Food Additive Petition Seeks to Reduce Neural Tube Defects Among Hispanics

In a relatively rare example of a request for regulatory action intended to benefit a specific racial or ethnic group, a coalition of businesses and nonprofits submitted a food additive petition asking FDA to amend the food additive regulation for folic acid to permit its addition to corn masa flour - a staple among populations of Latin American descent. Since the late 1990’s, standards of identity for several grain-based foods have required the addition of folic acid. According to the petition, that requirement is credited with decreasing the prevalence of neural tube defects among Hispanics and non-Hispanics. However, Hispanic women continue to have a higher rate of neural tube defects, and fewer of them consume folic acid from fortified foods. The petition contends that “[f]ortification of corn masa flour presents a clear opportunity to improve intake in those who consume corn masa flour products as a significant portion of their diet,” and could potentially decrease neural tube defects among Hispanic women.

The observation that diet-related risk factors for certain diseases may vary among racial and ethnic groups is not novel (see, e.g., CDC’s estimation of disparate rates of obesity for Whites, Blacks, and Hispanics). Nonetheless, it is not clear that a systematic approach to these issues has emerged in relation to food, as it has for drugs. A 1995 FDA guidance document geared to drug and biologics developers provides recommendations for the collection of race and ethnicity data in clinical trials, in recognition of the fact that numerous “[d]ifferences in response to medical products have already been observed in racially and ethnically distinct subgroups of the U.S. population.” That same year, FDA approved the first drug to treat a disease in patients identified by race (BiDil, for heart failure in Black patients).

Although perhaps difficult to estimate, the potential cost savings associated with dietary interventions that reduce the risk of disease could be significant, particularly in relation to the cost of the intervention. The corn masa petition estimates that the addition of folic acid to corn masa could prevent 40 cases of neural tube defects annually, each of which could generate direct lifetime costs of a half-million dollars.