following is a list of guidance documents and regulatory information related to infant formula.

For more information:

Regulations and Information on the Manufacture and Distribution of Infant Formula
	Status Update on FDA’s Infant Formula Response Activities
	Progress Update on FDA’s Evaluation of the Infant Formula Response
	Infant FormulaConsumers, please visit Food Safety for Infants & Toddlers.

Guidance for Industry

*Guidance documents contain nonbinding recommendations.*

Guidance for Industry: Labeling of Infant Formula March 2023
	Draft Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein (February 2023)
	Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion September 2022
	Guidance for Industry: Infant Formula Enforcement Discretion Policy May 2022
	Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
	Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk May 2019
	Guidance for Industry: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China  June 2017
	Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling September 2016
	Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports April 2016
	Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant Formulas June 2014
	Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006Laws, Regulations, and Rules

Final Rule: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements June 2015
	Final Rule: Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant FormulaJune 2014
	FINAL RULE CORRECTIONS: Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula July 2014
	Final Rule: Indirect Food Additives - Adhesives and Components of Coatings
	Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula; Proposed Rule July 9, 1996
	Federal Food Drug and Cosmetic Act, Section 412 - Requirements for Infant Formula
	61 FR 36154 - 1996 Proposed Rule for Infant Formula: Current Good Manufacturing Practice, Quality Control Procedures, Quality FactorsCurrent Manufacturing Regulations and Guidelines

21 CFR 106 Infant Formula Quality Control Procedures
	21 CFR 106.100 Records and Reports Regulations
	21 CFR 107.3 - 107.30 Infant Formula Labeling Requirements
	21 CFR 107.50 Exempt Infant Formulas
	21 CFR 107.100 Nutrient Requirements for Infant Formulas
	21 CFR 107.200 - 107.280 Infant Formula Recall Requirements
	21 CFR 110 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food
	21 CFR 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed ContainersGuidelines Concerning Notification and Testing of Infant Formulas 1985 (cited in the Federal Food, Drug, and Cosmetic Act 412(c)(2))
	Exempt Infant Formulas Marketed in the United States by Manufacturer and Category****Infant Formula Products for Export Only

Federal Food, Drug, and Cosmetic Act, Section 801(e)(1) - Imports and ExportsClinical Studies of Infant Formulas

21 CFR 50 Human Subjects Protection Informed Consent
	21 CFR 56 Institutional Review BoardsRequest for Comments on New **Electronic Submissions Form**

FDA developed a draft electronic form, Form FDA 3978. Form FDA 3978 will prompt a respondent to register and include the required submission in a standard electronic format. This will help the respondent organize their registration and submission to include the information needed for FDA’s review and will give the respondent access to the status of the review as well as access to their previous registrations and submissions.

Manufacturers that prefer to submit paper registrations and submissions in a format of their own choosing will still have the option to do so.

FDA sought comments on this draft electronic form. View Draft Screenshots and Draft Instructions for Form FDA 3978 (PDF: 10MB).

The comment period opened November 15, 2017 for 60 days. View electronically submitted comments in docket folder FDA-2013-N-0545 on http://www.regualtions.gov.

                                                                                  Content current as of:
      12/13/2023
                  
                   
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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