Q: What are FDA requirements related to Infant Formulas?


A: Sec. 412 of the Federal Food, Drug, and Cosmetic Act establishes nutrient requirements for infant formulas as defined by Section 201(z) of the Federal Food, Drug, and Cosmetic Act, and provides FDA authority to establish good manufacturing practice (GMP) requirements and requirements for nutrient quantity, nutrient quality control, recordkeeping, and for reporting and recall of infant formulas which pose a potential hazard to health. Section 412 also extends FDA's factory inspection authority to permit access to complaint files and other manufacturers' records, quality control records, and test results necessary to determine compliance with the Act.

Section 412 specifies that an infant formula is adulterated:

  1. if it fails to provide nutrients as required

  2. if it fails to meet the nutrient quality factors required by regulation

  3. if the processing is not in compliance with the appropriate GMP and quality control procedures or record retention requirements as prescribed by regulation

  4. if it otherwise fails to comply with Section 402 of the Federal Food, Drug, and Cosmetic Act.

Section 412 also requires manufacturers of infant formulas to notify FDA 90 days before any charitable or commercial distribution of any new infant formula or any infant formula that has had a major change in its formulation or processing.

Under authority of the Federal Food, Drug, and Cosmetic Act, FDA has established regulations (21 CFR 106) which specify quality control procedures for assuring nutrient content of infant formula. Similarly, regulations have been established for infant formula on the following: (21 CFR 107) the labeling of infant formula; the terms and conditions under which certain infant formulas may be exempt from some of the Federal Food, Drug, and Cosmetic Act's requirements; nutrient specifications for infant formula; infant formula recalls; and record retention. The FDA is also developing additional regulations in response to amendments to the Infant Formula Act, including regulations on good manufacturing practices.

Inquiries should be directed to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Special Nutritionals (HFS-450), 200 C Street, S.W., Washington, D.C. 20204.

-Access the Code of Federal Regulations for the provisions mentioned above.
-For additional information see Information Materials for the Food and Cosmetics Industries.

 

Source: Excerpted from Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration (1997).
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