Barriers and facilitators to the implementation of mandatory folate fortification as an evidence-based policy to prevent neural tube defects.

BACKGROUND: Neural tube defects continue to be one of the main congenital malformations affecting the development of the nervous system and a significant cause of disability and disease burden to individuals living with these conditions. Mandatory food fortification with folic acid is, by far, one of the most efficacious, safe, and cost-effective interventions to prevent neural tube defects. However, most countries fail to effectively fortify staple foods with folic acid, impacting public health and healthcare systems and generating dismal disparities. AIM: This article discusses the main barriers and facilitators for implementing mandatory food fortification as an evidence-based policy to prevent neural tube defects worldwide. METHODS: A comprehensive review of the scientific literature allowed the identification of the determinant factors acting as barriers or facilitators for the reach, adoption, implementation, and scaling up of mandatory food fortification with folic acid as an evidence-based policy. RESULTS: We identified eight barriers and seven facilitators as determinant factors for food fortification policies. The identified factors were classified as individual, contextual, and external, inspired by the Consolidated Framework for Implementation of Research (CFIR). We discuss mechanisms to overcome obstacles and seize the opportunities to approach this public health intervention safely and effectively. CONCLUSIONS: Several determinant factors acting as barriers or facilitators influence the implementation of mandatory food fortification as an evidence-based policy worldwide. Notoriously, policymakers in many countries may lack knowledge of the benefits of scaling up their policies to prevent folic acid-sensitive neural tube defects, improve the health status of their communities, and promote the protection of many children from these disabling but preventable conditions. Not addressing this problem negatively affects four levels: public health, society, family, and individuals. Science-driven advocacy and partnerships with essential stakeholders can help overcome the barriers and leverage the facilitators for safe and effective food fortification.

National Mandatory Grain Fortification Legislation Decreases Anemia Prevalence among Nonpregnant Women of Reproductive Age: Findings from Multiple Demographic and Health Surveys.

BACKGROUND: Two billion people are affected by anemia globally, mostly including women of reproductive age (WRA) and those residing in low- and middle-income countries (LMICs). Large national population-representative studies examining the impact of national grain fortification policies on the prevalence of anemia among WRA are lacking from recent years. OBJECTIVES: We aimed to determine whether mandatory national grain fortification policies reduce the prevalence of anemia among nonpregnant WRA. METHODS: We examined national food fortification policy characteristics from the Global Fortification Data Exchange (GFDx) database and anemia prevalence data from the Demographic and Health Surveys (DHSs). In total, 21 LMICs, with and without national grain fortification policies, completing ≥2 DHSs between 2000 and 2018, met study eligibility. We applied the difference-in-differences approach to compare changes in the prevalence of anemia among WRA in 10 countries with and 11 countries without fortification between each DHS year. Odds ratios (ORs) and average marginal effects, along with 95% confidence intervals (CIs) were calculated, adjusting for individual-, household-, and country-level factors. RESULTS: Our analytic study sample included 96,334 and 874,984 WRA in countries with and without fortification, respectively. Overall, countries with fortification showed 27% decreased odds of anemia (adjusted OR: 0.73; 95% CI: 0.63, 0.85) and a 7.47-percentage-point decrease in the mean anemia prevalence (average marginal effect: -7.47; 95% CI: -11.03, -3.92) from the pre- to the postfortification period, compared with countries without fortification, after controlling for selected individual-, household-, and country-level factors. CONCLUSIONS: Our findings, using nationally representative DHS data and applying a recommended analytic method to measure policy effectiveness, suggest significant reductions in anemia prevalence in WRA in countries with mandatory grain fortification compared with those without. Implementing national mandatory grain fortification in LMICs would effectively reduce anemia resulting from micronutrient deficiencies among WRA.

A global update on the status of prevention of folic acid-preventable spina bifida and anencephaly in year 2020: 30-Year anniversary of gaining knowledge about folic acid's prevention potential for neural tube defects.

BACKGROUND: Spina bifida and anencephaly are major neural tube defects largely preventable through maternal periconceptional intake of folic acid. We estimated the global proportion of folic acid-preventable spina bifida and anencephaly (FAP SBA) prevented through mandatory folic acid fortification of cereal grains, including wheat flour, maize flour, and rice, at the end of year 2020, a time point marking the 30th anniversary of the publication of landmark British Medical Research Council (MRC) study providing unequivocal knowledge on folic acid's FAP SBA prevention potential. METHODS: The Food Fortification Initiative database was used to identify countries with mandatory fortification policies with folic acid added to cereal grains. We examined the status of FAP SBA prevention assuming mandatory folic acid fortification at 200 mcg/day of folic acid protects against FAP SBA and reduces their prevalence to a minimum achievable rate of 0.5 cases/1000 live births. RESULTS: Our analysis showed that 61,680 FAP SBA cases were prevented in the year 2020 through mandatory folic acid fortification of cereal grains in 58 countries, translating to 22% prevention of total possible FAP SBA prevention globally. Many countries in Africa, Asia, and Europe are yet to implement fortification. In 2020, 30 years after the MRC study was published, 218,270 preventable FAP SBA cases still occurred globally. CONCLUSION: Global prevention efforts for FAP SBA are inadequate even after three decades of knowledge on their prevention. Universal mandatory fortification of staples should be urgently implemented to prevent thousands of FAP SBA and associated elective terminations, stillbirths, and child mortality.

Systematic Process Framework for Conducting Implementation Science Research in Food Fortification Programs.

Food fortification has proven to be an effective approach for preventing micronutrient deficiencies in many settings. Factors that lead to successful fortification programs are well established. However, due to the multisectoral nature of fortification and the added complexities present in many settings, the barriers to success are not always evident and the strategies to address them are not always obvious. We developed a systematic process for identifying and addressing gaps in the implementation of a food fortification program. The framework is composed of 4 phases: (1) connect program theory of change to program implementation; (2) develop an implementation research agenda; (3) conduct implementation research; and (4) analyze findings and develop/disseminate recommendations for next steps. We detail steps in each phase to help guide teams through the process. To our knowledge, this is the first attempt to outline a systematic process for applying implementation science research to food fortification. The development of this framework is intended to promote implementation research in the field of food fortification, thus improving access to and effectiveness of this key public health intervention.

Food Fortification With Folic Acid for Prevention of Spina Bifida and Anencephaly: The Need for a Paradigm Shift in Evidence Evaluation for Policy-Making.

Context-specific evidence evaluation is advocated in modern epidemiology to support public health policy decisions, avoiding excessive reliance on experimental study designs. Here we present the rationale for a paradigm shift in evaluation of the evidence derived from independent studies, as well as systematic reviews and meta-analyses of observational studies, applying Hill's criteria (including coherence, plausibility, temporality, consistency, magnitude of effect, and dose-response) to evaluate food fortification as an effective public health intervention against folic acid-preventable (FAP) spina bifida and anencephaly (SBA). A critical appraisal of evidence published between 1983 and 2020 supports the conclusion that food fortification with folic acid prevents FAP SBA. Policy-makers should be confident that with mandatory legislation, effective implementation, and periodic evaluation, food fortification assures that women of reproductive age will safely receive daily folic acid to significantly reduce the risk of FAP SBA. Current evidence should suffice to generate the political will to implement programs that will save thousands of lives each year in over 100 countries.

The Potential Contribution of Fortified Maize Flour, Oil, Rice, Salt, and Wheat Flour to Estimated Average Requirements and Tolerable Upper Intake Levels for 15 Nutrients in 153 Countries.

Food fortification is designed to improve the nutritional profile of diets. The purpose of this research was to estimate the potential nutrient contribution of fortified maize flour, oil, rice, salt, and wheat flour in 153 countries, using the national intake (or availability) of the food and the nutrient levels required for fortification. This was done under two scenarios-maximum, where 100% of the food is assumed to be industrially processed and fortified, and realistic, where the maximum value is adjusted based on the percent of the food that is industrially processed and fortified. Under the maximum scenario, the median Estimated Average Requirements (EARs) met ranged from 22-75% for 14 nutrients (vitamins A, B1, B2, B3, B6, B12, D, E, folic acid and calcium, fluoride, iron, selenium and zinc), and 338% for iodine. In the realistic scenario, the median EARs met were 181% for iodine and <35% for the other nutrients. In both scenarios, the median Tolerable Upper Intake Levels (ULs) met were <55% for all nutrients. Under the realistic scenario, no country exceeded 100% of the UL for any nutrient. Current fortification practices of the five foods of interest have the global potential to contribute up to 15 nutrients to the diets of people, with minimal risk of exceeding ULs.

A 2019 global update on folic acid-preventable spina bifida and anencephaly.

BACKGROUND: Mandatory folic acid fortification of staples is a proven intervention to prevent spina bifida and anencephaly, two life-threatening and disabling neural tube defects. We estimated the global proportion of folic acid-preventable spina bifida and anencephaly (FAP SBA) prevented through mandatory folic acid fortification of wheat and/or maize flour in 2019. METHODS: Using data from the Global Fortification Data Exchange, we identified countries with mandatory fortification policies that required at least 1.0 ppm folic acid be added to wheat and/or maize flour and had information on percentage of industrially milled flour that is fortified. We built FAP SBA prevention models assuming mandatory folic acid fortification at 200 µg/day of folic acid fully protects against FAP SBA and would lower the prevalence neural tube defects to 0.5 per 1,000 live births. RESULTS: In 2019, 56 countries met our criteria for mandatory folic acid fortification of wheat (n = 56 countries) and/or maize (n = 15 countries) flour and with complete data for our modeling. Overall, our prevention model estimated that 65,380 FAP SBA cases were prevented in 2019 through folic acid fortification of wheat and/or maize flour. We estimated the current global prevention proportion of all preventable FAP SBA cases worldwide to be at 23% of total possible prevention. CONCLUSION: Global prevention efforts for FAP SBA are slow and have stalled. Mandatory fortification should be urgently implemented in all countries to prevent epidemics of FAP SBA, and to achieve health-related Sustainable Development Goals for year 2030 by reducing child mortality due to preventable FAP SBA.

Fortified Foods Are Major Contributors to Apparent Intakes of Vitamin A and Iodine, but Not Iron, in Diets of Women of Reproductive Age in 4 African Countries.

BACKGROUND: Food fortification is implemented to increase intakes of specific nutrients in the diet, but contributions of fortified foods to nutrient intakes are rarely quantified. OBJECTIVES: We quantified iron, vitamin A, and iodine intakes from fortified staple foods and condiments among women of reproductive age (WRA). METHODS: In subnational (Nigeria, South Africa) and national (Tanzania, Uganda) cross-sectional, clustered household surveys, we assessed fortifiable food consumption. We estimated daily nutrient intakes from fortified foods among WRA by multiplying the daily apparent fortifiable food consumption (by adult male equivalent method) by a fortification content for the food. Two fortification contents were used: measured, based on the median amount quantified from individual food samples collected from households; and potential, based on the targeted amount in national fortification standards. Results for both approaches are reported as percentages of the estimated average requirement (EAR) and recommended nutrient intake (RNI). RESULTS: Fortified foods made modest contributions to measured iron intakes (0%-13% RNI); potential intakes if standards are met were generally higher (0%-65% RNI). Fortified foods contributed substantially to measured vitamin A and iodine intakes (20%-125% and 88%-253% EAR, respectively); potential intakes were higher (53%-655% and 115%-377% EAR, respectively) and would exceed the tolerable upper intake level among 18%-56% of WRA for vitamin A in Nigeria and 1%-8% of WRA for iodine in Nigeria, Tanzania, and Uganda. CONCLUSIONS: Fortified foods are major contributors to apparent intakes of vitamin A and iodine, but not iron, among WRA. Contributions to vitamin A and iodine are observed despite fortification standards not consistently being met and, if constraints to meeting standards are addressed, there is risk of excessive intakes in some countries. For all programs assessed, nutrient intakes from all dietary sources and fortification standards should be reviewed to inform adjustments where needed to avoid risk of low or excessive intakes.

The Fallacy of Using Administrative Data in Assessing the Effectiveness of Food Fortification. Comment on: "Folic Acid Fortification and Neural Tube Defect Risk: Analysis of the Food Fortification Initiative Dataset. Nutrients 2020, 12, 247".

Our objective in this comment is to highlight several limitations in an ecological research study that was published in Nutrients by Murphy and Westmark (2020) in January 2020. The study used data from the Food Fortification Initiative (FFI) website, and applying an ecological study design, made an error of "ecologic fallacy" in concluding that "national fortification with folic acid is not associated with a significant decrease in the prevalence of neural tube defects (NTDs) at the population level". We list study limitations that led to their erroneous conclusions, stemming from incorrect considerations regarding NTD prevalence, the average grain availability for a country, the fortification coverage in a country, the population reach of fortified foods within a country, and the absence of the consideration of fortification type (voluntary vs. mandatory), country-specific policies on elective terminations for NTD-affected pregnancies, stillbirth proportions among those with NTDs, and fortification implementation. FFI data are derived from many sources and intended for fortification advocacy, not for hypothesis testing. The flawed study by Murphy & Westmark (2020) in Nutrients promotes a confusing and incorrect message to stakeholders, misguides policy makers, and hinders progress in global NTD prevention through a cost-effective, safe, and effective intervention: the mandatory large-scale folic acid fortification of staple foods.

Fortification of wheat and maize flour with folic acid for population health outcomes.

BACKGROUND: Folate is a B-vitamin required for DNA synthesis, methylation, and cellular division. Wheat and maize (corn) flour are staple crops consumed widely throughout the world and have been fortified with folic acid in over 80 countries to prevent neural tube defects. Folic acid fortification may be an effective strategy to improve folate status and other health outcomes in the overall population. OBJECTIVES: To evaluate the health benefits and safety of folic acid fortification of wheat and maize flour (i.e. alone or in combination with other micronutrients) on folate status and health outcomes in the overall population, compared to wheat or maize flour without folic acid (or no intervention). SEARCH METHODS: We searched the following databases in March and May 2018: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In Process, Embase, CINAHL, Web of Science (SSCI, SCI), BIOSIS, Popline, Bibliomap, TRoPHI, ASSIA, IBECS, SCIELO, Global Index Medicus-AFRO and EMRO, LILACS, PAHO, WHOLIS, WPRO, IMSEAR, IndMED, and Native Health Research Database. We searched the International Clinical Trials Registry Platform and ClinicalTrials.gov for ongoing or planned studies in June 2018, and contacted authors for further information. SELECTION CRITERIA: We included randomised controlled trials (RCTs), with randomisation at the individual or cluster level. We also included non-RCTs and prospective observational studies with a control group; these studies were not included in meta-analyses, although their characteristics and findings were described. Interventions included wheat or maize flour fortified with folic acid (i.e. alone or in combination with other micronutrients), compared to unfortified flour (or no intervention). Participants were individuals over two years of age (including pregnant and lactating women), from any country. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, extracted data, and assessed risk of bias. MAIN RESULTS: We included 10 studies: four provided data for quantitative analyses (437 participants); five studies were randomised trials (1182 participants); three studies were non-RCTs (1181 participants, 8037 live births); two studies were interrupted time series (ITS) studies (1 study population of 2,242,438, 1 study unreported). Six studies were conducted in upper-middle-income countries (China, Mexico, South Africa), one study was conducted in a lower-middle-income country (Bangladesh), and three studies were conducted in a high-income country (Canada). Seven studies examined wheat flour fortified with folic acid alone or with other micronutrients. Three studies included maize flour fortified with folic acid alone or with other micronutrients. The duration of interventions ranged from two weeks to 36 months, and the ITS studies included postfortification periods of up to seven years. Most studies had unclear risk of bias for randomisation, blinding, and reporting, and low/unclear risk of bias for attrition and contamination.Neural tube defects: none of the included RCTs reported neural tube defects as an outcome. In one non-RCT, wheat flour fortified with folic acid and other micronutrients was associated with significantly lower occurrence of total neural tube defects, spina bifida, and encephalocoele, but not anencephaly, compared to unfortified flour (total neural tube defects risk ratio (RR) 0.32, 95% confidence interval (CI) 0.21 to 0.48; 1 study, 8037 births; low-certainty evidence).Folate status: pregnant women who received folic acid-fortified maize porridge had significantly higher erythrocyte folate concentrations (mean difference (MD) 238.90 nmol/L, 95% CI 149.40 to 328.40); 1 study, 38 participants; very low-certainty evidence) and higher plasma folate (MD 14.98 nmol/L, 95% CI 9.63 to 20.33; 1 study, 38 participants; very low-certainty evidence), compared to no intervention. Women of reproductive age consuming maize flour fortified with folic acid and other micronutrients did not have higher erythrocyte folate (MD -61.80 nmol/L, 95% CI -152.98 to 29.38; 1 study, 35 participants; very low-certainty evidence) or plasma folate (MD 0.00 nmol/L, 95% CI -0.00 to 0.00; 1 study, 35 participants; very low-certainty evidence) concentrations, compared to women consuming unfortified maize flour. Adults consuming folic acid-fortified wheat flour bread rolls had higher erythrocyte folate (MD 0.66 nmol/L, 95% CI 0.13 to 1.19; 1 study, 30 participants; very low-certainty evidence) and plasma folate (MD 27.00 nmol/L, 95% CI 15.63 to 38.37; 1 study, 30 participants; very low-certainty evidence), versus unfortified flour. In two non-RCTs, serum folate concentrations were significantly higher among women who consumed flour fortified with folic acid and other micronutrients compared to women who consumed unfortified flour (MD 2.92 nmol/L, 95% CI 1.99 to 3.85; 2 studies, 657 participants; very low-certainty evidence).Haemoglobin or anaemia: in a cluster-randomised trial among children, there were no significant effects of fortified wheat flour flatbread on haemoglobin concentrations (MD 0.00 nmol/L, 95% CI -2.08 to 2.08; 1 study, 334 participants; low-certainty evidence) or anaemia (RR 1.07, 95% CI 0.74 to 1.55; 1 study, 334 participants; low-certainty evidence), compared to unfortified wheat flour flatbread. AUTHORS' CONCLUSIONS: Fortification of wheat flour with folic acid may reduce the risk of neural tube defects; however, this outcome was only reported in one non-RCT. Fortification of wheat or maize flour with folic acid (i.e. alone or with other micronutrients) may increase erythrocyte and serum/plasma folate concentrations. Evidence is limited for the effects of folic acid-fortified wheat or maize flour on haemoglobin levels or anaemia. The effects of folic acid fortification of wheat or maize flour on other primary outcomes assessed in this review is not known. No studies reported on the occurrence of adverse effects. Limitations of this review were the small number of studies and participants, limitations in study design, and low-certainty of evidence due to how included studies were designed and reported.

Potential Dietary Contributions From Rice and Wheat Flour Fortification in the Solomon Islands: Results From the 2012-2013 Household Income and Expenditure Survey.

BACKGROUND: Solomon Islands (SI) mandated wheat flour fortification in 2010. Rice is a key staple food in SI, and its fortification may provide an opportunity to deliver additional micronutrients to the population. OBJECTIVE: To determine whether fortified rice (proposed) and fortified wheat flour potentially benefit women of reproductive age (WRA). METHODS: We analyzed data from the 2012-2013 Household Income and Expenditure Survey to quantify food purchases, which served as a proxy for food consumption. We accounted for varied household composition by using adult male equivalent (AME) adjustments. RESULTS: Among 4478 households, 95.6% purchased rice and 86.6% purchased at least 1 food containing fortified wheat flour in the previous 14 days. Median apparent intake of rice among WRA was 205 g/d/AME. If fortified according to proposed standards, this apparent intake could result in the consumption of 12.3 mg iron/d, fulfilling 44% of the estimated average requirement (EAR), and 226 µg folic acid/d, satisfying 57% of World Health Organization's recommended intake of 400 µg/d. Overall, apparent rice consumption could fulfill 113%, 114%, and 131% of the EAR for WRA for zinc, thiamin, and niacin, respectively. Fortified wheat flour was consumed in much lower quantities, with an estimated apparent median intake of 22 g/d/AME among WRA and 78 g/d/AME among women in urban populations. CONCLUSIONS: The potential benefit of fortified wheat flour in SI is likely limited to urban populations. Apparent consumption of fortified rice in SI could contribute considerably to daily intake of iron, B vitamins including folic acid, and zinc among WRA.

Review of Grain Fortification Legislation, Standards, and Monitoring Documents.

OBJECTIVE: Analyze the content of documents used to guide mandatory fortification programs for cereal grains. METHODS: Legislation, standards, and monitoring documents, which are used to mandate, provide specifications for, and confirm fortification, respectively, were collected from countries with mandatory wheat flour (n=80), maize flour (n=11), and/or rice (n=6) fortification as of January 31, 2015, yielding 97 possible country-grain combinations (e.g., Philippines-wheat flour, Philippines-rice) for the analysis. After excluding countries with limited or no documentation, 72 reviews were completed, representing 84 country-grain combinations. Based on best practices, a criteria checklist was created with 44 items that should be included in fortification documents. Two reviewers independently scored each available document set for a given country and food vehicle (a country-grain combination) using the checklist, and then reached consensus on the scoring. We calculated the percentage of country-grain combinations containing each checklist item and examined differences in scores by grain, region, and income level. RESULTS: Of the 72 country-grain combinations, the majority of documentation came from countries in the Americas (46%) and Africa (32%), and most were from upper and lower middle-income countries (73%). The majority of country-grain combinations had documentation stating the food vehicle(s) to be fortified (97%) and the micronutrients (e.g., iron) (100%), fortificants (e.g., ferrous fumarate) (88%), and fortification levels required (96%). Most (78%) stated that labeling is required to indicate a product is fortified. Many country-grain combinations described systems for external (64%) monitoring, and stated that industry is required to follow quality assurance/quality control (64%), though detailed protocols (33%) and roles and responsibilities (45%) were frequently not described. CONCLUSIONS: Most country-grain combinations have systems in place for internal, external, and import monitoring. However, documentation of other important items that would influence product compliance to national standard, such as roles and responsibilities between agencies, the cost of regulating fortification, and enforcement strategies, are often lacking. Countries with existing mandatory fortification can improve upon these items in revisions to their documentation while countries that are beginning fortification can use the checklist to assist in developing new policies and programs.

Instant noodles made with fortified wheat flour to improve micronutrient intake in Asia: a review of simulation, nutrient retention and sensory studies.

BACKGROUND AND OBJECTIVES: Consumption of foods made with wheat flour, particularly instant noodles, is increasing in Asia. Given this trend, fortifying wheat flour with vitamins and minerals may improve micronutrient intake in the region. The objective of this review was to understand what is known about fortifying wheat flour used to make instant noodles. METHODS AND STUDY DESIGN: A literature review of seven databases was performed using the search terms "noodle" and ("Asian" or "instant"). Grey literature was requested through a food fortification listserv. Articles were title screened first for relevance and duplicity, with exclusion criteria applied during the second round of abstract-level screening. This review considered studies examining simulation, retention, sensory, bioavailability, efficacy, and effectiveness of instant noodles made with fortified wheat flour. RESULTS: Fourteen relevant documents were reviewed for simulation (n=1), retention (n=11), and sensory studies (n=3). The documents revealed that instant noodles produced from fortified wheat flour have potential to improve nutrient intakes, have high retention of most nutrients, and provoke no or minimal changes in sensory characteristics. CONCLUSIONS: The available literature indicates that using fortified wheat flour for instant noodle production results in retention of the added nutrients, except thiamin, with no significant sensory change to the final product. Given the rising consumption of instant noodles, production of this item with fortified wheat flour has potential to improve nutrient intakes in Asia. This review provides a resource for the design of a wheat flour fortification program in countries where a large proportion of wheat flour is consumed as instant noodles.

A 2015 global update on folic acid-preventable spina bifida and anencephaly.

BACKGROUND: Spina bifida and anencephaly are two major neural tube defects. They contribute substantially to perinatal, neonatal, infant, and under-five mortality and life-long disability. To monitor the progress toward the total prevention of folic acid-preventable spina bifida and anencephaly (FAP SBA), we examined their global status in 2015. METHODS: Based on existing data, we modeled the proportion of FAP SBA that are prevented in the year 2015 through mandatory folic acid fortification globally. We included only those countries with mandatory fortification that added at least 1.0 ppm folic acid as a fortificant to wheat and maize flour, and had complete information on coverage. Our model assumed mandatory folic acid fortification at 200 µg/day is fully protective against FAP SBA, and reduces the rate of spina bifida and anencephaly to a minimum of 0.5 per 1000 births. RESULTS: Our estimates show that, in 2015, 13.2% (35,500 of approximately 268,700 global cases) of FAP SBA were prevented in 58 countries through mandatory folic acid fortification of wheat and maize flour. Most countries in Europe, Africa, and Asia were not implementing mandatory fortification with folic acid. CONCLUSION: Knowledge that folic acid prevents spina bifida and anencephaly has existed for 25 years, yet only a small fraction of FAP SBA is being prevented worldwide. Several countries still have 5- to 20-fold epidemics of FAP SBA. Implementation of mandatory fortification with folic acid offers governments a proven and rapid way to prevent FAP SBA-associated disability and mortality, and to help achieve health-related Sustainable Development Goals. Birth Defects Research (Part A) 106:520-529, 2016. © 2016 Wiley Periodicals, Inc.

Evidence of the effectiveness of flour fortification programs on iron status and anemia: a systematic review.

CONTEXT: More than 80 countries fortify flour, yet the public health impact of this intervention on iron and anemia outcomes has not been reviewed. OBJECTIVE: The objective of this systematic review was to review published and gray literature pertaining to the impact of flour fortification on iron and anemia. DATA SOURCES: A systematic review was conducted by searching 17 databases and appealing for unpublished reports, yielding 1881 documents. STUDY SELECTION: Only studies of government-supported, widely implemented fortification programs in which anemia or iron status was measured prior to and ≥12 months after initiation of fortification were included. DATA EXTRACTION: Details about the design, coverage, compliance with national standards, and evaluation (e.g., anemia prevalence before and after fortification) of flour fortification programs were extracted from the reports. DATA SYNTHESIS: Thirteen studies describing 26 subgroups (n = 14 for children ≤15 y, n = 12 for women of reproductive age) were included. During the period from pre- to postfortification (and as difference-in-difference for those studies that included a control group), there were statistically significant decreases in the prevalence of anemia in 4 of 13 subgroups of children and in 4 of 12 subgroups of women of reproductive age as well as significant decreases in the prevalence of low ferritin in 1 of 6 subgroups of children and in 3 of 3 subgroups of women of reproductive age. CONCLUSIONS: . Evidence of the effectiveness of flour fortification for reducing the prevalence of anemia is limited; however, evidence of effectiveness for reducing the prevalence of low ferritin in women is more consistent.

Anaemia prevalence may be reduced among countries that fortify flour.

The effectiveness of flour fortification in reducing anaemia prevalence is equivocal. The goal was to utilise the existing national-level data to assess whether anaemia in non-pregnant women was reduced after countries began fortifying wheat flour, alone or in combination with maize flour, with at least Fe, folic acid, vitamin A or vitamin B12. Nationally representative anaemia data were identified through Demographic and Health Survey reports, the WHO Vitamin and Mineral Nutrition Information System database and other national-level nutrition surveys. Countries with at least two anaemia surveys were considered for inclusion. Within countries, surveys were excluded if altitude was not consistently adjusted for, or if the blood-draw site (e.g. capillary or venous) or Hb quantification method (e.g. HemoCue or Cyanmethaemoglobin) differed. Anaemia prevalence was modelled for countries that had pre- and post-fortification data (n 12) and for countries that never fortified flour (n 20) using logistic regression models that controlled for time effects, human development index (HDI) and endemic malaria. After adjusting for HDI and malaria, each year of fortification was associated with a 2.4% reduction in the odds of anaemia prevalence (PR 0.976, 95% CI 0.975, 0.978). Among countries that never fortified, no reduction in the odds of anaemia prevalence over time was observed (PR 0.999, 95% CI 0.997, 1.002). Among both fortification and non-fortification countries, HDI and malaria were significantly associated with anaemia (P,0.001). Although this type of evidence precludes a definitive conclusion, results suggest that after controlling for time effects, HDI and endemic malaria, anaemia prevalence has decreased significantly in countries that fortify flour with micronutrients, while remaining unchanged in countries that do not.

Experiencias globales de la fortificación de la harina con ácido fólico para disminuir los defectos del tubo neural / Global experiences with folic acid fortification of flour to reduce neural tube defects

Los defectos del tubo neural son defectos congénitos del cerebro y la médula espinal que pueden provocar discapacidad permanente o muerte en los bebés afectados. Se estima que globalmente hay 320.000 defectos del tubo neural cada año. De estos, aproximadamente tres cuartos se pueden prevenir si la mujer tiene un buen estado de folato en el periodo alrededor de la concepción. La fortificación masiva de alimentos aporta ácido fólico a la dieta de mujeres en el periodo peri-concepcional. De los 81 países que requieren la fortificación de harina de trigo o maíz, 77 obligan la adición de ácido fólico. Se ha documentado en varios países que la fortificación obligatoria y masiva de harina con ácido fólico aumenta niveles séricos de folatos y reduce defectos del tubo neural. Una meta-análisis ha estimado en 46% la reducción promedio en defectos del tubo neural a raíz de la fortificación masiva de harina con ácido fólico. La espina bífida es uno de los defectos del tubo neural que se puede prevenir con ácido fólico; el costo:beneficio de prevenir la espina bífida es favorable y se ha estimado entre 1:12 y 1:48. A pesar de estos éxitos, se estima que solamente 15% de los defectos del tubo neural que se pudieran prevenir con ácido fólico se están previniendo con fortificación masiva de harina. Existen lineamientos y experiencias globales para guiar aquellos países interesados en fortificar la harina con ácido fólico para reducir defectos del tubo neural(AU)

