Folic Acid Fortification of Grain Products
Note: This report, written in response to Resolution 515 (A-05), represents information on this subject as of June 2006.
Full Text
Since 1998, when the Food and Drug Administration (FDA) mandated that enriched grain products be fortified with folic acid, the prevalence of neural tube defects (NTDs) has been significantly reduced.1 However, folic acid fortification has not been as successful in reducing NTDs in certain subsets of the population, primarily those of Hispanic origin.2,3 This has led to the proposal that grains commonly used in traditionally Hispanic foods, including corn grain products and grains not already labeled “enriched,” also be fortified with folic acid. Recent studies have shown that among those who regularly consume folic acid-fortified foods, folic acid intake is higher than originally predicted when fortification was mandated.4,5 Since mandatory folic acid fortification is a relatively new program, there are few data on its potential long-term adverse effects, especially in people not of child-bearing capacity or age.
This report reviews the benefits and possible adverse effects of folic acid fortification, and in light of established research results, evaluates the proposal to include all refined grains, not just those currently labeled “enriched,” in the 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 Prevention, and the FDA were also reviewed for relevant information.
Background
The ability of folic acid to dramatically reduce the occurrence of NTDs, including spina bifida and anencephaly, has been well-established for more than 20 years.6-9 Citing its protective effect, the U. S. Public Health Service in 1992 recommended that all women of child-bearing age consume 400 µg of folic acid daily, through both foods rich in folate and vitamin supplementation.10 The recommendation was accompanied by aggressive awareness campaigns; however, surveys indicated that only approximately 30% of American women were following the recommendation.1,11-14 The FDA mandated that by 1998, all enriched grain products sold in the United States be fortified with folic acid at 140 µg/100 g grain, a level intended to increase average daily intake of folic acid by approximately 100 µg.15 “Enriched” refers to grains that have been fortified with nutrients such as niacin, thiamin, and riboflavin to replace the loss of those nutrients during the processing steps. It has been estimated that post-fortification, folic acid intake actually increased by 190 µg to 240 µg, approximately twice the amount originally intended by the FDA.5 Since 1998, the number of live births affected by an NTD has been reduced by 19% to 30%, an achievement considered a public health success.1,16,17
Fortification of All Grains
While the folic acid fortification program has significantly reduced the occurrence of NTDs among the general U.S. population, the Hispanic population in this country has not experienced a reduction as significant. Prior to mandatory folic acid fortification, infants born to Hispanic women were 1.5 times more likely than those born to non-Hispanic white women to be affected by an NTD.18-21 Since mandatory fortification began, that risk was reduced, but is still significant, at approximately 1.25 times.2 Serum folate concentrations in Hispanic women are, on average, lower than those in non-Hispanic white women,22 possibly accounting for the increased risk of NTDs among infants born to Hispanic women.
Grain products traditionally used in Hispanic foods, including masa, nixtamal, and maize, are not commonly enriched, and as such, are not required to be fortified with folic acid. To increase the intake of folic acid and subsequently reduce the prevalence of NTDs among Hispanic women, several health care professionals and organizations including the March of Dimes and the National Council on Folic Acid have proposed that the FDA include all refined grains, not just those labeled “enriched,” in its mandatory folic acid fortification program.23-25 In 1999, the Costa Rican government began fortifying corn flour with folic acid at a level of 180 µg/100 g, and a subsequent study showed that daily folic acid intake increased by approximately 36 µg.26 Using the Costa Rican fortification program as a model for corn flour fortification in the United States, and assuming a fortification level of 140 µg/100 g (the current U.S. fortification level of enriched grains), it can be estimated that daily folic acid intake would increase by approximately 30 µg. Folate status affects several biological processes, so while the inclusion of all grains in the mandatory fortification program may slightly reduce the prevalence of NTDs, the consequences of a possible increase of 30 µg/day in folic acid intake must also be considered.
