FDA approves folic acid fortification of corn masa flour.

• Although many food ingredients are marketed in the United States on the basis of their “Generally Recognized as Safe” or “GRAS” status, FDA still must approve “food additives” via the approval of a formal food additive petition (FAP).  The FAP route generally is unpopular with the food industry because of the onerous submission requirements and the multi-year approval timeline.

• FDA recently approved the use of folic acid to fortify corn masa flour, specifically permitting manufacturers to voluntarily add up to 0.7 mg of folic acid per pound of corn masa flour.  This level of fortification is consistent with those already permitted for certain other enriched cereal grains.

• The corn masa fortification petition was submitted in April 2012 by the March of Dimes Foundation and the American Academy of Pediatrics, among other stakeholders who sought this additional avenue of fortification to reduce the incidence of neural tube defects (NTDs) among populations who regularly consume products made from corn masa flour as a staple in their diet (e.g., women of Latin American descent).  Although FDA’s approval is being met with praise, the four-year approval timeline serves as a continued reminder to the industry of the lengthy nature of the food additive approval process.