The Food and Drug Administration took action on a long-delayed petition Thursday, agreeing to allow folic acid to be added to corn-masa flour to possibly prevent birth defects, mostly in Hispanic babies. The vitamin has been added to other grains in the U.S. for years.
In a move critics said was long overdue, 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 Central Washington.
The Food and Drug Administration (FDA) announced the B vitamin used to fortify enriched wheat and rice flours for two decades can be added immediately to corn masa, the staple grain in the diets of many Hispanics.
The decision comes four years after the March of Dimes and other advocates first formally urged the agency to make the change, and nearly a year after a Seattle Times investigation into a Washington state rise in rare and fatal birth defects that may be prevented with folic acid.
The vitamin will be allowed at a level no higher than 0.7 milligrams per pound of corn-masa flour, similar to current requirements for other grains, according to the new rule published in the Federal Register.
Experts say folic acid, which is cheap, safe and stable in grain products, could help prevent dozens of disabling or fatal neural-tube birth defects each year, including spina bifida and anencephaly.
After folic-acid fortification of other grains 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 in the first decade of the 21st century.
FDA officials said their decision was based on a review of the effects of adding the supplement to corn masa.
“What we are saying today is we are confident in the safety of this addition to the U.S. food supply,” said Susan T. Mayne, director of the FDA Center for Food Safety and Applied Nutrition.
Advocates quickly praised the agency’s action.
“Today is a great day for babies and families, especially Hispanic families,” said Dr. Edward R.B. McCabe, chief medical officer for the March of Dimes. “We received the answer we’ve waited for so long.”
In Washington, at least 42 babies have been lost to anencephaly since 2010 at a rate that far exceeds the national average for the disorder that ravages the brain and skull.
Although no cause has been found, adequate folic-acid intake early in pregnancy is known to prevent the terrible defects.
Dr. Kathy Lofy, Washington’s health officer, said she was “thrilled” with the FDA’s decision and hopeful it would benefit the health of Hispanic women and reduce neural-tube defects across the state.
“This is a great step in our efforts to increase folic acid intake of reproductive-age women, but there’s more work to do,” she said in an email. “We’ll keep working to promote women taking vitamins with folic acid daily, and making it easier for women in Washington to get them.”
In February, state health officials and more than 40 members of Congress, led by Rep. Jaime Herrera Beutler, R-Camas, urged the FDA to accept the petition.
“I applaud the FDA’s swift decision to allow folic acid to be added to corn masa following our congressional letter,” Herrera Beutler said in a statement. “This will ensure that expectant mothers in Hispanic communities in Southwest Washington and throughout the country will receive a critical nutrient that has been proven to reduce birth defects.”
Her 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 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,” Dr. Benard Dreyer, president of the AAP, said in a statement.
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 of neural-tube defects than white women.
The petitioners asked for voluntary fortification, rather than mandatory, to make implementation far easier, said Michele Kling, a spokeswoman for the March of Dimes.
The FDA demanded additional tests to ensure that the folic acid remained stable, or kept its potency, in both raw flour and cooked products.
The March of Dimes turned to Michael Dunn, a Brigham Young University food scientist and one of a few experts in the world on grain fortification, to lead the complicated and expensive tests. He conducted studies last year that showed the vitamin remained stable, even after tortillas and chips were baked or deep-fried.
“I’m very hopeful,” he said Thursday. “I think you’ll see the kind of effect we saw with wheat flour. This, I think, will make a big difference.”
Adding folic acid to corn masa could prevent an average of 40 neural-tube defects in Hispanic women each year, and as many as 120 annually across the nation, according to research by the Centers for Disease Control and Prevention (CDC).
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, now director of the Center for Spina Bifida Research, Prevention and Policy at Emory University. “It’s only about 20 years too late.”
Mayne, the FDA expert, said the agency was required to follow the rules governing additives in the food supply.
“The big hitch, obviously, is that we need data,” she said. “Once we had the data, the process went very quickly.”
Oakley said public pressure, including The Seattle Times investigation into birth defects in Central Washington, likely contributed to the FDA decision.
Gruma, the world’s largest producer of corn-masa flour, co-sponsored the original petition. The firm already adds folic acid to corn-masa flour in several countries and is poised to begin adding the vitamin to its U.S. products as soon as it can reconfigure manufacturing plants. The fortified products probably will be available by September, if not sooner, said Felipe Rubio, a company spokesman.
“Gruma is very proud to be part of this important step to improve the health of babies in the U.S.,” he said.