fortification strategies to meet micronutrient needs ... industry publicly accepted their specific...

Proceedings of the Nutrition Society (2002), 61, 231-241© The Authors 2002

DOI:10.1079/PNS2002150

Fortification strategies to meet micronutrient needs: successes and failures

Ian Darnton-Hill1* and Ritu Nalubola2

[WorldHealth Organization, 20Avenue Appia, CH-1211 Geneva27, Switzerland2US Food and Drug Administration, Washington, DC, USA

Food fortification is likely to have played an important role in the current nutritional health andwell-being of populations in industrialized countries. Starting in the early part of the 20th century,fortification was used to target specific health conditions: goitre with iodized salt; rickets withvitamin D-fortified milk; beriberi, pellagra and anaemia with B-vitamins and Fe-enriched cereals;more recently, in the USA, risk of pregnancy affected by neural-tube defects with folic acid-fortified cereals. A relative lack of appropriate centrally-processed food vehicles, less-developedcommercial markets and relatively low consumer awareness and demand, means it has taken aboutanother 50 years for fortification to be seen as a viable option for the less-developed countries. Thepresent paper reviews selected fortification initiatives in developing countries to identify differentfactors that contributed to their successful implementation, as well as the challenges thatcontinually threaten the future of these programmes. Ultimately, the long-term sustainability offortification programmes is ensured when consumers are willing and able to bear the additionalcost of fortified foods. There has been an enormous increase in fortification programmes over thelast couple of decades in developing countries. Considerable progress has been made in reducingvitamin A and I deficiencies, although less so with Fe, even as Zn and folic acid deficiencies areemerging as important public health problems. Food fortification based on sound principles andsupported by clear policies and regulations can play an increasingly large role in this progresstowards prevention and control of micronutrient malnutrition.

Micronutrient malnutrition: Fortification: Vitamin A: Iron-deficiency anaemia:Iodine-deficiency disorders

Fortification of foods with micronutrients is a techno-logically, programmatically and economically-effectivemethod of increasing micronutrient intakes in populations(Nestel, 1993; Lotfi et al. 1996; Darnton-Hill, 1998). Foodfortification is likely to have played an important role incurrent nutritional health and well-being of populations inindustrialized countries. Starting in the 20th century,fortification was used to target specific health conditions:goitre with iodized salt; rickets with vitamin D-fortifiedmilk; beriberi, pellagra and anaemia with B-vitamins andFe-enriched cereals; more recently, in the USA, risk ofpregnancy affected by neural-tube defects with folic acid-fortified cereals.

Fortification is defined by the Codex Alimentarius as theaddition of one or more essential nutrients to a food,whether or not it is normally contained in the food, for thepurpose of preventing or correcting a demonstrateddeficiency of one or more nutrients in the population or

specific population groups (Food and Agriculture Organi-zation, 1996). The fortification vehicle can be either a staplefood, or a more-processed commercially-available food, andmany have been tried. The requirements for a potential foodvehicle for fortification are well established (Table 1; Foodand Agriculture Organization, 1996).

There is now extensive literature on food-fortificationprogrammes, especially recently in the non-industrializedworld (Nestel, 1993; Lotfi et al. 1996; MicronutrientInitiative, 1997; Darnton-Hill, 1998). Fortification of foodsis one intervention for the prevention and control ofmicronutrient malnutrition, along with other food-basedapproaches and supplementation, the mix of interventionsdepending on the local situation, experience, commitmentand resources, and infrastructure. Fortification has theadvantage of requiring relatively less change in consumerbehaviours and food habits than the other interventions,although this approach does not mean that nutrition

Abbreviation: NHANES, National Health and Nutrition Examination Survey."•Corresponding author: Ian Darnton-Hill, present address 111 East 14th Street, #190, New York, NY 10003, USA, fax +41 22 791 4186, email

[email protected]

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232 I. Darnton-Hill and R. Nalubola

Table 1. Requirements for a food vehicle for fortification (Food andAgriculture Organization, 1996)

Commonly consumed by the target populationConstant consumption pattern with a low risk of excess consumptionGood stability during storageRelatively low costCentrally processed with minimal stratification of the fortificantNo interactions between the fortificant and the carrier foodContained in most meals, with the availability unrelated to socio-

economic statusLinked to energy intake

education and social marketing can be ignored. Withoutconvincing consumers and policy makers of the need andbenefits of fortification, its sustainability will always be atrisk.

A relative lack of appropriate centrally-processed foodvehicles, less-developed commercial markets and relativelylow consumer awareness and demand has meant thatanother 50 years passed before fortification was seen as aviable option for the less-developed and industrializingcountries. The minimisation of many of these earlierconstraints and the increasingly global market, has led to agreat deal of current interest in the use of fortification as oneapproach to the prevention and control of micronutrientmalnutrition. The present paper will (1) outline the variousstrategies available for fortification of foods in theprevention and control of micronutrient malnutrition, (2)review currently successful programmes in developingcountries and the elements of success, some past illustrativefailed programmes and identified constraints, monitoringand evaluation and (3) finally, identify some innovations inthe field, followed by conclusions.

