May 3, 2016

In 1993, James L. Mills, MD, MS, a senior investigator at the National Institute of Child Health and Human Development, attended a series of US Food and Drug Administration (FDA) subcommittee meetings. The subcommittee was considering whether to recommend fortifying cereal grain products with the B vitamin folic acid as a public health strategy to reduce the risk of infant neural tube defects. A year earlier, the US Department of Health and Human Services’ Public Health Service (PHS) had recommended that all women of childbearing age consume 400 μg of folic acid daily to reduce the risk of having a child with spina bifida, anencephaly, or another neural tube defect (MMWR Recomm Rep. 1992;41[RR-14]:107). The PHS’ recommendation was based, in part, on a landmark UK Medical Research Council clinical trial, which demonstrated that among women who had previously given birth to babies with neural tube defects, those who took 4 mg of folic acid supplements daily had a 72% reduced risk of having another baby with neural tube defects relative to those who did not take supplements (Wald N et al. Lancet. 1991;338[8760]:131-137). Despite the PHS’ recommendation, committee members were cautious about moving forward with fortification, Mills recalled (

Julie A. Jacob, MA