Malawi has been involved in food fortification efforts, but the policy evolution appears less structured compared to Mozambique. The Food Fortification Initiative (FFI) database shows data for Malawi, but specific legislative milestones and timelines are not as clearly documented in the available sources. Malawi lacks the same level of documented policy clarity in the available sources, though this may reflect documentation gaps rather than actual policy deficiencies ie a lack of implementation.

The key drivers for Malawi were mainly food security challenges in Malawi dating back to the country’s food crisis of 1991 and 1992, when a drought in southern Africa severely reduced maize production. Climate vulnerability is also prominent, as most livelihoods depend on rain-fed agriculture, making the population highly vulnerable to disasters, particularly droughts and cyclone-induced floods. Despite facing numerous challenges, Malawi has made notable progress in reducing hunger since 2000, as measured by the Global Hunger Index, which tracks overall hunger and undernutrition levels. Malawi appears to have a less formalized comprehensive framework based on available evidence, although large-scale food fortification may be a cost-effective intervention to increase micronutrient supplies in the food system when implemented under appropriate conditions. This can be supported by modeling food fortification contributions to micronutrient requirements in Malawi using Household Consumption and Expenditure Surveys (17).

The2016 landmark law (Decreto n. 9/2016 de 18 de Abril) calls for fortification of five food vehicles: wheat flour, maize flour, cooking oil, sugar, and salt. Specifically, wheat flour and maize flour are to be fortified with iron, zinc, folic acid, and vitamin B12, and optionally with vitamin A, thiamine, riboflavin, niacin, and vitamin B6. Cooking oil and sugar will be fortified with vitamin A, while salt will be fortified with iodine. This encompasses the policy and regulatory scopes. The key drivers for the mandate were the high malnutrition rates that led to the development of this policy as part of a comprehensive strategy to address chronic undernutrition. International partnerships, including the Global Alliance for Improved Nutrition (GAIN), Helen Keller International (HKI), Irish Aid, the United Nations Children’s Fund (UNICEF), the Food and Agriculture Organization of the United Nations (FAO), the World Food Program, and Population Services International (PSI), also played a role in pushing the fortification agenda. Technical capacity building by Smarter Futures, where representatives from Mozambique have attended multiple training events. Lastly, the multi-sector approach ensured national leaders have included the Ministry of Industry and Commerce, the Ministry of Finance, the Ministry of Agriculture, as well as the Ministry of Health.

Mozambique’s legislation exempts the smallest producers from mandatory fortification, leaving its 13 roller maize mills, 13 hammer mills, and 10 industrial wheat mills as the main implementers of the policy. This implementation strategy follows the landmark law for mandatory food fortification. Mozambican stakeholders have been trained to use Fortification Monitoring and Surveillance (FORTIMAS) as a monitoring tool in addition to physical inspections. A clear timeline has also been set, where the law gives industries 6 months to meet the new requirements and provides detailed specifications for each food vehicle. However, exemptions are also defined where clear criteria for which producers are exempt, for example, small-scale producers are not heavily monitored and penalized. Mozambique is now seeing a structured progression from voluntary (2013) to mandatory (2016) food fortification policies.

Table 3 provides a summary of the policy timelines in Malawi and Mozambique.

Malawi has 2 main documents that outline their policy on fortification the Salt Iodization Act was introduced earlier in 1999, followed by the Malawi Gazette Supplement, dated 27th March, 2014 which cover sugar, maize flour and wheat flour. The Decreto n. 9/2016 de 18 de Abril from Mozambique is the law that covers the mandate to fortify all the food vehicles. Table 3 reveals that Malawi adopted mandatory food fortification earlier than Mozambique, a difference that is significant in terms of program maturity and institutional learning. Malawi’s earlier start allowed more time to integrate fortification into national nutrition strategies, establish standards, and build regulatory experience. However, the extended duration of implementation does not always result in uniformly better micronutrient outcomes due to persistent challenges in compliance, enforcement, and coverage of small-scale mills. In contrast, Mozambique’s later adoption means that population-level nutritional impacts are less evident to date, but its more centralized legal framework may enable faster gains if implementation bottlenecks are addressed. This comparison suggests that while early policy adoption can facilitate long-term capacity development, reductions in malnutrition depend on other factors like implementation quality and regulatory effectiveness than on timing alone.

