Situation analysis of procurement and production of multiple micronutrient supplements in 12 lower and upper middle-income countries.

Globally, there are few vitamin and mineral ingredient manufacturers. To support local, in-country or regional procurement and production of multiple micronutrient supplements (MMS), the following production scenarios are possible: (a) straight ingredients of vitamins and minerals forms imported or locally produced that are mixed, tableted, or encapsulated and packaged by a local manufacturer; (b) import or local production of a vitamin and minerals premix that is tableted or encapsulated and packaged locally; (c) import of a bulk, finished product (tablets or capsules) that is packaged and branded; and (d) or import of a branded packaged product. This paper is a situation analysis of the market, manufacturing, and policy factors that are driving the production of MMS in 12 lower and upper middle-income countries. Key informants completed a self-administered structured questionnaire, which examined the local context of products available in the market and their cost, regulations and policies, in Brazil, Colombia, Guatemala, Mexico, Peru, Bangladesh, India, Vietnam, Ghana, Kenya, Nigeria, and South Africa. Our study found that although most countries have the capacity to produce locally MMS, the major barriers observed for sustainable and affordable production include (a) poor technical capacity and policies for ensuring quality along the value chain and (b) lack of policy coherence to incentivize local production and lower the manufacture and retail price of MMS. Also, better guidelines and government oversight will be required because not one country had an MMS formulation that matched the globally recommended formulation of the United Nations Multiple Micronutrient Preparation (UNIMMAP).

Quantifiable risk-benefit assessment of micronutrients: From theory to practice.

The EU Food Supplements Directive (2002/46/EC) mandates the determination of both maximum and minimum permitted levels (MPLs) for micronutrients. In order to determine MPLs which are feasible for particular population groups, a scientific approach should be used in which risk of high intake, risk of inadequacy and benefits are assessed in an integrated way taking all available data and severity and incidence of effect into account. In 2004, Renwick et al. (ILSI Europe) published a scientifically valid, flexible and pragmatic basis for a risk-benefit approach, which has been further developed here to make it a practical and quantifiable approach to be used by risk managers. The applicability of the approach is demonstrated using demo cases on iron and folate. The proposed approach has the capacity to utilize all relevant data available, including data from human studies, bioavailability data showing variability between specific forms of micronutrients and, in the case of animal studies, data on species comparability. The approach is therefore both practical and flexible, making it well suited to risk managers tasked with determining safe intake levels for micronutrients in different forms and for particular population groups.

Micronutrient intake and food sources in the very old: analysis of the Newcastle 85+ Study.

A number of socio-economic, biological and lifestyle characteristics change with advancing age and place very old adults at increased risk of micronutrient deficiencies. The aim of this study was to assess vitamin and mineral intakes and respective food sources in 793 75-year-olds (302 men and 491 women) in the North-East of England, participating in the Newcastle 85+ Study. Micronutrient intakes were estimated using a multiple-pass recall tool (2×24 h recalls). Determinants of micronutrient intake were assessed with multinomial logistic regression. Median vitamin D, Ca and Mg intakes were 2·0 (interquartile range (IQR) 1·2-6·5) µg/d, 731 (IQR 554-916) mg/d and 215 (IQR 166-266) mg/d, respectively. Fe intake was 8·7 (IQR 6·7-11·6) mg/d, and Se intake was 39·0 (IQR 27·3-55·5) µg/d. Cereals and cereal products were the top contributors to intakes of folate (31·5 %), Fe (49·2 %) and Se (46·7 %) and the second highest contributors to intakes of vitamin D (23·8 %), Ca (27·5 %) and K (15·8 %). More than 95 % (n 756) of the participants had vitamin D intakes below the UK's Reference Nutrient Intake (10 µg/d). In all, >20 % of the participants were below the Lower Reference Nutrient Intake for Mg (n 175), K (n 238) and Se (n 418) (comparisons with dietary reference values (DRV) do not include supplements). As most DRV are not age specific and have been extrapolated from younger populations, results should be interpreted with caution. Participants with higher education, from higher social class and who were more physically active had more nutrient-dense diets. More studies are needed to inform the development of age-specific DRV for micronutrients for the very old.