Fortification as a means of addressing micronutrientmalnutrition

Over 2000 million of the world's population, or more thanone in three individuals throughout the world, are at risk ofFe, vitamin A or I deficiency (World Health Organization,1995; Micronutrient Initiative, 1997). Zn, folic acid andother micronutrients are also increasingly being recognizedas public health problems in many disadvantaged popula-tions. The public health importance of micronutrientmalnutrition in the developing world was recognized andacknowledged globally in December 1992, at theFAO/WHO International Conference on Nutrition, whererepresentatives of 159 countries agreed to eliminate theI-deficiency disorders and vitamin A as public healthproblems by the end of the century and to substantiallyreduce Fe-deficiency anaemia by one-third of the 1990levels. In 1990 the World Summit for Children, sponsoredby UNICEF, had established broader goals for the healthand well-being of children (UNICEF, 1990), and thenutrition goals, including those for micronutrients, agreed toat this forum were echoed at the International Conference onNutrition. It is likely that these goals will be re-affirmed andextended at a UN Special Session on Children to be held inMay 2002. The proposed goals are to 'achieve sustainableelimination of iodine deficiency disorders by 2005 and

vitamin A deficiency disorders by 2010, reduce by one thirdthe prevalence of anaemia, including iron deficiency, by2010, and accelerate progress towards reduction of othermicronutrient deficiencies, through food fortification andsupplementation.' It is notable that this time, one decadeafter the 1992 International Conference on Nutritiondeclaration, fortification is specifically mentioned as anintervention strategy.

The World Bank (1993) has identified micronutrientinterventions in general, and food fortification in particular,as amongst the most cost-effective of all health inter-ventions and as a major factor in the control of themicronutrient deficiencies in the industrialized world. In thepast fortification efforts have been less effective, both interms of start-up and sustainability, in developing countriescompared with the more industrialized world. However, inthe last few years the experience in many countries of LatinAmerica, especially with vitamin A in sugar (Mora et al.2000) and with Fe and B-vitamins in cereals indicates thepotential for considerable expansion of fortification as anapproach to address micronutrient malnutrition in thedeveloping world (Murphy, 1996). Indeed, fortification ofappropriate food vehicles is being used as a public healthintervention in many developing countries, as will bediscussed.

Successes in developing countries

Food-fortification programmes that have been successfullyimplemented in developing countries have been reviewedpreviously (Nestel, 1993; Lotfi et al. 1996; Darnton-Hill,1998) and, therefore, are only summarized here. Table 2presents foods that are fortified under mandatory fortifi-cation regulations in selected developing countries. Themost common food-fortification practice has been saltiodization, which has been in existence for over 70 years(Biirgi, 1998). Its success has been largely through itsrelative simplicity and low cost, but also the more recentinternational endorsement and advocacy and its coalition ofpartners. In 1994 UNICEF and WHO recommendeduniversal salt iodization as the prime approach to correctingI deficiency in the many countries where it is a public healthproblem. In 1992 at the 7th World Salt Symposium inKyoto, Japan introduced the global elimination goal in aspecial session presented by International Council for theControl of the Iodine Deficiency Disorders Board members.Following the introduction of this goal, in 1993 KiwanisInternational, the worldwide service organization, becamean important contributor. Finally, at the 8th Session ofthe World Salt Symposium at The Hague in 2000, thesalt industry publicly accepted their specific role andresponsibility for delivering the fortified product and theservice necessary in achieving and sustaining this goal(International Council for the Control of the IodineDeficiency Disorders, 2000a). Today, almost 126 countriesin the developing world have salt-iodization programmes inplace (Mason et al. 2001).

During the 1970s sugar fortification with vitamin A wasfirst implemented in Guatemala, followed by other CentralAmerican countries, including Costa Rica, Honduras and ElSalvador. Although the programmes have been suspended at





Strategies to meet micronutrient needs 233

Table 2. Mandatory food fortification programmes in developing countries (from Nutriview, 2000)

Country

BoliviaBrazilChile

Colombia

Costa Rica

Dominican RepublicEcuador

El Salvador

Guatemala

Honduras

Mexico

Nicaragua

Panama

ParaguayPeru

Venezuela

NigeriaSouth Africa

ZambiaIndiaIndonesia

Malaysia

PakistanPhilippines

ThailandTurkey

Food vehicle(s)

Wheat flourDried skimmed milk for complementary food programmesWheat flourPastaMargarineWheat flourMargarineWheat flourSugarWheat flourWheat flourMargarineWheat flourMargarine, sugarWheat flourPastaSkimmed milkMargarine, sugarWheat flourMilk, margarineSugarSterilized low-fat milk, pasteurized low-fat milk, evaporated

whole and low-fat milk, margarine/spreadsWheat flourSugarWheat flourSugarWheat flourWheat flourMargarineWheat flourPrecooked maize flourDried milk powderEnriched flourEnriched maize mealMargarineSugarVanaspati, margarineWheat flourMargarineEvaporated milk, condensed milk, filled milkTable margarineOil products (ghee, butter oil)Filled milkMargarineSweetened condensed milkTable margarine

