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FDA Approves Folic Acid to be Added to Masa Flour

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The U.S. Food and Drug Administration (FDA) has decided to allow manufacturers to fortify their corn masa foods with folic acid. “Folic acid is a synthetic form of folate, a B vitamin that helps prevent severe defects of the brain and spinal cord when consumed by women before and early [on] in pregnancy,” an NPR article reported.

Pregnancy women with folate deficiency have a higher risk of giving birth to infants affected with neural tube defects. NPR cited findings from the CDC (Centers for Disease Control) that since 1998, when the FDA required that breads, pasta, breakfast cereals and other grains made with enriched flour be fortified with folic acid, the number of babies born in the U.S. with neural tube defects dropped about 35 percent (about 1,300 babies a year).

The CDC urges all women who are capable of becoming pregnant to get at least 400 mcg of folic acid every day.

The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains, the FDA said.

The March of Dimes Foundation, the American Academy of Pediatrics, and others submitted a food additive petition in 2012 to request the extension of voluntary fortification to corn masa flour to increase the folic acid intake for U.S. women of childbearing age who regularly consume products made from corn masa flour as a staple in their diet.

“Increased consumption of folic acid in enriched flour has been helpful in reducing the incidence of neural tube defects in the general population,” said Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition. “Our analysis shows that adding folic acid to corn masa flour will help increase the consumption of folic acid by women who consume this flour as a staple in their diet.”

Iodine In Pregnancy Supplements“Hispanic women are about 20 percent more likely than other women to have babies with those conditions[neural tube defects], and they continue to have far lower levels of folic acid intake, either through diet or supplements,” NBC News shared.

The FDA could approve the use of a food additive only after conducting a scientific safety review of the information provided in the petition to ensure that the additive is safe for the general population. With regard to folic acid, the FDA evaluated the projected human dietary exposure, toxicological data, and other relevant information, including whether folic acid remained stable in corn masa flour.

The FDA worked with the petitioners throughout the review process to obtain data needed to address safety questions as expeditiously as possible. Based on that data, the FDA concluded that the petitioned addition of folic acid to corn masa flour at a level not to exceed 0.7 milligrams of folic acid per pound of corn masa flour is safe.

Exposure estimates from the FDA and the petitioners show that adding folic acid to corn masa flour could increase folic acid consumption in those who regularly consume products made from corn masa flour, including many Latina women. The petitioners contend that increased consumption of folic acid will reduce the risk of births with neural tube defects among this group. The FDA’s approval is not based on the possibility of this reduced risk, but is instead based on a review of the safety of the proposed use of folic acid.

Manufacturers may begin voluntary fortification of corn masa flour with folic acid on April 15, 2016.

For more information, visit www.fda.gov.