FDA to allow folic acid in corn masa to prevent birth defects

Federal regulators agreed Thursday to allow folic acid to be added to corn masa flour, possibly preventing devastating birth defects such as those affecting families in Benton, Franklin and Yakima counties.

The Food and Drug Administration, acting on a 2012 petition from the March of Dimes and other groups, announced the B vitamin used to fortify enriched wheat and rice flours in products for two decades can be added starting Friday to corn masa, the staple grain in the diets of many Hispanics.

Folic acid will be allowed at a level no higher than 0.7 milligrams per pound of corn masa flour, similar to present requirements for other grains, according to the new rule published in the Federal Register.

Experts say the vitamin, which is cheap, safe and stable in grain products, will help prevent dozens of disabling or fatal neural-tube birth defects each year, including spina bifida and anencephaly.

After folic-acid fortification of other flour used in bread, pasta and cereal began in 1996, the rates of defects plunged by 36 percent, preventing 10,000 cases in a decade. It’s widely regarded as one of the top public-health interventions of the 20th century.

FDA officials said their decision was based on a review of the safety of adding the supplement to corn masa.

“Today’s announcement represents a major victory for maternal and child health, especially in our Hispanic communities,” said Dr. Jennifer Howse, president of the March of Dimes.

In Yakima, Franklin and Benton counties, at least 42 babies have been lost to anencephaly since 2010, a rate four to five times the national average for the disorder that ravages the brain and skull. Almost all cases are fatal.

No cause has been found and state health officials have ruled out some possible causes, including contamination from Hanford, based on where the mothers live.

However, adequate folic acid intake early in pregnancy is known to prevent the terrible defects.

In February, state health officials and more than 40 members of Congress, including Rep. Dan Newhouse, R-Wash., urged the FDA to accept the petition.

“The approval of folic acid fortification of corn masa flour after multiple petitions and a Congressional request is a long-awaited victory for maternal and child health,” Newhouse said Thursday.

“In Hispanic communities in which corn masa is a staple, the ability to fortify corn masa with nutritious vitamins is a commonsense measure to promote health and reduce the likelihood of tragic birth defects.”

His views were echoed by officials with the American Academy of Pediatrics (AAP), the Spina Bifida Association and the National Council of La Raza, groups that co-sponsored the petition that was stalled at the FDA for nearly four years.

“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 Dr. Benard Dreyer, president of the AAP.

Those are disorders that occur when the neural tube, which forms the brain and spinal cord, fails to close properly in early pregnancy. Ideally, a woman should have adequate levels of folic acid before becoming pregnant to prevent defects, a goal achieved by adding the supplement to staple grains, March of Dimes experts said.

Corn masa wasn’t included in the FDA directive in the 1990s, partly because it wasn’t as popular as it is now in foods such as corn chips and tortillas.

Since then, the U.S. Hispanic population has surged to more than 55 million people. A quarter of all babies are born to Hispanic mothers, who have about a 20 percent higher risk than white women of neural-tube defects.

The Washington State Department of Health launched an information campaign last year to spread the work on the importance of folic acid while it investigates the cause of the high number of anencephaly cases, although it was uncertain how long its money for the campaign would last.

It has aired messages on English- and Spanish-language radio stations in Benton, Franklin and Yakima counties. It also has aired a Spanish-language radio novella that follows a young Latina woman through 12 episodes, incorporating messages about preconception health, including the importance of folic acid.

The petitioners to the FDA asked for voluntary folic acid fortification, rather than mandatory, to make implementation far easier, said Michele Kling, a spokeswoman for the March of Dimes.

Adding folic acid to corn masa could prevent an average of 40 neural-tube defects in children born to Hispanic women each year, and as many as 120 annually across the nation, according to research by the Centers for Disease Control and Prevention.

Critics, including a former director of the CDC’s birth defects division, said about 800 defects could have been prevented if the action had been taken earlier.

“That’s great news,” said Dr. Godfrey Oakley, director of the Center for Spina Bifida Research, Prevention and Policy at Emory University. “It’s only about 20 years too late.”

Oakley said public pressure, including a Seattle Times investigation into the birth defects in Washington, likely contributed to the FDA’s decision.

Gruma, the largest producer of corn masa flour, co-sponsored the original petition and will add folic acid to its U.S. products, according to a company statement.

“We will put our best efforts to deliver the higher quality and improved nutrition that folic acid will bring to our Hispanic companies in the U.S.A,” the statement said.

This story was originally published April 14, 2016 at 8:39 PM with the headline "FDA to allow folic acid in corn masa to prevent birth defects."