In April of this year, the New Zealand Government once again sought to defer the introduction of manadatory folic acid fortification of bread in their nation, until September 2012. This additional time frame was sought to further allow assessment of outstanding health and community concerns in relation to this public health measure. This same level of concern led to the New Zealand government departing from its FSANZ charter back in 2009, when this very same public health measure was introduced into Australia with little public or scientific discourse.
As a patient in the care of any health practitioner in Australia, consent to treatment of any kind is enshrined in law. Treatment without consent is liable to assault and battery charges under criminal law in all Australian jurisdictions. Yet daily, most Australians are being treated without consent through the food they eat. Since 2009, all wheat flour destined for bread making in Australia is required by mandate to be fortified with folic acid, a synthetic analogue of the naturally occurring folate. The rationale of this measure is to target the relatively small focus group of pregnant women in their first trimester of pregnancy, who may not otherwise be receiving enough folate, in a bid to reduce the relatively small proportion of children born with devastating neural tube defects. While arguably a sensible public health measure on the surface, is such a shot gun approach to medicating, whereby the vast bulk of recipients do not require the medication, let alone have consented to it, really a benign public health measure? This question is set to be further tested in scientific, legal and public policy circles as there is a growing body of evidence that excess folic acid is not necessarily a harmless addition to the human diet.
In September 2009, The Australian Government through its statutory food authority – Food Standards Australia, New Zealand (FSANZ) implemented the mandatory fortification of wheat flour for bread making with folic acid. Only certified organic flour is exempted. The measure which was instigated under the Howard federal government and implemented under the Rudd federal government appears to enjoy bipartisan political support. The New Zealand Government, which shares the same statutory body as the name suggests, postponed the implementation of folic acid fortification until at least 2012 on the grounds that further research on public safety was required. The impetus for folic acid fortification of wheat flour has existed for some time in Australia. A number of other countries implemented such fortification some time ago, most notably the US and Canada which have both had the measure in place since 1998. Currently, the UK and Germany are considering the measure under fierce debate and raging controversy. The public acrimony, largely absent from the Australian scenario in 2009, within these European countries, stems from a growing body of evidence that folic acid is associated with some potential detrimental effects. It is argued that simply not enough is known about its long term effects under a constant dosage regime as would be occurring under the daily consumption of bread.
The link between folate deficiency and neural tube defects (NTD’s) within the early embryo is clear and the role of increased folate or folic acid during this early stage of pregnancy in averting such defects is also well established. For many decades now, Australian women have been targeted with a public health message of supplementing folic acid when planning to become pregnant or at the first instance of becoming aware of pregnancy. It is standard antenatal care from health practitioners to promote this over the counter supplement to their pregnant female patients. Of course under such circumstances the choice to take the medication is entirely that of the individual women in question. Under this approach NTD rates in Australia had fallen from approximately 16 cases per 10 000 live births in 1982 to approximately 7 cases per 10 000 live births in 1997. However, despite ongoing promotion and advocacy of folic acid supplementation in early pregnancy, NTD rates in Australia had remained constant from 1997 through to 2005 at 4.6 cases per 10 000 live births.
In the US rates of NTD’s have decreased 26% from the time of folic acid fortification programs in 1998 up until 2005 and over the same period NTD rates in Canada fell an impressive 54%. However over the concurrent period some research has found colorectal cancer rates to have increased in both countries leading to many scientists to urge caution in relation to folic acid dosing and calls for greater research into the potential harmful effects of excess folic acid particularly in relation to tumour cell growth promotion. Conversely, other recent studies in the U.S. point to no significant increase in colorectal cancer rates since mandatory folic acid fortification. Meanwhile, researchers looking at the molecular link between precancerous lesions and tumour promotion in the presence of folic acid have found a plausible link. Confused? Well you may not be alone. The scientific community is similarly vexed over the public health complexities of folic acid fortification.
Contributing to the concern over excess folic acid consumption, a recent comprehensive study in Canada, found that only 1% of the population were shown to be folate deficient and that 40% were demonstrated to have excessive free folic acid in their blood leading the authors to conclude that folate deficiency in Canada is almost entirely absent yet excessive folate concentrations do exist. The authors further state;
“Correction of folate deficiency and improved folate status, in part through fortification, has been associated with positive health outcomes such as the dramatic reduction in neural tube defects, However, given speculations about the possible adverse effects associated with high levels of folic acid, including increased risk of certain cancers in those with pre-existing neoplasms, further attempts to improve the folate status of Canadian women of childbearing age by increasing fortification levels should be approached cautiously.”
A similar study conducted in Ireland in 2009 found both 90% of fasting mothers and 80% of their fasted newborns contained excessive free plasma folic acid levels in the absence of recent dietary intake. Closer to home a study conducted here in Australia to assess the impact of mandatory folic acid fortification on plasma levels of folic acid found that there had been a 77% reduction in folic acid deficiency in the period of just one year from the 2009 introduction of the fortification program. Excess free folic acid was not reported on in this study.
Folates, commonly referred to as vitamin B9, are a naturally occurring family of compounds, known as tetrahydofolates, found in a wide range of foods, most notably in green leafy vegetables. Folate plays a critical role in human cell DNA synthesis and repair. It has pivotal role during rapid cell division and growth. Although the terms folate and folic acid are often used interchangeably, they are distinctly different compounds. Folic acid is a synthetic analogue of folate that does not occur in nature and was not a constituent of the human diet until it became a common supplement for naturally occurring folates. This is a critical distinction within the debate over folic acid fortification, not least due to the paucity of knowledge on the exact metabolism of folic acid in the human body. Perhaps more crucial to the debate, however, is the fact that it should be viewed unquestionably as a drug or medication, due to its wholly synthetic origin and its addition to food with the intent to treat for a medical condition. Fortification with folic acid is not simply a case of adding additional naturally occurring compounds to food as occurs with iodine fortification.
In addition to concerns over excess folic acids role as a tumour growth promoter, other known concerns include folic acids documented role in contributing to and masking vitamin B12 deficiency anaemia – especially in the elderly with resulting cognitive impairment, a link to immune system suppression, and a demonstrated link to increased twins in pregnancy. In another recent study conducted in Canada, analysing vitamin B12 and folic acid status post mandatory folic acid fortification, essentially none of the population was found to be folic acid deficient, however a very significant figure of 5% was now found to be vitamin B12 deficient. Perhaps ironically, research now points to low vitamin B12 status in pregnant mothers as an additional risk factor for NTD’s. Some researchers have further concerns over excess folic acid relating to incidence of asthma and epigenetic changes brought about by folic acids inherent role in DNA synthesis. Furthermore, excess folic acid is known to interfere with the metabolism of a number of important drug therapies, including medications prescribed for cancer, malaria, rheumatoid arthritis and psoriasis.
Compounding the problematic nature of wheat flour fortification with folic acid is the inexact delivery of dose, not only to the target group of women in early pregnancy, but exposure to the population at large. Australian health authorities recommend folic acid in daily doses of 400mcg for pregnant women. FSANZ has mandated a dose of 2000mcg -3000mcg of folic acid per 1000grams of bread. This would equate roughly to 1400mcg – 2100mcg per standard loaf of bread. It is clearly not difficult to perceive that a large proportion of the population would consume in excess of two to three times the standardised dose, through the consumption of bread and bread like products, on a daily basis. If additional folic acid is consumed through supplements such as a multivitamin, with a typical dose of 200 – 800mcg, on a daily basis, it is difficult to see how dose exposure across the population can be correctly accounted for. A measure of this problem comes from a 2010 study in Chile, a country with a mandatory folic acid fortification program, which demonstrated that 99% of women and 100% of men consumed greater than the standardised daily consumption requirement.
This is of serious concern to critics of the program such as lawyer Joe Lederman at FoodLegal, a specialist law firm based in Melbourne that focuses on food related legal issues – ‘the mandatory fortification of a food may leave Australian consumers legally vulnerable in the event that it has an adverse impact on any sector of the population.’. The issue of excessive dose exposure is further complicated by the fact that the bulk of recipients would be unaware that they are being medicated. This fact is demonstrated by a West Australian survey conducted prior to the introduction of the mandatory 2009 program which showed 86% of respondents knew little or nothing about folic acid and the intended fortification program. It is unlikely these figures would have altered considerably as public awareness campaigns over the program have been conspicuous in their absence since 2009.
When queried over the problematic nature of dose control for this article, FSANZ deferred questions to the Department of Health, who in turn suggested FSANZ field such questions. FSANZ is the statutory authority that was responsible for promulgating and assessing the folic acid fortification program and is responsible for mandating its technical standards, yet it appears quick to shovel responsibility for the ongoing management and debate of the program to other jurisdictions. Mark Laucke, of Laucke Flour Mills in South Australia and former head of the Flour Millers Council of Australia agrees that FSANZ appears to lack any ongoing responsibility over the program. As an industry representative, he remains opposed to the program citing unresolved concerns over the health impacts of folic acid and the impractical and imprecise nature of medicating through food. As Laucke puts it; ‘Millers have been put in the invidious position of playing pharmaceutical factory, and they are simply not in a place to do it properly.’
