US Allows Corn Masa Flour to be Fortified with Folic Acid

In the United States, 55 million people - 17% of the total population - have Hispanic origins, according to the US Census Bureau. Photo by Marco Antonio Torres on Flickr.

In the United States, 55 million people - 17% of the total population - have Hispanic origins, according to the US Census Bureau. Photo by Marco Antonio Torres on Flickr.

Decision offers lessons for other countries

14 April 2016

The US Food and Drug Administration (FDA) announced today that it will allow folic acid to be added to a maize product called corn masa flour. The decision is intended to prevent more serious birth defects of the brain and spine known as neural tube defects (NTDs) among the nation’s Hispanic population. Corn masa flour is a specially treated maize flour used for tortillas, tamales, and other foods commonly consumed by Hispanics.

Most NTDs such as spina bifida and anencephaly can be prevented if women have at least 400 micrograms of folic acid daily prior to conception and the early days of pregnancy. To improve folic acid intake, in 1996 the FDA changed the US standard for enriched cereal grains to include folic acid. The only maize products included, however, were grits and maize meal. Because corn masa flour was not mentioned in the 1996 standard, manufacturers could not legally fortify these products for the US market.

A review published in 2014 showed that fortifying other grain products with folic acid led to a 36% decline in NTDs in the US, but the NTD prevalence among Hispanics was 21% higher than among non-Hispanics. In 2012, six organizations - March of Dimes, American Academy of Pediatrics, Spina Bifida Association, National Council of La Raza, Royal DSM, and Gruma Corporation - filed a citizens petition for the FDA to allow fortification of corn masa flour.

In February 2016, more than 40 members of the US Congress urged the FDA to add folic acid to the enrichment standard. Media stories, such as this news service and radio feature, have called attention to the petition for the past several months.  Guatemala, Mexico, and El Salvador include fortification of corn masa flour in their fortification mandates.

With the new FDA decision, corn masa flour may be fortified with folic acid at a level not to exceed 0.7 milligrams per pound. It is effective immediately. Gruma Corporation, the world´s largest producer of corn masa flours and tortillas, has committed to deliver fortified products in the US. The North American Millers Association also supports the change.

“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.  Leaders of the organizations that filed the citizens’ petition held a news conference today to hail the FDA’s decision. They noted that fortifying corn masa products will save many lives and improve quality of life by preventing birth defects.

“We commend the public and private sectors for working together to find a solution to this public health issue,” said Scott J. Montgomery, Director of the Food Fortification Initiative. He noted that the experience offers several lessons for grain fortification. First, a country’s standard needs to include grains commonly consumed by all segments of the target population. In this case, it was an oversight to exclude corn masa flour from the 1996 legislation. Another lesson is that monitoring is essential as it was NTD surveillance that alerted policy makers to the higher NTD prevalence among Hispanics. A third lesson is that the FDA scientific review confirmed that folic acid is safe for the general population.

In 2012 a retired physician wrote that an opinion piece in support of the petition. He delivered two infants with anencephaly during his career. “They constituted my most devastating obstetric experiences,” he wrote.

Anencephaly is a type of NTD in which the brain and/or skull is not formed properly. It is nearly always fatal. In spina bifida, the neural tube fails to close correctly and causes spinal defects. Many affected children undergo repeated surgeries and have lifelong health issues.  Severely affected children experience paralysis of the lower limbs and varying degrees of loss of bowel and bladder control. Even mildly-affected children have permanent loss of some sensation or movement.  An assessment of the cost savings in the US from preventing spina bifida showed an annual net savings of US$ 603 million.

Though folic acid for women of child-bearing age has been recommended for more than 25 years, only about one-third of American women take a daily multivitamin containing folic acid. The form of this B vitamin found in leafy green vegetables, fruits, and legumes is hard for the body to absorb, making it very difficult to get the equivalent of 400 grams of folic acid a day from unfortified food alone.