The Current U.S. Regulatory System

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. 

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  

TABLE 4-1 Comparison of Safety Standards Included in Federal Regulations 

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