Costs and benefits of folic acid fortification in the United States: economic analysis, regulatory action, and public health

The United States Food and Drug Administration (FDA) required that as of January 1, 1998, manufacturers of enriched cereal- grain products fortify their products with folic acid to reduce the number of pregnancies affected by a neural tube defect (NTD). Prior to adoption of the regulation in 1996, three economic evaluations projected the net economic benefits or cost savings of folic acid fortification. The expected percentage decline in NTDs in these three studies was between 2.6% and 10.5%. Birth defects surveillance data indicate that since fortification there has been a 20% to 30% decline in births with either spina bifida or anencephaly. We estimate that folic acid fortification is associated with an economic benefit of $425 million per year in the United States and constitutes a major public health success that has resulted from regulatory action