Nutrient

Thiamine, riboflavin, niacin, folic acid, FeVitamins A and DThiamine, riboflavin, niacin, folic acid, FeThiamine, riboflavin, niacin, FeVitamins A and DThiamine, riboflavin, niacin, folic acid, FeVitamins A and DThiamine, riboflavin, niacin, folic acid, FeVitamin AThiamine, riboflavin, niacin, folic acid, FeThiamine, riboflavin, niacin, folic acid, FeVitamins A and DThiamine, riboflavin, niacin, folic acid, FeVitamin AThiamine, riboflavin, niacin, folic acid, Fe, CaThiamine, riboflavin, niacin, FeVitamins A and DVitamin AThiamine, riboflavin, niacin, folic acid, FeVitamins A and DVitamin A

Vitamins A and DThiamine, riboflavin, niacin, folic acid, FeVitamin AThiamine, riboflavin, niacin, folic acid, FeVitamin AThiamine, riboflavin, niacin, folic acid, FeFeVitamins A and DThiamine, riboflavin, niacin, FeThiamine, riboflavin, niacin, vitamin A, FeVitamins A and DThiamine, riboflavin, niacin, Fe, CaRiboflavin, niacinVitamins A and DVitamin AVitamin AThiamine, riboflavin, Fe, ZnVitamins A and DVitamin AVitamins A and DVitamin AVitamins A and DVitamins A and D, thiamineVitamin AVitamins A and D

various times since their inception due to political and otherconstraints, all three countries currently operate successfulsugar-fortification programmes because of active collabo-ration between the public and private sectors. Theprogrammes are estimated to reach about 95 % of house-holds in El Salvador and Guatemala, and more than 80 % ofhouseholds in Honduras (Mora et al. 2000). The successof these programmes provided the impetus for sugarfortification to be explored as an effective interventionstrategy in other developing countries. Fortification of sugarwith vitamin A was initiated in 1998 in Zambia and isongoing despite economic constraints, including the fallinginternational price of sugar and the continuous infiltration of

cheaper unfortified sugar from bordering countries.Currently, other African and Asian countries are alsoexploring the feasibility of sugar fortification with vitaminA (Micronutrient Initiative/UNICEF/International SugarOrganization/USAID/Swaziland Sugar Association, 1999).

Other food vehicles, besides sugar, fortified with vitaminA include fats and oils, tea, cereals, flour, monosodiumglutamate and instant noodles, as well as milk or milkpowder, whole wheat, rice, salt, soyabean oil and infantformulas (Nestel, 1993; Lotfi et al. 1996). At least onecommon brand of margarine is currently fortified withvitamin A in the Philippines, along with fourteen otherfoods commercially available, and efficacy has been






demonstrated for margarine (Solon et al. 1996), although itis unclear if the at-risk rural poor are being reached.Similarly, the feasibility and efficacy of vitamin A added towheat flour fortified with Fe and B-vitamins has been testedin a small-scale trial in the Philippines (Solon et al. 2000).Although the implementation aspects and the effectivenessof such a fortification programme still need to be clarified,over half the flour millers have agreed to fortify, andlegislation has recently been enacted. Malaysia has donemuch work with retaining the p-carotene content of refinedred palm oil (Ong, 1994), and the use of red palm oil as avitamin A fortificant added to other edible oils is beingexplored in Asia (Solomons, 1998) and in West Africa.Additionally, noodles (or the accompanying sauce or spicessachet) are increasingly being used as vehicles for vitamin Afortification in South East Asia (Nutriview, 2000). Twenty-nine developing countries are now actively fortifying, or arein advanced development stage, a range of foods withvitamin A (Mason et al. 2001).

Fortification of cereal products with Fe and B-vitaminshas been in practice for a number of years throughout thedeveloping world (Johnson, 2000). Fortification withmultiple micronutrients is increasingly being used asmicronutrient deficiencies tend to manifest concurrently inat-risk populations. Several Latin American countries haveextensive experience fortifying maize flour and maize mealwith Fe, thiamin, riboflavin and niacin, and more recentlywith folic acid and vitamin A. Wheat-flour fortification isnow policy in most countries in Central and South America(Darnton-Hill et al. 1999). Cereal flour or meal fortificationwith B-vitamins, Fe, and sometimes vitamin A, is goingahead in several Middle East countries (A Verster,personal communication), and is being explored in manymore throughout Asia and Africa (Nutriview, 2001).Fe-fortification programmes have faced several dauntingchallenges, technological as well as programmatic.Achieving a balance between the bioavailability of theFe fortificant, its cost and its stability in foods has been amajor challenge in delivering Fe through foods to at-riskpopulations. Another challenge has been the lack of aclear demonstration of benefit of national Fe-fortificationprogrammes to at-risk population groups, includingchildren. The multi-factorial causative factors of anaemia,including non-dietary factors such as helminth infestations,further adds to the challenge of demonstrating a benefit ofFe fortification of foods. Nevertheless, thirty countriesthroughout the developing world now have a range ofcommodities (mainly wheat flour but also maize flour, milk,rice and weaning foods) that have fortification programmeswith Fe actively in place, although to a greater or lesserextent (Mason et al. 2001).

