What flour has to do with human dignity
On 8 May 2000 the former Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV) organized a public hearing on the fortification of flour with folic acid (folate). Prof. Dr. med. R. Großklaus, head of the Institute’s department for Nutritional Medicine, opened the hearing with the following words: “Human dignity and basic human rights should be granted to the unborn from the beginning of their existence.”
There was no denying the facts: 98% of the women and 95% of the men in Germany had an inadequate intake of the vitamin folate. The associated health risk was pregnancies resulting in severe deformities in the newborn (neural tube defects: spina bifida). At the time there were still 800 – 1,000 neural tube defects every year (1‰ of all pregnancies).
Representatives of four interested groups were asked to give their opinions:
- The nutritional physicians felt that fortification of flour with folate would have a beneficial effect on health.
- The Association of the German Milling Industry (Verband deutscher Mühlen, VDM) expressed the view that to dose folate at mills would be technically feasible since it was possible to treat flour very precisely with ascorbic acid in any case. The cost of fortifying all basic German flour with folate would be less than one million EUR a year – a fraction of the cost to the economy of treating neural tube defects at that time.
- On the other hand, the German Nutrition Society (DGE) had reservations about fortifying staple foods. Its members felt it would be sufficient for all consumers to eat more fruit and vegetables.
- The Study Group of the Consumer Associations (AgV) commented that only a minority of pregnant women was affected. It would be better to inform women about the need for folate. The statement was accompanied by an open threat: “We shall take action against any mandatory fortification.”
Fifteen years have passed since this hearing. Fifteen years in which the consumption of fruit and vegetables has not increased. Fifteen years in which women have not been given more information about the preventive consumption of folate as a vitamin. Fifteen years, and over 10,000 severely deformed children. Fifteen years of suffering and grief. And also fifteen years in which a multitude of new data have been collected on the efficacy and safety of fortification with folate. So let us give a current overview of the use of folate in flour.
The present status of flour fortification
The fortification of wheat flour is prescribed by law in 81 countries (FFI, 2014). In most cases the addition of vitamins and minerals is restricted to iron preparations and folate. Numerous scientific studies and epidemiological surveys have demonstrated the benefit of fortifying staple foods even in developed countries. In all cases the few contrary results have been refuted, or considerable systematic shortcomings were found in the studies on which they were based.
In Europe, flour is only fortified (with iron) in the United Kingdom. One argument put forward against fortification in Europe is loss of the consumer’s freedom of choice as a result of mandatory fortification of staple foods. It is also argued that consumers are adequately supplied with nutrients, or that there is even a risk of overdosing if food supplements are consumed at the same time. A vitamin B12 deficiency is often accompanied by an undersupply of folate; some 30 percent of all elderly people have an inadequate intake of vitamin B12. The increased administration of folate through a basic food may conceal a vitamin B12 deficiency; this can only be prevented by simultaneously fortifying foods with vitamin B12. One argument in favour of fortifying staple foods is that this is the only reliable way to reach financially weak or poorly educated sections of the population.
Effects of folate deficiency
Folic acid and its salts, the folates, are involved in cell division, growth processes and protein metabolism. A lack of folate in the blood of expectant mothers can lead to severe developmental anomalies in the foetus, which may result in reduced intellectual ability or even neural tube defects (NTDs, e.g. an open spinal canal [Spina bifida], Hydrocephalus, Anencephalus etc.) or death of the unborn or newborn child. In Europe, about one neonate in 1,000 births is affected. That does not include prematurely aborted foetuses. About two-thirds of the babies survive, but a quarter of these are so severely disabled that they die within a month (Fig. 1). The remaining half of the newborn children with neural tube defects are affected to different degrees. In some cases their life expectancy and quality of life are drastically impaired (Tab. 1).
1.0 = full quality of life)
Besides the negative effects of folate deficiency in mothers on the development of the unborn child there are indications that the quality of the sperm is impaired too. The effects of folate deficiency presumably include changes in the number of chromosomes. That mayresult in sterility, miscarriages or developmental anomalies caused by the Down syndrome, Turner syndrome or Klinefelter syndrome.
