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Proposal P295 – Consideration of Mandatory Fortification with Folic Acid – Draft Assessment Report

31 July 2006

Dear Sir/Madam

Thank you for the opportunity to comment on this proposal. The following sets out the views of the New Zealand Food Safety Authority (NZFSA). The submission also represents the views of the Ministry of Foreign Affairs and Trade (MFAT), Ministry of Economic Development (MED) and the Ministry of Consumer Affairs (MCA). The Ministry of Health (MoH) supports this submission in principle. A comment from the Commerce Commission in relation to the Fair Trading Act is provided in this submission.

All the government departments involved in this joint submission have strong concerns at the very short consultation period provided for this proposal. It has not allowed sufficient time to prepare considered responses in a number of areas for what is a very important issue. We are continuing to work on some of these areas beyond the closing date for submissions on the basis that this information may be useful in the decision making process.

This submission supports the principle of mandatory fortification of food as long as it can be demonstrated to be the most effective way to achieve a health benefit across the target New Zealand population. An alternative approach has been proposed and details of this are provided in this submission.

This submission does not support FSANZ’s preferred approach for the food vehicle as outlined in P295 Consideration of Mandatory Fortification with Folic Acid – Draft Assessment Report (DAR). This approach would require mandatory fortification of all bread-making flour with folic acid at a proposed level of 230-280 micrograms (µg) of folic acid per 100 g of bread-making flour to achieve an average residual level of approximately 200 µg folic acid in the flour component of the final food. The approach would maintain current voluntary folic acid permissions, except for bread-making flour which will be changed to a mandatory requirement.

The approach outlined in P295 is not acceptable in New Zealand for the following reasons. Further detail on each of these issues follows.

• Mandatory fortification of all bread-making flour would not allow New Zealanders’ a choice between fortified and unfortified bread products because New Zealand flour mills are unable to separate out fortified and unfortified bread-making flour.

• There is potential risk of exceeding the upper level of intake (UL) for folic acid for particular groups of the New Zealand population especially young children and older people.

• Some parts of the New Zealand flour milling industry could become non-viable due to the additional infrastructure and capital expenditure that would be required to add folic acid to bread-making flour.

• Assumptions made in the dietary modelling and lack of consumer research on bread intakes in the target and at risk populations could underestimate the folic acid intakes of the target population and thus reduce the effectiveness of mandatory fortification.

• Trade issues, particularly in relation to export of bread and related products with added folic acid to countries that either do not allow the addition of folic acid or do not want product with added folic acid.

• The cost-benefit analysis is deficient in a number of areas that have significant cost implications for New Zealand eg, consumer choice was not accounted for, no cost included for communication and education strategies, monitoring and compliance.

• Further work needs to occur to ensure the proposed level is appropriate for New Zealand. FSANZ needs to consider the impact of the proposed fortification level and the continued consumption of foods that are voluntarily fortified on big consumers of bread products and the risk of exposure to high levels of folic acid in the long term, especially children.

• The monitoring process needs to be in place prior to the gazettal of a mandatory standard.

• Women planning a pregnancy will still be required to take a folic acid supplement four weeks before and 12 weeks after conception. Therefore education will still be an important component of increasing folic acid intakes and folic acid tablets.

Consumer choice

NZFSA commissioned Peter Glen and Associates to undertake research on consumer attitudes to mandatory fortification. This research, conducted in 2005, showed that 84% of the consumers interviewed, even after providing information on the reasons for fortification, did not support mandatory fortification. This research supported the findings of the New Zealand Association of Bakers research undertaken in 2004.

Given the level of resistance to fortification in the New Zealand population it is vital that consumers are provided with choice between fortified and unfortified bread products. The FSANZ preferred option to fortify all bread-making flour would result in New Zealanders having no choice between fortified and unfortified bread and bread products. All retail bread mixes and retail flour for bread making would be fortified so even making your own bread at home would not allow consumers to avoid folic acid fortified flour.

We note FSANZ’s point that there is a paucity of research about consumers’ attitudes to fortification. However FSANZ did not undertake any research before this DAR was released to ascertain consumers’ views in New Zealand. Consumer acceptance is essential to the effectiveness of any mandatory fortification programme.

There is potential for consumer backlash to the addition of iodine to food as a result of FSANZ’s preferred option. Consumer acceptance of mandatory fortification is critical to ensure the on-going success of this and any other mandatory fortification programmes that may be introduced in the future. Increasing folic acid levels is not necessary for the majority of the population. It is important that consumers are not disadvantaged either by lack of choice or economically.

Risk to particular population groups (young children, older people)

The modelling presented in P295 is not necessarily accurate for New Zealand populations. It is appropriate to use Australian consumption data for New Zealand children only if the use of New Zealand data and modelling has been investigated and exhausted. FSANZ appears not to have taken into account the fact that all flour, not just bread-making flour may be fortified with folic acid in New Zealand. Some New Zealand flour mills cannot separate out bread-making flour resulting in some ranges of biscuits, fresh and dried pasta, pastry and noodles containing fortified flour. Therefore the percent of New Zealand children exceeding the UL could be far greater than 6%.

There are also unknown risks that may not become apparent for one or two generations. Children will be exposed to much higher levels of folic acid than in previous generations. It may not be until this generation of children has their own children that adverse effects become apparent.

No monitoring of young children has been undertaken in the USA or Canada but both these countries provide some consumer choice between fortified and unfortified bread. Providing choice would remove the risk of caregivers, who do not want their children to consume fortified bread, removing bread from the diets of the very young children which would not be in keeping with the New Zealand National Nutrition Guidelines.

Labelling

NZFSA and the MoH recommend that the level of folic acid should be included in the Nutrition Information Panel (NIP) when it is added to bread products rather than only being declared as a requirement when making a nutrition claim for folate on those products. The requirement to declare folic acid in the ingredient list will not be sufficient for women to be able to calculate the amount of folic acid they are getting from fortified foods and thus the level of supplementation required to reach the optimum level of 400 µg of folic acid a day. Under the FSANZ proposal the level of folic acid will not be the same for all bread types as it will be determined by the white flour component in the bread. By declaring the amount of folic acid in the NIP consumers will be able to make comparisons between products and then choose products with the amount of folic acid they want to consume.

Ministerial Policy Guidelines for mandatory fortification state “consideration should be given, on a case by case basis, to a requirement to include information in the Nutrition Information Panel”. This gives the scope to be able to include folic acid levels in the NIP and NZFSA would support this happening.

NZFSA recommend that any reference to folic acid on food labels should use the term folic acid and dietary folate equivalents (DFEs) so that the public becomes familiar with the new terminology. With education this will help the population to understand the relationship between folic acid and DFEs and be aware of how much they are consuming.

Within the Australia New Zealand Food Standards Code (the Code) the terms folic acid and folate are used interchangeably and this creates confusion. Standard 1.1.1 refers to the RDI for folate but is given as 200 µg of folic acid. Standard 1.1A.2, permits a health claim for folate but part of the permitted claim states “the recommendation that women consume a minimum of 400 µg of folate per day…..”. The MoH recommendation in New Zealand is that women consume 800 µg of folic acid not folate¹. It is important that this confusion is clarified at the time any mandatory standard is proposed otherwise women may not be consuming the optimum amount of folic acid to reduce the risk of a NTD pregnancy.

In addition we note that the proposed claim for folic acid and neural tube defect as per P293 “recommendation that women consume at least 680 µg of dietary folate equivalents per day or 400 µg of folic acid per day,……”. This could lead to further confusion because the Code will be using three different terms, folate, dietary folate equivalents and folic acid. FSANZ needs to ensure that at the very least the Code is using consistent terminology throughout with regard to folic acid, folate and dietary folate equivalents.

The Code currently permits the level of folic acid to be given as an average value in the NIP for voluntarily fortification with folic acid. Mandatory fortification as per P295 proposes an upper and lower limit for the content of folic acid. Therefore any amount quoted in the NIP of bread products, as an average value, will have the inherent accuracy limits carried over from the limits of the folic acid levels in the bread-making flour.

Currently products that are voluntarily fortified with folic acid may state the average value of folic acid in the NIP, with no tolerance levels given. This allows for the actual folic acid content to be over or under the stated level. This issue will remain and will make it difficult for consumers to calculate their overall intake of folic acid when including food products voluntarily fortified with folic acid in their diet. Results from the ESR report “Fortification Overages of the Food Supply – Folate and Iron”, prepared as part of a NZFSA contract for scientific services, indicate that women could be getting anything from less than one third and up to three times more of the average amount declared for folic acid from voluntary fortification.

Industry issues

In New Zealand the flour mills range from small to large and relatively sophisticated to older plant and equipment. The milling industry has identified a number of reasons why it does not support FSANZ’s preferred option.

Industry has explained that the cost of duplicating the storage capacity to provide fortified and unfortified flour is significant. This is in addition to purchasing equipment to add the folic acid to the flour. We understand that some milling businesses would be forced to close down because the costs required to add folic acid to flour would make them unviable.

• The point at which folic acid is added in the milling process may vary depending on the production process in each mill. Despite this the very small amount of folic acid that is being added to flour means it would be very difficult to obtain a homogenous mix in bread-making flour. This would also be an issue for the small artisan type mills which produce small quantities of flour for farmer’s markets and home use.

• In some New Zealand mills wholemeal flour is not supplied to bakeries as it is more economical to supply the wholemeal component separately. The bakeries blend the white flour and wholemeal to make wholemeal flour when producing bread. Additionally, bakeries only have one silo so cannot store wholemeal flour separately.

• The draft standard in P295 states that “flour for bread-making must contain no less than 2.3 mg/kg and no more than 2.8 mg/kg of folic acid”. This creates an issue for wholegrain or wholemeal breads, which ever way the draft standard is interpreted.

1. If the drafting proceeds as proposed in Attachment 1 (page 66 of the DAR), then in NZ for most wholemeal/wholegrain bread, only the white flour component of wholemeal / wholegrain bread would contain folic acid. The wholemeal component of wholemeal bread is bran, and this is not “flour”, so would not be required to contain folic acid. Therefore all wholemeal and wholegrain breads would contain less folic acid than white bread.

2. The alternative interpretation is that “flour for bread-making” would catch the wholemeal flour component of the bread, as they are ingoing ingredients even though they are mixed together to make wholemeal flour during the production of wholemeal bread. In this scenario, the white flour component would need to be fortified at the mill, and the amount needed to top up the level so that “wholemeal flour” contained the correct level of folic acid would need to be added at the bakery. Clearly this is not a sensible outcome.

3. Cross contact/contamination may also be an issue as the milling process involves flour of particles being moved through rollers, sifters and into storage silos. Flour particles get lodged throughout the process and even with the best cleaning practices it would be impossible to remove all traces of folic acid between batches of flour being milled. Whilst the level of folic acid would be low in these unfortified flours the mills would not be able to say the product was folic acid free.

Dietary Modelling

There are several uncertainties around FSANZ’s estimate of baseline folic acid intakes in the target population. Firstly, P295 estimates the mean and median daily intake of the target group to be 58 and 21 mcg of folic acid respectively (derived from 1997 NNS consumption data and the uptake of voluntary fortification practices by industry, and does not include intakes from naturally occurring folates or folic acid from supplements). The exclusion of naturally occurring folate from baseline intakes is not justified given that folate intakes could have been converted to dietary folate equivalents. As reported by Russell et al (1999), the median daily intake of folate from food for New Zealand females was 212 mcg (intakes varied little across age groups). Using the conversion factor cited in P295, 212 mcg of dietary folate equates to approximately 127 mcg of folic acid. Russell et al (1999) also state that folate food composition data used in this survey may lead to an underestimate of folate intakes. The figure of 127 mcg of folic acid as extrapolated from the 1997 NNS is considerably higher than the baseline median daily intake as proposed by FSANZ of 21 mcg. It is reasonable to assume that voluntary fortification practices have become more widespread since the survey was conducted in 1997, resulting in greater potential total folate intakes.

FSANZ proposes that to achieve 400 mcg of folic acid per day, women could consume one 40 g serve of voluntarily fortified breakfast cereal (containing 120 mcg folic acid) plus two slices of bread (containing approximately 90 mcg folic acid, based on 37 grams bread per slice) plus a supplement containing 200 mcg of folic acid. This scenario assumes that women will consume at lease one serving of fortified breakfast cereal. However data from the 1997 NNS show that New Zealand women are unlikely to consume one serving of breakfast cereal per day. Furthermore, FSANZ’s estimated baseline mean and median intakes of 58 and 21 mcg respectively also show that New Zealand women do not consume a serving of breakfast cereal per day.

