Regulating Fatty Acids in Infant Formula: Critical Assessment of U.S. Policies and Practices


George Kent – International Breastfeeding Journal

International Breastfeeding Journal 2014, 9:2  doi:10.1186/1746-4358-9-2

16 January 2014

Abstract (provisional)


Fatty acids in breast-milk such as docosahexaenoic acid and arachidonic acid, commonly known as DHA and ARA, contribute to the healthy development of children in various ways. However, the manufactured versions might not have the same health benefits as those in breast-milk. There is evidence that the manufactured additives might cause harm to infants’ health, and they might lead to unwarranted increases in the cost of infant formula. The addition of such fatty acids to infant formula needs to be regulated. In the U.S., the Food and Drug Administration has primary responsibility for regulating the composition of infant formula. The central purpose of this study is to assess the FDA’s efforts with regard to the regulation of fatty acids in infant formula.


This study is based on critical analysis of policies and practices described in publicly available documents of the FDA, the manufacturers of fatty acids, and other relevant organizations. The broad framework for this work was set out by the author in his book on Regulating Infant Formula, published in 2011.


The FDA does not assess the safety or the health impacts of fatty acid additives to infant formula before marketed, and there is no systematic assessment after marketing is underway. Rather than making its own independent assessments, the FDA accepts the manufacturers’ claims regarding their products’ safety and effectiveness.


The FDA is not adequately regulating the use of fatty acid additives to infant formula. This results in exposure of infants to potential risks. Adverse reactions are already on record. Also, the additives have led to increasing costs of infant formula despite the lack of proven benefits to normal, full term infants. There is a need for more effective regulation of DHA and ARA additives to infant formula.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.


TRANSCEND member George Kent is Professor of Political Science (Emeritus) at the University of Hawai‘i, U.S.A. He currently teaches an online course on the Human Right to Adequate Food at the Centre for Peace and Conflict Studies, University of Sydney, Australia, and also the Transformative Social Change concentration at Saybrook University in San Francisco. His recent books on food policy issues are Freedom from Want: The Human Right to Adequate Food, Global Obligations for the Right to Food, Ending Hunger Worldwide, and Regulating Infant Formula.

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