This post, authored by Dr Clare Craig , is republished with permission from The Daily Sceptic
Folic acid has been sold for decades as the vitamin B9. But in fact, vitamin B9 is folate, a reduced molecule that is essential for function in every cell. Folic acid, on the other hand, is a synthetic oxidised molecule which is never found in nature and is only slowly converted by the body into molecules that can be used. It’s a drug by any definition and the NHS tells people with cancer, a heart stent or B12 deficiency not to take it without medical advice.
Earlier this year a minister was asked in Parliament what people who have been told to avoid folic acid should do once it is in the nation’s flour. The answer was that they should read the leaflet that comes with their medicine and speak to their doctor. But no leaflet comes with a loaf.
Folic acid, when sold in a box, is a licensed medicine. It carries a patient information leaflet listing who must not take it and the drugs it interacts with. When folic acid is added to flour, the only warning will be in the small print ingredients if the manufacturer has updated its packaging. The dosage people will be exposed to will depend on their diet. Most people are totally unaware this is even happening.
What the regulations require
The Bread and Flour (Amendment) Regulations 2024 were introduced in November 2024 and, overnight, adding folic acid to flour went from being banned to being permitted. On December 13th 2026 they will come into force and every commercial mill in the country producing more than 500 tonnes of flour a year will be mandated to add 250 micrograms of synthetic folic acid to each 100 grams of non-wholemeal wheat flour.
The regulations were made by a statutory instrument signed off by a minister. There was no debate on the floor of the House of Commons and no vote. It seems that no one thought about the consequences of this legislation.
The millers’ own trade body says flour is an ingredient in about 30% of everything on supermarket shelves and that 99.8% of British households buy bread. Wholemeal and gluten-free flour are exempt, which is offered as consumer choice, but much of what is on those shelves has been, since November 2024, voluntarily fortified anyway. Folic acid has already turned up in organic sausages, Quorn, cup-a-soup, gravy granules and flavoured milk drinks. Almost everyone in the country will eat it every day. On a carbohydrate-heavy day the dosage could be significant, especially for young children.
The ethical test
The Nuffield Council on Bioethics sets out an intervention ladder for judging public health measures. The further a measure goes towards removing a person’s choice, the stronger the justification and the evidence it must show. Providing information is the bottom rung. Eliminating choice altogether is the top rung, where the burden of proof is heaviest. Mandatory fortification of a staple food is that top rung, because it removes any choice.
No ethics assessment of medicating a population without consent was published. Nor was any risk-benefit assessment weighing the medical modelled gain against the side-effects. The only appraisal carried out was financial, and even that was the light-touch de minimis form – the short version used when the cost to business is judged too small to merit a full assessment. That assessment names potential harms to cancer patients and to people with undiagnosed B12 deficiency, but then lists them as non-monetised effects and assigns them a value of zero.
Because the only appraisal was financial the defence offered is that folic acid is cheap. The addition costs about 0.008 pence per loaf. Cost is not the bottom line in this case. Seventy million people are about to be mass medicated without their knowledge, let alone consent, with a medicine known to have adverse effects. That is an ethical question not a financial one.
Why are they doing it?
The WHO promotes folic acid fortification as a route to the 2030 Sustainable Development Goals. It also grades the evidence behind its own recommendation as of low or very low certainty. In Europe, only Moldova and Kosovo mandate it. No Western European country does, and Britain’s own Food Standards Agency board decided against it in 2002, on the grounds of B12 masking and consumer choice.
The ‘greater good’ claim that government has used to justify this decision is that a modelled 200 pregnancies affected by a neural tube defect could be saved each year. It has been repeated in press releases, in the Commons and by every organisation supporting the policy. That number is based on a hoped-for 20% reduction and a claimed 1,000 cases a year (despite the fact that there were only 621 in England in 2022 which would be about 730 if scaled to the UK).
A more recent Government assessment gives a smaller figure. The effect it claims is 31 fewer affected live births a year in England. Around 28 of those are children who would have lived with disability and three are averted fatal cases of anencephaly, where the brain and skull do not form. The rest of the modelled benefit is around a hundred fewer terminations after a scan has found a defect.
Bangladeshi mothers have a disproportionately high risk of neural tube defects. However, Chapatti flour, which is their main source of flour exposure, is exempt from the mandate.
