las. The basic models of food safety are based upon the assumption that nearly all individuals function basically in similar ways with regard to the safety of substances in their diet (although there are gross subtypes with different dietary needs, such as premature infants and infants with food allergies). However it may be speculated that there are more subtle underlying subgroups (e.g., genetic subtypes) for which new substances may or may not have the same safety characteristics as they would for individuals not in those subgroups. In clinical trials the minimum sample size required to detect systematic group differences in response to a new ingredient is likely to be entirely inadequate for subgroup analyses.

5. Infant formulas could be considered as more than just food. The rules governing the safety of infant formulas are regulated under the logic of infant formulas being a “food product,” and there is no doubt that the primary purpose of infant formulas is nutrition. However infant formulas can also be seen as a potential delivery system for non-nutritional agents. This potential as a delivery system should cause one to consider the question of what are the appropriate (both legal and ethical) boundaries for additions to infant formulas. Consideration must be given to constructs that will appropriately set the limits and provide the definitions for an addition being “nutritional.” The presence of the substance in human milk may not be a sufficient definition of a nutritional substance, and other factors, such as whether the substance is produced from genetically modified sources, need to be considered. In addition, the regulatory steps to follow to ensure the safety of a substance whose purpose is non-nutritional (e.g., a substance whose purpose is to reduce infant discomfort) need to be determined.

6. Potential benefits, along with safety, should be considered when adding a new ingredient to formulas. Food products are generally considered to be inherently beneficial or efficacious (with inherent sensory properties and nutrition) and thus efficacy (i.e., health benefits) has not been a consideration in the safety assessment of foods. In the case of infant formulas, this starting assumption may be modified through the additional requirement in proposed regulations (FDA, 1996) that the product be capable of sustaining physical growth for a specified period of time, that is, it is already required that the final formulated product be demonstrated to be efficacious from the point of view of physical development. (This proposed requirement, however, is usually stated as a safety criterion rather than as an efficacy criterion, that is, a lack of efficacy would be a risk to the organism and therefore a safety concern.)

Other than this proposed requirement for sustaining physical growth, however, the manufacturer would not need to demonstrate the benefits of any proposed new ingredient to infant formulas. Given the special circumstances of the use of infant formulas and the fact that is it virtually impossible to understand the long-term outcomes of adding any given ingredient (the clinical trials are, of necessity, of relatively short duration), prudence would seem to dictate that an ingredient not be added to an infant formula unless it can be shown that some benefit is accrued to the infant through its addition. Since the committee was not charged with addressing efficacy, it recommends that consideration be given to convening a group of experts to explore if benefit could be an appropriate requirement for adding a new ingredient to infant formulas.

SUMMARY

Infancy is a uniquely vulnerable period that complicates the interpretation of safety guidelines. Manufacturers may propose the addition of a new ingredient to infant formulas by demonstrating the safety of the proposed ingredient. They are not required to demonstrate the benefit of an individual ingredient in the product. Although the committee believes



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