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.

Guidance for Industry

Guidance documents contain nonbinding recommendations.

Laws, Regulations, and Rules

Current Manufacturing Regulations and Guidelines

Infant Formula Products for Export Only

Clinical Studies of Infant Formulas

  • 21 CFR 50 Human Subjects Protection Informed Consent
  • 21 CFR 56 Institutional Review Boards

Request for Comments on New Electronic Submissions Form

FDA has 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 is seeking comments on this draft electronic form. Draft screenshots of Form FDA 3978 and draft instructions are available below for review and comments.

The comment period opens November 15, 2017 for 60 days. Submit comments electronically to docket folder FDA-2013-N-0545 on For more information on how to comment, see the Federal Register Notice.  

Page Last Updated: 01/30/2018
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