Trade issues

MED is concerned that FSANZ’s preferred option may harm New Zealand companies that export, or that are associated with the export of flour based products. This could potentially include pastry and frozen dough, bread-crumb products and any products coated in bread crumbs, such as fish and meat. MED has had insufficient time to identify exact dollar amounts but considers that the related costs to industry would outweigh the benefits of the proposal. The markets most affected would be in Asia where these products are marketed on New Zealand’s clean, green image containing no additives.

One of the New Zealand Government’s main priorities is achieving economic transformation which relies on industries becoming export focused. FSANZ’s preferred option does not consider the effects it may have on bread and bread product exports in the New Zealand baking sector.

MFAT has requested that a copy of the draft notification to the WTO be provided before it is sent to the WTO along with prior warning of the date that this is likely to occur.

Other issues

Monitoring

Submissions in response to the initial assessment report identified monitoring as a key issue. A monitoring programme needs to be established prior to the implementation of mandatory fortification. However, as the responsibility for establishing and funding a monitoring system extends beyond FSANZ’s responsibilities, FSANZ has not adequately addressed this important issue in the DAR.

In the DAR, FSANZ states it will contribute directly to some elements of a monitoring system, including updating food composition databases and tracking changes in food consumption patterns, which are, in New Zealand, the MoH’s responsibility. However, it is not clear how it is intended this be done for New Zealand.

Key issues in developing a monitoring programme for folic acid:

• A comprehensive monitoring programme should have been developed as part of the DAR, including consultation with all relevant agencies;

• The MoH’s existing monitoring activities (e.g. National Nutrition Surveys) are not as comprehensive or frequent as would be required to monitor nutritional and health status;

• For a comprehensive monitoring programme to be developed the following needs to be considered: monitoring frequency, schedule, sample size, target populations and biochemical tests used;

• The costs of establishing and implementing ongoing monitoring will be substantial and should have been included in the cost-benefit analysis;

• The likely time for P295 being gazetted is insufficient to establish a monitoring programme and collect baseline data before the start of the transition period;

• The monitoring process needs to include education of the public and health practitioners and that health practitioner’s give appropriate and accurate advice.

A suitable and comprehensive monitoring programme for New Zealand should be developed and established to ensure monitoring occurs. The monitoring programme should include the collection of baseline measurements prior to the implementation of mandatory fortification, to ensure a true picture of the effect of mandatory fortification on the general population and the target population.

Measuring folate status

The only way to objectively measure the folate status of an individual or the population is to take blood samples. This has never been done before in the New Zealand Adult National Nutrition Survey (NNS) and even though monitoring folate status is a priority, it may not be monitored in future surveys.

Measuring red blood cell folate is the best way to measure folate status. However measuring serum folate is a more feasible and cheaper option and can be used to indicate folate status of a population level.

The next NNS is scheduled to begin in late 2007 and will collect data over a 12 month period. This survey will not provide sufficient data to provide baseline measures of folate status of all New Zealanders. It does not include children under 15 years of age, therefore measurements from a potential group of high consumers (children) will not be taken. This survey is scheduled to begin in late 2007, so depending on the timing of implementation, some participants in the survey may already be consuming foods with additional folic acid due to mandatory fortification. There are also feasibility and cost issues with regard to collecting blood samples that may affect folate status being monitored in the adult nutrition survey.

Therefore, the results from the 2007 NNS are not ideal for providing baseline folate status data. However, if the NNS was used to collect baseline measures, a plan for further regular monitoring would need to be established as the next adult nutrition survey will be undertaken 10 years after the 2007 survey is completed.

The 2002 National Children’s Nutrition Survey did not measure folate status and there is no baseline data available for this population. Therefore, baseline measurements of children aged 2-14 years will need to be conducted before implementation, to ensure we can effectively monitor the effects of mandatory fortification on this population.

Two studies (Watson and McDonald 1999 and Ferguson et al 2000) conducted in the late 1990s can be used as part of baseline measures. However, further studies will need to be conducted on women of childbearing age, children and young men to ensure sufficient baseline measures are available for comparison with future results.

NTD Monitoring

New Zealand has a comprehensive monitoring system for NTDs (as well as other major birth defects) and is able to detect any change in the occurrence of NTDs over time.

The New Zealand Birth Defects Monitoring Programme (NZBDMP) was established in 1977 to enable clusters of birth defects to be detected, the effects of teratogens (agents disrupting foetal growth and causing malformations) to be investigated, and enable epidemiological studies of birth defects to be carried out.

