Effective April 15, FDA approved folic acid fortification of corn masa flour paving the way for food manufacturers to voluntarily add up to 0.7 mg of folic acid per pound of corn masa flour, which is consistent with the levels of certain other enriched cereal grains. Folic acid is the synthetic form of folate, an important B vitamin essential to fetal development and other body functions.

The ruling is in response to a 2012 food additive petition filed jointly by Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V. and National Council of La Raza asking FDA to require fortification of corn masa flour with folic acid in an effort to curb neural tube defects (NTD) among Hispanics.

Corn masa flour is made from specially treated corn and used to make products common in Latin American diets, such as corn tortillas and tamales. The petition noted Hispanic women are about 20 percent more likely to have a child with an NTD, which includes spina bifida and anencephaly, than non-Hispanic Caucasian women. Although the reasons for the disparity are not well understood, Hispanic women have been found to have lower intake of folic acid overall compared to non-Hispanic Caucasian women.

FDA began a mandatory folic acid fortification program in 1998, requiring folic acid to be added to enriched cereal grains and cereal grain products that have a standard of identity under 21 CFR parts 136, 137, and 139 at levels ranging from 0.43 mg to 1.4 mg/lb of the finished product.

Fortification with folic acid was required for enriched cereal-grain products that already had standards of identity at the time the 1996 final rule went into effect on Jan. 1, 1998. Standards of identity are FDA regulations that define a given food product, its name, and ingredients that must be used, or may be used, in the manufacture of the food. They were created to maintain the integrity of food products and to ensure that foods meet buyers’ expectations. Many foods do not have standards of identity, including CMF. The amounts of folic acid required in enriched cereal-grain products (bread, rolls, and buns; wheat flours; corn meals; farina; rice; and macaroni and noodle products) were specifically chosen to increase daily folic acid consumption for women of childbearing age without consumers in the general population exceeding established safe levels. In addition to mandatory fortification of these foods, folic acid may voluntarily be added at specified levels in breakfast cereal, corn grits, meal replacement products, infant formula, foods for special dietary uses and medical foods.