Institutional coordination for the fortification process was established through the establishment of the National Fortification Alliance to bring together the government (Ministry of Health, Bureau of Standards), the private sector, NGOs, and donors. The National Fortification Alliance provides private-public oversight and coordinates compliance and feedback loops.

Government inspectors perform routine factory-level monitoring quarterly by sampling at mills and laboratories and tracking results via Malawi’s Fortification Monitoring Tool. Projects by NGOs like World Vision also champion community-level fortification piloting, where premix is added to grains in village mills or homes, relying on community structures and cost-recovery models (18).

Despite these systems being established and partially functional, compliance fluctuates due to fragmented funding and reliance on donor funding rather than stable government funding, leading to inconsistent district-level activities (11). There is also a lack of technical capacity and funding to maintain quality control standards at small mills. Small mills face limited premix supply, testing tools, and expertise hinder quality control (18). Other challenges include weak community models, home-level fortification struggled to sustain cost recovery and quality once external funding ended (18). The limited private sector engagement, leading to private sector uptake remaining low, is usually attributed to a lack of incentives (5, 19).

The National Committee for Food Fortification (CONFAM) was established as part of Mozambique’s implementation strategy to coordinate multi-stakeholder governance and advocacy. This was later followed by the adoption of the FortifyMIS digital monitoring system. This mobile and online management information system allows inspectors and producers to upload data, track compliance, and generate dashboards. It was rolled out in Maputo province in 2019 for digital real-time monitoring (20). The National Inspectorate for Economic Activities (INAE) pushed the regulatory rollout through an inspectorate expansion; 30 more regulatory agents were trained in 2024 to standardize inspection protocols nationwide and improve physical oversight (21).

Effectiveness is, however, still a challenge; it was reported in 2025 by CONFAM that coverage of fortified products reached 70% of industrial production, including salt iodization at 50 to 60% market share (22). However, monitoring remains inconsistent across regions, compliance is uneven, and malnutrition rates remain high. The main challenges arise from market smuggling, unregistered maize flour from informal trade circumvents fortification (23). Evidence was suggestive that inspection capacity gaps exist due to a lack of equipment and training, small producer constraints from premix procurement and technical capacity, as well as geographic coverage and integration across sectors being weak.

Table 4 summarizes the implementation strategies used by both countries.

Overall, Table 4 demonstrates that differences in governance structure, decentralized in Malawi versus centralized in Mozambique shape how monitoring systems operate and where compliance breakdowns occur, with both systems facing shared challenges in extending regulatory reach beyond the formal industrial sector.

Malawi has functional legal and monitoring frameworks at the industrial level, supported by multi-stakeholder oversight. The Salt Iodization Act of 1999, The Malawi Gazette Supplement, dated 27th March, 2014 and Decreto n. 9/2016 de 18 de Abril provide a legal mandate, backed by the necessary standards for both countries. Yet, sustainable funding and small-mill capacity remain weak links. Mozambique excels with tech-driven monitoring and formal coordination via CONFAM and FortifyMIS, and strong industrial coverage (24). However, informal markets, inspection reach, and rural/small-producer challenges persist for both.

Large-scale millers and processors swiftly invested in fortification equipment and sourcing premix once national standards became mandatory in 2018 (19). The Ministry of Health and the Bureau of Standards provide technical support to comply. Small and medium-scale processors (SMSPs), often cooperatives or small mills, struggle with certification and technical capacity. Rural cooperatives face bureaucratic delays (for example, year-long waits for certification) and limited ability to scale beyond local markets. Technical and financial barriers, including the high cost of premix and dosing equipment, are prohibitive for smaller processors, as they lack the economies of scale typical of large mills. The high cost and lengthy process for Bureau of Standards approval prevent expansion and broader market access (25).

