Protein Quality and Growth Monitoring Studies: Quality Factor Requirements for Infant Formula (2025)
Chapter: Appendix B: Disclosure of Unavoidable Conflict of Interest
Appendix B
Disclosure of Unavoidable Conflict of Interest
The conflict-of-interest policy of the National Academies of Sciences, Engineering, and Medicine (the National Academies; http://www.nationalacademies.org/coi) prohibits appointing an individual to a committee authoring a consensus study report if they have 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 it 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 good practice for protein quality in infant formula. 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 and protein efficiency studies in conformance with current regulations. Based on his background at the
U.S. Food and Drug Administration 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 formula from both a policy and nutrition perspective.
The National Academies has determined that his experience and expertise were 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 did not have a conflict of interest. Therefore, the National Academies concluded that the conflict was unavoidable.
The National Academies believed that Dr. Wallingford could serve effectively as a member of the committee and the committee produce an objective report, taking into account its composition, the work to be performed, and the procedures to be followed in the study.
