Key Considerations for Policymakers-Iodized Salt as a Vehicle for Iron Fortification: Current Evidence, Challenges, and Knowledge Gaps.

Could DFS help prevent iron deficiency and anemia? Studies in controlled settings (efficacy) demonstrate that double-fortified salt (DFS; iron added to iodized salt) reduces the prevalence of anemia and iron deficiency anemia. Studies in program settings (effectiveness) are limited and reported differing levels of DFS coverage, resulting in mixed evidence of impact on anemia. What iron formulations are available and how do they affect iodized salt? Ferrous sulfate and encapsulated ferrous fumarate (both with various enhancers and/or coating materials) are the main iron formulations currently in use for DFS. Adding iron to iodized salt may lead to adverse changes in the product, specifically discoloration and losses in iodine content. These changes are greatest when the iodized salt used in DFS production is of low quality (e.g., contain impurities, has high moisture, and is of large crystal size). DFS requires iodized salt of the highest quality and a high-quality iron formulation in order to minimize adverse sensory changes and iodine losses. Appropriate packaging of iodized salt is also important to prevent losses. What is known about the minimum requirements to manufacture DFS? DFS producers must use high-quality refined iodized salt meeting the minimum standards for DFS production (which is higher than standards for salt intended for iodization alone), and an iron formulation for which there are rigid quality-assurance measures to ensure consistent quality and blending techniques. The actual proportion of iodized salt meeting the stringent requirements necessary for DFS production is unclear, but likely to be low in many countries, especially those with fragmented salt industries and a low proportion of industrially produced salt. What are the financial implications of adding iron to iodized salt? As a result of higher input costs both for input salt and the iron compound, DFS is more expensive to produce than iodized salt and thus has a higher production cost. Various grades of iodized salt are produced and consumed in different sectors of the market. Experience in India indicates that, on average, producing DFS costs 31-40 US dollars/metric ton or 0.03-0.04 US dollars/kg more than high-quality refined iodized salt. The exact impact of this production-level cost difference on profit margins and consumer price is specific to the conditions of different salt markets. Factors such as transport costs, customary wholesale and retail mark-ups, and taxes all vary greatly and need to be assessed on a case by case basis. Is DFS in alignment with salt-reduction efforts? The WHO has long recognized that salt iodization is an important public health intervention to achieve optimal iodine nutrition and is compatible with salt-reduction goals. Fortification of salt (with any nutrient) should not be used to justify or encourage an increase in salt intake to the public. Any effort to expand salt fortification to other nutrients should be done in close consultation with WHO and those working on salt reduction. What has been the experience with DFS delivery under different platforms? To date, DFS has been introduced into the retail market and in social safety net (primarily in India) programs, but sensory changes in DFS have been raised as concerns. The higher price for DFS has limited expansion in the retail market. In social safety net programs where the cost of DFS is subsidized for beneficiaries, programs must consider long-term resourcing for sustainability. Overall: The optimal production and delivery of DFS are still under development, as many challenges need to be overcome. There is a beneficial impact on hemoglobin in efficacy trials. Thus, if those conditions can be replicated in programs or the technology can be adapted to better fit current production and delivery realities, DFS may provide an effective contribution in countries that need additional food-fortification vehicles to improve iron intake.

Improved micronutrient status and health outcomes in low- and middle-income countries following large-scale fortification: evidence from a systematic review and meta-analysis.

BACKGROUND: Micronutrient malnutrition is highly prevalent in low- and middle-income countries (LMICs) and disproportionately affects women and children. Although the effectiveness of large-scale food fortification (LSFF) of staple foods to prevent micronutrient deficiencies in high-income settings has been demonstrated, its effectiveness in LMICs is less well characterized. This is important as food consumption patterns, potential food vehicles, and therefore potential for impact may vary substantially in these contexts. OBJECTIVES: The aim of this study was to determine the real-world impact of LSFF with key micronutrients (vitamin A, iodine, iron, folic acid) on improving micronutrient status and functional health outcomes in LMICs. METHODS: All applicable published/unpublished evidence was systematically retrieved and analyzed. Studies were not restricted by age or sex. Meta-analyses were performed for quantitative outcomes and results were presented as summary RRs, ORs, or standardized mean differences (SMDs) with 95% CIs. RESULTS: LSFF increased serum micronutrient concentrations in several populations and demonstrated a positive impact on functional outcomes, including a 34% reduction in anemia (RR: 0.66; 95% CI: 0.59, 0.74), a 74% reduction in the odds of goiter (OR: 0.26; 95% CI: 0.16, 0.43), and a 41% reduction in the odds of neural tube defects (OR: 0.59; 95% CI: 0.49, 0.70). Additionally, we found that LSFF with vitamin A could protect nearly 3 million children per year from vitamin A deficiency. We noted an age-specific effect of fortification, with women (aged >18 y) attaining greater benefit than children, who may consume smaller quantities of fortified staple foods. Several programmatic/implementation factors were also reviewed that may facilitate or limit program potential. CONCLUSIONS: Measurable improvements in the micronutrient and health status of women and children are possible with LSFF. However, context and implementation factors are important when assessing programmatic sustainability and impact, and data on these are quite limited in LMIC studies.

Large-Scale Food Fortification and Biofortification in Low- and Middle-Income Countries: A Review of Programs, Trends, Challenges, and Evidence Gaps.

BACKGROUND: Food fortification and biofortification are well-established strategies to address micronutrient deficiencies in vulnerable populations. However, the effectiveness of fortification programs is not only determined by the biological efficacy of the fortified foods but also by effective and sustainable implementation, which requires continual monitoring, quality assurance and control, and corrective measures to ensure high compliance. OBJECTIVE: To provide an overview of efficacy, effectiveness, economics of food fortification and biofortification, and status of and challenges faced by large-scale food fortification programs in low- and middle-income countries (LMIC). METHODS: A literature review of PubMed publications in English from 2000 to 2017, as well as gray literature, targeting nongovernmental organizations whose work focuses on this topic, complemented by national reports and a "snowball" process of citation searching. The article describes remaining technical challenges, barriers, and evidence gap and prioritizes recommendations and next steps to further accelerate progress and potential of impact. RESULTS: The review identifies and highlights essential components of successful programs. It also points out issues that determine poor program performance, including lack of adequate monitoring and enforcement and poor compliance with standards by industry. CONCLUSIONS: In the last 17 years, large-scale food fortification initiatives have been reaching increasingly larger segments of populations in LMIC. Large-scale food fortification and biofortification should be part of other nutrition-specific and nutrition-sensitive efforts to prevent and control micronutrient deficiencies. There are remaining technical and food system challenges, especially in relation to improving coverage and quality of delivery and measuring progress of national programs.

A public health approach for preventing neural tube defects: folic acid fortification and beyond.

In this paper we review the evidence basis for prevention of folic acid-sensitive neural tube defects (NTDs) through public health interventions in women of reproductive age (WRA), the proven vehicles for delivery of folic acid, and what is needed to effectively scale these, and provide a snapshot of potential innovations that require future research. Our primary focus is on the global situation affecting large-scale food fortification (LSFF) with folic acid, in particular the fortification of wheat flour and maize meal. Our overarching conclusion is that folic acid fortification is an evidence-based intervention that reduces the prevalence of NTDs, and that LSFF with folic acid is underutilized. Thus, food fortification with folic acid should be a component of most national public health strategies, in particular where folate status is insufficient and a fortifiable food vehicle, processed by a centralized industry, is consumed regularly by WRA. The evidence shows that there is still much work needed (1) to build the enabling environment and expand programs where there is currently no legislation, (2) to improve the low quality of delivery of existing programs, and (3) to measure and sustain programs by generating new coverage data and demonstrating evidence of impact in low- and middle-income countries.