The factors contributing to the success of establishedfood-fortification programmes both in the industrialized anddeveloping countries have been previously addressed(Nestel, 1993; Darnton-Hill, 1998; Asian DevelopmentBank/Micronutrient Initiative/International Life SciencesInstitute, 2000; Bishai & Nalubola, 2002). However,relatively little is known about the impact of fortificationprogrammes, primarily due to the limited number of goodassessments that have been conducted or documented.Nevertheless, there are some data available which highlight

the potential effectiveness of a properly-implementedfortification programme. A recent evaluation of the possiblehealth impact of niacin fortification of flour and bread in theUSA showed that food fortification played an important rolein the decline of pellagra-attributed mortality in the 1930sand 1940s, and finally, in the elimination of pellagra in theUSA (Park et al. 2000). Anaemia and vitamin A deficiencyceased to be public health problems in Newfoundland,Canada only after the fortification of margarine and flour in1945 (Micronutrient Initiative, 1997). Folic acid fortifi-cation of cereal products was authorized in the USA in 1996as a public health measure to decrease the risk of pregnancyaffected by neural-tube defects. Since the programme beganneural-tube birth defects have decreased by 19 %, andfortification, educational outreach and increased consumerawareness have been noted to contribute to this decrease(Caudill et al. 2001; Center for Disease Control, 2001;Honeine/a/. 2001).

National programmes of sugar fortification with vitaminA in Central American countries have been evaluated fortheir effects on vitamin A deficiency in at-risk populationgroups. National surveys conducted between 1995 and 1998in Guatemala, Honduras and El Salvador have shown clearreductions in the prevalence of vitamin A deficiency amongpreschool-age children (Mora et al. 2000). The primarysource of dietary vitamin A in these countries has beenfound to be fortified sugar, with a coverage of > 80 % of thehouseholds in these countries. When fortification was haltedin the 1980s for various political reasons in Guatemala,vitamin A deficiency prevalence was found to haveincreased (Arroyave et al. 1979; Mora et al. 2000; Dary,2001).

The effectiveness of Fe-fortification programmes incombating anaemia has been less clear. In 1994 Swedenceased fortifying its bread because of a lack of perceivedbenefit in a replete society, although this action is currentlybeing re-evaluated. In Venezuela fortification of wheat andmaize flours with Fe, B-vitamins and vitamin A wasinitiated in 1993, and a preliminary survey carried outamong a small group (n 307) of children in 1994 showedthat the prevalence of Fe deficiency and anaemia haddecreased significantly (P<005) (Layrisse et al. 1996). Themean average increase in Fe intake of 6mg/d that wasobserved is similar to that found in other interventions inLatin America, South Africa and Thailand (Beard, 1996). Alarge-scale effectiveness trial of wheat-flour fortificationwith two different Fe fortificants, electrolytic Fe andhydrogen-reduced Fe, has been completed recently inSri Lanka, and results from this trial are awaited (P Nestel,personal communication).

A single micronutrient addition to an appropriate foodvehicle is increasingly the less common approach in food-fortification programmes. As Huffman et al. (1998) haveshown, women in developing countries are often consumingdiets of poor bioavailability and limited micronutrientcontent, leading to concurrent deficiencies of Fe, vitamin A,Zn, folic acid and vitamins B^ and B12, and occasionallyother vitamins and minerals. Such deficiencies haveimportant consequences for women's own health,pregnancy outcomes and their breast-fed children's healthand nutritional status (Huffman et al. 1998). UNICEF has






recently recommended that a combined vitamin-mineralsupplement for pregnant women, similar in composition tothose freely available in the more industrialized world is anoption that needs to be considered for developing countries(UNICEF/World Health Organization/United NationsUniversity, 1999).

Fortifying foods with multiple micronutrients is anotheravenue to deliver micronutrients, complementing supple-ments. This approach is important, as supplementation maynot reach non-pregnant women, female adolescents andyoung children, who are not usually being directly targetedby supplementation programmes, but who might be reachedby appropriately fortified foods. One example is theVitaLeite programme in the State of Sao Paulo in Brazil,where the distribution of free milk fortified with vitamins Aand D and Fe is targeted to over 700000 poor families.A small survey (n 269, children aged 6 months-2 years) inAngatuba found anaemia prevalence dropped from 62-3 %to 264 % in 1 year (Ferrer, 2001). In Asia, at least,investment per head in fortifying staples and comple-mentary foods for older infants is one-tenth that ofsupplementation programmes (Mason et al. 1999).Fortification of complementary foods has been shown notonly to improve the status of the young child, but where thecommunity is involved, to empower the women in thesecommunities. Another important delivery mechanism usingfortification is the internationally-recognized imperative offortifying all food used in humanitarian aid, although thisprovision is tragically occasionally still not made.

Elements of successful fortification in industrializingcountries

From the experiences of successful fortification pro-grammes, facilitating factors have been briefly summarized(Darnton-Hill, 1998) as the following:

political will and support, which must be maintainedfrom the development stage;understanding of the problem by having adequate dataon the magnitude of the nutritional problem beingaddressed;adequate data on food-consumption patterns;support of industry, with early involvement of localindustry and the private sector;adequate technical expertise, proper testing under arange of real field conditions, and adequate training infortification technology, quality assurance and control;a multi-sectoral approach in establishing a programme,including key governmental organizations, the scientificcommunity, consumers, marketing specialists and otherrelevant interested parties early in the process;adequate application of legislation and regulations,including resources for effective enforcement;facilitative rather than punitive regulations, i.e. guide-lines should not be so restrictive as to impede theprovision of high-quality fortified foods nor hindercommunication on fortification between relevantparties;human resource training at the industry and marketinglevels and of public health and food-safety personnel;

appropriate fortification levels evaluated and adjustedaccording to the bioavailability of the nutrient in thediets of the target population;good bioavailability of the compound and no constraintson procurement of the micronutrients, e.g. financialsupport for initial batch of fortificant;intensive and appropriate investment in the information,education and communication about the problem andthe fortification approach to raise consumer awarenessand ensure consumer acceptability, and also to ensurethat there are no cultural or other objections againstfortified foods;minimal cost increase to the consumer, to the extentfeasible;relevant nutritional information available throughadequate labelling to help ensure consumer involve-ment, commitment and understanding of the advantagesof fortifying foods.

