Report 6 of the Council on Science and Public Health (A-06)

Folic Acid Fortification of Grain Products

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Summary

Objective.  To review the benefits and possible adverse effects of folic acid fortification, and in light of established research results, evaluate the proposal to include all refined grains, not just those currently labeled “enriched,” in the Food and Drug Administration’s (FDA) mandatory folic acid fortification program. 

Methods.  Literature searches were conducted in the PubMed and Nexis databases for English-language articles published between 2000 and 2006 using the search terms folic acid fortification and folic acid in combination with grain, corn, and enriched.  Additional articles were identified by review of the literature citations in those articles identified using PubMed and Nexis.  Web sites of the National Council on Folic Acid, the March of Dimes, the Centers for Disease Control and Prevemtopm, and the FDA were also reviewed for relevant information.

Results.  The protective benefit of proper folate status during the periconceptional period in reducing neural tube defects (NTDs) is unquestioned.  While FDA’s mandated fortification program has led to a reduction in NTDs, subsets of the population have not experienced the same benefit.  Women of Hispanic origin have lower folate levels than non-Hispanic white women, and infants born to Hispanic women are more likely than those born to non-Hispanic white women to be affected by an NTD.  Foods that are part of a traditionally Hispanic diet are made up in large part by corn grains such as masa, nixtamal, and maize, which are not enriched and therefore not fortified with folic acid. 

Conclusions. Since folate status affects several biological processes, it is necessary to be aware of the consequences of including all grains in the mandatory folic acid fortification program beyond the effect on NTDs.  It is possible that risks for vitamin B12 deficiency, vascular disease, cancer, and immune function, among others, may be affected.  However, the solidly established benefit of folic acid on NTD occurrence, coupled with the lack of complete and concrete evidence on the effect of folic acid on other biological processes, lends support for the inclusion of all grains in the mandatory fortification program.  Patients at risk for those processes affected by folate status, including Hispanic women of child-bearing age, should be carefully monitored to determine the impact of mandatory folic acid fortification of all grains.

RECOMMENDATIONS

The following statements, recommended by the Council on Science and Public Health, were adopted by the AMA House of Delegates as AMA directives at the 2006 AMA Annual Meeting:

1. The AMA urges the Food and Drug Administration  (FDA) to recommend folic acid fortification of all grains marketed for human consumption, including grains not carrying the “enriched” label;
2. The AMA will write letters to domestic and international producers of corn grain products, including masa, nixtamal, maize, and pozole, to advocate for folic acid fortification of such products; and
3. The AMA amends existing Policy H-440.898 as follows: The AMA  (a) encourages the Centers for Disease Control and Prevention (CDC) to continue to conduct surveys to monitor nutritional intake and the incidence of neural tube defects (NTD); (b) continues to encourage broad-based public educational programs about the need for women of child-bearing potential to consume adequate folic acid through nutrition, food fortification, and vitamin supplementation to reduce the risk of NTD; (c) encourages the CDC and the National Institutes of Health to fund basic and epidemiological studies and clinical trials to determine causal and metabolic relationships among homocysteine, vitamins B12 and B6, and folic acid, so as to reduce the risks for and incidence of associated diseases and deficiency states; (d) encourages research efforts to identify and monitor those populations potentially at risk for masking vitamin B12 deficiency through routine folic acid supplementation of enriched food products; (e) urges the FDA to increase folic acid fortification to 350 µg per 100 g of enriched cereal grain; and (f) encourages the FDA to require food, food supplement, and vitamin labeling to specify milligram content, as well as RDA levels, for critical nutrients, which vary by age, gender, and hormonal status (including anticipated pregnancy); and (g) encourages the FDA to recommend the folic acid fortification of all refined grains marketed for human consumption, including grains not carrying the “enriched” label. (Directives)

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