JAMA research letter: New FDA regulation fails to close birth defects prevention gap

Woodruff Health Sciences Center | Oct. 16, 2018

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Scientists at the Emory Rollins School of Public Health published a research letter in JAMA noting that the U.S. Food and Drug Administration’s (FDA) 2016 regulation permitting folic acid fortification of corn masa flour has not resulted in preventing the birth defects the regulations sought to prevent. 

The study, which was the first of its kind to evaluate market penetration of corn masa fortification was conducted by public health researchers at Emory’s Center for Spina Bifida Prevention, directed by Godfrey P. Oakley, MD, MSPM. The study examined the prevalence of folic-acid-fortified corn masa flour and tortillas available in the Atlanta area 18 months after the FDA regulations were issued.

Adding folic acid to flour has dramatically reduced the number of birth defects of the brain and spine—such as spina bifida and anencephaly—around the world. In the United States, grain products labeled “enriched” must contain folic acid to stay in compliance with an FDA regulation passed in 1996, but this does not apply to corn masa flour. The prevalence of these birth defects is 21 percent higher among Hispanics than non-Hispanics. 

The Emory-led study evaluated in a laboratory folic acid content in 41 corn masa flour and tortilla products readily available in 11 northeast Atlanta groceries and convenience stores, and found that based on the samples tested, all soft corn tortillas and most of the corn masa flour products were not fortified with folic acid. While the study was conducted in Atlanta, the researchers tested national brands and surveyed national grocery chains and found that the shortage of folic-acid-enriched products may point to a national deficiency.

“This unfortunately means that the prevalence [of spine and brain defects] among the Hispanic population will probably remain high until corn masa products are fortified with folic acid,” says Ben Redpath, student researcher from the Emory School of Medicine and first author of the letter.

Oakley adds, “These findings demonstrate why we recommend Hispanic women of reproductive age eat only corn masa flour and products like tortillas and tortilla chips that have folic acid printed on their nutrition labels. In addition, we recommend, as does the US Centers for Disease Control and Prevention and the US Public Health Service, that all women of reproductive age regularly consume a daily vitamin pill with 400 micrograms of folic acid to prevent birth defects and folate-deficiency anemia.”