Programmes and problems

An innovative approach to vitamin A deficiency inBangladesh was tried in the late 1980s, whereby a shellaccontaining vitamin A was to be sprayed on wheat coming inas aid wheat from the USA. As wheat was much the less-preferred staple, this cereal had the added advantage ofbeing indirectly targetted to the very poor, those in thevulnerable-group feeding programme of the UN WorldFood Programme. Although it was new technology, it wasvery extensively developed and tested and was technicallyfeasible (Darnton-Hill, 1989). After a great deal of effort itfinally became untenable and politically unacceptable;partly, it appeared that there was concern about a foreignpower being involved in the food system, rumours about thefortificant and it was also probably insensitively handled(Darnton-Hill, 1989). Atta (ground wheat flour) may befortified now through a partnership of UN World FoodProgramme, USAID and the Government of Bangladesh,and the millers. A similar process occurred with vitamin Ain monosodium glutamate in Indonesia; again a combinationof technology and politics led to this programme beingstopped by the government after extensive laboratory work,efficacy trials and a successful effectiveness trial (Muhilaletal. 1988). Although the microencapsulated vitamin Aremained white in rigorous laboratory testing, when hangingin the sun in small cellophane packets outside the small ruralsarisari shops there was enough discolouration to concernthe producer who sold monosodium glutamate as the whitestof white products, and who had anyway been excluded fromthe early planning (R Tjiong, unpublished results). Therewas also some concern from professional medical associa-tions and the government about possible toxicity ofmonosodium glutamate, although it is not classified as suchby Codex Alimentarius.

The fortification of sugar with vitamin A in thePhilippines did not go ahead when the world market priceplummeted just a few months after the launch in February1997; the sugar company was sent into financial crisis andthen had to withdraw (FS Solon, personal communication),but sugar fortification is now being tried again. In Zambia,while certainly not a failure, results are still awaited due to






problems with private sector commitment, price offortificant and the considerable duty to be paid on thefortificant, which the government has said it will lift, but hasnot yet done so.

With the iodization of salt in the Philippines, a monopolywas given to a single producer as an incentive, but it was notthen produced as anticipated. Special provisions given toone firm to encourage start-up action can distort incentivesfor other companies, as happened in this case, when theconcession of an extended monopoly effectively inhibitedcompetitors from also fortifying salt. The nationalparliament of India recently repealed legislation thatmandated universal iodization of salt, thus turning a successstory into a potential failure. This action hinged onarguments of personal rights of access to non-iodized salt,and underlines the importance of consumer education andpolitical will. It seems the Indian states may enact their ownlegislation. However, as was the case with the cantons ofSwitzerland (Biirgi, 1998), some states will be considerablymore pro-active about enacting legislation than others. Withall fortification programmes there is concern about theleakage of non-fortified (and hence usually cheaper) foodsacross borders, e.g. leakage of non-iodized salt acrossborders in Africa. Some apparent success stories, such as theiodization of salt in Eritrea and its export to neighbouringcountries, collapsed under the pressure of the conflict withEthiopia. Another such reverse occurred in Sierra Leone,where iodized salt coverage declined from 75 % to 8 % in1999 due to the civil war (International Council for theControl of the Iodine Deficiency Disorders, 2000fc).

Similarly, in the USSR, where severe I-deficiencydisorders had been eliminated by effective control measuresas early as the 1940s and 1960s, government programmeswere discontinued in 1970. After the dissolution of theUSSR in 1991, I-deficiency disorders again became acommon problem in nearly all the newly-independent states(Gerasimov & Delange, 1998). Dary (2001) sees suchreversals as a continuing tension between the needs of 'freetrade' and 'public health', and that legislative tools may beinsufficient without reliable enforcement mechanisms andconsumer awareness.

