Maternal consumption of folate, or its synthetic form folic acid, is strongly associated with a reduced risk of neural tube defect (NTD) in the early states of pregnancy. Fortification of certain food groups with folic acid has been mandatory in North America since 1998, and the number of pregnancies affected by NTDs is reported to have fallen by 26 per cent.
To date no European country has followed suit, although the wheels are in motion in Ireland and it now looks increasingly likely that the UK will introduce measures in 2007.
Folic acid fortification has been on the table in the UK since 2000, following a report by SACN's predecessor COMA, which concluded that universal fortification of flour with folic acid would significantly reduce the number of conceptions and births complicated by NTDs.
But after consultation with stakeholders the decision was taken not to make fortification mandatory at that time due to concern that it may mask vitamin B12 deficiency in some sectors of the population and because it would impinge on consumer choice.
However the matter remained on the table, and in April the FSA asked its board to consider SACN's (Scientific Advisory Committee on Nutrition) draft opinion that neither continuing voluntary fortification nor raising awareness amongst women of childbearing age alone would have an effect. The FSA was planning its final consultation, but had to put it on ice when, in May, the SACN said it needed more time to look at additional evidence on risks and benefits - particularly relating to high level folate consumption (over 1mg per day). The SACN finally published its recommendations yesterday.
"Following a detailed assessment of the evidence, SACN is recommending mandatory fortification of flour with folic acid as the most effective way to increase folate intakes of women most at risk of NTD-affected pregnancies, provided voluntary fortification is controlled and advice is given about supplement use," said SACN chair Professor Alan Jackson.
SACN said that, even with mandatory fortification, women should still continue to take a daily supplement of 400 micrograms of folic acid prior to conception and until the 12th week of pregnancy.
This position does not, in fact, differ from SACN's previous stance, but it is bolstered by consideration of the latest evidence.
Although the recommendations point towards a future where fortification is mandatory, the matter will not be settled until next spring, when the FSA will consider them alongside responses to the final consultation in the advice it will present to health ministers after its board meeting in May 2007.
The consultation, which is to run for 13 weeks, seeks views on four options for fortification:
To continue with the current policy of advising all women planning to get pregnant to take a 400 microgram supplement before conception and until the 12th week of pregnancy; to increase efforts to encourage to women to take supplements or eat more folate-rich foods (natural sources include grains, lentils, chick peas and green leafy vegetables; to encourage the food industry to fortify more foods on a voluntary basis; or to recommend mandatory fortification of bread or four with folic acid.
The consultation package includes a detailed analysis of the costs of supporting each individual NTD sufferer throughout their lifetime.
The monetised benefit reflecting value of averted pain, grief, and suffering, alongside a productivity component, is said to be around £487,000 per individual.
"Already at this stage, we start to see that the benefits to fortification will significantly outweight the costs," says the paper.
The findings of consumer focus groups held in the UK are also presented; throughout the duration of the focus groups, there was a significant shift in opinion from education campaigns towards mandatory fortification. It appeared that this was down to doubt that educational or voluntary measures would be effective (half of all pregnancies in the UK are unplanned, and only a quarter of women presently follow the advice on supplements), rather than anxieties over mandatory fortification being removed.
Consideration is given to the question vitamin B12 deficiency, and how this condition may be masked with mandatory fortification.
However SACN points out most adverse effects related to B12 deficiency are reported at doses exceeding 5mg/day - whereas the UK is considering maximum daily intake of only 1mg/day.
Cases of irreversible neurological harm as a result of B12 deficiency are rare in the UK: only 28 cases were reported in 2002. Moreover in the US and Canada cases have remained constant at around 30 per year, even after the introduction of fortification.
Folate has also been researched for its role in colorectal cancer. Evidence indicates that is pre-cancerous growths are already present, folic acid supplementation can promote progression to tumours. But there is also evidence that, where pre-cancerous growths are not present, folate deficiency seems to predispose their formation while folic acid fortification seems to have an inhibitory effect.