Advocates Hail FDA Decision to Improve Infant Health, Prevent Birth Defects

SpinaBifidaAssociation

Fortification of corn masa flour with folic acid will prevent serious birth defects like Spina Bifida

WASHINGTON, DC—Advocates enthusiastically praised today’s announcement by the U.S. Food and Drug Administration (FDA) that the agency will permit fortification of corn masa flour with folic acid to prevent birth defects, effective immediately.  The announcement reflected a decision to accept a Citizens’ Petition filed in 2012 by the March of Dimes, American Academy of Pediatrics, Spina Bifida Association, National Council of La Raza, Royal DSM and Gruma Corporation.

In 1996, the FDA directed all manufacturers of wheat and many other types of flour to fortify them with folic acid in order to increase folic acid levels across the general U.S. population.  In the years following mandatory fortification, neural tube defects dropped by 27% — a major public health victory, which prevents about 1,300 births per year from being affected by neural tube defects.  However, neural tube defects remained higher in the Hispanic population.  One theory for this disparity was that corn masa flour, a dietary staple for many Hispanic families, was not required to be fortified with folic acid.  Today’s decision will allow corn masa flour to be fortified as well.

“Today’s announcement represents a major victory for maternal and child health, especially in our Hispanic communities,” said March of Dimes President Dr. Jennifer L. Howse.  “The FDA’s decision will prevent numerous cases of devastating birth defects like Spina Bifida.  The March of Dimes and our partners applaud the FDA for moving forward with this vital public health effort.”

“Fortifying grains with folic acid has been a tremendously successful intervention in promoting healthier pregnancies and preventing birth defects, leading to a one-third decline in neural tube defects,” said AAP President Benard Dreyer, MD, FAAP. “The American Academy of Pediatrics welcomes FDA’s action to permit folic acid fortification of corn masa flour; mothers and young children will be healthier and safer as a result.”

When leading Hispanic non-profit organization NCLR (National Council of La Raza) reached out Gruma Corporation to support folic acid fortification aimed to reduce risks of neural tube defects within Mexican and Hispanic populations living in the USA, the company immediately responded favorably to this request. Gruma Corporation is the world´s largest producer of corn masa flours and tortillas; for most U.S. residents of Mexican and Hispanic descent, corn tortillas are a staple food.

Being a social responsible company and caring for the nutrition of our customers is not only Gruma’s Corporation vision but also a directive from CEO and President Juan Gonzalez Moreno. “We will continue to honor and contribute to these initiatives and will put our best efforts to deliver the higher quality and improved nutrition that folic acid will bring to our Hispanic customers in the USA,” said the company.

Sara Struwe, CEO of the Spina Bifida Association, commented, “We’re thrilled that the FDA has prioritized the extension of folic acid fortification to corn masa flour which will help a great deal to prevent birth defects such as Spina Bifida in Hispanic populations. Women need 400 mcg of folic acid daily, thus, this is a giant step forward in contributing to the prevention of neural tube defects and a decision to be celebrated. I want to thank all our elected officials, partners, and those at the FDA that have worked so hard to bring about this important policy change.”

“Latinos are disproportionately affected by Spina Bifida and other neural tube defects.  The scientific evidence that the major cause of this disparity is the absence of fortification of corn flour products is convincing,” stated Charles Kamasaki, Senior Cabinet Advisor at NCLR. “That’s why NCLR is proud to join the March of Dimes, Spina Bifida Association of America, American Academy of Pediatrics, and Gruma to petition the FDA to permit such fortification.”

The FDA’s announcement that corn masa flour may be fortified with folic acid at a level not to exceed 0.7 milligrams per pound is effective immediately.  The announcement was accompanied by language making this change in the applicable federal regulations.

Folic acid has long been known to prevent many cases of serious birth defects known as neural tube defects, such as Spina Bifida.  These birth defects occur early in pregnancy when the neural tube, which becomes the spine and brain, fails to form properly.  Ideally, a woman should have adequate folic acid levels before becoming pregnant to help prevent neural tube defects.  Rates of neural tube defects vary by racial and ethnic background.  For example, Spina Bifida affects 2.73 per 10,000 live births among non-Hispanic blacks or African-Americans and 3.09 per 10,000 live births among whites, but 3.80 per 10,000 live births among Hispanics.  In many other nations where corn masa flour is a major part of the diet, governments have encouraged and endorsed fortification with folic acid to reduce neural tube defects.

The organizations listed above filed the Citizens’ Petition regarding fortification of corn masa flour with FDA in April 2012.  In 2013, the FDA requested additional scientific data to support the petition, which required the petitioners to design and execute a new research study.  Funded by the March of Dimes, this study was completed and the data submitted to the FDA in late 2015.
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About March of Dimes
The March of Dimes is a national voluntary health agency whose volunteers and staff work to improve the health of infants and children by preventing birth defects, premature birth and infant mortality. Founded in 1938, the March of Dimes funds programs of research, community services, education and advocacy. For the latest resources and information, visit marchofdimes.org or nacersano.org.  Find us on Facebook and follow us on Twitter.
About the American Academy of Pediatrics
The American Academy of Pediatrics is an organization of 64,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit http://www.aap.org or follow @AmerAcadPeds on Twitter and Facebook.

About the Spina Bifida Association
The Spina Bifida Association (SBA) serves adults and children who live with the challenges of Spina Bifida. Since 1973, SBA has been the only national voluntary health agency solely dedicated to enhancing the lives of those with Spina Bifida and those whose lives are touched by this challenging birth defect. Its tools are education, advocacy, research, and service.

About the National Council of La Raza
The National Council of La Raza is the largest national Hispanic civil rights and advocacy organization in the United States and works to improve opportunities for Hispanic Americans. For more information on NCLR, please visit www.nclr.org or follow along on Facebook and Twitter.

About Gruma Corporation
Gruma, S.A.B. de C.V., known as Gruma, is a Mexican multinational corn flour and tortillas manufacturing company headquartered in San Pedro, near Monterrey, Mexico. It is the largest manufacturer of corn flour and tortillas.  Its brand names include Mission (Misión in Mexico), Maseca, and Guerrero.

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