Constraining factors in non-sustained programmes

A recent review of food-fortification practices, whichstarted as public health intervention programmes early in the20th century in the USA, concluded that the primary factorcontributing to the long-term sustainability of food fortifi-cation is consumer awareness of the nutrient deficiency andconsumer demand for and perceived benefits of the fortifiedfood (Bishai & Nalubola, 2002). It has become apparentthat constraining factors in non-sustained programmes indeveloping countries are the lack of consumer demand dueto a non-recognition of any likely benefits to come fromconsuming fortified foods, as well as the lack of publicsector policy makers' recognition of the nutrient defi-ciencies as a public health problem. That fortificationrequires minimal consumer involvement and little-to-nochange in dietary habits is often stated as an advantage offood fortification over other interventions. In the past thisapproach has been construed to mean that there is therefore

no need to educate the public of the need and role of foodfortification, and the result was less emphasis on consumereducation in national fortification programmes. Theimportance of advocacy at the political level, as well asraising consumer awareness regarding the magnitude andeffects of the nutrient deficiency, and the role of fortificationas a complementary approach to other interventions, need tobe recognized as prerequisites for success (MicronutrientInitiative, 1997). A recent example of this approach was thepreviously mentioned revoking of universal iodization ofsalt in India, but examples could be quoted from Europeancountries with long histories of iodization, such asSwitzerland, where the programme continues to needconstant monitoring and adjustment, in particular inresponse to importation of food prepared with non-iodizedsalt (Biirgi, 1998).

The socio-economic constraints faced by consumerswhen fortified foods are being promoted, and the likelybenefits of food fortification, are now being increasinglyrecognized as critical factors in gaining public and privatesector commitment to, and eventually the success of, afortification programme, and these factors need to beaddressed early. Ignoring these factors has been shown tocontribute to the failure of programmes. Nevertheless, evenwith the best social marketing, price can remain a constraint.In very poor households there is very little price elasticity,and even a minimal increase can discourage the buying offortified foods. In a study in South Kalimantan and SouthSulawesi in Indonesia it was found that while instantnoodles were consumed in nearly all households in bothareas, consumption of fortified noodles was related to socio-economic status and was lowest among farmers and sharecroppers, who might well be some of those most at risk(Melse-Boonstra et al. 2000).

These and other constraints can be summarized as thefollowing:

technical constraints: installation and maintenance offortification machinery; stability of fortificants underthe suboptimal distribution and storage conditionstraditionally found in developing countries; thedevelopment of new cost-effective fortificants;socio-economic constraints: the targeted groups areoften those with least purchasing power; price of initialbatch of fortificant and capital costs; the demand onforeign exchange;infrastructural constraints: poor distribution systems dueto poor infrastructure; lack of access to commercially-processed food limited by geography, poverty or culturalpreferences; limited experience of intersectoralcoordination; frequent changes of government;political constraints: political support may be lackingdue to perceived priority of other health and nutritioninterventions; lack of awareness of magnitude ofproblem and benefits of addressing it; lack of facilitatinglegislation and of equal opportunities for all potentialfortifying companies;other implementation constraints: often there is a lack ofa clearly appropriate food vehicle that addresses allthe desirable qualities of Table 1; weak qualityassurance systems at the private sector level; ineffective






enforcement of any existing fortification regulations atthe public sector level; a lack of proper monitoring andevaluation of the programme and, therefore, limitedintermediate corrective follow-up measures. Perhapsthe greatest potential constraint is who bears the addedcost, e.g. to the millers, the added cost is the sum ofpremix, equipment amortization, labour and qualitycontrol. To these factors must be added advocacy, socialmarketing, increased public awareness, monitoring andeffectiveness of quality assurance, and someone mustpay for all this additional cost, however small the actualamount (Micronutrient Initiative, 1997).

Monitoring and evaluation as a critical factor in thesustainability of fortification

As discussed earlier, the success of fortificationprogrammes depends on several essential factors. One of thecritical ones that is needed for long-term sustainability isdiscussed in detail here, not because it is more importantthan the others discussed earlier, but primarily because it islargely ignored in the implementation of fortificationprogrammes. Monitoring and evaluation are critical aspectsof a fortification programme, and a key constraint forcountries with limited funds. The current trend is towardsa public-private sector collaboration, with facilitativelegislation and quality assurance by the fortifying company.It is recommended that any new legislation sets forth inthe regulations the requirements and standards for foodfortification, rather than amending the food laws in a piece-meal fashion to address fortification of a particular foodvehicle with a particular nutrient (Nathan, 2000). Thisapproach puts the onus on the commercial company itself toassure the quality of the fortified food. It is not clear,however, whether this system has necessarily beensuccessful, even though it is frequently cited as a pre-requisite to sustained food fortification.

Monitoring includes measures taken by the private andpublic sectors to assure that the food is fortified at adequatelevels and is properly labelled when it reaches the consumer.A good monitoring system needs specific mechanisms forprompt corrective actions to be taken by relevant partieswhen problems are identified. Evaluation includes:identifying patterns of consumer behaviour in terms of thepurchase and consumption of the fortified food; determiningintake of the nutrient of interest and the contribution ofthe fortified food to this intake (in the case of multiplemicronutrient fortification, one nutrient may be chosen as anindicator); impact on the public health problem beingaddressed. As discussed earlier, few programmes have beenproperly evaluated and impact on public health determined,although some successful programmes have been shown tohave had the intended health benefits. Despite economicconstraints, evaluation should be given more emphasis inthe design and implementation of fortification. It has beenshown that demonstrating the public health benefits offortification programmes is critical in long-term sustaina-bility and in gaining the commitment of public and privatesectors as well as consumer demand for the fortified food(Mora et al. 2000; Bishai & Nalubola, 2002). The Instituteof Medicine of the US National Academy of Sciences also

identified demonstrated feasibility, along with efficacy,appropriateness and political commitment, as essential forsustainability (Institute of Medicine, 1998). In this report theauthors point out that sustainability has two components:process, the continuity of a successful intervention;outcomes, continuation of a substantial positive impact onthe intended beneficiaries.