Iodine Intake through Processed Food: Case Studies from Egypt, Indonesia, the Philippines, the Russian Federation and Ukraine, 2010-2015.

The current performance indicator for universal salt iodisation (USI) is the percentage of households using adequately iodised salt. However, the proportion of dietary salt from household salt is decreasing with the increase in consumption of processed foods and condiments globally. This paper reports on case studies supported by the Global Alliance for Improved Nutrition (GAIN)-UNICEF USI Partnership Project to investigate processed food industry use of adequately iodised salt in contrasting national contexts. Studies were conducted in Egypt, Indonesia, the Philippines, the Russian Federation, and Ukraine. In all cases, the potential iodine intake from iodised salt in selected food products was modelled according to the formula: quantity of salt per unit of food product × minimum regulated iodine level of salt at production × average daily per capita consumption of the product. The percent of adult recommended nutrient intake for iodine potentially provided by the average daily intake of bread and frequently consumed foods and condiments was from 10% to 80% at the individual product level. The potential contribution to iodine intake from the use of iodised salt in the processed food industry is of growing significance. National USI strategies should encourage co-operative industry engagement and include regulatory monitoring of iodised salt use in the food industry in order to achieve optimal population iodine status.

Coverage and Utilization in Food Fortification Programs: Critical and Neglected Areas of Evaluation.

The need for evidence to inform nutrition program design and implementation has long been recognized, yet the generation and use of evidence for program decision making has lagged. The results of the coverage surveys reported in this supplement highlight some of the strengths and areas for improvement of current population-based (i.e., staple foods and condiments) and targeted (e.g., foods for infants and young children) fortification programs. Among other topics, the results identify a few striking successful fortification programs whereby the majority of the food vehicle used is fortifiable and fortified, and coverage is equitable among those classified as vulnerable and not. Other programs have great potential based on very high use of a fortifiable food vehicle, including in most cases among the vulnerable, but that potential is not currently reached because of low compliance with fortification requirements. Programs were also identified whereby the food vehicle has limited potential to make public health contributions to micronutrient intake, given the low proportions of the population who consume the food vehicle in general or who consume the fortifiable food vehicle. Four key lessons were learned: 1) the potential for impact of food fortification depends on the appropriate choice of food fortification vehicle but also on the proportion of the food vehicle consumed that is fortifiable; 2) the design of fortification programs should be informed by the magnitude and distribution of inadequate intake and deficiency and consumption of fortifiable foods, and part of micronutrient deficiency control strategies to ensure coordination with other programs; 3) effective quality control of fortification levels in foods urgently needs strengthening, including the many governance and other policy factors that influence the capacity, resources, and commitment to do this; 4) periodic review of the assumptions related to dietary patterns that underpin food fortification is needed to ensure continual safe and impactful programs.

Coverage of Large-Scale Food Fortification of Edible Oil, Wheat Flour, and Maize Flour Varies Greatly by Vehicle and Country but Is Consistently Lower among the Most Vulnerable: Results from Coverage Surveys in 8 Countries.

