This report, prepared at the request of the Food and Drug Administration (FDA) and Health Canada (with potential international utility), addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infant formulas.


The Committee on the Evaluation of the Addition of Ingredients New to Infant Formula, convened by the Institute of Medicine, was asked to:

  • review methods currently used to assess the safety of ingredients new to infant formulas,

  • identify gaps in current safety assessment guidelines, and

  • identify tools to evaluate the safety of ingredients new to infant formulas under intended conditions of use in term infants.

The committee was asked to focus on ingredients that are regulated under the food provisions of the law and to consider the health and well-being of term infants from birth to 12 months of age. This charge included determining which new ingredients or classes of ingredients are of lesser or greater concern, which additional data would be needed to demonstrate the safety of a component already present in human milk when it is added to the matrix of infant formula, the usefulness of certain safety tools and approaches, and the utilization of preclinical and clinical studies and in-market monitoring. Finally, the committee was asked to apply its recommendations to long-chain polyunsaturated fatty acids (LC-PUFAs), recently determined GRAS, as a new ingredient in infant formulas and to other ingredients as appropriate.

The committee reviewed U.S., Canadian, and European laws and regulations to examine current processes for manufacturers who wish to add new ingredients to infant formulas: a GRAS Notification and a Food Additive Petition. The committee drew on this review, especially the GRAS Notification process, as it developed its recommendations. The committee also reviewed the special needs of infants and their implications for evaluating the safety of infant formulas.

The committee developed and used algorithms throughout the report to graphically depict the overall process and recommends the use of stepwise decision-tree approaches for the process and for preclinical studies, clinical studies, and in-market surveillance. Each algorithm is a step-by-step decision tree that depicts the logic of a process but does not denote a particular chronology. Algorithms provide a useful tool and a visual way to explain the process of planning the type and depth of safety assessments; to improve data collection, problem solving, and decision making; to incorporate multiple levels of information into a single document; and to utilize a linear approach to identify critical information needed at major decision points. The committee also applied its recommended approaches to LC-PUFAs and to probiotics, recently determined GRAS, to examine the utility of the approaches.

The committee recognizes that some of its recommendations may require statutory changes. Even with this limitation, the committee encourages dialogue among members of government agencies, the public, industry, and academia to act on the recommendations set forth by this report in the best interest of our most vulnerable members of society—our infants.

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