FIGURE 1-1 Percent of infants who were exclusively breastfed from birth to 12 months of age in the United States.

SOURCE: Adapted from Hediger et al. (2000) and Ryan et al. (2002).

met six times over 18 months to fulfill its charge. This report is intended to provide recommendations for regulatory bodies, industry, and basic and clinical investigators involved in determining the safety of new ingredients added to infant formulas.


United States

Food products that are designed and marketed for infants are regulated under the Federal Food, Drug and Cosmetic (FD&C) Act of 1938 (21 U.S.C. §301) (Vanderveen, 1991). FDA, an agency in the U.S. Department of Health and Human Services (HHS), regulates infant formulas and evaluates the safety of food and color additives.

Two sections of the FD&C Act, 409 and 412, are the primary laws that relate to infant formulas. Section 409 gives authority to HHS to ensure the safety of new food ingredients (e.g., food additives and Generally Recognized as Safe [GRAS] substances) “under the conditions of its intended use” (e.g., in infant formulas). Manufacturers may propose the addition of new ingredients to infant formulas in the United States by either filing a Food Additive Petition with FDA to request a formal premarket review, or making a GRAS determination. It is important to point out that it is the use of the substance, rather than the substance itself, that is eligible for the GRAS determination (see Chapter 4).

Under Section 412 of the FD&C Act, regulations have been promulgated and ultimately implemented that are intended to ensure proper formulation for infants to thrive. They include:

  • Infant Formula Quality Control Procedures (21 C.F.R. §106),

  • Records and Reports Regulations (21 C.F.R. §106.100),

  • Infant Formula Labeling Requirements (21 C.F.R. §107.10–107.30),

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