The NZBDMP ascertains cases with birth defects, including neural tube defects, from live births diagnosed with a defect at birth or an infant subsequently requiring treatment in a public hospital. The NZBDMP has a continuous ascertainment period, so a baby born in 2002 but diagnosed with a birth defect in 2004 would be included in the 2002 birth cohort. This period from birth allows a more complete ascertainment of all birth defects, but the majority of the major birth defects are ascertained in the first year of birth. In addition, data on birth defects in stillbirths is added later to the database, as this data is provided by NZHIS from their infant and perinatal data system.

Since 2004, data on terminations of pregnancy, primarily carried out during the second trimester, for a birth defect has also been added to the NZBDMP database.

Compliance and enforcement

Testing of either fortified bread-making flour or bread is going to be pivotal to the outcome of the proposal and will be an essential component of compliance and enforcement. NZFSA is aware that there are three different tests available to test folic acid and folate levels in food. If testing is done on-site then ELISA kits would be the most commonly used test. However each site would be required to set up testing facilities with the necessary equipment and trained personnel and this would come at a cost to the industry. Sample testing takes up to 8 hours for an urgent test and up to several days if samples are out-sourced to, for example, Agriquality for testing. In addition some tests measure natural folates as well as folic acid and others measure folic acid only. The turnaround time of milled flour and bread on site may mean that the results of testing will not be available before the product leaves the site.

Education

Education campaigns need to be targeted at health professionals and women of child-bearing age. The education campaign to health practitioners needs to be in place well before the implementation of the proposal so that they are aware of the changes and are able to provide the right advice both during the transition phase and once the system is in place. Education campaigns must be ongoing and should be regularly monitored to check that they are being effective and reaching the target audiences.

The education campaign must dispel any expectation in the target group that they can get the recommended level of folic acid from consuming fortified foods.

A series of strategies should be adopted to educate the public about the benefits of folic acid and this will be pivotal to the ongoing success of the proposal.

The low figures for bread consumption indicate that ongoing education will be required to ensure women in the target group are meeting the food and nutrition guidelines for breads and cereals to ensure optimum folic acid intake through food fortification.

Communication strategy

A well designed communication strategy that takes account of the education needs identified above is required. This was seen by many of the submitters to the IAR as essential. The strategy will need to be undertaken in collaboration with the key stakeholders, to take advantage of their networks within industry, with consumers and health professionals and must be responsive to the unique aspects of this standard and the related concerns concerning the adequacy of the standard to being about the intended health benefits.

It is important that the communication strategy is tailored to meet the needs of both countries and has a high level of acceptance by health authorities and providers in all jurisdictions. The standard should ideally be presented as a joint initiative with the relevant health authorities as part of an ongoing strategy to achieve a reduction in NTDs. Targeted communication with young women and their caregivers and advisors should be a fundamental aspect of the strategy.

Organics and Natural

The New Zealand Commerce Commission considers there may be implications in the proposed standard in terms of Fair Trading and labelling issues and label claims. However given the short consultation time frame the Commerce Commission has been unable to prepare a Commission view. The Commerce Commission requests the opportunity to discuss these issues further before any decision is made to mandatorily fortify bread-making flour with folic acid.

International experience

In the United Kingdom it has just recently been announced by the Food Standards Agency Board that a preferred option for improving the folate status of young women should not be put forward and the publication of the Scientific Advisory Committee on Nutrition (SACN) report on folate and disease prevention be delayed. SACN has requested further time to consider the potential risks and benefits of increased folic acid intakes. SACN are undertaking further analysis of national nutrition survey data to inform any food fortification strategies in relation to folic acid. When SACN has reviewed all the available evidence, its advice will be finalised and the final report will be published.

The Food Safety Authority of Ireland has just recently recommended to the Minister of Health and Children that bread should be mandatorily fortified with folic acid at a level of about 120 µg per 100 g bread. However the report also recommends that an implementation committee be established to decide the point at which folic acid will be added to the bread (milling or bread-making). This committee has been given 12 months to do this. The committee has also been tasked with a number of other implementation issues such as provision of strategies for education campaigns and ensuring consumer choice can be maintained.

The greatest reductions in the rate of NTDs after mandatory fortification have been recorded in countries where the rate was much higher than the current rate in New Zealand, eg the USA and Canada. We cannot expect to see the same reductions in New Zealand because the rate is already very low.