Neural tube defects are congenital anomalies of the brain and spine that can lead to permanent disability or death in affected babies. There are an estimated 320,000 neural tube defects annually throughout the world. Of these, approximately three-fourths are preventable if women have sufficient folate status in the peri-conceptional period. Mass food fortification contributes folic acid to women's diets in the peri-conceptional period. Of 81 countries that mandate wheat flour or maize flour fortification, 77 require the addition of folic acid. It has been documented in several countries that mandatory mass fortification of flour with folic acid increases blood folate levels and reduces neural tube defects. A metaanalysis estimated a 46% average reduction in neural tube defects due to folic-acid fortification of flour. The cost:benefit ratio of preventing spina bifida, a type of neural tube defect that can be prevented with folic acid, is favorable and estimated to be between 1:12 and 1:48. Despite these successes, it is estimated that only 15% of those neural tube defects that can be prevented by folic acid are being prevented through mass fortification of flour. There are international guidelines and experiences that interested countries can draw upon to fortify flour with folic acid to reduce neural tube defects(AU)

Infant and young child feeding in four departments in Haiti: mixed-method study on prevalence of recommended practices and related attitudes, beliefs, and other determinants / Alimentación de los lactantes y niños pequeños en cuatro departamentos de Haití: un estudio con diseño de método mixto sobre la prevalencia de las prácticas recomendadas y las actitudes, las creencias y otros determinantes relacionados

OBJECTIVE: To determine and describe the prevalence and patterns of three recommended practices for infant and young child feeding-exclusive breastfeeding (EB), continued breastfeeding (CB), and achievement of minimum dietary diversity-in four regions in Haiti, and to identify the attitudes and beliefs that inform these practices and any other factors that may facilitate or impede their implementation. METHODS: This study utilized a mixed-methods approach consisting of 1) a cross-sectional survey (n = 310) and 2) 12 focus group discussions among women ≥18 years old with children ≤ 2 years old. Multivariable logistic regression analyses were conducted to identify factors associated with 1) EB during the first six months of life, 2) CB for children ≥ 2 years old, and 3) receipt of a diverse variety of complementary foods. Qualitative data were recorded, transcribed verbatim, and analyzed for common themes. Data were collected in June and July 2013 in four departments in Haiti: Artibonite, Nippes, Ouest, and Sud-Est. RESULTS: Prevalence of EB, CB, and achievement of minimum dietary diversity was 57.0%, 11.9%, and 21.2% respectively. EB was statistically significantly associated with infant's age when controlling for annual household income, location of most recent birth, or receipt of CB counseling (odds ratio (OR) = 0.67 (95% CI: 0.47-0.97)). CB was not statistically significantly associated with rural place of residence, receipt of CB counseling, parity, or infant's age. Meeting minimum dietary diversity was not significantly associated with parity, receipt of postnatal care, rural place of residence, location of most recent birth, receipt of infant and young child feeding counseling, or level of schooling. Beliefs surrounding the relationship between the mother's health and her diet on the quality of breast milk may prohibit EB and CB. Qualitative data revealed that dietary diversity may be low because 1) mothers often struggle to introduce complementary foods and 2) those that are traditionally introduced are not varied and primarily consist of grains and starches. CONCLUSIONS: Prevalence of the three recommended infant and young child feeding practices examined in this study is suboptimal, particularly CB and achievement of minimum dietary diversity. Future communication and programming efforts should address the misunderstandings and concerns identified through the qualitative methods used in this research.

OBJETIVO: Determinar y describir la prevalencia y los modelos de tres prácticas recomendadas para la alimentación de los lactantes y los niños pequeños (la lactancia materna exclusiva [LME], la lactancia materna continuada [LMC] y el logro de una diversidad alimentaria mínima, en cuatro regiones de Haití, y determinar las actitudes y creencias en las que se basan estas prácticas y otros factores que puedan facilitar o impedir su implantación. MÉTODOS: Este estudio utilizó un diseño de método mixto que consistió en 1) una encuesta transversal (n = 310) y 2) 12 grupos de discusión formados por mujeres de ≥ 18 años de edad o mayores con niños de ≤ 2 años de edad o menores. Se llevaron a cabo análisis de regresión logística multivariable para determinar los factores asociados con 1) la LME durante los seis primeros meses de vida, 2) la LMC en niños de ≥ 2 años de edad o mayores, y 3) el aporte de una amplia variedad de alimentos complementarios. Se registraron, se transcribieron al pie de la letra y se analizaron los datos cualitativos referentes a temas comunes. Estos datos se recopilaron en junio y julio del 2013, en cuatro departamentos de Haití: Artibonite, Nippes, Oeste y Sudeste. RESULTADOS: Las prevalencias de la LME, la LMC y el logro de una diversidad alimentaria mínima fueron de 57,0, 11,9 y 21,2%, respectivamente. La LME se asoció de manera estadísticamente significativa con la edad del lactante si se controlaban las variables de ingresos familiares anuales, ubicación del parto más reciente, o provisión de orientación en materia de LMC (razón de posibilidades [OR] = 0,67 [IC de 95%:0.47-0.97]). La LMC no se asoció de una manera estadísticamente significativa con la residencia en un entorno rural, la provisión de orientación en materia de LMC, la paridad o la edad de lactante. El logro de una diversidad alimentaria mínima no se asoció significativamente con la paridad, la provisión de atención posnatal, la residencia en un entorno rural, la ubicación del parto más reciente, la provisión de orientación en materia de alimentación de los lactantes y los niños pequeños, o el nivel de escolarización. Las creencias con respecto a la relación entre la salud de la madre y su régimen alimentario con la calidad de la leche materna pueden limitar la LME y la LMC. Los datos cualitativos revelaron que la diversidad alimentaria puede ser escasa como consecuencia de que 1) las madres a menudo se esfuerzan por introducir los alimentos complementarios, y 2) los que se introducen tradicionalmente no son variados y consisten principalmente en cereales y féculas. CONCLUSIONES: Las prevalencias de las tres prácticas de alimentación de los lactantes y los niños pequeños recomendadas analizadas en este estudio son subóptimas, en particular las correspondientes a la LMC y al logro de una diversidad alimentaria mínima. Las futuras iniciativas de comunicación y programación deberían abordar los malentendidos y las inquietudes detectadas mediante los métodos cualitativos utilizados en esta investigación.

