1.  How widespread is anaemia in India?

India has one of the highest burdens of anaemia in the world. According to the National Family Health Survey conducted in 2021 (NFHS-5), 67% of children between 6-59 months of age and 52% of pregnant women in India are anaemic. By contrast, the 2016-2018 Comprehensive India National Nutrition Survey found that 41% of pre-school age children, 24% school-age children (5-9 years) and 28% of adolescents (10-19 years) are anaemic. The methods used by the NFHS-5 and CNNS to measure the incidence of anaemia are different and hence the results from the two surveys are not directly comparable. 

Studies have shown a clear connection between micronutrient deficiencies, including iron and vitamin B deficiencies, and the high rates of anaemia among the Indian population (Ghosh et al., 2019). Indeed, iron deficiency anaemia is thought to be the most common form of anaemia in India and globally (WHO, 2001).

2.  What evidence is there for fortification of wheat flour being effective in addressing iron deficiency anaemia? 

There is ample evidence globally and within India that points to health improvements as a result of fortified wheat flour. The WHO recognises fortification as one of the most cost-effective public health measures to reduce health disparities. In a resolution adopted in May 2023, delegates at the World Health Assembly described large scale food fortification as ‘a powerful evidence-informed and cost-effective intervention to fight the consequences of vitamin and mineral deficiencies’.

A large body of existing evidence supports the efficacy of fortification interventions in reducing anaemia, including iron-deficiency anaemia. For example: 

1. Field et al., 2021, which focused on randomised controlled trials relating only to wheat flour fortification, concluded that the interventions reduced the risk of anaemia by 27% in children less than two years old;
2. Gera et al., 2012, a systematic review of about 60 randomised controlled trials/quasi-randomised controlled trials, observed that fortification interventions worldwide reduced the risk of anaemia by 41% and iron deficiency by 52%;
3. Muthayya et al., 2012 which reported a significant decrease in iron deficiency anaemia from 18% to 9% due to wheat flour fortification in a randomised controlled trial among children aged 6-15 years in India. 

3. If people are already consuming other fortified staple foods (salt, rice and edible oil), why do we need to fortify wheat flour?

There are two reasons why consuming fortified chakki atta as well as other fortified staples can be beneficial. 

First, fortified chakki atta contains different micronutrients from many other fortified foods. In India, fortified salt has iodine added to it; edible oil has vitamin A and D added to it; fortified milk has vitamin A and D added to it. Consuming fortified milk, salt or oil may therefore address an individual’s vitamin A or vitamin D deficiency, but it won’t help with iron deficiency. Individuals should consume all of these fortified foods if they are at risk of micronutrient deficiencies.  

Second, the reach of chakki atta in India is different from that of other fortified foods such as rice (Chakrabarti et al., 2019). The advantage of targeting multiple food vehicles with the same nutrients is that greater numbers of people can be reached with these essential nutrients and those consuming multiple vehicles that are fortified come closer to reaching necessary Recommended Daily Allowance (RDA) levels, which cannot be provided through one fortified food alone. 

When national standards are created, the potential overlap between different fortified foods is taken into consideration so that the correct percentage of the RDA is being provided to individuals consuming multiple foods fortified with the same nutrient(s). One recent study from 2022, for example, concluded that large-scale food fortification could be safely implemented in India given current dietary intake and micronutrient deficiencies (Duggal et al., 2022).

4.  Why focus on food fortification instead of supplementation, bio-fortification or dietary diversification?

There are four key food-based strategies for reducing micronutrient deficiencies among affected communities:  

• Dietary diversification - this involves people changing their diets to eat foods with naturally higher levels of micronutrients. Governments and other organisations can encourage dietary diversification by increasing the production of micronutrient-rich foods or encouraging people to prepare and cook food differently, so that micronutrients in food are preserved. In India, the Food Safety and Standards Authority has started the Eat Right India campaign to remote diverse and healthy diets.
• Supplementation - this involves people consuming tablets containing specific micronutrients on a regular basis. Governments and other organisations often provide supplements to vulnerable populations free of charge.
• Fortification - this is the addition of key micronutrients to staple foods. Governments can require that producers of key foodstuffs fortify what they produce or provide incentives for them to do so. 
• Bio-fortification - this involves using selective breeding or genetic modification to increase the content of micronutrients in crops. This differs from traditional fortification because nutrients are increased during crop growth, rather than in food processing after crops have been harvested. 

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Food fortification cannot completely solve micronutrient deficiencies on its own and must be pursued alongside these other strategies in the long-term. However, Fortify Health focuses particularly on food fortification because:

• food fortification is extremely cost effective, whereas dietary diversification, bio-fortification and supplementation tend to be more expensive; 
• fortification does not require consumers to make any changes to their behaviour, as staples that are already widely consumed can be fortified, whereas both dietary diversification and supplementation require consumers to change what they consume or take tablets, meaning progress can be slower; and 
• fortification often does not require changes to existing supply chains, as producers (for example, millers) can often fortify food as part of existing production processes. 

5.  Does fortification present any health risks? 

A wide range of high income countries (including the UK and the USA) and low and middle income countries (including Sri Lanka, Vietnam, the Philippines and Nepal) have mandated that wheat flour should be fortified with micronutrients and several global studies have found fortification to be safe. Fortification does not generally present health risks because of the level of nutrients that are provided through fortification programmes. The Food Safety and Standards Authority of India (FSSAI) sets dosages in fortification standards at a level to provide only 30-50% of an individual’s daily requirement (FSSAI FAQs, question 10). In setting these standards, the FSSAI takes into account Recommended Daily Allowances and consumption patterns.