Benefits and Risks of Folic Acid Intake
Vitamin B12 Deficiency. Vitamin B12 deficiency, estimated to affect 10% to 15% of the population over age 60 years, results in megaloblastic anemia and an irreversible decline in cognitive function and memory.27,28 Elevated levels of folate metabolites, including those generated when fortified folic acid is ingested, can interfere with a diagnosis of vitamin B12 deficiency by ameliorating the megaloblastic anemia associated with it. However, the irreversible neurological damage caused by vitamin B12 deficiency still occurs.27 Recognition of this problem was one of the reasons the FDA mandated fortification at 140 µg/100 g grain, a level considered low enough that only a very small percentage of the population would exceed the Institute of Medicine-set upper limit of 1000 µg/d of folic acid.29 In one study estimating intake of folic acid, approximately 11% of supplement users, but no non-supplement users, exceeded the upper limit.4 Among those exceeding the upper limit, the average intake of folic acid was 1031 µg/d, and the highest was 1093 µg/d.4 Vitamin B12 deficiency has not become more prevalent since recommendation of supplementation and mandatory fortification of enriched grains began.28,30 An additional 30 µg of daily folic acid from mandatory fortification of all grains would result in an approximately 2.7% increase in folic acid intake in people already consuming the highest levels. This small increase is unlikely to appreciably increase the prevalence of vitamin B12 deficiency. Nevertheless, careful monitoring of folic acid intake by patients at risk for vitamin B12 deficiency and by their physicians is recommended.30,31
Vascular Disease. Hyperhomocysteinemia, an elevation in blood homocysteine levels, is considered a significant risk factor for atherosclerotic vascular disease in the coronary, cerebral, and peripheral vessels and for arterial and venous thromboembolism.32-34 Of several doses tested, daily folic acid intakes of at least 400 to 500 µg/d were found to lower blood homocysteine levels by approximately 25%.32,33,35,36 When coupled with vitamin B6, folic acid plays a role in improving subclinical markers of vascular disease risk.32,37,38 However, it is not yet known whether lowering blood homocysteine and improving vascular disease risk markers will translate into a reduction in the overall incidence of vascular disease.32 Given the beneficial effect on vascular disease risk of at least 400 to 500 µg/d of folic acid, and depending on the folate status of each individual, an additional 30 µg of daily folic acid from mandatory fortification of all grains may very slightly enhance this beneficial effect.
Cancer. Many studies examining the effects of folate on cancer risk have shown an inverse relationship between folate status and the risk of colorectal, lung, pancreatic, esophageal, stomach, cervical, ovarian, and breast cancers, and neuroblastoma and leukemia.12,39,40 The precise nature of these relationships is variable, if established at all, but it is thought that folate deficiency predisposes normal tissue to neoplastic transformation by inducing DNA strand breaks, impairing DNA repair, increasing mutations, and affecting DNA methylation.12,39-41 Conversely, folate supplementation suppresses development of tumors in normal tissue by correcting some of the defects caused by folate deficiency.12,39-41 Therefore, mandatory folic acid fortification, and the possible inclusion of all grains in the fortification program, may have a beneficial effect on cancer risk. However, clinical observations, along with some animal studies, suggest that the dose and timing of folate intake determine the positive or negative nature of its effect on breast and colorectal cancer progression. Folate supplementation may have a promoting effect on undiagnosed premalignant and malignant lesions, although this was seen only with exceptionally high supplemental doses.12,39,40 It has also been suggested that DNA hypermethylation induced by high folate levels may preferentially silence expression of tumor suppressor genes, thus having a possible detrimental effect on cancer risk.12,42 Given the conflicting evidence on folate status in cancer risk and prevention, it is unclear how an additional 30 µg of daily folic acid from mandatory fortification of all grains would affect the general population.
Natural Killer Cell Cytotoxicity. Recently, a link between unmetabolized plasma folic acid and reduced natural killer (NK) cell cytotoxicity in postmenopausal overweight and obese women was reported.43 Among the study participants consuming a diet rich in folate, those also using a supplement had reduced NK cell cytotoxicity, particularly women aged 60 to 75 years.43 Since NK cells are a vital part of the nonspecific immune response, it is possible that immune function may be modulated by folate intake. NK cells are also thought to play a role in the destruction of tumor cells, suggesting another mechanism by which excess folate may promote existing premalignant and malignant lesions.43 The authors note, however, that these data are preliminary and alternatively suggest that a low capacity to metabolize large amounts of folic acid might be a metabolic correlate of immune function.43 Until these results are confirmed and expanded upon by additional studies, the effect on NK cell cytotoxicity of including all grains in the mandatory fortification program will be unclear.