Avances en la fortificación de harina de trigo a nivel global / Advances in the fortification of wheat flour

: Por 90 años, alimentos han sido industrialmente fortificados (o enriquecidos) con vitaminas y minerales. Los granos básicos, específicamente la harina de trigo, la harina de maíz y el arroz, son aptos para la fortificación debido a su alta disponibilidad en la mayoría de países del mundo. El propósito de este artículo es revisar la evidencia del impacto en salud pública de la fortificación de granos básicos (con un enfoque en harina de trigo), describir los retos mundiales que enfrenta la fortificación y enlistar las herramientas que puedan ayudar con el diseño, el monitoreo y la evaluación de programas de fortificación de alimentos. Hay evidencia sólida y consistente que la fortificación con ácido fólico aumenta el folato sérico y reduce defectos del tubo neural, además de que la fortificación con hierro aumenta la ferritina sérica. Sin embargo, para la hemoglobina, los resultados son contradictorios: algunos estudios reportan un aumento, otros una disminución y otros ningún cambio en hemoglobina después de fortificar los granos básicos con diferentes nutrientes. Los dos retos principales de la fortificación mundial es que varios países se podrían beneficiar de la fortificación de granos cereales, sin embargo, no implementan esta intervención de salud pública. Además, son pocos los países que de manera consistente reportan los resultados de monitoreo y evaluación de sus programas de fortificación. Para abordar estos retos, hay varias herramientas disponibles o en desarrollo que guían el diseño, el monitoreo y la evaluación de programas de fortificación de alimentos(AU)

Food has been industrially fortified (or enriched) with vitamins and minerals for 90 years. Cereal grains, specifically wheat flour, maize flour and rice, are good vehicles for fortification because they are available in large amounts in most countries around the world. The purpose of this paper is to review the evidence for the public-health impact of fortification, describe challenges to worldwide fortification, and list tools that are available to aid in the design, monitoring and evaluation of food-fortification programs. There is strong and consistent evidence that folic-acid fortification of cereal grains improves serum folate and reduces neural tube defects, and that iron-fortification increases serum ferritin levels. The results for hemoglobin are equivocal: some studies report increases, others decreases, and others no change in hemoglobin after cereal-grain fortification commenced with several nutrients. The two main challenges to worldwide fortification are that many countries that could benefit from cereal-grain fortification do not undertake this public-health intervention, and that few countries consistently report monitoring or evaluation data that suggests they are keeping track of the implementation of fortification. Finally, to overcome these challenges, many tools are available or under development to help with the design, monitoring and evaluation of food-fortification programs(AU)

Technical considerations for maize flour and corn meal fortification in public health: consultation rationale and summary.

Fortification is the purposeful addition of vitamins and minerals to foods during their industrial processing, as a way to improve the nutrition and health of populations who consume these foods. Twelve countries have mandatory maize (Zea mays subsp. Mays) flour or meal fortification. The World Health Organization (WHO) is updating evidence-informed guidelines for the fortification of staple foods in public health, including the fortification of maize flour and corn meal with iron and other micronutrients. Although there is limited experience with fortification of maize, mass fortification of maize flour with at least iron has been practiced for many years in several countries in the Americas and Africa: Brazil, Costa Rica, El Salvador, Kenya, Mexico, Nigeria, Rwanda, South Africa, Tanzania, Uganda, the United States, and Venezuela. The WHO, in collaboration with the Sackler Institute for Nutrition Science and the Flour Fortification Initiative (FFI), convened a consultation on technical considerations for fortification of maize flour and corn meal in public health in New York, New York on April 8-9, 2013 to provide input into the guideline-development process and to discuss technical considerations of the fortification processes for maize flour and corn meal.