Specifically, FSANZ has mandated that all wheat flour other than that deemed ‘organic’ destined for bread making be fortified. The retail product so effected are those products ‘made by baking a yeast-leavened dough prepared from one or more cereal flours or meals and water’ as stipulated in the relevant FSANZ standard for folic acid fortification . The ‘organic’ wheat flour market is thought to represent just 1% of the overall market. FSANZ has stipulated that wheat flour for products such as pizza bases, pastries, cakes and biscuits, be free from folic acid. In effect, according to Laucke, most retail products containing wheat flour have fortified wheat flour as it is too difficult and costly to segregate the manufacturing process for most producers. As Laucke puts it; ‘Most of my clients who purchase wholesale flour, purchase solely fortified flour for their full range of retail products.’ The actual levels of folic acid in final retail products are largely arbitrary according to Laucke, with an apparent lack of active regulation and oversight.
This highlights another apparent flaw in the program, namely responsibility for actual regulatory policing of the program, which currently appears poorly defined. Currently, each state and territory jurisdiction or their delegated officers (including local government officers) has the responsibility for ensuring food standards are met. In regards to monitoring of folic acid levels in bread and its potential appearance in non-mandated wheat flour products, very little if any active regulation and policing appears to be taking place. FSANZ has a duty to ‘co-ordinate the monitoring, surveillance and enforcement of activities relating to food available in Australia, yet FSANZ has no power of enforcement in relation to ensuring compliance by flour millers. Accordingly, FSANZ is not even in a legal position to monitor compliance. Complicating matters is that shelf life affects the levels of folic acid in wheat flour as it is readily oxidised. Often millers over compensate the folic acid dose initially to ensure mandated levels of folic acid are met in time frames distant to the time of milling, all in an inherently imprecise manner. According to Laucke, the “Folic Acid Compliance and Enforcement Model” confirms that there exists an informal agreement between Millers and relevant Jurisdictions that if millers follow agreed but informal protocols regarding “best endeavours” as part of a Quality Assurance Approach, their efforts will be regarded as “good enough” even though the legislated Standard for Fortification has not been met.
Control for dose exposure would seem critical in light of the growing body of evidence surrounding the metabolic effects of folic acid. Some researchers argue that the seemingly conflicting reports on folic acids role in cancer, ranging from tumour growth promoter to stated protective effects against cancer, is dependent on dose. This dichotomy according to Emeritus Professor David Smith from Oxford University is explained by the fact that negative cancer effects occur in the context of prolonged excessive exposure to folic acid and the phase at which a cancer cell exists in its development. As US researchers state in a paper on the effects of folic acid on cervical cancer; ‘These results suggest that mandatory fortification with folic acid in the US seems to have different effects on cancer depending on the stage of carcinogenesis.’ Australian scientists Lucock and Yates also point to the complexities of dose exposure of folic acid on many metabolic outcomes and summarise the debate with the following statement; ‘The highly complex and critical biological importance of folic acid-related molecular nutrition makes it a difficult micronutrient to deploy as a simple intervention at a population level – it has far too many biochemical spheres of influence to predict effects in a generalized way.’
It would appear that many of these concerns have been taken on notice by our co-signatory, New Zealand, to the food regulatory framework overseen by FSANZ. The New Zealand government decided to postpone the introduction of a mandatory folic acid fortification program until at least September 2012, breaking ranks with its Australian partner, whilst it assessed further scientific evidence. This highlights the concerns that many in Australia have, that the potential adverse effects of folic acid in a population wide program were never properly assessed by FSANZ prior to its 2009 introduction. Similarly, the UK and German governments have held off any decision to introduce a folic acid fortification program, while further scientific evidence, and its cost-benefit analysis, is conducted. In contrast to Australia, both of these governments have faced considerable public, scientific and industry pressure to abort the program.
Traditionally, the role of FSANZ and its predecessors has been to ensure food supply is safe. The emergence of public health benefit programs is a relatively new role for Australia’s food safety authority. There exists a raft of administrative and legal shortfalls within the folic acid fortification program according to Lederman. In an issues paper published in the Deakin Law Review, Lederman covers these issues in depth. He points out that while FSANZ takes its policy directions through a ministerial council, it is uniquely charged with making a full and frank assessment and appraisal of any variations to food standards. Its main objective in such an assessment, as dictated by the FSANZ Act 1991 is ‘to assess the safety of food through risk analysis in order to protect the health of the public.’
