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Problems Associated with the Establishment of Maximum Nutrient Limits in Infant Formula¹

University of Texas, Health Sciences Center, San Antonio, TX 78284-7819

Because each increase in personal security is accompanied by a small but measurable decrease in individual liberty, congress and the American people have been reluctant to provide to the regulatory agencies authority beyond that which they believe is the minimum necessary to avoid a crisis. For government to act in any area involving nutrient fortification of foods requires an acceptable database demonstrating a health hazard. The requirements of current law demand that new formulas be investigated by appropriate clinical studies but do not grant the FDA clear authority to establish maximum limits for nutrients in infant formulas. Except when an unquestionable hazard can be demonstrated, there are important barriers to governmental action in this area. Without a clearly defined, scientifically acceptable database, without concensus in the scientific and professional community, and without public support for action to be taken in this area, the establishment of maximum limits for many nutrients will be extremely difficult.

KEY WORDS: • infant formulas • regulations • Food and Drug Administration

¹ This paper was presented at a symposium, "Upper Limits of Nutrients in Infant Formulas," November 7–8, 1988, in Iowa City, IA.