FDA approves folic acid fortification of corn masa flour
April 14, 2016 - 12:00 PM
The U.S. Food and Drug Administration today approved folic acid
fortification of corn masa flour. 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
Folic acid, a synthetic form of folate, is a B vitamin
that when taken by a pregnant woman may help prevent neural tube
defects, which are birth defects affecting the brain, spine, and spinal
cord. Pregnant women with folate deficiency have a higher risk of giving
birth to infants affected with neural tube defects.
flour, sometimes called masa (Spanish for dough), is produced by cooking
corn in alkali and then grinding it. Corn masa flour is a staple food
for many Latin Americans including individuals of Mexican and Central
American descent in the United States. It can be used to make foods such
as tortillas, tortilla chips, tamales, taco shells, and corn chips.
manufacturers may use folic acid as an optional ingredient at specified
levels in breakfast cereals and certain other foods, such as infant
formula and medical foods, so that it is easier for people to get enough
folic acid in their diets. Additionally, folic acid must be added to
certain enriched grains and enriched grain products like breads, rolls,
noodles and pasta. 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
“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, Ph.D., 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
The FDA may 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.
may begin voluntary fortification of corn masa flour with folic acid on
April 15, 2016. Consumers wishing to purchase products made with corn
masa flour fortified with folic acid should check the ingredients
statement for the presence of folic acid.
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