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Fortifying Corn Masa Flour Products with Folic Acid

Corn masa flour

en español (Spanish)

Manufacturers who have questions about FDA regulations related to fortifying corn masa flour or other corn masa products with folic acid can contact the FDA through our inquiry portal: Corn_Masa_Inquiries@fda.hhs.gov.

Folic acid, a synthetic form of folate, is a B vitamin that when taken by pregnant people may help prevent neural tube defects, which are birth defects affecting the brain, spine, and spinal cord. Pregnant people with folate deficiency have a higher risk of giving birth to infants affected with neural tube defects. A wide range of foods are fortified with folic acid so that it is easier for people to get enough folic acid in their diets. These foods include many breakfast cereals and many types of pasta, flour, bread, crackers, and other snack foods. Folic acid is also available in supplement form, often as a stand-alone supplement or as part of a multivitamin or prenatal vitamin.

Corn masa flour, sometimes called masa (Spanish for dough), is produced by cooking corn in alkali and then grinding it. Corn masa flour is a food used by many Hispanics/Latinos. It can be used to make foods such as tortillas, tortilla chips, tamales, taco shells, arepas, pupusas, and corn chips.

Manufacturers may add folic acid to corn masa flour at a level of up to 0.7 milligrams per pound. The FDA encourages manufacturers to add folic acid to corn masa flour to help address health disparities among Hispanics/Latinos related to birth defects. Fortifying corn masa flour with folic acid, and using the fortified corn masa flour as an ingredient in manufactured foods, offers a significant opportunity to make a positive impact on public health.

Regulatory Approach

Under the law, the FDA may approve the use of a food additive only after conducting a scientific safety review of the information provided in the petition and other available information to ensure that use of ingredients added to foods are safe for the general population. For 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. In 2016, the FDA amended the food additive regulations to allow for the addition of folic acid to corn masa flour. See the Federal Register Notice for more information.

Manufacturers who choose to fortify their corn masa flour products with folic acid should keep in mind the following considerations:

  • Fortification Levels: The FDA determined that a safe level of folic acid is no more than 0.7 milligrams per pound of corn masa flour.
  • Labeling Requirements: Food manufacturers must ensure accurate and transparent labeling of all their products, including fortified corn masa products. Labels should comply with all applicable FDA regulations, including the requirement to include added substances such as folic acid in the list of ingredients. Manufacturers can also choose to use an authorized health claim in their food labeling on folic acid fortified corn masa flour products. These are claims that have been reviewed by the FDA and that are allowed on food products or dietary supplements to show that a food or food component may reduce the risk of a disease or health-related condition. The FDA has authorized a health claim about the relationship between folate and neural tube defects, as described in 21 CFR 101.79.
  • Manufacturing Requirements: Food manufacturers are responsible for complying with all applicable FDA regulations, including regulations regarding Current Good Manufacturing Practices (CGMPs).

By complying with FDA requirements, food manufacturers can ensure the safety, efficacy, and integrity of fortification efforts.

More Information about Folic Acid Fortification

Folic acid fortification is not mandatory in the U.S. except for some standardized foods. A standardized food is a food for which a standard of identity has been set in regulation. For example, any flour that is labeled as “enriched” must have folic acid, among other vitamins and minerals, as specified in 21 CFR 137.165. However, manufacturers are not required to enrich their products. For every standard of identity for an enriched product, the FDA also has a standard of identity for the unenriched product. See the FDA’s fortification policy for more information. The FDA does not have a standard of identity for corn masa flour (neither enriched nor unenriched). However, as described above, 21 CFR 172.345 permits the addition of folic acid to corn masa flour, and the FDA encourages manufacturers to fortify corn masa flour in this way.

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