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Amanda Clarke
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Tue 4 Aug, 19:20
There are few studies on the impact of folic acid and certainly not sufficient to cause people to have little choice but here are the supported reasons given for not mandating. In 1875, Parliament made it a criminal offence to adulterate flour. The Sale of Food and Drugs Act of that year addressed a scandal that had been building for decades in which bakers bulked out their bread with alum, chalk and plaster of Paris. The principle laid down by the Act was clear and has never been repealed - you must not tamper with the staple food of the nation nor put anything into bread that is injurious to health. One hundred and fifty-one years later, your department is about to do exactly that. From 13 December 2026, under the Bread and Flour (Amendment) Regulations 2024, every sack of non-wholemeal white flour sold in this country must contain synthetic folic acid. Imported flour is included. Organic flour is included. There is no opt-out for anyone who would prefer not to ingest folic acid. Dr Craig has set out the full case, with references, in a published series. What follows is a summary of why the proposed mandate is unscientific and harmful and must be abandoned. No Folate-Deficient Group to Treat The policy assumes there is a group of women of childbearing age who are short of folate, requiring supplementation to reach normal levels. There is no such group. If you measure folate across a population, you get a bell curve. There is no level below which deficiency begins and no level that predicts a neural tube defect (NTD). The Irish data of Daly and colleagues showed that NTD risk falls as folate levels rise, but the risk never reaches zero, not even at the very top of the distribution. There is no deficient subgroup. No one needs their folate levels to be corrected.Your own department once said as much. In 1981, the Committee on Medical Aspects of Food Policy investigated this issue and found no public health problem of folate deficiency in the general population and, therefore, no nutritional justification for adding folic acid to flour. The Chief Medical Officer of the day set the conclusion out in his preface. Since then, British folate intakes have not fallen. If anything, diet and intake have improved. When Chile fortified its flour in 2000, serum folate in women of reproductive age rose almost fourfold and red cell folate by nearly two and a half times. The before-and-after curves barely overlap; almost no one in fortified Chile had a folate level that would have counted as normal the year before. That is not the correction of a deficiency, it is what a drug does. We do not know the effect of giving this synthetic drug to every person of every age, sex and state of health, year after year. Worryingly, folate fuels cell division, which is exactly why people with cancer are advised to avoid it. Folate RDA Unscientific and not Evidence-Based The dose tells its own story. The body loses about 50 micrograms (μg) of folate a day but the minimum Recommended Daily Allowance (RDA) was set at 100μg of bioavailable folate to ensure sufficient intake. Any and every diet can easily achieve that level each day. In 1989, a US panel doubled the RDA to 200μg, to allow for the poorer absorption of folate from plant sources. In 1998 a second panel – part-funded by a corporate donors’ fund that included Roche Vitamins, then the largest maker of synthetic folic acid in the world, alongside two other firms with a vested interest – took 200μg as if it were the requirement and doubled the RDA again to 400μg. Again, based on lower availability of folates from plant sources. The same excuse was used to double the level twice over. Later work put plant folate absorption far higher than originally assumed, making even the first doubling too generous. The unnecessarily high RDA of 400μg that resulted from these erroneous calculations cannot be achieved through diet. Industry involvement in this decision made it appear that (unnecessary) folate supplementation was, in fact, essential. Folic Acid is a Synthetic Drug Impairing Natural Folate Absorption Importantly, the folic acid used to fortify flour is not the same as folate found in food. Folate in food is a reduced molecule. Folic acid is a synthetic, oxidised version with a much longer shelf life. It can be converted to something the body can use, but the enzyme needed to do that (dihydrofolate reductase) has a very low efficiency so can take several hours. In fresh human liver, Bailey and Ayling found that dihydrofolate reductase handles folic acid about 1,300 times slower than natural folate and 56 times slower than the same enzyme in rats, on which most of the safety testing was done. In humans, it rapidly saturates and the unconverted surplus then circulates. This surplus (synthetic) folic acid is detectable in roughly four in ten adults, even after a long fast. It has the unwanted (negative) effect of binding the transporter that carries folate into the brain more tightly than natural folate, effectively blocking folate