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


Page Last Updated: 07/27/2017
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