Contribution to the development of a food guide in Benin: linear programming for the optimization of local diets.

OBJECTIVE: Food guides are important tools for nutrition education. While developing a food guide in Benin, the objective was to determine the daily number of servings per food group and the portion sizes of common foods to be recommended. DESIGN: Linear programming (LP) was used to determine, for each predefined food group, the optimal number and size of servings of commonly consumed foods. Two types of constraints were introduced into the LP models: (i) WHO/FAO Recommended Nutrient Intakes and dietary guidelines for the prevention of chronic diseases; and (ii) dietary patterns based on local food consumption data recently collected in southern Benin in 541 adults. Dietary intakes of the upper tertile of participants for diet quality based on prevention and micronutrient adequacy scores were used in the LP algorithms. SETTING: Southern area of the Republic of Benin. SUBJECTS: Local key-players in nutrition (n 30) from the government, academic institutions, international organizations and civil society were partners in the development of the food guide directed at the population. RESULTS: The number of servings per food group and the portion size for eight age-sex groups were determined. For four limiting micronutrients (Fe, Ca, folate and Zn), local diets could be optimized to meet only 70 % of the Recommended Nutrient Intakes, not 100 %. CONCLUSIONS: It was possible to determine the daily number of servings and the portion sizes of common foods that can be recommended in Benin with the help of LP to optimize local diets, although Recommended Nutrient Intakes were not fully met for a few critical micronutrients.

A surveillance tool to assess diets according to Eating Well with Canada's Food Guide.

BACKGROUND: A surveillance tool was developed to assess dietary intake collected by surveys in relation to Eating Well with Canada's Food Guide (CFG). The tool classifies foods in the Canadian Nutrient File (CNF) according to how closely they reflect CFG. This paper describes the validation exercise conducted to ensure that CNF foods determined to be "in line with CFG" were appropriately classified. DATA AND METHODS: With statistical modelling, 8,000 simulated diets (500 for each of the 16 Dietary Reference Intake [DRI] age/sex groups) were generated using commonly consumed foods classified as "in line with CFG." Criteria for assessing the energy content and nutrient distributions of the simulated diets were based on factors considered in the development of CFG, including Estimated Energy Requirement (EER) and Dietary Reference Intake (DRI) values. RESULTS: The median energy content of the simulated diets was at or below reference EERs. Most age/sex group distributions had macronutrient profiles that met the assessment criterion of 80% of the distribution within the Acceptable Macronutrient Distribution Range, and almost all age/sex group distributions had a low prevalence (less than 10%) of micronutrient profiles below the Estimated Average Requirements. Overall, the findings indicate that diets consisting of foods that are commonly consumed by Canadians and that are "in line with CFG" have a low probability of energy excess and nutrient inadequacy. INTERPRETATION: The classification of foods in the CNF accurately reflects CFG recommendations and can be used to assess surveillance data.

Development of a nutritionally balanced pizza as a functional meal designed to meet published dietary guidelines.