availability to the brain. In other words, the likely effect of forcingfolic acid into the blood is that, for a period of time, LESS folate (not more) reaches the developing brain. The irony is hard to miss. In addition, four in ten Britons carry at least one copy of the common MTHFR variant which makes them particularly vulnerable to exposure to folic acid. Slowness in this enzyme creates yet another bottleneck, resulting in periods of sustained exposure to synthetic folic acid in the bloodstream. Patients Advised to Avoid Folate Supplementation As well as the 40 percent with genetic vulnerability to the negative effects of folic acid, the NHS warns specific groups to avoid folic acid supplementation on the NHS “Who can and cannot take folic acid” page. This includes those with; an allergy, low B12, pernicious anaemia, cancer, kidney dialysis, or a heart stent. Yet the public have not been warned to avoid all products made with white flour if they fall into one of these categories. Studies also suggest that men face a doubling of prostate cancer risk from folic acid exposure. The positive public health claim is that fortification will prevent an estimated 150 to 200 cases of neural tube defects (NTDs) in babies each year. An estimate based partly on the UK having higher prevalence of NTDs than the USA – but this was true before any fortification in the US. In fact, UK NTD rates have fallen far more since the 1980s without fortification than USA rates have with fortification. Nine Dead Babies For Every NTD Prevented The fall in NTD live births after fortification was not matched by a fall in affected pregnancies. European EUROCAT data, which count terminations and stillbirths as well as live births, show the total NTD cases broadly flat for decades. Fewer affected babies were born because more were found and aborted as diagnostic ultrasound improved, not because fewer were conceived. The only large, randomised trial in low-risk women, the Hungarian trial of Czeizel and Dudás, recorded in its own published table six neural tube defects prevented against around seventy excess foetal deaths in the supplemented group. Per pregnancy, that is nine dead babies (mostly miscarriages) for every defect prevented. Nine. The trial’s own principal investigator then co-authored a paper in the Lancet asking whether folic acid works not by preventing these defects, but by killing the affected babies in the womb before they can be born. He gave it a name: terathanasia – the death of monsters. The studies that could have confirmed this were forbidden after public health officials said it would be “unethical” to carry out further research. Thirty years on, the question still stands. Risk Outweighs Benefit for Majority and Uncontrolled Folic Acid Dose It is unethical to justify harming one person by claiming a theoretical benefit for someone else. Seventy million people will eat this fortified flour. Only around 600,000 women in the first weeks of a pregnancy have even a hypothetical chance of gain. For the other sixty-nine and a half million - men, children, older women and most women most of the time - there is no possible benefit from fortification at all. Only risk. For each of them the benefit is not small but nil, so any risk at all, however slight, is significant and unacceptable. The risk to benefit ratio is negative for the vast majority of the population. In addition, there is no ability to control for the dose of folic acid ingested by an individual. Folic acid intake will vary by dangerous orders of magnitude, depending on dietary choices containing white flour. Cheaper and ultra processed foods are more likely to contain white flour than organic wholefoods, negatively impacting the economically disadvantaged by exposing them to far higher levels of folic acid than those who can afford wholemeal, unadulterated flour and unprocessed foods. Mass Medication of the Public Violates Informed Consent Mass medication of this kind is unethical and incompatible with legally mandated informed consent for all medical interventions. Individuals should always have the right to refuse any medication. Fortification of a staple food denies the public the right to make an individual risk v benefit calculation and choose to avoid exposure to a synthetic chemical. Individual folic acid supplementation is easy and cheap to offer to the only people who may benefit - women who plan to get pregnant or who are in the early stages of pregnancy - which is already a standard and well adopted part of prenatal care. Conclusion and Request There is no significant public demand for folic acid fortification of flour. In the 2021 Government Public Consultation, the result was close with just over half the respondents (53%) supporting the plan. Comments included worries about lack of autonomy, especially for those individuals at particular risk from excess folic acid intake. Only 35% of businesses from the heritage and artisan milling sector were supportive. The impact assessment accompanying the consultation included no information on potential risks of folic acid supplements.
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