To those who are not affected, these phenomena may seem very abstract and distant. But for the many victims of folate insufficiency in food they mean a drastic impairment of their quality of life – and one that need not have happened, because it could have been prevented by simple means.
But as we will explain below, our society as a whole is affected – if not because of the sympathy we feel obliged to show, then at least because of the considerable cost of making survival possible or easier for the disabled sufferers.
Causes of folate deficiency
It seems unlikely that malformation due to folate deficiency was not filtered out in the course of human evolution. So we have to assume that folate deficiency did not start to play a role in man’s development until fairly recently. One significant reason could be the change in our diet. Although the likelihood of a reliable supply of food became much greater with settlement and agriculture, the amount of food necessary to maintain our weight has decreased considerably, since modern man no longer has to hunt or collect his food. Folate plays a major role in cell development processes. In the foetus, especially, folate demand for these processes is not coupled with energy demand. Consequently, a lower nutrient intake may lead to a vitamin deficiency in spite of an ample and balanced diet. With 145 µg/100 g wet weight, spinach is a vegetable fairly rich in folate. Nevertheless, an adult would have to eat 140 g of spinach daily in order to achieve only the recommended daily intake of 200 µg.
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Genetic causes of folate deficiency
Besides the general, diet-related undersupply of folate there are genetic reasons in a fairly large section of the population. These persons are therefore predisposed to a deficiency.
Our chromosomes are the blueprint of life. They contain genes, which are the construction plans for proteins. 5 – 15% of the population of Europe have chromosomes with certain mutations, of which they are unaware and which disrupt the utilization of folate in the body.
The persons affected have an increased risk of:
• neural tube defects (spinal cord malformation),
• psychiatric disorders such as schizophrenia and depression, and also
• coronary heart disease.
• Moreover, the mutation increases the risk of cancer.
In order to compensate for the disruption of folate and homocysteine metabolism caused by the mutation, these persons need larger amounts of folate (the vitamin folic acid). Since most of them are unaware of the defect, the requirement can only be met by means of fortified food.
The evolution of skin colour
Evolution scientists have discovered that people with a fair skin have less folate in their blood than dark-skinned people. According to Jablonski and Chaplin (2003), that is due to the damaging effect of UV light on the folic acid level in the blood. For example, irradiation of blood plasma with artificial sunlight reduces the folate concentration of the plasma by half within an hour. According to evolution scientists, that also explains why the people of sunny Africa have dark skin: in the course of evolution, dark skin came about as a protection against UV light and thus the folate reserves in human blood. When men migrated from Africa and found their way into Asia and Europe, this protection against UV light was no longer necessary, since UV radiation is less intense in northern regions than in the south, and northern people also had more protection in the form of clothing. The evolutionary pressure to form pigment therefore ceased. It may be that today’s trend towards scanty clothing and sunbathing is partly responsible for our increased folate requirement.
The necessity of flour fortification in the industrialized countries
A study in the Netherlands in 2008 revealed impressively that even in a highly developed industrial nation like the Netherlands, numerous cases of neural tube defects (NTDs) could be prevented by fortifying staple foods with folate (Jentink et al., 2008).
This is confirmed in a recent study conducted by Aarhus University, according to which the mandatory fortification of foods could prevent about 500 NTD cases a year in Germany (Obeid et al., 2015).
Taking the total number of births in Europe (5.5 million p.a.) and the NTD rate (1 affected child in 1,000 births) it is possible to calculate 5,500 NTD cases per year, of which 2,750 could be prevented by fortification (Godfrey, 2014).
In the USA, flour fortification with folate was introduced on a voluntary basis in 1997 and became mandatory in 1999. Since then, a substantial reduction in the number of NTD cases has been reported in all ethnic groups, although prevalence varies considerably between groups for genetic reasons or for reasons of diet (Fig. 2). Grosse et al. (2005) estimate that in the USA, 1,000 cases of NTD annually are prevented by flour fortification.
Cost to the economy
Every single NTD case costs the European economy an average of a quarter of a million EUR. This is the sum Jentink et al. calculated in their report of 2008 based on data from the Netherlands. He includes stillborn babies and cases in which the children fail to survive the first month of their life. Tab. 2 does not show these cases, which explains the higher sums. In addition to the direct cost of health care, the costs include extra expenditure on aids to coping with everyday life, such as a wheelchair, the cost of special education and the indirect costs resulting from lower productivity in working life as compared to healthy adults.
