Charities Commission Registration CC22512

Submission to the Ministry of Health and the Food Safety Authority on folate fortification of food to reduce neural tube defects - 19 August 2004

This is the full text of our submission made in support of CCS New Zealand's call for mandatory fortification of flour with the dietary supplement folate, and in response to the questions in the consultation document.
 
Q.1 What is your view on the effectiveness of voluntary fortification in delivering folic acid to women of childbearing age?

The available evidence suggests strongly that a voluntary regime falls well short of being an effective method of folic acid delivery to the target population.
Indications of some impact in Western Australia with a voluntary regime, should be seen in the context of a relatively poor outcome for the effort expended, despite a significant public awareness campaign, and the likelihood that this reductions was also influenced by concurrently increased levels of pregnancy termination through greater identification during pregnancy (an indicator of failure rather than success of the programme).
The apparent reluctance of the food industry to engage strongly in voluntary fortification measures, is a key factor demonstrating the failure of a voluntary approach.

Q.2 Are you aware of any evidence relating to voluntary fortification not considered in this discussion document? Please give details.

The socio-economic factors involved in food choices, discretionary spending, and awareness of such matters relating to fetal health, clearly indicate that a voluntary regime will see benefits accrue to the best educated and wealthiest, with a disproportionate burden of preventable death and morbidity bearing on those in lower socio-economic groups, including Maori and Pacific populations.
The evidence suggested for this is an extrapolation of extensive work done on the Determinants of Health by the National Health Committee, and work associated with Maori Health and Pacific Health Strategies. Australian experience also bears this out starkly in relation to the absence of any beneficial impact of a voluntary regime on the aboriginal population.

Q.3 What is your view on the effectiveness of mandatory fortification to deliver folic acid to the target group?

The available evidence strongly indicates that mandatory fortification is the only practical way to ensure widespread delivery of this vitamin across all target populations, in quantities that are able to have a significant impact on the serious public health problem of Neural Tube Defects.
However there is a need for careful consideration of the Tolerable Upper Intake Level (TUIL), the potential for masking of Vitamin B12 deficiency, and how these two factors influences levels of fortification and the decision of whether to fortify or not. In this regard there should be consideration of the following factors:
• The TUIL is set at one-fifth of the level at which symptoms from excess ingestion are likely to occur.
• The potential masking of B12 deficiency is, in itself, not a direct harm from the folate additive. Harm that might occur to certain people would be harm from their B12 deficiency, not from the folate’s “masking” effect. Management strategies are possible to counter that underlying cause.
• Other emerging evidence pointing to additional health benefits of folate should be taken into account in balancing these issues and determining fortification levels.
In assessing these factors we support the submission of CCS that fortification of flour with folic acid should occur at the current level permitted under the voluntary regime (285mg/100g flour). The balance of risks and benefits lies strongly in favour of fortification. The solution to any masked B12 deficiency lies in action to screen and diagnose this condition, not in “not doing” fortification at all, nor in doing it at an inadequate level.

Q.4 What is your view on the impact of mandatory fortification on consumers?

Modern society contains a range of views on matters of government regulation, desirability of food additives, and acceptability of change. It is probably inevitable that some voices will be raised in opposition to mandatory fortification, with arguments including a preference for “natural” foods, and individual responsibility for people’s own health. Similar arguments are found in opposition to fluoride in water, and to vaccination against preventable disease.
NZORD suggests that such views are not supported by the substantial majority of New Zealanders. Our experience is that among well-informed people there will be overwhelming support for carefully managed and thoroughly researched programmes to improve public health and avoid preventable death and disability among babies. This is despite some strident voices that might argue against such proposals, and give a distorted impression of levels of “public concern.”
Consumers might respond at first with some anxiety if the explanation is not well managed. Anxiety might be higher if opponents to mandatory fortification engage in organised campaigns to raise public concern. The Ministry and the Food Safety Authority should accept a responsibility to specifically counter any misinformation that might emanate from opponent groups, and to inform the public of the evidence base and the actual experience in many other countries.
Like iodine in salt, vitamin C in fruit drinks, vitamins added to Marmite and Vegemite, and many other additives, folate is an added form of a vitamin, a boost with an equivalent to a natural dietary substance. It should not be considered like a “chemical” additive in terms of risk or appropriateness. It should be welcomed as an ideal way to manage health risks.
If public awareness is handled well, consumers will appreciate mandatory fortification as the equivalent of improvement of other food with vitamins and minerals. In this case the fortification will be seen to have a very significant benefit for babies through the avoidance of Neural Tube Defects, and other potential health benefits for all of us, at minimal risk to the population at large.
In assessing public responses we urge the Ministry and the Food Safety Authority to give significant weight to the submission of CCS. As the group most representative of individuals and the families directly affected by Neural Tube Defects, their voice should carry greater weight than any other interest group in the public, as they carry the burden presented by the current risks. Their submission is a clear identifier of the urgency for a policy changes, and a significant indictment of the opportunities lost through delay here in New Zealand compared to other countries.
NZORD also has a representative role in this debate, to the extent that we have extensive networks with a range of support groups and individuals affected by many significant health conditions. Despite some divergent and sometimes strongly held personal views (as would be expected in a free and plural society) the perspective of these groups, families and individuals is overwhelmingly supportive of well planned efforts to safely reduce the incidence and severity of disease and disability in our community.
The worst case scenario is one where the “European disease” prevails and opponent groups stall the proposal as happened in the United Kingdom in 2002. This will only happen in a vacuum of good information, and if the positive experiences in North America and other countries are ignored.
Of particular significance in assessing public response, is the fact that as with many other food choices today, those with particular preferences or strongly held views on additives will have alternative food sources that are not fortified, and will be able to manage their own voluntary fortification if that is their wish. This will retain their “informed dissent” options.