As early as 2004, under the then Howard federal government, FSANZ was tasked with assessing to determine the most effective way to increase the folate intake in women to reduce the occurrence of neural tube defects (NTDs) and to take into consideration the risks and benefits to the general population of increased dietary folate intake. Subsequently in 2006, the Australian Health Ministers Advisory Council convened an expert panel to report on cost / benefit issues surrounding folic acid fortification. Interestingly, two of the four main contributors to the expert panel were long standing vocal proponents for folic acid fortification programs – Professor Fiona Stanley and Professor Creswell Eastman. Their report to the AHMAC consisted of just two pages. In November of 2006 FSANZ was then asked to address the technical aspects of introducing a folic acid fortification program. In keeping with its statutory obligations under the FSANZ Act 1991, on the 13th April 2007, FSANZ released a lengthy issues paper for public comment and submission. The public submissions closed just 5 days later on the 18th of April, 2007. A little over a month later the draft standard for folic acid fortification of wheat flour for bread making, standard 2.1.1., was revised and published and within weeks given the stamp of approval by the ministerial council for implementation on 13th September 2009. Throughout this process and through its submissions, industry remained opposed to the program. Critics point out that other public health measures exist, and are yet to be explored, to address folic acid supplementation of pregnant women. Alternative proposed measures include adding folic acid to the contraceptive pill as a more pointed means of reaching the target population of menstruating women.
In reviewing the implementation of the revised food standards code 2.1.1 by FSANZ, Joe Lederman maintains that FSANZ breached a number of its legal obligations. Namely, it failed to make its own public health and safety assessments as required by the Act,;instead it based its proposal on advice that could reasonably be perceived as both inadequate and biased; and it failed to fully consider the practicalities of the programs implementation including such issues as dose control and exposure. Also of concern is that FSANZ’s own issues paper for the draft report identified that the target audience of pregnant women are not known to eat a lot of bread and that practical delivery of folic acid to this audience could not be assured. Meanwhile, it is known that men represent the largest consumers of bread products and therefore conceivably are the audience most exposed to excess folic acid and any inherent risks.
So what legal recourse does the at-risk consumer have in relation to a demonstrable harm caused by excessive folic acid intake? Very little it would seem. Whereas both criminal law and tort law allows for a patient of a health care practitioner to seek redress if incorrectly or unknowingly treated without consent, the ‘consumer’ nature of exposure to folic acid in fortified bread does not engender the same legal safety net. Potential avenues exist under the Trade Practices Act, but this would leave the unwitting flour millers and bakers exposed to liability. Individual state law enforcement bodies, those supposedly responsible for monitoring food safety are unlikely to be liable, as enforcement of the presence of folic acid compliance is their main responsibility under the food standards code and not any ensuing harm it may cause. This leaves the unlikely avenue of FSANZ and the Federal Government being held liable. Currently the FSANZ Act 1991 exempts ‘FSANZ itself, any person assisting FSANZ, any member of the Board of FSANZ and the Commonwealth government from any civil or criminal proceeding in relation to any loss or injury directly or indirectly sustained by a person because of the consumption of, or other dealing with, food.’ In May of this year, The Ministerial Council and FSANZ flagged instigation of a review of the folic acid fortification program which in effect meets an undertaking to review after three years that was taken at the time of implementing the program.
While increased folate levels in early pregnancy has demonstrable effects in lowering NTD’s, the issue of folic acid fortification as a public health measure is not the benign act of a paternal state, as it may first appear. Instead it has been a program that has utilised a crude delivery of a drug for a limited target audience across the population at large. It was implemented with little safety assessment, such that New Zealand forestalled its implementation, and without due consideration to monitoring of dose exposure across the population. It held little regard for the practicalities of delivering the drug and heaped undeserved responsibility upon unwilling flour millers. Furthermore it delivered almost nothing in the way of a public awareness campaign, such that most consumers are likely unaware of its existence. All of this in a legal framework that likely obfuscates FSANZ and all other promulgators of the program from any legal recourse if in fact, time and further research is to demonstrate, a definitive negative health impact on part of the community due to excess folic acid exposure.
Shane Humphreys is an emerging freelance journalist who has previously worked for over a decade in the healthcare sector. Shane is now pursuing his career and passion in investigative journalism and documentary film making. Shane is President of the Tasmanian Branch of the Surfrider Foundation.
• Big Chem, Big Harm?
By NICHOLAS D. KRISTOF
Published: August 25, 2012
NEW research is demonstrating that some common chemicals all around us may be even more harmful than previously thought. It seems that they may damage us in ways that are transmitted generation after generation, imperiling not only us but also our descendants.
