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The National Academies will convene a Committee to conduct a study to examine and report on the state of the science regarding methodologies for assessing biological quality of protein in an infant formula and the state of the science regarding methodologies for assessing the ability of an infant formula to support normal physical growth.
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Consensus
ยท2025
Formula is often the sole source of nutrition for many infants, making its safety and quality particularly critical. While most food laws and regulations apply to infant formulas, they are also subject to additional requirements and manufacturer regulations for certain quality factors. These include...
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Description
The National Academies of Sciences, Engineering, and Medicine will convene a committee of experts to undertake a review and assessment of the current scientific evidence on the state of the science regarding methodologies for assessing the biological quality of protein in an infant formula and the state of the science regarding methodologies for assessing the ability of an infant formula to support normal growth. In its review of evidence, the committee will consider:
1. the strengths and weaknesses of study designs that may be in common use in other global regions;
2. the extent to which specific study designs have been validated; and
3. the appropriateness of specific animal models.
The committee will produce a report that includes a detailed evaluation of the state of the science on methodologies for assessing protein quality in infant formula and the ability of infant formula to support normal physical growth. The committee will also recommend alternate study designs and supplementary information that could potentially be used to show whether the biological quality of protein in infant formula and its ability to support normal physical growth have both been met and are consistent with regulatory standards.
Contributors
Committee
Chair
Member
Member
Member
Member
Member
Member
Member
Member
Ann L. Yaktine
Staff Officer
Conflict of Interest Disclosure
The conflict-of-interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.
John Wallingford has a conflict of interest in relation to his service on the Committee on Protein Quality and Growth Monitoring Studies to Satisfy Quality Factor Requirements for Infant Formula due to receiving compensation attributable to his work as an independent consultant representing Jovie and Arla, two infant formula companies.
The National Academies has concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one person who has substantial recent experience in applying regulatory standards for protein quality in infant formula standards for good practice. As described in his biographical summary, Dr. Wallingford has extensive experience working on regulatory requirements for infant formulas, including guidance regarding clinical studies undertaken to satisfy growth monitoring study regulations as well as protein efficiency studies in conformance with current regulations. Based on his background at FDA overseeing infant formula notifications and his work at Wyeth Nutrition on global regulatory compliance of infant formula with Codex standards, and European Union directives and regulations, Dr. Wallingford has deep knowledge of the current standards for good practice in regulatory analysis of infant formula from both a policy and nutrition perspective.
The National Academies has determined that the experience and expertise of Dr. Wallingford is needed for the committee to accomplish the task for which it has been established. The National Academies could not identify another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.
The National Academies believes that Dr. Wallingford can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.
Sponsors
Department of Health and Human Services
Staff
Ann Yaktine
Lead
Sarah Poncet
Melanie Arthur
Jen Stephenson
Major units and sub-units
Center for Health, People, and Places
Lead
Food, Nutrition, and Agriculture Program Area
Lead