The way the ‘200 babies saved’ claim has been presented is that it would stop 200 people each year from living a life of disability. The honest benefit is 28 affected live births a year in the Government’s own model.
Even if the 200 figure were accurate, there is a huge imbalance between the stated benefit and the more than 69 million people who could never benefit because they would not be pregnant that year. For those people it is all risk and no benefit.
What is the claim of benefit based on?
Only one large randomised trial has ever tested a modest dose of folic acid in women not at high risk. It was run in Hungary by Andrew Czeizel and reported fully in 1994. It is the only relevant trial evidence for what is about to be done to the British food supply.
It found six neural tube defects among the women given a placebo of trace elements and none among the women given folic acid along with a multivitamin. That result is the basis of the policy.
The same trial also recorded that every category of foetal death, miscarriage, ectopic pregnancy and stillbirth was more common in the group given folic acid. Added together, there were about 70 more pregnancy losses among those women. That imbalance was statistically significant but the importance of this finding has been ignored while the six defects figure has been used to dictate policy globally. Adjusted for the higher conception rate in the treatment group, it works out at roughly nine dead foetuses for every defect prevented.
In 1997 Czeizel himself, with co-author and epidemiologist Ernest Hook, published a paper in the Lancet asking whether folic acid was selectively ending the pregnancies in which a defect had already formed. They named that mechanism terathanasia, the loss of a damaged foetus, and stated that selective loss could account for the entire apparent protective effect.
Judith Hall, one of North America’s most senior clinical geneticists, wrote in reply that pathological data on the losses would be highly desirable, then argued that any further research would be unethical as it could interfere with a very important public health opportunity.
Nearly 30 years on, the question is still unanswered.
Either way, when mothers are told to take folic acid, none are told that the risk of them losing their pregnancy as a result is nine-fold higher than the chance of preventing a neural tube defect.
NHS advice
The NHS has long advised particular groups to avoid folic acid or to take it only on medical advice: people with vitamin B12 deficiency especially if not yet diagnosed, people with cancer, those on renal dialysis and people with a coronary stent.
These are not rare categories. Around 3.5 million people in Britain are living with cancer at any one time and more than 400,000 are newly diagnosed each year; roughly 100,000 receive a stent. Undiagnosed B12 deficiency is also common, affecting around one in five people over 60.
As the implementation date approaches, the cautions for dialysis and stent patients have been quietly removed from the NHS folic acid page. Internal records released under freedom of information show the dialysis warning was cut deliberately, because staff found the evidence “confusing”; there was no recorded reason at all for cutting the stent warning. Asked in Parliament why, the responsible minister said the new format was shorter and simpler. No trial was cited showing that folic acid had become safe for either group. The stent warning has since been restored, after a member of the public refused to accept the explanation. The dialysis warning has not.
There is also a dose problem. The UK expert group could not set a safe upper level for folic acid. It was set at a guidance level instead, because the evidence on adverse effects was judged insufficient. It was set at none at all for children, because there were no data to understand the effects. The one figure that exists, a provisional guidance level of a milligram a day, is based on a single adverse effect, the masking of B12 deficiency, which can lead to permanent neurological harm; everything else was left unmeasured.
Meanwhile a pooled analysis of the randomised trials at doses below one milligram a day, the range relevant to fortification, found cancer incidence 23% higher in the folic acid group when the trials’ own individual level records are used and 18% higher when only their published summaries are. The signal is absent above one milligram and it therefore disappears when all doses are averaged together. It is accepted that drugs have different positive effects on the body at different doses but the fact that there was no signal at higher doses of folic acid is used to dismiss the clear signal at fortification level doses.
Implications
Whatever you may think about folic acid, this legislation has far broader implications. It crosses an ethical red line in allowing government to add a licensed medicine into a staple food exposing people to unmeasured doses – and all for the claim of a benefit that can only affect a tiny minority of the country. Furthermore, this is being done without any Parliamentary vote, risk benefit analysis, ethics assessment or public information campaign.
There is a petition to try to trigger a belated parliamentary debate.
Dr Clare Craig is a diagnostic pathologist and Co-Chair of the HART group. She is the author of Expired – Covid the untold story and Spiked: A shot in the dark.
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