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L. D. MEYERS, Food and Nutrition Board, Institute of Medicine, 500 Fifth St. N.W., Washington, DC 20001 At the request of the U. S. Food and Drug Administration and of Health Canada, a 10-member committee of the Institute of Medicine of the National Academies conducted a 2- year study of the approaches currently used to assess the safety of ingredients new to infant formulas. The committee was asked to identify tools that could be used to evaluate the safety of these ingredients as well as data needed to demonstrate the safety of a component already present in human milk. Given the importance of the specific form, matrix, and presence of other ingredients with which a new ingredient might interact, algorithms were developed that provide a step-by-step decision tree to follow in conducting each safety assessment. The committee found that safety assessment of infant formulas needs to be standardized (e.g., toxicity studies, risk assessment) and that manufacturers should establish balanced, qualified expert panels in consultation with the regulatory agency. In addition, a two-level assessment approach should be used that would determine the potential toxicity of the ingredient, its metabolites, and their effects within the matrix, on developing organ systems, and which should include a distinct set of procedures that use an appropriate number and type of animal models tested at relevant developmental stages in preclinical studies. With regard to clinical studies, while the committee recommended that growth studies be continued, they found that the 120 day growth study, as currently used, is insufficient. An important area that needs to be included in clinical studies is assessment of developmental behavioral outcomes, including sensory-motor, cognitive development, temperament, and neural function. And finally, the committee recommended that there be a systematic plan for continued monitoring and long-term surveillance post-marketing to ensure that any potential adverse effects not picked up in preclinical or clinical studies be detected as early as possible.
Session 44, Evaluating the safety of bioactive components for infant formula
2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana |