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.

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.

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.

Stability of Vitamin A, Iron and Zinc in Fortified Rice during Storage and Its Impact on Future National Standards and Programs--Case Study in Cambodia.

Fortified rice holds great potential for bringing essential micronutrients to a large part of the world population. The present study quantified the losses of three different micronutrients (vitamin A, iron, zinc) in fortified rice that were produced using three different techniques (hot extrusion, cold extrusion, and coating) and stored at two different environments (25 ± 5 °C at a humidity of 60% and 40 ± 5 °C at a humidity of 75%) for up to one year. Fortified rice premix from the different techniques was mixed with normal rice in a 1:100 ratio. Each sample was analyzed in triplicate. The study confirmed the high stability of iron and zinc during storage while the retention of vitamin A was significantly affected by storage and the type of techniques used to make rice premix. Losses for iron and zinc were typically <10% for any type of rice premix. After 12 months at mild conditions (25 °C and humidity of 60%), losses for vitamin A ranged from 20% for cold extrusion, 30% for hot extruded rice 77% for coated rice premix. At higher temperatures and humidity, losses of vitamin A were 40%-50% for extruded premix and 93% for coated premix after 6 months. We conclude that storage does lead to a major loss of vitamin A and question whether rice is a suitable food vehicle to fortify with vitamin A. For Cambodia, fortification of rice with iron and zinc could be an effective strategy to improve the micronutrient status of the population if no other food vehicles are available.

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.

A Call to Action to Bring Safer Parenteral Micronutrient Products to the U.S. Market.

The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) started an intensive review of commercially available parenteral vitamin and trace element (TE) products in 2009. The chief findings were that adult multi-TE products currently available in the United States (U.S.) provide potentially toxic amounts of manganese, copper, and chromium, and neonatal/pediatric multi-TE products provide potentially toxic amounts of manganese and chromium. The multivitamin products appeared safe and effective; however, a separate parenteral vitamin D product is needed for those patients on standard therapy who continue to be vitamin D depleted and are unresponsive to oral supplements. The review process also extended to parenteral choline and carnitine. Although choline and carnitine are not technically vitamins or trace elements, choline is an essential nutrient in all age groups, and carnitine is an essential nutrient in infants, according to the Food and Nutrition Board of the Institute of Medicine. A parenteral choline product needs to be developed and available. Efforts are currently under way to engage the U.S. Food and Drug Administration (FDA) and the parenteral nutrient industry so A.S.P.E.N.'s recommendations can become a commercial reality.

Are the Recommended Dietary Allowances for Vitamins Appropriate for Elderly People?

BACKGROUND: An adequate vitamin intake is essential for a good nutritional status, especially in older women, who are more sensitive to nutritional deficiencies. The American, European and Italian Recommended Dietary Allowances (RDAs) derive mainly from studies on adults, and it is not clear whether they also apply to elderly people. Comparing the RDAs with the actual vitamin intake of a group of healthy older women could help to clarify the real needs of elderly people. OBJECTIVE: Our aim was to compare the American, European, and Italian RDAs with the actual vitamin intake of a group of healthy older women. DESIGN: This was a cross-sectional study. PARTICIPANTS: The study included 286 healthy women aged older than 65 years. MAIN OUTCOME MEASURES: For each micronutrient, the 50th percentile of the distribution of its intake was considered as the average requirement, and the corresponding calculated RDA for our sample was the average requirement×1.2, as recommended by the US Food and Nutrition Board. This calculated RDA was then compared with the American, European, and Italian RDAs. STATISTICAL ANALYSES PERFORMED: Student's t test or the Mann-Whitney test (after checking the normal distribution of the micronutrient) for continuous variables; the χ(2) test for categorical variables. RESULTS: The calculated RDA were 2,230 µg retinol equivalents for vitamin A, 2.8 µg for vitamin B-12, 0.9 mg for thiamin, 1.4 mg for riboflavin, 3.6 mg for pantothenic acid, 1.4 mg for vitamin B-6, 320 µg for folic acid, and 115 mg for vitamin C. CONCLUSIONS: Our findings suggest that the current RDAs are adequate for older women's intake of riboflavin, vitamin B-6, and folic acid, but should be raised for vitamin B-12 and for vitamin C.

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.

Legislative frameworks for corn flour and maize meal fortification.

Corn flour and maize meal fortification can benefit the consumer when the added nutrient contents are in amounts appropriate to address nutrient gaps. Legislative instruments (standards and regulations) are needed to provide guidance to the producers and food control authorities. We reviewed a number of national standards and regulations of fortified corn flour and maize meal and identified constraints; contrary to current belief, the practice of using minimum contents or ranges of nutrients has caused confusion, misinterpretation, and conflict, and should therefore be abandoned. On the basis of the findings, a model of fortification legislation is proposed, in which the additional content and the expected average nutrient content in a final product are recommended as the main parameters for quality control and enforcement. For labeling, the average content, or one adjusted to the expected content of the product at the market, can be applied. Variation in micronutrient contents should still be checked to ensure homogeneity but with adherence to clear procedures of sampling and testing, which should be part of the standards and regulations.

Stability of key micronutrients added to fortified maize flours and corn meal.

Maize is a dietary staple in many countries. Although nutritious in many ways and a good source of energy, typical maize lacks several key micronutrients (MNs) that are often added to maize meals or flours to enhance nutritional value. Many factors affect MN stability in maize products, including uncontrolled conditions during distribution, long storage times, and MN premix composition. Consumer preparation also affects the final MN content of food. This review summarizes research relating to MN stability during processing, transport, storage, and meal preparation, focusing on those MNs most often added to maize and maize-based foods. Significant losses in B vitamins (B1, B2, B3, B6, B9, and B12) occur during manufacturing, distribution, and cooking. Added minerals (e.g., iron, zinc, calcium) are generally retained, although phytates in corn may affect bioavailability. Vitamins A and D3 are recent additions to fortification premixes for maize and are not well studied. Although there have been numerous studies of MN fortification in wheat flour, maize has not been as thoroughly examined, so recommendations are not as well supported. Future investigations should include well-designed and executed studies of the most labile MNs added to maize flours and meals, and their fate during all steps of processing, shipping, and preparation.

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.