Surveillance systems set up to observe trends in theprevalence of the public health problem over time helpevaluate the impact of the fortification as well as otherintervention programmes. For example, in Australia and theUSA it seemed that I levels may have needed to be reduced,largely because individuals are getting I from other sources,e.g. in bread, and when iodophors are used to clean cow'sudders. Urinary I was measured in the National Health andNutrition Examination Survey (NHANES) I (1970^4), andfound to be higher than desirable, which prompted bans onsome iodophors and adoption of alternatives for I in dairyoperations. However, the median concentration decreasedmore than 50 % between 1971-4 and 1988-94 (NHANESIII). These findings, although not indicative of I deficiencyin the overall US population, were considered to define atrend that needed monitoring (Hollowell et al. 1998). On theother hand, in European countries, at times, I levels havedecreased even when fortification has been in place formany years; for example, Germany, after the adoption of the'principles of voluntary action' following reunification(Meng & Schindler, 1998), and in Switzerland, where tocorrect for falling levels of urinary I it was decided to raisethe salt I to 20-30 mg/kg in 1998 (Btirgi, 1998). Europe hashad fortification for over 70 years now, and still has notachieved true sustainability, as evidenced in the rising ratesof I-deficiency disorders in the Eastern Block countries(Gerasimov & Delange, 1998), and as in the examples ofGermany and Switzerland.

Monitoring and evaluation is also helpful to addressconcerns of safety of food fortification. For example,concern has been expressed in the case of vitamin Afortification, especially when several foods are fortified. Anintake of 3 mg/d has been set as the level safe for adults,including pregnant women. Excessive amounts of vitamin Aare known to have teratogenic effects in pregnant women,especially during the first few weeks of pregnancy. Indeveloping countries, where levels of fortification arepoorly monitored, the introduction of several commercialfoods each fortified with up to 100 % of the recommendeddaily intake for vitamin A might lead to potentiallyunacceptable levels of vitamin A intake in pregnant women.However, it should be noted that at the levels of fortificationcurrently practised around the world, enormously high andpractically impossible amounts of an individual food or acombination of fortified foods would have to be consumedon a daily or regular basis to reach this toxicity threshold forhuman subjects. Thus, vitamin A toxicity from fortifiedfoods is highly unlikely. Indeed, even in developedcountries where many foods may be fortified with vitaminA, there have been no reports of vitamin A toxicityattributed to the intake of fortified foods (Nalubola, 2000).A case study of vitamin fortification in the USA shows that,although many foods are fortified with vitamin A in theUSA and, according to NHANES III, about 40 % of the US






population regularly consumes dietary supplements, therehave been no reports to date of vitamin A toxicity throughfortified foods in the USA (Nalubola, 2000).

Nevertheless, theoretical concerns continue to be ofrelevance when a programme is being started. Sometimesthese are real concerns, which is where monitoring isessential. In Zimbabwe, and later in the People's Republicof Congo, there were several reports of salt fortification withI in communities with chronic I deficiency leading topotentially fatal cases of Jodbasedow or I-induced hyperthy-roidism disease (Delange, 1998; International Council forthe Control of the Iodine Deficiency Diseases, 2000ft).These cases were found to be due to poor or absentmonitoring, and sudden introduction of overly-fortified saltcoming in from surrounding countries (Todd et al. 1995). Amore theoretical possibility is Fe overload, especially inCaucasian men suffering from a tendency to haemochroma-tosis. With the exception of massive amounts of Fe inlocally-brewed beer in south and east Africa, this potentialoverload does not appear to be a real concern in developingcountries where Fe deficiency is widespread (Harvey et al.2000).

Given the presumed success of fortification in theindustrialized countries, coupled with the greaterdemonstrated need in developing countries, fortificationshould be actively pursued in the developing world. It hasbeen shown in Europe that adults and children who includefortified foods in their diets have higher micronutrientintake and status compared with those who do not(McNulty, 1999; Serra-Majem, 2001). There is alsoevidence that fortification may be particularly important incontributing to the micronutrient status in those with lownutrient intakes generally (McNulty, 1999). It remains forthis possibility to be confirmed in the developing world. Themost pressing factor to be actively addressed is thedevelopment of adequate monitoring mechanisms that mustbe in place.

Innovations

While much of the fortification technology and implemen-tation is transferable to developing countries, based on therelatively long experience in the industrialized countries, itmay need new approaches or innovative thinking in orderfor the programmes to benefit the target population. Thisrequirement for innovation is for all the reasons discussedearlier, but probably the overwhelming one is that the targetpopulations are most often poor, relatively isolated andsomewhat out of the global or even national market. Otherfacilitating groups may need to be involved, e.g. the non-governmental organizations that have been instrumental intesting the feasibility of hammer-mill stage fortification ofmaize in Africa. Maize meal fortification and hammer-milltechnology is currently being tested for effectiveness inZimbabwe. Families when they bring their maize to thehammer mill are offered a sachet of premix (vitamin A,B-vitamins, Fe and Zn) costing approximately $US 0-80 toadd to 20 kg maize meal. Evaluated after 1 year, half of allmaize in the operational research area was being fortified(although the local mixing process was seen as takingtoo long and a constraint; Lindsey & Kwaramba, 2001).