Background: Large-scale food fortification (LSFF) of commonly consumed food vehicles is widely implemented in low- and middle-income countries. Many programs have monitoring information gaps and most countries fail to assess program coverage.Objective: The aim of this work was to present LSFF coverage survey findings (overall and in vulnerable populations) from 18 programs (7 wheat flour, 4 maize flour, and 7 edible oil programs) conducted in 8 countries between 2013 and 2015.Methods: A Fortification Assessment Coverage Toolkit (FACT) was developed to standardize the assessments. Three indicators were used to assess the relations between coverage and vulnerability: 1) poverty, 2) poor dietary diversity, and 3) rural residence. Three measures of coverage were assessed: 1) consumption of the vehicle, 2) consumption of a fortifiable vehicle, and 3) consumption of a fortified vehicle. Individual program performance was assessed based on the following: 1) achieving overall coverage ≥50%, 2) achieving coverage of ≥75% in ≥1 vulnerable group, and 3) achieving equity in coverage for ≥1 vulnerable group.Results: Coverage varied widely by food vehicle and country. Only 2 of the 18 LSFF programs assessed met all 3 program performance criteria. The 2 main program bottlenecks were a poor choice of vehicle and failure to fortify a fortifiable vehicle (i.e., absence of fortification).Conclusions: The results highlight the importance of sound program design and routine monitoring and evaluation. There is strong evidence of the impact and cost-effectiveness of LSFF; however, impact can only be achieved when the necessary activities and processes during program design and implementation are followed. The FACT approach fills an important gap in the availability of standardized tools. The LSFF programs assessed here need to be re-evaluated to determine whether to further invest in the programs, whether other vehicles are appropriate, and whether other approaches are needed.

Vitamin A Supplementation Programs and Country-Level Evidence of Vitamin A Deficiency.

Vitamin A supplementation (VAS) programs targeted at children aged 6-59 months are implemented in many countries. By improving immune function, vitamin A (VA) reduces mortality associated with measles, diarrhea, and other illnesses. There is currently a debate regarding the relevance of VAS, but amidst the debate, researchers acknowledge that the majority of nationally-representative data on VA status is outdated. To address this data gap and contribute to the debate, we examined data from 82 countries implementing VAS programs, identified other VA programs, and assessed the recentness of national VA deficiency (VAD) data. We found that two-thirds of the countries explored either have no VAD data or data that were >10 years old (i.e., measured before 2006), which included twenty countries with VAS coverage ≥70%. Fifty-one VAS programs were implemented in parallel with at least one other VA intervention, and of these, 27 countries either had no VAD data or data collected in 2005 or earlier. To fill these gaps in VAD data, countries implementing VAS and other VA interventions should measure VA status in children at least every 10 years. At the same time, the coverage of VA interventions can also be measured. We identified three countries that have scaled down VAS, but given the lack of VA deficiency data, this would be a premature undertaking in most countries without appropriate status assessment. While the global debate about VAS is important, more attention should be directed towards individual countries where programmatic decisions are made.

The growing importance of staple foods and condiments used as ingredients in the food industry and implications for large-scale food fortification programs in Southeast Asia.

BACKGROUND: Food fortification is a viable strategy to improve the nutritional status of populations. In Southeast Asia, recent growth and consolidation of the food industry provides an opportunity to explore whether certain widely consumed processed foods could contribute to micronutrient status if they are made with adequately fortified staples and condiments. OBJECTIVE: To estimate the potential contribution certain processed foods can make to micronutrient intake in Southeast Asia if they are made with fortified staples and condiments; e.g., via the inclusion of iodized salt in various processed foods in the Philippines, fortified wheat flour in instant noodles in Indonesia, and fortified vegetable oil in biscuits in Vietnam. METHODS: For Indonesia, the Philippines, and Vietnam, a review of consumption trends, relevant policies, and industry practices was conducted using publicly available sources,food industry market data and research reports, and oral communication. These informed the estimates of the proportion of the Recommended Nutrient Intake (RNI) that could be delivered via select processed foods. RESULTS: In the Philippines, Indonesia, and Vietnam, the processed food industry is not always required to use fortified staples and condiments. In the Philippines, dried salted fish with iodized salt would provide 64% to 85% of the iodine RNI for women of reproductive age and 107% to 141% of the iodine RNI for children 1 to 6 years of age. In Indonesia, a 75-g pack of instant noodles (a highly consumed product) with fortified wheat flour would provide 45% to 51% of the iron RNI for children 4 to 6 years of age and 10% to 11% of the iron RNI for women of reproductive age. In Vietnam, biscuits containing vegetable oil are increasingly popular. One 35-g biscuit serving with fortified vegetable oil would provide 13% to 18% of the vitamin A RNI for children 4 to 6 years of age and 12% to 17% of the vitamin A RNI for women of reproductive age. CONCLUSIONS: Ensuring that fortified staples and condiments such as flour, salt, and vegetable oil are used in widely consumed processed foods would ensure that these foods contribute to improvement in micronutrient intake among populations in Southeast Asia, particularly as the consumption of these foods is increasing. Policymakers and nutrition program managers should consider the contribution to nutritional intake that fortified staples and condiments can provide through processed foods, in addition to being used for cooking in the home, and ensure that the food industry is required to use these fortified staples and condiments rather than nonfortified foods.