OBJECTIVE: To develop a worked example of product reformulation of a very popular 'junk food' to meet nutritional guidelines for public health in a ready meal. DESIGN: Indicative survey of popular Margherita pizzas, followed by product reformulation, applying dietary guidelines to generate a single-item pizza meal containing 30 % daily amounts of energy and all nutrients. An iterative process was used; first to optimize nutrient balance by adjusting the proportions of bread base, tomato-based sauce and mozzarella topping, then adding ingredients to provide specific nutrients and consumer tasting. SETTING: Urban areas of contrasting socio-economic status. SUBJECTS: Untrained unselected adults (n 49) and children (n 63), assessing pizza at tasting stations. RESULTS: Most commercial pizzas provide insufficient information to assess all nutrients and traditional Margherita pizza ingredients provide insufficient Fe, Zn, iodine, and vitamins C and B12. Energy content of the portions currently sold as standard range from 837 to 2351 kJ (200 to 562 kcal), and most exceed 30 % Guideline Daily Amounts for saturated fat and Na when a 2510 kJ (600 kcal) notional meal is considered. The 'nutritionally balanced pizza' provides the required energy for a single-item meal (2510 kJ/600 kcal), with all nutrients within recommended ranges: Na (473 mg, ∼45 % below recommended level), saturated fat (<11 % energy) and dietary fibre (13·7 g). Most adults (77 %) and children (81 %) rated it 'as good as' or 'better than' their usual choice. CONCLUSIONS: Nutritional guidelines to reduce chronic diseases can be applied to reformulate 'junk food' ready meals, to improve public health through a health-by-stealth approach without requiring change in eating habits.

EURRECA-Framework for Aligning Micronutrient Recommendations.

There is currently no standard approach for deriving micronutrient recommendations, and large variations exist across Europe, causing confusion among consumers, food producers, and policy makers. More aligned information could influence dietary behaviors and potentially lead to a healthier population. Funded by the European Commission, EURRECA (EURopean micronutrient RECommendations Aligned) has developed methods and applications to guide Nutrient Recommendation Setting Bodies through the process of setting micronutrient reference values. The EURRECA approach is crystallized into its framework that outlines a standard process for deriving and using dietary reference values for micronutrients in a transparent, systematic, and scientific way. The 9 activities of the framework can be clustered into four stages (i) defining the problem, (ii) monitoring and evaluating, (iii) deriving dietary reference values, and (iv) using dietary reference values in policy making. The EURRECA framework should not be interpreted as a prescriptive description of a linear process, but as a structured guide for checking that all issues essential for deriving requirements have at least been considered.

EURRECA-Evidence-based methodology for deriving micronutrient recommendations.

The EURopean micronutrient RECommendations Aligned (EURRECA) Network of Excellence explored the process of setting micronutrient recommendations to address the variance in recommendations across Europe. Work centered upon the transparent assessment of nutritional requirements via a series of systematic literature reviews and meta-analyses. In addition, the necessity of assessing nutritional requirements and the policy context of setting micronutrient recommendations was investigated. Findings have been presented in a framework that covers nine activities clustered into four stages: stage one "Defining the problem" describes Activities 1 and 2: "Identifying the nutrition-related health problem" and "Defining the process"; stage two "Monitoring and evaluating" describes Activities 3 and 7: "Establishing appropriate methods," and "Nutrient intake and status of population groups"; stage three "Deriving dietary reference values" describes Activities 4, 5, and 6: "Collating sources of evidence," "Appraisal of the evidence," and "Integrating the evidence"; stage four "Using dietary reference values in policy making" describes Activities 8 and 9: "Identifying policy options," and "Evaluating policy implementation." These activities provide guidance on how to resolve various issues when deriving micronutrient requirements and address the methodological and policy decisions, which may explain the current variation in recommendations across Europe. [Supplementary materials are available for this article. Go to the publisher's online edition of Critical Reviews in Food Science and Nutrition for the following free supplemental files: Additional text, tables, and figures.].

The development and implementation of quality assurance programs to support nutritional measurements.

The National Institute of Standards and Technology administers quality assurance programs devoted to improving measurements of nutrients and related metabolites in foods, dietary supplements, and serum and plasma samples. These programs have been developed in collaboration with the National Institutes of Health to assist measurement communities in their efforts to achieve accurate results that are comparable among different laboratories and over time. Targeted analytes include micronutrients, botanical markers, nutritional elements, contaminants, fatty acids, and vitamin D metabolites.

EURRECA/WHO workshop report: 'Deriving Micronutrient Recommendations: Updating Best Practices'.