Q.5 What is your view on the impact of mandatory fortification on the food industry?

The evidence points to an industry that is willing to support the proposal provided an appropriate lead is given by government.

Q.6 How would you like to see folic acid in the food supply monitored?

Carefully planned and adequately funded research projects should be put in place to monitor the implementation and the benefits, assess any possible risks, and evaluate the outcomes.

Q.7 Are you aware of any evidence relating to mandatory fortification not considered in this discussion document? Please give details.

NZORD supports the suggestion of CCS that benefits of fortification to over 50s ought to be factored into the decision making process. It would appear that these benefits alone might well outweigh any “indirect” disadvantage that masking of B12 deficiency might cause.
Cost effectiveness is not mentioned in the consultation document. Perhaps the strongest “cost” argument in favour of fortification is a comparison with the impact of the current meningococcal epidemic in New Zealand. This has caused, on average, 400 cases, 16 deaths and unspecified amounts of significant permanent disability, each year since it began in 1991. It is rightly seen as a case for urgent public health action and over $200million is spent to control it. NTDs in approximately the same timeframe have led (CCS data) to between 30 and 50 affected live or still births each year, and termination of approximately 50 affected pregnancies. The cost to achieve significant control of NTDs is to put a trace vitamin in food, for what seems at face value an equivalent or greater level of mortality and morbidity.
The significance of the public health problem inherent in NTDs is not well recognised in the consultation document.  If public health is about promoting well-being and preventing ill health before it happens, through the organised efforts of society (Ministry of Health: An Overview of public Health, 2002), then fortification would fit the mould very well. There is an unfortunate frequent perception of public health as dealing mainly with external risks to individuals. Perhaps that flows from so much public health effort being directed to those environmental factors. However the vulnerability that individuals have to disease because of their diet or genetic makeup is equally a public health issue where patterns and possible interventions can be identified. This is well established in screening programmes for breast and cervical cancers, and in newborn screening for metabolic diseases. Taking a public health approach to NTDs will help strengthen the case for the implementation of mandatory fortification, as well as strengthen the concept of responsibility for the government to implement such a programme.
The argument of the responsibility of government is about the moral duty (perhaps this ethical imperative is also a legal obligation) to provide services and programmes to improve the health and wellbeing of its citizens. In other words, what is demonstrated as proven and safe, and is effective in improving health and wellbeing, or preventing mortality and morbidity, and is reasonably achievable within the resources available, must be done with reasonably expeditious effort. The stronger the evidence of safety and benefit, with low or managed risk, and the easier the implementation is, so the greater the moral and legal obligation on the government to act to implement. This argument is supported by reference to the delay in implementing screening of blood products for hepatitis C, and the resulting compensation paid to some affected patients. We think this area of ethical and legal duty needs more exploration for this policy consultation as well as other health policy matters. It is a potentially strong counterbalance to any suggestion that public concern is a reason not to act.

Q.8 How do you think folic acid should be increased in the food supply to prevent NTD’s?
Option one: Continuation of the status quo – voluntary fortification yes/no
Option two: Introduction of a new policy - mandatory fortification yes/no

NZORD support option two - a new policy of mandatory fortification, and specifically endorses the submission of CCS that fortification of flour should be the vehicle of delivery. Additional voluntary fortification should also be encouraged.