Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have been adequate in the past; however they were not designed to address the unique needs and vulnerabilities of infants and potential new types of ingredients. This chapter provides an overview of the current regulatory system with a discussion of the existing laws; definitions of safety, quality, food, drugs, and dietary supplements; and routes to add new ingredients to infant formulas in the United States. The committee then describes four major limitations of the current system. Finally, an approach is presented to assess the safety of new ingredients to be added to infant formulas, using the current GRAS Notification process as a starting model. The committee suggests that these guidelines could be applied in other countries as regulation parameters.


In the United States infant formulas and ingredients added to infant formulas fall within the purview of the Office of Food Additive Safety and the Office of Nutritional Products, Labeling and Dietary Supplements of FDA’s Center for Food Safety and Applied Nutrition. The safety of new ingredients added to infant formulas is regulated under Section 409 of the Federal Food, Drug and Cosmetic (FD&C) Act (21 U.S.C. §348), which was the primary focus of the committee.

The Infant Formula Acts of 1980 (P.L. 96-359) and 1986 (P.L. 99-570) were incorporated into the FD&C Act as Section 412 (21 U.S.C §350a), which deals with proper manufacturing, formulation, and quality factors of infant formulas. This chapter will focus mainly on safety issues of ingredients (Section 409), but it should be noted that some aspects of Section 412 (quality factors) also play a critical role in the safety assessment process.

Foods, Dietary Supplements, and Drugs as Defined by the Federal Food, Drug and Cosmetic Act

The definition of foods, dietary supplements, and drugs and their respective safety standards are essential to the understanding of the regulatory differences between these classes of bioactive materials. It is beyond the scope of this chapter to delve into the rationale behind the regulations, but the concept of intended use is a critical differentiator between foods, dietary supplements, and drugs, which are defined in the following manner:

  • Foods are “articles or components of articles used for food or drink for humans or animals” (21 U.S.C. §321 (f)(1)).

  • Drugs are “articles intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” (21 U.S.C. §321 (g)(1)(b)).

  • Dietary Supplements are products “… intended to supplement the diet that bear or contain one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any ingredient described above” (21 U.S.C. §321 (ff)(2)).

Table 4-1 provides a comparison of the safety standards for foods, drugs, and dietary supplements. Infant formulas are considered food and, thus, a risk-benefit analysis would be inappropriate because foods are safe for everyone—young or old, male or female, healthy or

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