49I-8 |
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M. P. ORIA and L. Vogelsang. Food and Nutrition Board, Institute of Medicine/The National Academies, 500 5th St NW, Washington, DC 20001 Infant formulas serve as substitutes for human milk and have a special role because they are the only source of nutrients for some infants. Currently, in the United States and many other countries, the vast majority of infants receive infant formulas at some time during the first year of life. Because of the vulnerability of infants and the fact that infant formula is their sole source of nutrients, the optimization of nutrition and minimization of exposure to potentially harmful substances in the food supply is of heightened importance and safety measures of different parameters during infancy need be equally or even more stringent than at other periods during the life cycle. Currently there are only a small number of guidelines or recommendations from organizations regarding approaches to assessing the safety of ingredients added to infant formula. Infant formulas have been modified over the years to make them similar in performance to breastfeeding, to improve flavor and to increase shelf life, or to improve the quality of nutrition for infants. However, infant formula manufacturers have recently proposed ingredients (e.g., probiotics and other complex ingredients) that have created new scientific challenges that existing regulations may not specifically address. In 2002, the U.S. Food and Drug Administration and Health Canada asked the Institute of Medicine’s Food and Nutrition Board to formulate a committee of experts to provide guidelines/advice on what is important to consider when assessing ingredients new to infant formula. This presentation discusses the findings and recommendations of the Committee on Evaluation of the Addition of Ingredients New to Infant Formula that was specifically asked to: review methods currently used to assess new ingredients; identify gaps in current safety guidelines; and identify tools of preclinical, clinical and in market assessment to evaluate the safety of new ingredients for infant formulas.
Session 49I, Toxicology & Safety Evaluation: General
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