to infant formulas might have been missed in preclinical or clinical trials involving the ingredient.
In-market monitoring information must be assessed for each area of function reviewed, as appropriate. Level 1 assessments are recommended only when all the following conditions occur:
There is no evidence of adverse effects in preclinical or clinical studies, including adverse effects with potentially plausible alternative explanations (e.g., the effects are viewed as the result of random chance or the reviewers believe that there may be methodological or statistical problems in the studies).
A review of the relevant scientific literature indicates there is no link between the new ingredient, metabolites, secondary effectors, or source and development of any of the areas of infant function previously described.
Level 2 assessments are required when any one of the above conditions does not occur or when level 1 assessments indicate unexpected problems in a function area, based on previous surveys, clinical information, or population-based rates.
In-market follow-up information must be assessed for each area of function reviewed, as appropriate. Level 2 assessments are recommended when any one of the following conditions occurs:
A review of the relevant scientific literature indicates that there is existing evidence linking the new ingredient, metabolites, secondary effectors, or source to the growth and development of organ systems that could result in cumulative adverse effects over time.
There is evidence of adverse effects in preclinical or clinical studies, including adverse effects with potentially plausible alternative explanations.
In-market monitoring reveals any adverse effects reported for the new ingredient, metabolites, secondary effectors, or source.
Level 3 assessments for in-market follow-up are required when any one of the above conditions occurs and level 2 assessments of in-market follow-up (review by the expert panel) indicate potential for harm in a function area.
This report describes the critical need to ensure the safety of infant formulas resulting from a number of converging issues:
Infancy is a uniquely vulnerable period of life.
Infant formulas are consumed by the vast majority of infants and are the sole source of nutrition for a large segment of infants up to the first 6 months of life.
Manufacturers are increasingly interested in adding new ingredients to formulas in an attempt to mimic the perceived and potential benefits of human milk.
Existing guidelines and safety regulations lack clarity and completeness in adequately addressing the unique growth and development requirements of infants and the vast diversity of potential new ingredients.
The committee is confident that this report will provide regulatory agencies—FDA, Health Canada, and others—with the recommendations, tools, and resources required to improve guidelines to ensure the safety of infant formulas for generations to come.