Adding folic acid to corn Masa flour: Partnering to improve pregnancy outcomes and reduce health disparities

Abstract

Although strides have been made in preventing neural tube defects (NTDs), Hispanic women remain more likely to have a baby born with an NTD and less likely to know the benefits of, or consume, folic acid than women of other race/ethnic groups. In 1998, the U.S. Food and Drug Administration (FDA) mandated that all enriched cereal grain products be fortified with folic acid; however, corn masa flour (CMF), used to make many corn products that are a diet staple of many Hispanic groups, was not included under this regulation. In 2006, a Working Group began a collaboration to address this disparity by pursuing a petition to FDA to allow folic acid to be added voluntarily to CMF. The petition process was a monumental effort that required collaboration and commitment by partners representing the affected population, manufacturers, scientists, and others. The petition was approved in 2016 and folic acid is now added to CMF products, with expected results of more women achieving the recommended daily folic acid intake, more infants born per year without an NTD, and millions of dollars in direct medical expenditures averted. This 10-year public-private partnership brought together diverse groups that traditionally have different goals. The Working Group continues to work toward ensuring that fortified CMF products are available to the consumer, with the end goal of achieving a reduction in NTD-affected pregnancies.

Sociodemographic, health behavioral, and clinical risk factors for anotia/microtia in a population-based case-control study

“…This may in part be due to lower consumption of cereals and enriched grains, which are required to be fortified with folic acid in the US, and higher consumption of staple foods made with corn flour (masa), which was not fortified during the study period. To address folate insufficiency and neural tube defects (NTDs) in this population, the U.S Food and Drug Administration recently authorized voluntary fortification of corn flour in 2016 [45]. Many other countries do not have any mandatory folate fortification.…”

Impact of Voluntary Folic Acid Fortification of Corn Masa Flour on RBC Folate Concentrations in the U.S. (NHANES 2011–2018)

“…Studies have also shown that acculturation, an individual's experience entering a new culture, is a mediating factor for NTD risk among infants of Mexican-American women, the largest subgroup of Hispanics in the U.S. [12]. In 2016, the March of Dimes, in collaboration with corn masa manufacturer GRUMA, successfully petitioned the FDA to allow for the voluntary fortification of corn masa flours with folic acid in order to reduce NTD-affected pregnancies among lesser acculturated Mexican-American women [13].…”

Focused Revision: Policy statement on folic acid and neural tube defects

“…9 This is estimated to prevent 40 additional cases of NTDs in Hispanic infants every year. 10 As approximately 50% of pregnancies in the United States are unplanned, universal prophylaxis with daily folic acid of 400 µg (0.4 mg) is recommended for general reproductive-age women, in addition to a folate-rich diet. In women contemplating pregnancy, the intake should commence at least one month before conception and continue till 12 weeks gestation for maximal protection.…”