In terms of influence on investment, public–private partnerships like Techno Serve’s (SAFE) initiative, supported by USAID and global food companies, have provided technical assistance and facilitated investments in fortification infrastructure for over 1,000 processors across Africa, including Malawi (26). Government grants and innovation funds have also helped processors adopt new technologies and build capacity.

CONFAM coordination brought together large and medium processors, encouraging investment in dosing equipment and premix use. Digital monitoring systems (for example, FortifyMIS) incentivized investment by enabling real-time compliance tracking and making it more rewarding to invest in fortification equipment. Small miller exclusion led to mandatory regulations focusing on larger mills, while small informal hammer-mills often remain exempt or non-compliant and even though it relieves the small mills, this limits access to fortified staples in rural areas. Support mechanisms are lacking, without dosing machines or reliable premix supply, small processors cannot comply, leaving them at a disadvantage (27).

Ecosystem building through donor and NGO-backed advocacy and blended finance has attracted investments in premix blending facilities, dosing technology, and mill upgrades (27). Government industrial strategy has also created broader investments in food processing, indicating a favorable policy environment supportive of fortified food technology.

Table 5 is a summary of the industry response to the national fortification initiatives in both countries.

Table 5 shows that mandatory fortification has been most readily adopted by large firms in both Malawi and Mozambique, reflecting their superior technical capacity, access to finance, and closer engagement with regulatory authorities. In Malawi, adoption has been supported by technical outreach and grant-funded programs, whereas in Mozambique compliance among large firms is driven more by centralized coordination through CONFAM and digital monitoring tools. In contrast, small and medium-scale processors face substantial barriers in both countries: in Malawi, rising production costs, certification requirements, and bureaucratic delays undermine sustainability, while in Mozambique SMSPs are largely excluded due to limited technical support and restricted access to premix. These differences indicate that while fortification policies are legally clear and effective within the formal industrial sector, persistent capacity gaps and weak integration of smaller producers constrain coverage and limit the potential population-level nutritional impact.

Dietary adequacy modeling before 2025 revealed that stronger enforcement of oil and sugar fortification (widely consumed staples) could significantly boost vitamin A intake, especially among higher-income and urban groups. However, less boost for poor rural populations (28). A cross-sectional study combining community-level flour fortification with dietary diversification and iron–folate supplementation reported reduced anemia over 4 years. Effectiveness could not be fully quantified due to a lack of baseline data, but it suggested a real improvement (29).

However, unintended and adverse consequences exist from equity concerns; modeling data highlight that fortified foods benefit wealthier, urban households more, leaving rural and low-income groups behind. There is also a risk of excess intake. Malawi was flagged as one of the countries at risk of vitamin A hypervitaminosis due to the overlap of supplementation and fortification (28). As well as limited iron efficacy, globally, food fortification on its own contributes modestly to iron intake, 0–13% of RNI for women, implying limited anemia impact unless programs are carefully tailored.

Biofortification evidence shows that the introduction of orange-fleshed sweet potato (OFSP), a home and crop-based fortification strategy, led to a long-term increase in vitamin A intake. In one trial, women’s vitamin A intake remained higher in OFSP areas even 3 years post-intervention (29). Integrated dietary interventions, which are programs involving fortified complementary foods, IYCF counseling, and water/sanitation, showed reduced anemia risk among children in other LMIC contexts (29) Similar mixed-model approaches are implemented in Mozambique.

Bioavailability constraints from high phytate content in local diets may inhibit absorption of fortified minerals (for example, iron/zinc), reducing effectiveness unless dephytinization or complementary interventions are added. Inconsistencies in monitoring have also led to uneven fortification levels across provinces no direct evidence of nutrient toxicity yet, but the potential risk of under- or over-fortification exists (14).

Table 6 provides a summary of the effectiveness and impact of national fortification policies in both countries.