Vitamin A--fortified vegetable oil exported from Malaysia and Indonesia can significantly contribute to vitamin A intake worldwide.

BACKGROUND: Vitamin A deficiency is a public health problem worldwide, affecting approximately 190 million preschool-aged children and 19.1 million pregnant women. Fortification of vegetable oils with vitamin A is an effective, low-cost technology to improve vitamin A intake. OBJECTIVE: To examine the potential contribution of fortification of vegetable oils with vitamin A in Indonesia and Malaysia to increasing vitamin A consumption in these two countries and in countries to which oil is exported. METHODS: Detailed interviews were administered and a desk review was conducted. We also estimated potential vitamin A intakes from fortified vegetable oil. RESULTS: Malaysia and Indonesia are two of the largest producers and exporters of vegetable oil. Fortification of vegetable oil in both countries has the potential to be used as a tool for control of vitamin A deficiency. Both countries have the capacity to export fortified vegetable oil. Vegetable oil fortified at a level of 45 IU/g could provide 18.8% of the Estimated Average Requirement (EAR) for an Ethiopian woman, 30.9% and 46.9% of the EAR for a Bangladeshi child and woman, respectively, and 17.5% of the EAR for a Cambodian woman. Although concerns about obesity are valid, fortification of existing vegetable oil supplies does not promote overconsumption of oil but rather promotes consumption of vegetable oil of higher nutrient quality. CONCLUSIONS: Fortifying vegetable oil on a large scale in Malaysia and Indonesia can reach millions of people globally, including children less than 5 years old. The levels of fortification used are far from reaching the Tolerable Upper Intake Level (UL). Vegetable oil fortification has the potential to become a global public health intervention strategy.

Processed foods as an integral part of universal salt iodization programs: a review of global experience and analyses of Bangladesh and Pakistan.

BACKGROUND: Despite the reference to salt for food processing in the original definition of universal salt iodization (USI), national USI programs often do not explicitly address food industry salt. This may affect program impact and sustainability, given the increasing consumption of processed foods in developing countries. OBJECTIVE: To review experience of the use of iodized salt in the food industry globally, and analyze the market context in Bangladesh and Pakistan to test whether this experience may be applicable to inform improved national USI programming in developing countries. METHODS: A review of relevant international experience was undertaken. In Bangladesh and Pakistan, local rural market surveys were carried out. In Bangladesh, structured face-to-face interviews with bakers and indepth interviews with processed food wholesalers and retailers were conducted. In Pakistan, face-to-face structured interviews were conducted with food retailers and food labels were checked. RESULTS: Experience from industrialized countries reveals impact resulting from the use of iodized salt in the food industry. In Bangladesh and Pakistan, bread, biscuits, and snacks containing salt are increasingly available in rural areas. In Bangladesh, the majority of bakers surveyed claimed to use iodized salt. In Pakistan, 6 of 362 unique product labels listed iodized salt. CONCLUSIONS: Successful experience from developed countries needs to be adapted to the developing country context. The increasing availability of processed foods in rural Bangladesh and Pakistan provides an opportunity to increase iodine intake. However, the impact of this intervention remains to be quantified. To develop better national USI programs, further data are required on processed food consumption across population groups, iodine contents of food products, and the contribution of processed foods to iodine nutrition.