National Academy of Medicine

Safety Assessment of Macronutrients: Creating a New Paradigm

By Joseph A. Scimeca
February 11, 2016 | Commentary

Unlike with most food additives, the safety evaluation of macronutrients poses a challenge to risk assessors because of their inherent nutritional value and relatively large dietary exposure. A safety assessment model of macronutrients based solely on traditional toxicological studies faces limitations, whereas nutritional studies of macronutrients are often designed to provide information to support dietary recommendations for optimal health.

Although both nutritional and toxicological research shares a common goal of improving public health, the manner in which the studies are used differ because of limitations in their design and conduct. Many nutritional studies enjoy the benefit of using human subjects that can reflect real-world exposure scenarios, but consequently these studies are beset with unknown confounding variables that make drawing causative conclusions difficult. Toxicological studies must be conducted with laboratory animals, but they are concomitantly more easily controlled, permitting better causation determinations. What is needed to improve the safety determination of macronutrients is a hybrid model that encompasses both types of studies integrated toward a shared problem definition.

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Disclaimer: The views expressed in this paper are those of the authors and not necessarily of the authors’ organizations, the National Academy of Medicine (NAM), or the National Academies of Sciences, Engineering, and Medicine (the National Academies). The paper is intended to help inform and stimulate discussion. It is not a report of the NAM or the National Academies. Copyright by the National Academy of Sciences. All rights reserved.