Have you noticed the number of new term infant formula preparations that are currently on the market? For example, several preparations have new formulas with DHA and ARA added, based on data supporting their beneficial effect on preterm infant cognitive and visual development. One manufacturer (Mead Johnson) conducted live audio-conferences on the benefits of these two ingredients during the months of April and May 2004.

Given the increasing popularity of new ingredients in infant formula, have you ever wondered how the safety of these ingredients is determined? Are there rules that manufacturers must follow in order to add ingredients to infant formula? A recent publication by the Institute of Medicine (IOM) provides considerable insight about establishing the safety of new ingredients, as well as answers to these questions (IOM, 2003). The report also discusses the benefits of breastfeeding, the importance of pre-clinical and clinical studies when testing formula ingredients, and criteria and methods for in-market surveillance. It's a great resource!!

This column deals with one aspect of the report: formula safety. An understanding of certain fundamental terms is critical to the discussion of safety. The concept of safety "refers to a reasonable certainty of no harm" (IOM, 2003, p. 2-1). Safety is neither an inherent biological property of a substance nor an absolute value, but is "described by noting a range along a continuum" (IOM, 2003, p. 2-2). In the United States, the primary responsibility for regulating new ingredients for infant formulas rests with the U.S. Food and Drug Administration (FDA).

Understanding the concept of safety and how it can be determined requires clarity about other terms associated with safety: hazard, risk, harm, and benefit. A hazard is something that may produce an "undesired health-related outcome" (IOM, 2003, p. 2-2). However, being exposed to a hazard does not mean that the undesired outcome will occur. Risk is the probability or chance that an undesired outcome will occur. The nature of the undesired outcome is defined as harm. The nature of harm varies, as does individual perspectives of harm, and is frequently evaluated in terms of cost. B enefit is the opposite of harm. The cost-benefit ratio is a common consideration when evaluating a treatment.

Not only are there models for assessing safety, but because infancy is such a critical time for growth and development, there also are additional factors to consider when addressing safety relative to infant formula (IOM, 2003, pp, 2-10-2-11):

* Infant formulas are the sole or predominant source of nutrition for many infants. Thus, models used to determine safety for persons with a greater variety of food sources may be inappropriate for infants.

* Formulas are fed during a sensitive period of development and may, therefore, have short- and long-term consequences for infant health. Current safety models only consider short-term outcomes; however, consequences may not be evident in infancy.

* Animals may not be the most appropriate model on which to base decisions of safety. Animals may not experience the same biologic and developmental responses to a new ingredient as a human infant, which can limit the ability to detect long-term outcomes.

* "One size fits all" food safety models may not work for all new additions for formulas. The possibility exists that there are subtle differences among subgroups of infants that are difficult to detect. Current sampling methods may be inadequate to detect these subtleties.

* Infant formulas could be considered as more than just food. Formulas also can provide nonnutritional ingredients. Legal and ethical boundaries need to be determined, as does clarification of what constitutes being nutritious.

* Potential benefits, along with safety, should be considered when adding a new ingredient to formula. Interestingly, "food products are generally considered to be inherently beneficial or efficacious" (IOM, 2003, p. 2-11). However, given the uniqueness of infant formula, evidence of a benefit resulting from the addition of an ingredient seems prudent.

As these factors show, determining safety in relation to adding ingredients to infant formula is a complex undertaking. Not only must we be clear about relevant terms, but we also must be sensitive to the special circumstances of nutrition during infancy. The information in this column can help you frame your questions and guide your discussion when new formulas are introduced.

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