Similar pilot schemes are also being undertaken in Malawi,Mozambique, Tanzania and Zambia. Quality assuranceclearly becomes a challenging issue under these circum-stances. Mobile self-contained mills for fortifying maize inrefugee camps are also being tried. The UN World FoodProgramme is involved in Bangladesh and Afghanistan; inAfghanistan the World Food Programme is facilitating localfortification of its flour with vitamin A, thiamine, riboflavin,niacin, folic acid and Fe.

Exactly what is meant by fortification and whatconstitutes a fortified food has expanded. These definitionsnow include: a single micronutrient added to food, multiplemicronutrients added to foods (e.g. triple fortification ofsalt); supplements (e.g. 'sprinkles') added to weaning foodsand porridges; foods bioengineered to contain micronu-trients that are not present in the traditional varieties; vastlyimproved fortification techniques, allowing for multiple,stable and acceptable fortification. 'Sprinkles' are micro-encapsulated micronutrients, including ferrous fumarate,which are available in a single-dose sachet, and can besprinkled onto complementary and weaning foods, and otherfoods. In a randomized controlled trial in Ghana they werefound to be as efficacious as Fe-containing drops in thetreatment of anaemia (Zlotkin, 2001).

While multiple fortification has always been used in flourand breakfast cereals, many micronutrients are now beingadded to other commercially-processed foods, includingconfectionery foods in Indonesia (Sari et al. 2001), fortifieddrinks in Nicaragua, Peru, the Philippines and Tanzania(Micronutrient Initiative, 1997; Ash et al. 1999; Solon et al.2001), and shortbread type biscuits in South Africa (vanStuijvenberg et al. 1997). An example of the technologicalinnovations being explored is the double or triple fortifi-cation of salt with I, Fe and vitamin A, where the nutrientsare microencapsulated to minimize cross-reactivity andimprove stability. Preliminary studies to determine thefeasibility of this technology are now underway in India andIndonesia, and may be expanded to Kenya and Nigeria(Micronutrient Initiative, 1997). The efficacy of fortifyingfish sauce with lOmg Fe as NaFeEDTA in 10 ml fish saucehas been demonstrated in Vietnam (Thuy et al. 2001) andtrials of Fe fortification of soya sauce are well underway inChina (Fidleref al. 2001).

Conclusions

There is a clearly identified need for interventions to combatmicronutrient deficiencies worldwide. In the more affluentindustrialized countries these have been, and continue to be,addressed by food fortification, as well as by overalleconomic growth and general improvements in health,sanitation and nutrition that have contributed to theprevention and control of these deficiencies. These sameaspects must be addressed in any prevention and controlprogrammes in non-industrialized countries. Fortification,supplementation, other food-based approaches and comple-mentary public health measures are all necessary. Thisprocess can only be carried out by partnerships withgovernment, industry and the consumer. There is a need toassess more widely the impact of interventions, not least foradvocacy. Ultimately, the success, impact and sustainability






of food fortification, like other interventions, rest witheducating the consumer, developing consumer demand anddemonstrating impact.

Successful fortification programmes have been identifiedas needing at least the following: strong politicalcommitment and the ability to enforce regulations in afacilitative manner; early private sector involvement andwillingness to comply with regulations; public sectorbacking including endorsement by professional medicalorganizations and financial support by donors; strong andactive consumer education to raise consumer awareness andpromote demand. Equally important is the necessity for asound scientific basis in the design of any fortificationintervention, including: documentation of the severity andeffects of the deficiency in the relevant population groups;data on food consumption patterns, along with technologicaland market feasibility assessments; measures to monitor andevaluate the implementation of the intervention, followed bytimely and effective corrective actions where needed. Aminimal change in the cost of fortified food is ideal.Initially, absorption of the additional cost of fortification bythe private sector or through government subsidies may benecessary. Ultimately, the long-term sustainability offortification programmes is ensured when consumers arewilling and able to bear the additional cost of fortified foods.

There has been an enormous increase in the number offortification programmes in developing countries over thelast couple of decades. With increasing urbanization thistrend will continue. Considerable progress has been made inreducing vitamin A and I deficiencies, although less so withFe, even as Zn and folic acid deficiencies are emerging asimportant public health problems. The recently-formedglobal forum on fortification, GAIN, is made up of multi-lateral organizations, bilateral agencies (Canada, USA) andthe private sector, including the food industry and the GatesFoundation, suggesting a new level of identification of forti-fication as an important strategy in the less-industrializedworld. Food fortification based on sound principles andsupported by clear policies and regulations will play anincreasingly large role in the progress towards preventionand control of micronutrient malnutrition.

Acknowledgements

The paper was written based on the experience of the twoauthors and the referenced literature. However, many of themost recent field reports and experiences were taken frommonthly updates from the Micronutrient Initiative, theMOST Project of USAID, and Helen Keller International.I.D.-H. is currently with WHO as a Senior Global HealthLeadership Fellow and R.N. is currently with the US Foodand Drug Administration. The opinions expressed herein arethose of the authors and do not necessarily reflect the viewsof either the World Health Organization or the US Food andDrug Administration.

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