Positive gains, especially for vitamin A, anemia, and goiter (globally, LSFF reduces anemia by 34%, goiter by 74%) (3). Effectiveness hinges on context, program reach, dietary patterns, enforcement quality, and baseline nutrition status significantly influence outcomes. Risks persist from equity gaps, nutrient absorption issues, and possible overexposure; these demand careful design and continuous refinement. Integrated strategies work best by combining fortification with crop-based biofortification (for example, OFSP), supplementation, and dietary diversification, and supplementation yields more robust micronutrient improvements in children and mothers.

Both countries mandate fortification of key staples, including salt (with iodine), sugar (with vitamin A), cooking oil (with vitamin A), wheat flour, and maize flour (with iron, zinc, folic acid, and other micronutrients). This aligns with global best practices for reducing deficiencies in vitamin A, iodine, and iron, as seen in Sub-Saharan African programs (11). Policies prioritize industrially milled products, with standards enforced by national bodies like Malawi’s Bureau of Standards and Mozambique’s National Institute of Standards and Quality, both emphasize monitoring imports to ensure compliance (30, 31). Fortification is complemented by dietary diversification and supplementation in national nutrition policies, recognizing it as a cost-effective food-based approach to combat deficiencies.

Malawi introduced mandatory fortification in 2011, covering four staples (wheat flour, maize flour, sugar, oil) with detailed standards updated by 2015 (31). Mozambique’s policy, enacted in 2016 via Decree No. 9/2016, mandates similar vehicles but includes rice in some voluntary aspects and faces delays in full implementation (32). Malawi’s earlier start ensured more mature monitoring systems. Malawi emphasizes robust regulatory enforcement at district levels and multi-stakeholder coordination, leading to higher compliance in large-scale operations. Mozambique struggles with uneven enforcement, particularly for small-scale mills, due to limited resources and bureaucratic hurdles (33). Malawi’s policies better integrate small mills through sensitization and equipment support, while Mozambique’s approach highlights gaps in covering community-level processing, leading to voluntary elements for non-mandatory vehicles like rice.

Mandatory strategies in both countries have increased fortified food availability, with Malawi achieving higher household coverage for vitamin A-fortified oil and sugar. Mozambique reports 78.4% household coverage for fortified salt, but lower for maize flour due to small-scale exemptions (34). Overall, both reduce micronutrient deficiencies, but Malawi’s earlier policy correlates with better vitamin A status (35). Mandatory approaches yield higher compliance compared to voluntary, with improved public health outcomes (36). Mozambique’s partial voluntary inclusion for rice shows lower effectiveness, emphasizing the need for full mandates. Combined strategies (fortification and diversification) improve outcomes more than fortification alone. Both policies are cost-effective and beneficial in averting deficiencies; however, uneven coverage exacerbates rural–urban disparities (37).

The effectiveness of mandatory food fortification policies is determined by the extent to which regulatory requirements are implemented and enforced across the food system. While the existence of fortification mandates reflects strong political commitment, policy effectiveness depends on consistent compliance by food processors, effective regulatory oversight, and sustained coordination among public and private stakeholders.

Strong regulatory frameworks, supported by clear fortification standards, routine inspections, and enforcement mechanisms, play a critical role in ensuring compliance. Evidence indicates that countries with well-resourced regulatory agencies and systematic import monitoring achieve higher compliance rates, particularly where fortified foods are sourced from both domestic and international markets (17). Multi-stakeholder coordination—linking government ministries, standards authorities, industry associations, and development partners further enhances effectiveness by aligning incentives, sharing technical expertise, and facilitating problem-solving across the supply chain.

Monitoring and evaluation tools are essential for assessing whether fortification policies are achieving their intended nutritional outcomes. Modeling tools are commonly used to estimate population-level impacts and guide policy adjustments; however, these approaches rely on assumptions about consumption patterns and compliance that may not reflect real-world conditions. In this context, the premix reconciliation calculation represents an under-utilized but potentially powerful method for assessing compliance. By comparing the quantity of premix procured by producers against reported production volumes, this approach provides a more direct and objective estimate of both producer-specific and national compliance levels (6). Wider adoption of this method could substantially improve accountability and evidence-based decision-making.