Infectious diseases
Some have argued that iron deficiency decreases the susceptibility of patients to infections (including malarial infections) because pathogens feed off iron in the body. It is possible that large doses of iron, such as those delivered through supplementation, may increase a patient’s susceptibility to disease by introducing free roaming iron into the body, which may be used by pathogens to survive. However, given that iron consumed through fortified products contains significantly lower doses of iron (and folic acid) when compared to supplementation, is consumed in smaller amounts throughout the day, and is absorbed more slowly, similar concerns around malaria-endemic areas and iron fortification have not been identified. Indeed, a detailed study in 2021 discusses how food fortification avoids the problems associated with giving iron medicines in malaria endemic areas (Hurrell et al., 2021). Furthermore, the areas in which Fortify Health tends to work have low incidence of malaria.  

Thalassemia and sickle-cell anaemia
Thalassemia is an inherited red blood cell disorder that causes the body not to make sufficient amounts of haemoglobin (Fucharoen et al., 2011). Thalassemia can cause iron overload if not properly treated, which may eventually lead to organ damage. Among those with thalassemia, evidence suggests that only those with clinically significant forms of thalassemia are at risk of iron overload (Grant, 2012). Iron overload experienced by thalassemia patients is also generally caused by blood transfusion (not consumption of fortified foods) because the amount of iron derived from blood transfusions dwarfs the amount of dietary iron provided through fortification. Even so, individuals at risk of iron overload should seek advice before consuming fortified foods. The Food Safety and Standards (Fortification of Foods) Regulations 2018 specifically require that foods fortified with iron should specify that people with thalassemia should consume those products ‘under medical supervision’.

6.  Why does Fortify Health work in the open market and with government actors? 

There are two core distribution channels for wheat and wheat flour in India (Grain and Feed Annual, 2022). 

• First, wheat flour is sold in the open market by private millers (either directly to consumers or via retailers and consumer-facing businesses). 
• Second, state governments in India also distribute wheat at no cost or at subsidised rates directly through social safety net programmes to certain eligible individuals. 

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Both of these channels serve large segments of the Indian population, where anaemia rates are relatively similar across all economic quintiles (​NFHS-4). Fortify Health’s mission is to increase access to micronutrient-rich wheat flour throughout India and reduce anaemia at scale; we consider that we can only do that by supporting fortification of wheat flour through both of these distribution channels. 

7.  Why does Fortify Health use iron from NaFeEDTA and not other sources?

NaFeEDTA (sodium iron ethylenediaminetetraacetate) is a form of iron used to fortify wheat flour. Fortify Health uses NaFeEDTA (rather than other potential fortificants like ascorbic acid or phytase) for two reasons. First, NaFeEDTA actively facilitates the absorption of iron already present in wheat, by preventing phytic acid in the wheat flour from inhibiting iron absorption (Horrell, 2002). Second, NaFeEDTA does not generally impact the sensory attributes of fortified wheat flour or chapatis. Iron is generally susceptible to oxidation, causing it to change to a reddish colour upon exposure to oxygen. However, when using NaFeEDTA as a source of iron, the iron is coated by EDTA which opens in the intestine, enhancing the iron's bioavailability in the body. This protective coating ensures that during the processing of iron-fortified chakki atta (using NaFeEDTA as the source), any contact with oxygen, water, or heat does not change the sensory properties of fortified chakki atta.  

The World Health Organisation recommends NaFeEDTA as a fortificant for high extraction flour, including chakki atta. For more information, please see the WHO’s guidelines on fortificants.

8.  What rules and regulations do millers have to comply with to produce fortified wheat flour?

The Food Safety and Standards Authority of India has implemented a series of regulations on fortification, the Food Safety and Standards (Fortification of Foods) Regulations (2016 and 2018). As part of the regulations: 
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1. the FSSAI issued a fortification standard for chakki atta and maida flour, which specifies which micronutrients and how much of each micronutrient should be added to chakki atta in the fortification process;
2. the FSSAI has released the +F logo as an identifier of fortified food, which producers of fortified products must put on their packaging; and
3. the FSSAI required that millers using the +F logo must submit their flour for bi-annual testing at accredited laboratories. 

In addition to the above, the following regulations also apply for fortified foods:

• Food Safety and Standards (Labelling and Display) Regulations, 2020, in relation to labelling;
• Food Safety and Standards (Advertising and Claims) Regulation, 2018 in relation to claims and advertising;
• Food Safety and Standards (Packaging) Regulation, 2018, in relation to packaging; and
  
• Food Safety and Standards (Food Products Standards and Food Additives) Regulation, 2011, in relation to product standards.

9. ​Are there any changes to the sensory characteristics of fortified atta (when compared with unfortified atta)?

​If fortification is completed correctly, consumers will not be able to tell that flour has been fortified by sight or taste. There is no distinction in taste, colour or smell between fortified chakki atta and unfortified chakki atta (Muthayya et al., 2012). Consumers may only identify chakki atta as fortified based on the packaging of the flour, as the labels on packages of fortified flour contain the +F logo and information specified by the FSSAI.

10. ​Are the fortificants that Fortify Health uses vegetarian?

​Yes, the fortificant that Fortify Health uses (NaFeEDTA) is plant-based and is therefore suitable for vegetarians.