This paper describes the outcome of the workshop 'Deriving Micronutrient Recommendations: Updating Best Practices' which took place in Brussels in April 2012. The workshop was organised jointly by the European Micronutrient Recommendations Aligned (EURRECA) Network of Excellence and the World Health Organization (WHO) Regional Office for Europe. The delegates included, among others, representatives from nutrient recommendation setting bodies (NRSBs) across Europe. The current paper focuses on the gaps and needs of NRSBs as identified by the workshop participants: (i) practical tools and best practices to adapt dietary reference values, (ii) comparable nationally representative food consumption data (including updated and complete food composition databases), (iii) adequate financial resources and technical capacity, (iv) independence and transparency in expert selection, research conduct and communication of research results and (v) clear correspondence of terminology used at national levels.

The power of vitamins.

Although a healthy, varied diet should be sufficient for the majority, certain population groups are at risk of micronutrient deficiencies, particularly young women of childbearing age, whose diets are commonly micronutrient poor and whose requirements increase peri-conceptually and throughout pregnancy and lactation. Infants and young children are also vulnerable to micronutrient deficiencies, associated with the high nutritional demands of rapid growth alongside the transition from milk to solids during weaning. The DH and NICE recommend i) periconceptual folic acid supplementation ii) vitamin D supplementation during pregnancy and lactation, for breastfed infants over 6 months of age (> 1 month if at high risk of deficiency), in those taking less than 500ml infant formula and for all 1-5 year olds iii) vitamin A supplementation during infancy and early childhood. The vitamin and mineral supplement industry is vast, with a third of the UK population and half of children being reported to be taking micronutrient supplements, although it is predominantly by those who do not need them. Guidance on suitable micronutrient supplementation from health professionals, supported by dietitians if required, is therefore likely to be welcomed by many families.

[Enriched and functional foodstuffs: similarities and differences].

A comparison of fortified and functional foods on such parameters as destination, food group, the principles of enrichment with vitamins and/or macro- and micronutrients, doses and forms of vitamins and minerals, hygienic regulations of micronutrients usage and content in the final product, regulatory and technical documentation, duration of application, effectiveness, labeling, information for consumers has been carried out. Insufficiency and the need to improve the regulatory framework for functional foods are noted.

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health.

BACKGROUND: Theoretically, consumption of complex, multinutrient formulations of vitamins and minerals should be safe, as most preparations contain primarily the nutrients that have been in the human diet for millennia, and at safe levels as defined by the Dietary Reference Intakes. However, the safety profile of commercial formulae may differ from foods because of the amounts and combinations of nutrients they contain. As these complex formulae are being studied and used clinically with increasing frequency, there is a need for direct evaluation of safety and tolerability. METHODS: All known safety and tolerability data collected on one complex nutrient formula was compiled and evaluated. RESULTS: Data were assembled from all the known published and unpublished studies for the complex formula with the largest amount of published research in mental health. Biological safety data from 144 children and adults were available from six sources: there were no occurrences of clinically meaningful negative outcomes/effects or abnormal blood tests that could be attributed to toxicity. Adverse event (AE) information from 157 children and adults was available from six studies employing the current version of this formula, and only minor, transitory reports of headache and nausea emerged. Only one of the studies permitted a direct comparison between micronutrient treatment and medication: none of the 88 pediatric and adult participants had any clinically meaningful abnormal laboratory values, but tolerability data in the group treated with micronutrients revealed significantly fewer AEs and less weight gain. CONCLUSIONS: This compilation of safety and tolerability data is reassuring with respect to the broad spectrum approach that employs complex nutrient formulae as a primary treatment.

Regulatory and Policy-Related Aspects of Calcium Fortification of Foods. Implications for Implementing National Strategies of Calcium Fortification.

