Coalition Petitions FDA to Fortify Corn Masa Flour with Folic Acid

The petitioners believe that by targeting traditional Hispanic food made with corn masa for folic acid fortification, it would be possible to lower the rate of NTDs among Hispanics, particularly Mexican-Americans.

24 April 2012 --- Serious birth defects of the brain and spine in America's babies, particularly those of Hispanic origin, could be reduced if the nation's corn masa flour products were fortified with the B vitamin folic acid, according to a new petition filed with the U.S. Food and Drug Administration (FDA) by a coalition of six organizations:

- Gruma Corporation
- Spina Bifida Association
- March of Dimes Foundation
- American Academy of Pediatrics
- Royal DSM N.V.
- National Council of La Raza

The coalition members note that Hispanic women are about 20 percent more likely to have a child with a neural tube defect (NTD), which includes spina bifida and anencephaly, than non-Hispanic white women. Although the reasons for the disparity are not well understood, Hispanic women have been found to have lower intake of folic acid overall compared to non-Hispanic white women.

Fortification of enriched cereal grains such as bread and pasta with folic acid was mandated by the FDA in 1998; however, corn masa flour lacks federal regulatory approval for the addition of folic acid. The rate of NTDs in the U.S. has decreased by nearly one-third since fortification. Despite this success, about 3,000 pregnancies in the U.S. still are affected by NTDs annually and Hispanics have the highest rate when compared to other race or ethnic groups.

Corn masa flour is made from specially treated corn and used to make products common in Latin American diets such as corn tortillas and tamales. The petitioners believe that by targeting traditional Hispanic food made with corn masa for folic acid fortification, it would be possible to lower the rate of NTDs among Hispanics, particularly Mexican-Americans. Studies have shown that folic acid works if taken before conception and during early pregnancy. Many countries in Latin America already allow fortification of corn masa products with folic acid, including Costa Rica, El Salvador and Mexico.

The FDA accepted the petition on April 17. The petition now will be reviewed by the agency, which is not required to follow a prescribed timetable on the approval process.

"Gruma Corporation has been privileged to work with its fellow petitioners to pursue the addition of folic acid to corn masa flour so that consumers of its Mission tortillas and other leading corn masa-based products may receive the benefits of this important nutrient," said Joel Suarez, Chief Executive Officer of Gruma. "We strive to produce products that support the health of consumers and are proud to be among organizations like the Spina Bifida Association and the March of Dimes in supporting this effort to reduce neural tube defects in the Hispanic community."

"This is an important moment in the history of fortification," said Cindy Brownstein, President and CEO of Spina Bifida Association. "If fortification of corn masa can be achieved, lives will be saved and families spared a lifetime of struggling to ensure the complicated health and social needs of their loved ones are met. We are grateful to our colleagues who have participated in this important endeavor and look forward to an outcome that will truly make a difference in the lives of many."

"We've seen the success with fortifying cereal grains with folic acid," said Dr. Jennifer L. Howse, President of the March of Dimes. "Adding folic acid to corn masa flour can successfully decrease neural tube defects in the Hispanic community. This is a safe and effective way to address the disparities we see in the Hispanic community and will give even more babies a healthy start in life. I'd like to thank our fellow petitioners for their leadership on this important health issue. We look forward to the FDA's determination on our petition."

"Folic acid fortification has been a common sense policy that has helped improve pediatric health and significantly reduce the number of neural tube defects, but there is more progress to be made in this area," said American Academy of Pediatrics President Robert W. Block, MD, FAAP. "The AAP strongly encourages the Food and Drug Administration to allow the fortification of corn masa flour so that a greater population of pregnant women and their unborn children can benefit from this critical nutrient."

"Fortifying corn masa flour with folic acid is a simple but highly effective step in protecting the health of Hispanic children in this country," said Janet Murguía, President and CEO of the National Council of La Raza. "This is a proven technique that has already lowered the rates of birth defects in most groups of babies and adding folic acid to the food products that are staples within Latino diets would specifically address the substantially higher rates of birth defects that our community faces. We are glad to see so many groups committed to the health and safety of Latino children and hope the FDA thoughtfully considers this incredibly important petition."

The U.S. Public Health Service recommends that all women of childbearing age consume at least 400 micrograms daily of folic acid, beginning before pregnancy. Women are urged to take a daily multivitamin containing folic acid as part of a healthy diet that includes leafy green vegetables and fortified foods.