With these figures the author estimates the cost in various randomly selected areas (Tab. 3). Whereas the amount of the lifetime costs is an estimate – it is much lower in countries like China or India than in Europe – the incidence of NTD and the number of births are based on the official national statistics.
Although the lifetime costs in China and India were estimated to be only about one-tenth of the costs in Europe, the total cost to the economies of the EU, India and China together can be calculated as 3 billion EUR. If global wheat flour consumption is assumed to be 460 million tonnes p.a. (from 700 million tonnes of flour), the cost of fortifying the total amount of flour with the recommended dose of folate would be only about 90 million EUR. That would prevent about half of the NTD cases and result in a saving of 1.5 billion EUR.
The evaluation carried out by Williams et al. (2015) on the basis of real data from the USA calculates the annual saving resulting from fortification with folate as 500 million US dollars. This represents a saving of 8 billion dollars for the USA since the introduction of fortification in 1997 (including two voluntary years at the start of the programme).
Consequences of an overdose
Opponents of mandatory fortification of staple foods often allege that the simultaneous consumption of voluntarily fortified foods or food supplements might result in an overdose, with damaging effects on health.
However, the recommended addition of folate to flour is still far below the optimum dosage which would be desirable from the medical point of view. It is only intended to achieve a folic acid intake of about 150 - 200 µg/day. A desirable level would be 400 µg/day, and as much as 800 µg/day for women prior to conception.
For decades, women in the USA have been given 1,000 µg in the context of pre-natal care.
For therapeutic and preventive purposes, as much as 5,000 – 50,000 µg/day have been used without detrimental effects on health (Oakley, 2014).
We may conclude from this that the general fortification of flour with 2 ppm folate is a very safe measure, since it only represents an intake of 274 µg of folic acid per person and day at an annual consumption of about 50 kg of flour (Tab. 4). The fairly considerable losses resulting from storage and processing are not taken into account in these calculations.
Epidemiological surveys in den USA reveal a steady decrease in the number of deaths among women from nearly all types of cancer (except lung cancer), also continuing since mandatory fortification of flour with folate was introduced in 1999 (Fig. 3). A potential connection between fortification and certain forms of bowel cancer was also disproved (Bayston et al., 2007).
These findings rather surprised us, since cancer is a very fast-growing tissue which might be assumed to have a higher vitamin requirement – meaning that an increased vitamin intake in general might conceivably promote it.
Age-adjusted to the 2000 U.S. standard population.
Source: National Center for Health Statistics, Centers for Disease Control and Prevention (Oakley, 2014)
The technical process of fortification presents no problem in the case of most micronutrients, and their addition does not usually have any negative effects on product quality. Problems, if any, may occur with quality control, since it is difficult to detect some micronutrients in flour because of their low concentration and the presence of interfering substances. Folate, and especially, cyanocobalamine (vitamin B12), are added in very small amounts, and their detection is therefore subject to uncertainty.
Because of the small amounts added, most micronutrients are diluted with suitable carriers to concentrations that can be dosed accurately. For continuous addition by means of micro-metering devices at the mill, the dosage is usually set to 100 to 250 ppm (grams per tonne of flour). The technique used does not differ from the usual procedure for adding other micro-components such as ascorbic acid. To ensure even distribution in the flour, the products should be introduced from the metering devices at least four metres before the end of the collecting screw conveyor. Alternatively, batch mixers can be used, but then it is advisable to dilute the micronutrients further to the factor 1/10 in order to ensure homogeneous distribution.
Whereas minerals lose little of their efficacy through preparation of the food, vitamins may be impaired by physical or chemical effects at all stages of processing.
The activity of a vitamin is already reduced during storage of the preparation and in the fortified flour. Vitamin preparations are therefore sold at a slightly higher concentration than specified in order to ensure their efficacy up to the end of the stated maximum shelf-life. The amount added to the flour must then take the usual storage time of the flour into account, which means it may have to be somewhat higher.
Most flour is processed further by thermal methods. The approximate losses of folic acid caused by thermal stress are shown in Tab. 5. It can be seen from the table that baking, for example, causes a maximum loss of half of the vitamin.