Daily calcium intake is well below current recommendations in most low- and middle-income countries (LMICs). Calcium intake is usually related to bone health, however an adequate calcium intake has also been shown to reduce hypertensive disorders of pregnancy, lower blood pressure and cholesterol values, and to prevent recurrent colorectal adenomas. Food fortification of foods has been identified as a cost-effective strategy to overcome micronutrient gaps in public health. This review summarizes regulatory aspects of fortification of commonly consumed foods with micronutrients, with an emphasis on calcium. We selected a convenient sample of 15 countries from different WHO regions and described the regulatory framework related to calcium fortification of staple foods. We assessed the relevant policies in electronic databases including the WHO Global database on the Implementation of Nutrition Action (GINA) for fortification policies and the Global Fortification Data Exchange Database, a fortification database developed and maintained by Food Fortification Initiative (FFI), Global Alliance for Improved Nutrition (GAIN), Iodine Global Network (IGN), and Micronutrient Forum. Food fortification with micronutrients is widely used in many of the selected countries. Most countries had national legislation for the addition of micronutrients to staple foods, especially wheat flour. These national legislations, that includes regulations and standards, can provide the framework to consider the implementation of adding calcium to the fortification strategies, including the selection of the adequate food vehicle to reach the targeted population at risk safely. The strategy to include calcium in the fortification mix in fortified staple foods seems promising in these countries. However, potential undesired changes on the organoleptic characteristics of fortified foods and products thereof, and operational feasibility at the manufacturing site should be evaluated by the stakeholders during the planning stage. Codex Alimentarius standards should be considered by regulators in order to assure adherence to international standards. While the selected countries already have established national regulations and/or standards for fortification of key staple food vehicles, and there are experiences in the implementation of fortification of some staple foods, national food intake surveys can help plan, design, and modify existing fortification programs as well as monitor food and nutrient consumption to assess risk and benefits.

Physical stability of an all-in-one parenteral nutrition admixture for preterm infants upon mixing with micronutrients and drugs.

Objectives: The main objective was to investigate Y-site compatibility of intravenous drugs with one standard total parenteral nutrition (TPN) admixture for preterm infants. Since micro-precipitation was observed in the water phase after addition of trace elements, the concentration effect on micro-precipitation formation developed as a sub-goal. Methods: Seven drugs (ampicillin, ceftazidime, fluconazole, fosphenytoin, furosemide, metronidazole and paracetamol) were mixed in three mixing ratios with one preterm TPN admixture. Samples were investigated within 1 hour and again after 4 hours. Precipitation was studied in a lipid-free version called TPNaq by light obscuration, turbidimetry and visual examination. Emulsion stability data were assessed by light obscuration and laser diffraction. pH was measured to assess the theoretical risk of precipitation and emulsion destabilisation. The influence of different concentrations of trace elements on precipitation was investigated by visual examination, turbidimetry and light obscuration. Results: Ampicillin, ceftazidime, fosphenytoin and furosemide led to precipitation after mixing with TPNaq. In some samples of TPN and fluconazole, metronidazole and paracetamol, the emulsion droplet size was above the acceptance limit, although this might also be inherent to the TPN admixture. An unexpected formation of micro-precipitate correlating with increasing amounts of added trace elements might be caused by an interaction of cysteine and copper, and complicated the compatibility assessment with drugs. Conclusions: The micro-precipitate resulting from the addition of trace elements should be investigated further. This study did not provide sufficient evidence to recommend Y-site infusion of the tested drugs and the preterm admixture; however, it might offer some additional support to other compatibility data.

Why RDAs and ULs are incompatible standards in the U-shape micronutrient model: a philosophically orientated analysis of micronutrients' standardizations.