Despite the availability of regulatory frameworks and monitoring tools, inadequate compliance by millers and other food processors remains a major constraint to policy effectiveness. High fortification costs particularly the recurring expense of premix, equipment maintenance, and quality assurance pose significant barriers, especially for small and medium-scale processors operating with narrow profit margins. Technical capacity gaps, including limited knowledge of fortification standards, insufficient laboratory facilities, and lack of trained personnel, further undermine consistent implementation. These challenges are often compounded by weak monitoring systems, infrequent inspections, and limited enforcement, which reduce incentives for compliance.

In addition, low consumer awareness of fortified foods diminishes market-driven demand for compliant products, reducing pressure on producers to adhere to standards. Supply-chain disruptions, including inconsistent premix availability and logistical challenges in rural or import-dependent settings, further compromise fortification quality and continuity. As a result, mandatory fortification policies may exist in law but fail to deliver meaningful nutritional impact in practice. Studies indicate that many local companies perceive fortification as technically complex and financially burdensome, leading to partial, inconsistent, or complete non-compliance (26).

Table 7 shows a policy comparison summary for Malawi and Mozambique.

Early adoption/adaptation of mandatory legislation with monitoring for Malawi in 2011 (38) for multiple staples, backed by district inspections, achieved high compliance and coverage. Mozambique’s (34) decree, on the other hand, came after years of implementing a voluntary fortification program. It is therefore our belief that early adoption or adaptation of interventions allows for learning and improvement of implementation nuances. Additionally, as much as the voluntary start pushed an extensive reach for Mozambique, it left gaps in monitoring and evaluation structures that only became worse with the introduction of mandatory fortification. Mandatory fortification does not require consumers to change food purchasing preferences, distributes the health benefits more equitably than voluntary fortification across a population, establishes safe levels of included nutrients, and is not subject to the food manufacturers’ marketing investments or discretion (36).

Mozambique’s economy is gaining momentum in a challenging global context. Economic recovery has gathered pace, with growth reaching 4.1% in 2022, despite the worsening global economy, and inflation hit a five-year high as global fuel and food prices surged, and adverse weather reduced domestic food production (39). Mozambique’s economic performance deteriorated markedly in 2024, annual real GDP growth declined to 2.2% in 2024 from 5.5% in 2023 primarily attributable to post-election protests and climate-related shocks, including Cyclone Chido and the El Niño phenomenon (40). Since 2020, Malawi’s economy has experienced a deep and protracted economic crisis, and economic growth rates have dropped from an average of 4.1% (2011–2019) to 2.2% since 2020. While external shocks like cyclones, droughts, and geopolitical instability have adversely affected Malawi, neighboring countries have tended to recover more quickly from the same shocks, but Malawi’s challenges have been compounded by long-standing policies that have contributed to widening fiscal and current account deficits. Inflation remains elevated, Malawi’s private sector is facing a challenging business environment, and the high cost of borrowing further limits investment and expansion opportunities (41). According to Resnick (42), political economy factors within and across countries intersect with LSFF efforts and sometimes undermine progress (Incoherent trade, tax, and macroeconomic policies in a context of multiple shocks and crises, protectionist impulses aimed at building up domestic agro-industries, lack of financial commitment to LSFF structures in the absence of donor support, and uneven contributions). In that context, the best policy is to introduce and push for LSFF in windows of a relatively stable economy, as this facilitates easier uptake by the food industry.

Providing exemptions for Small and Medium Enterprises, in the case of maize flour, fortification is not mandatory whenever it is produced by small-scale mills which provide milling services exclusively for family consumption (30) Small-scale exclusions cause coverage gaps (Mozambique); inadequate monitoring during crises (for example, COVID) disrupts programs. High costs and quality gaps require ongoing investment. Lessons emphasize policy support and consumer education. Complementarity with other strategies has also been shown to be an effective method in improving public health outcomes. Combining fortification with dietary diversification enhances nutritional outcomes, for example, orange-fleshed sweet potatoes and vitamin A supplementation (14, 16). Interventions must be carefully designed to complement other interventions covering the same problem; however, to prevent issues of redundancy and hypervitaminosis (29).