We note that that in the USA un-enriched cereal-grain products are not fortified with folic acid to allow for consumer choice.

Supplementation issues for New Zealand.

The NZFSA has had preliminary discussions with the MoH and Medsafe regarding the supply of a lower dose folic acid supplement that would meet the requirements of the current recommendation that women take a folic acid supplement that is a registered medicine.² The implications of providing a lower dose registered folic acid supplement are greater than first anticipated and based on current legislative requirements it is unlikely that a lower dose folic acid supplement would be available by November 2007 (the proposed end of transition phase). However given the short consultation period we have not been able to take this matter further. NZFSA will continue to work with the MoH and Medsafe to look at alternative options and will update FSANZ of developments as they occur.

Form of folic acid used in mandatory fortification

The DAR comments on different forms of folic acid and the fact that there appears to be varying degrees of stability for the different forms. If this is indeed the case then FSANZ must specify the form of folic acid to be used for mandatory fortification.

Alternative approach for New Zealand

The New Zealand Government suggests the following alternative approach to mandatory fortification.

This approach would involve:

• mandatory fortification of a selected range of bread products that will be identified as being consumed on a regular basis by the target group ie, women 14-44 years of age. The folic acid would be added to bread during the bread making process, rather than to the bread-making flour; and

• declaration of the amount of folic acid in the nutrition information panel (NIP).

The remainder of this alternative approach would be consistent with P295 ie, folic acid supplements and on-going education strategies would be required.

• We support this alternative approach for the following reason and this approach should be exhausted as an option before considering a move to fortify all bread. Bread-making flour in New Zealand is used in many other food products besides bread so folic acid would potentially be in pastry, biscuits, cakes, some pastas and noodles if there was mandatory fortification of all flour for bread-making.

• Adding folic acid to a selected range of breads rather than the bread-making flour is intended to achieve the aim in the target group without putting the rest of the population at risk.

• Fortification of a selected range of breads would allow consumer choice as not all bread would be fortified.

• Targeting fortification more closely to bread types that the target group consumes could potentially allow for higher levels of fortification with the potential for further reductions in NTD affected pregnancies.

• This is a more cost-effective option for the New Zealand flour milling and bread baking industries.

• Adding folic acid to bread in a premix during the bread making process would provide better quality control of the folic acid in bread than adding it to flour during the milling process.

• This approach would not impact on export of bread and bread products, eg frozen bread doughs and breadcrumbs because manufacturers could prepare separate batches without folic acid if the country they were exporting to would not accept product with folic acid added.

• This alternative approach would cover all bread manufactured in the large bakeries, in-store bakeries, large chain bakeries and most small bakeries who use bread premixes which would be fortified. We understand that artisan bakeries who make bread from scratch may not be captured through premixes but the New Zealand industry estimates this would be no more than 5% of total bread sales in New Zealand.

• The alternative approach is intended to limit consumer backlash to mandatory fortification of food with iodine.

This alternative proposal would still require that women planning a pregnancy take additional folic acid supplementation and consume voluntarily fortified food to reach the optimum level of 400 µg per day. An ongoing communication and education campaign would also be required to health professionals and women of child-bearing age enforcing the benefits of folic acid in reducing the risk of NTDs in pregnancy.

Note that in our alternative option we have not identified the specific range of bread products that should be fortified. Factors that should be taken into account in identifying a range of bread products include the types of breads consumed by different socio-economic groups, the bread purchasing patterns of families including women and young children, the types of breads purchased by different ethnic groups and the food and nutrition guidelines which state “eat plenty of breads and cereals, preferably wholegrain”. This information will be provided to FSANZ as soon as possible.

Yours sincerely

¹ The New Zealand MoH recommend women planning a pregnancy or in the early stages of pregnancy take either an 800 µg (or 5000 µg if at risk of having a pregnancy affected by a NTD) folic acid tablet daily for at least four weeks before and 12 weeks after conception, as well as consuming folate rich foods and foods fortified with folic acid.

² The New Zealand MoH recommend women planning a pregnancy or in the early stages of pregnancy take either an 800 µg (or 5000 µg if at risk of having a pregnancy affected by a NTD) folic acid tablet daily for at least four weeks before and 12 weeks after conception, as well as consuming folate rich foods and foods fortified with folic acid. Women are recommended to take only folic acid tablets that are registered as medicines and not rely on dietary supplements for their folic acid.