Risk assessments of micronutrients are carried out in the customary deficiency-excess model. It is regarded as straightforward and unambiguous. Nevertheless, it is a problematic amalgamation of two different and to a certain extent contrasting perspectives on risk and science that we will criticize in this contribution. Our critique is framed in a conceptual scheme of opposing perspectives highlighted by the rival characteristics of RDAs and SULs and the role of science therein. The one part of our scheme holds the typically modern approach that centers on risks that can be scientifically assessed more or less confidently. Subsequent policies are aimed at preventing major health problems that affect the majority of the population from early on in life. The RDAs are the ideal type-case here. The other part of our scheme holds a much more postmodern approach in which health risks are explicitly recognized as "uncertain." Dealing with those risks has little to do with major health problems from early on in life. Here, we encounter the scientific quandary of disentangling complex factors and impacts that may relate to some extra quality of life later on in life. SULs are exemplarily thereof. We will show that RDAs originally spawned from the scientific aim of securing objective knowledge "to lay down the requirements of an adequate" diet. SULs, conversely, are the upshot of generating acceptable outcomes driven by ever-increasing safety requirements. This shift from securing objective knowledge to generating acceptable outcomes will be addressed in relation to precautionary culture.

Quality criteria for micronutrient powder products: report of a meeting organized by the World Food Programme and Sprinkles Global Health Initiative.

Distribution of micronutrient powder (MNP), also known as Sprinkles", is becoming a preferred strategy for addressing micronutrient deficiencies. In response, different formulations are being developed, different producers manufacture MNP and several organizations coordinate distribution. However, as yet, the supply of MNP as well as experience with large-scale MNP programs is limited. To facilitate expansion of MNP use such that acceptability and compliance are high and effectiveness maintained, product quality, of both powder and packaging, good advocacy among decision makers, and providing good information to the target population are crucial. A meeting was organized in Toronto by the Sprinkles Global Health Initiative and the World Food Programme to review and reach consensus on quality criteria for composition, manufacturing, packaging, and labeling of MNP propose guidelines for wide-scale production, and discuss MNP program experience. It was recognized that the durability of some of the more sensitive micronutrients in their powdered form in the harsh climatic conditions of many countries has implications for formulation, packaging, storage, and handling of the MNP product. A question-and-answer manual would greatly facilitate program design and implementation. It was agreed to form an interim Technical Advisory Group to prepare for formation of a Technical Advisory Group with agreed-upon tasks and responsibilities. The MNP manufacturing manual of the Sprinkles Global Health Initiative can continue to be used, with reference to the recommendations from the Toronto Meeting outlined in this paper. Meanwhile, the Sprinkles Global Health Initiative will not place any encumbrances on production using its manual; however, the brand name Sprinkles" will stay protected under various trademark laws.

Longitudinal change in the diet's monetary value is associated with its change in quality and micronutrient adequacy among urban adults.

BACKGROUND: Reducing diet costs may lead to the selection of energy-dense foods, such as refined grains or foods high in added sugars and/or fats, which can lower overall dietary quality. We examined the longitudinal association between the monetary value of the diet (MVD) and the overall dietary quality across sex, race and income groups. METHODS AND FINDINGS: Longitudinal data from 1,466 adult urban participants from Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study were used. Healthy Eating Index-2010 (HEI-2010) and Mean Adequacy Ratio (MAR) were computed and a national food price database was used to estimate MVD. Multiple linear regression analyses were conducted linking annual rates of change (Δ) in MVD to ΔHEI-2010 and ΔMAR, stratifying by sex, race and income groups. Among key findings, ΔHEI-2010 was comparable across socio-demographic groups, while ΔMAR was higher among women and individuals above poverty. Adjusting for key covariates, ΔMVD was positively associated with both ΔHEI-2010 and ΔMAR, and with a consistently stronger association among individuals above poverty, specifically for the total proteins and empty calories components of HEI-2010 and several nutrient adequacy ratios (NARs: vitamins C, E, B-6 and Zinc). ΔMVD-ΔMAR association was stronger in women, mainly influenced by ΔMVD's positive associations with B-vitamins, copper, calcium, magnesium and phosphorus NARs. ΔMVD-Δvitamin D NAR's positive relationship was stronger among Whites, while ΔMVD-Δvitamin B-12 NAR's association was stronger among African-Americans. CONCLUSIONS: In sum, a potential increase in MVD may have a stronger impact on dietary quality among urban adult women and above-poverty individuals.