Infant Formula Guidance Documents & Regulatory Information
Persons 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).
For more information, see Regulations and Information on the Manufacture and Distribution of Infant Formula.
The following is a list of guidance documents and regulatory information related to infant formula.
Consumers, 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- Draft Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological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
- 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- Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling September 2016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, 2006
Laws, 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 Formula June 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 Factors
Current 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 Containers
- Guidelines 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 Exports
Clinical Studies of Infant Formulas
Request 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.