Political opposition to flour fortification
In the past, the reasons given for opposing fortification were mainly medical, or it was argued that in Europe, all sections of the population had a reliable supply of food containing the necessary vitamins. In the meantime, however, we have numerous reports based on years of experience in many parts of the world which show that no negative effects on consumer health are to be expected following the addition of folate to flour. Moreover, several studies such as that by Jentink et al. (2008) have shown that a large number of avoidable NTD cases occur even in highly developed industrial countries, and that fortification is therefore advisable for medical reasons in these countries too.
It is often argued that women can be given preventive folate preparations by their doctors, which means that not all consumers would be obliged to take in additional folate. But it is often forgotten that scarcely half of all pregnancies are planned (Whiteford, 2014). Moreover, it is necessary to take the preparations 6 – 8 weeks before conception in order to achieve an adequate concentration in the blood. The planning required for a preventive intake of folate assumes that all the persons concerned understand the problem. But the average consumer does not usually start to think about problems until they occur. All of us who are honest enough can see that from our own behaviour, although education and previous experience play a major role in this connection.
Those opposed to fortification further argue that it would restrict the fundamental right to self-determination. This argument would seem cynical in the extreme, since unborn children are not asked whether they wish to be born without a brain or live with severely and permanently impaired health. Is the right to physical integrity so much less important? This is a question we should all ask ourselves – irrespective of the monetary costs, which are the main focus of this article.
- The fortification of staple foods like flour with folate makes sense from both the economic and the medical point of view.
- The cost of fortification is only a fraction of the economic benefit.
- The addition of micronutrients presents no technical problems.
- Micronutrients like folate have no effect on product quality.
- Politically, it is still difficult to enforce mandatory fortification in Europe.
Bayston, R., Russell, A., Wald, N.J. and Hoffbrand, A.V., 2007. Folic acid fortification and cancer risk. The Lancet 370, 2004
FFI, 2014. www.ffinetwork.org/global_progress/index.php
Grosse, S.D., Waitzman, N.J., Romano, P.S., and Mulinare, J., 2005. Reevaluating the Benefits of Folic Acid Fortification in the United States: Economic Analysis, Regulation, and Public Health. American J. Public Health 95, 1917-1922
Nina G. Jablonski, N.G., and Chaplin, G., 2003. Die Evolution der Hautfarben. Spektrum der Wissenschaft 6, 38-44
Jentink, J., van de Vrie-Hoekstra, N.W., de Jong-van den Berg, L.T.W., and Postma, M.J., 2008. Economic evaluation of folic acid food fortification in The Netherlands. European J. Public Health 18(3), 270-274
Oakley, G.P. Jr., 2014. Accelerating the pace of preventing Spina bifida F and Anencephaly F. European Teratology Congress, Sept. 2014, Hamburg, Germany
Obeid, R., Oexle, K., Rißmann, A., Pietrzik, K., and Koletzko, B., 2015. Folate status and health: challenges and opportunities. J. Perinatal Medicine. DOI: 10.1515/jpm-2014-0346
Whiteford, M.L., 2014. The impact of Spina bifida on individuals, families and society. European Teratology Congress, Sept. 2014, Hamburg, Germany
WHO (World Health Organization), 2015. Optimal serum and red blood cell folate concentrations in women of reproductive age for prevention of neural tube defects. Richtilinie. ISBN: 978 92 4 154904 2. Download unter www.who.int/nutrition/publications/ guidelines/optimalserum_rbc_womenrep_tubedefects/en/
Williams, J., Mai, C.T., Mulinare, J., Isenburg, J., Flood, T.J., Ethen, M., Frohnert, B., and Kirby, R.S. , 2015. Updated Estimates of Neural Tube Defects Prevented by Mandatory Folic Acid Fortification - United States, 1995-2011. MMWR Morbidity and Mortality Weekly Report 64(1), 1-5
Young, S.S., Eskenazi, B., Marchetti, F.M., Block, G., and Wyrobek, A.J., 2008. The association of folate, zinc and antioxidant intake with sperm aneuploidy in healthy non-smoking men. Human Reproduction. 23(5), 1014-1022