Miscarriage and Multiple Births. Conflicting evidence exists for the effect of folic acid on both miscarriage and multiple births. Analysis of two randomized trials showed that increased levels of folic acid were associated with an increase in miscarriages.28,44 However, larger and more comprehensive studies have found no link between folic acid supplement use or plasma folate levels and the risk of miscarriage.28,45,46 An increase in the occurrence of multiple births (primarily dizygotic twins) has been suggested,28,47,48 but as with miscarriage risk, more recent studies have discounted this hypothesis.28,49,50 The inclusion of all grains in the mandatory folic acid fortification program is therefore unlikely to affect miscarriage and multiple births.
Selection for Folic Acid Dependency. The 677T mutation in methylenetetrahydrofolate reductase (MTHFR), a gene encoding one of the enzymes required for folic acid metabolism, is associated with a number of developmental and degenerative conditions, including spina bifida and other midline defects, Down’s syndrome, fetal growth restriction, and recurrent pregnancy loss (of fetuses carrying the mutation).51,52 These are conditions that are usually prevented by proper folic acid levels, making it possible that the 677T-MTHFR variant is being selected for by adequate folic acid intake, and that fortification perpetuates the selection for 677T-MTHFR.51 These ideas are speculative and controversial, and may require several years of careful monitoring to determine whether selection is occurring. At present, it is unclear whether inclusion of all grains in the mandatory fortification program would affect the genetic selection of the 677T-MTHFR variant.
Summary and Conclusion
The protective benefit of proper folate status during the periconceptional period in reducing NTDs is unquestioned. The FDA has recognized the benefit and mandated folic acid fortification in enriched grains. While the fortification program has led to a 19% to 30% reduction in NTDs, subsets of the population have not experienced the same reduction. 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 of corn grains such as masa, nixtamal, and maize, which are not enriched and therefore not fortified with folic acid. In an effort to reduce the occurrence of NTDs among the Hispanic population, it has been proposed that the FDA include all refined grains, not just those labeled “enriched,” in its mandatory folic acid fortification program.
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 and policy at the 2006 AMA Annual Meeting:
- 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. (Directive)
- 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. (Directive)
- 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 Recommended Daily Allowance (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. (Policy)
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References
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37. Title LM, Cummings PM, Giddens K, Genest JJ Jr, Nassar BA. Effect of folic acid and antioxidant vitamins on endothelial dysfunction in patients with coronary artery disease. J Am Coll Cardiol. 2000; 36(3):758-765.
38. Vermeulen EG, Stehouwer CD, Twisk JW, van den BM, de Jong SC, Mackaay AJ, et al. Effect of homocysteine-lowering treatment with folic acid plus vitamin B6 on progression of subclinical atherosclerosis: a randomised, placebo-controlled trial. Lancet. 2000; 355(9203):517-522.
39. Kim YI. Role of folate in colon cancer development and progression. J Nutr. 2003; 133(11 Suppl 1):3731S-3739S.
40. Kim YI. Folate and carcinogenesis: evidence, mechanisms, and implications. J Nutr Biochem. 1999; 10(2):66-88.
41. Choi SW, Mason JB. Folate status: effects on pathways of colorectal carcinogenesis. J Nutr. 2002; 132(8 Suppl):2413S-2418S.
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43. Troen AM, Mitchell B, Sorensen B, Wener MH, Johnston A, Wood B, et al. Unmetabolized folic acid in plasma is associated with reduced natural killer cell cytotoxicity among postmenopausal women. J Nutr. 2006; 136(1):189-194.
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46. George L, Mills JL, Johansson AL, Nordmark A, Olander B, Granath F, et al. Plasma folate levels and risk of spontaneous abortion. JAMA. 2002; 288(15):1867-1873.
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Resolution 515 (A-05)
Resolution 515 (A-05), introduced by the Medical Student Section at the 2005 Annual Meeting and referred to the Board of Trustees, asks:
That the American Medical Association (AMA) urge the Food and Drug Administration to recommend the folic acid fortification of all grains marketed for human consumption, including grains not carrying the “enriched” label;
That the AMA 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
That the AMA amend existing Policy H-440.898 as follows:
The AMA will: (1) encourage 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); (2) continue 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; (3) encourage 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; (4) encourage 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; (5) urge the Food and Drug Administration to increase folic acid fortification to 350 µg per 100 g of enriched cereal grain; and (6) encourage 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 (7) encourage the FDA to recommend the folic acid fortification of all grains marketed for human consumption, including grains not carrying the “enriched” label.
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