Published online August 31, 2005
PEDIATRICS Vol. 116 No. 3 September 2005, pp. 753-755 (doi:10.1542/peds.2005-1536)

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COMMENTARY

The Food and Drug Administration Must Require the Addition of More Folic Acid in "Enriched" Flour and Other Grains

Robert L. Brent, MD, PhD and Godfrey P. Oakley, Jr, MD, MSPM

Departments of Pediatrics, Radiology, and Pathology,
Thomas Jefferson University,
A.I. duPont Hospital for Children,
Wilmington, DE 19899
Department of Epidemiology,
Rollins School of Public Health of Emory University,
Atlanta, GA 30322

Abbreviations: CDC, Centers for Disease Control and Prevention • FDA, US Food and Drug Administration

The first 300 words of the full text of this article appear below.

In 1991 Wald and his colleagues¹ first provided unambiguous evidence that synthetic folic acid in a pill would prevent most children from getting spina bifida and anencephaly. Sufficient folic acid fortification of foods eaten by most women of reproductive age would prevent almost all folic acid–preventable spina bifida and anencephaly. In this issue, Williams and colleagues² at the Centers for Disease Control and Prevention (CDC) and in state health departments have tracked the continuing occurrence of spina bifida and anencephaly before and after folic acid fortification of "enriched" grains. It is a tragic failure of public policy, both in the United States and around the world, that a single case of folic acid–preventable spina bifida and anencephaly occurs. We brought this urgent problem to the attention of the US Food and Drug Administration (FDA) and the world medical community through a commentary in Pediatrics in 2000.³ However, the response for action has been inadequate. In fact, it has been ignored. The title of that commentary was "The Unnecessary Epidemic of Folic Acid–Preventable Spina Bifida and Anencephaly." Unfortunately, it is not a few cases here and there. The CDC estimates that 2000 cases of folic acid–preventable spina bifida and anencephaly pregnancies continue to occur yearly in the United States.⁴ There are 200000 children each year around the world born with these preventable birth defects.⁵ We must do better for children everywhere.

We know why folic acid–preventable birth defects continue to occur unnecessarily and tragically in the United States. Our government has failed to take the steps needed to assure that not a single child is affected with folic acid–preventable spina bifida and anencephaly. The FDA did not require a high enough concentration of folic acid in enriched grain products.⁶ Although the requirement of folic acid in enriched grain products has had . . . [Full Text of this Article]

Address correspondence to Robert L. Brent, MD, PhD, Department of Pediatrics, A.I. duPont Hospital for Children, Box 269, Wilmington, DE 19899. E-mail: rbrent@nemours.org

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