Folate Fortification: Did switching from voluntary to mandatory fortification make a difference?

By Tony Zipper (food technologist, ARMIT (App. Chem.), FAIFST, FRACI) and Joe Lederman
FoodLegal Lawyers and Consultants
© Lawmedia Pty Ltd, March 2011

On 17 January 2011, the Food Standards Australia New Zealand (FSANZ) website published a Media Release issued on 16 January 2011 by the Parliamentary Secretary for Health and Ageing entitled “Government Welcomes Study on Folic Acid”, which emphasised the results included in a recent paper in the Medical Journal of Australia (MJA).

In a November 2009 article in FoodLegal Bulletin “FSANZ Shortcomings in Post-marketing Surveillance” by A F Zipper, the author discussed the mandatory fortification of bread with folate, iodine and thiamine and the commitments by FSANZ to conduct follow-up surveys to ensure that the requirements of the Australia New Zealand Food Standards Code (ANZFSC) in Standard 2.1.1 – Cereals and Cereal Products, were being complied with by bread producers and that the desired health benefits were being achieved by the designated target markets.

It was contended in the FoodLegal article that FSANZ had not conducted the surveys as committed during the consultation period and there was very little evidence available from any Australian source on the outcomes of the fortification of bread.

Thus it was with some enthusiasm and heightened expectation of this situation being rectified when the said Media Release was publicized.

The MJA paper “The impact of mandatory fortification of flour with folic acid on the blood folate levels of an Australian population” (by Ross D Brown, Mark R Langshaw, Elaine J Uhr, John N Gibson and Douglas E Joshua, MJA2011; 194 (2): 65.67) did state, as mentioned in the said FSANZ-publicized Media Release, that the addition of “folic acid to bread flour is improving levels of folate in the Australian population is extremely welcome”.

However, while some of the results in the study address the particular target demographic for folate fortification (women who are planning a pregnancy or may become pregnant or those during the first trimester of their pregnancy, i.e. women between 15 and 50 years), the relationship between mandatory folate fortification of bread and the incidence of NTDs (neural tune defects), which cause several severe health problems in babies, was NOT actually reported.

It has been previously stated elsewhere that:

“Neural tube defects are major congenital anomalies that result from very early disruption in the development of the brain and spinal cord. There are three distinct forms of neural tube defects described in this report: anencephaly, which is the absence of a major part of the brain, skull and scalp; encephalocele, which is a protrusion of brain tissue and/or its covering membranes through a defect in the skull; and spina bifida, in which the vertebrae that cover the spinal cord have one or more openings in the middle, allowing exposure and/or protrusion of nervous tissue and coverings with various degrees of damage to nerves” (“Neural tube defects in Australia – An epidemiological report” Samanthi Abeywardana, Elizabeth A Sullivan AIHW National Statistics Unit, Sydney, November 2008).

However, the results in the MJA paper, as a proportion of all samples tested, actually show that the incidence of low red blood cell folate levels in females of childbearing age decreased from 0.6% in April 2009 to below 0.2% in April 2010, “possibly” as a result of the introduction of mandatory folate fortification in October 2009. This paper also reports that in this cohort of the study, it is not known what, if any, proportion may have been using a folate supplement.

It ought to be noted that folate fortification was permitted as a voluntary addition in certain foods in 2002; refer ANZFSC Standard 1.1.A.2 – Transitional Standard – Health Claims. The results of the voluntary fortification in 2002 have not been subjected to critical review or monitoring as discussed in the earlier FoodLegal Bulletin article.

At this time (March 2011), it is difficult to obtain any statistics on NTDs since 2006.  In the paper “Neural Tube Defects in Australia – An epidemiological report”, in the period 1998 -2005 there were 944 births affected of NTD, of which 421 were fetal deaths and the total is equivalent to 4.6 per 10,000 births.

However the “overall prevalence of NTD, including early terminations was 10.1 per 10,000 pregnancies”. See the following table from page 14 of this paper for each year’s figures.

Table 1.1: Number and rates of NTD among births (a) as reported to the ACAMS, Australia, 1998–2005

                                           Live births                                          *Fetal deaths                                    All births

Year        Number   %(b)      Rate(c)   Number  %(b)    Rate(c)  Number   Rate(c)

1998            73         57.9           2.9          53        42.1       2.1         126     5.0

1999            72         61.5           2.8          45        38.5       1.8         117     4.6

2000            74         62.2           2.9          45        37.8       1.8         119     4.7

2001            58         52.3           2.3          53        47.7       2.1         111     4.4

2002            57         51.8           2.3          53        48.2       2.1         110     4.4

2003            48         46.6           1.9          55        53.4       2.1         103     4.1

2004            71         55.9           2.8          56        44.1       2.1         127     5.0

2005            70         53.4           2.6          61        46.6       2.2         131     4.9

1998 –

2005            523       55.2           2.6        421        44.8       2.0         944     4.6

(a) Includes all live births, stillbirths and pregnancy terminations of at least 20 weeks gestation or at least 400 g birthweight.

(b) Percentage of all births with NTD.

(c) Rates are per 10,000 live births and stillbirths.

* Still births and pregnancy terminations of at least 20 weeks gestation are included in fetal deaths.

Thus it is NOT possible, and it would be incorrect, to draw any conclusions based on the above results, since the 2002 introduction of voluntary folate fortification:

“From 1996 to 2006, there was a 32% reduction in anencephaly, 23% in spina bifida, and 34% in encephalocele compared with 1980 to 1992. There were no differences seen from 1993 to 1995 compared with 1980 to 1992. For Aboriginal infants, the rates were higher than for non-Aboriginal infants, for each type of NTD. The prevalence ratios, comparing 1996 to 2006 with 1980 to 1995, were 0.70 (CI, 0.61-0.79) for non-Aboriginal infants and 0.90 (CI, 0.61-1.32) for Aboriginal infants.”

The above paragraph incidentally is taken from another published study from the results of voluntary fortification: 

Neural tube defects in Australia: trends in encephaloceles and other neural tube defects before and after promotion of folic acid supplementation and voluntary food fortification.” Bower C, D'Antoine H, Stanley FJ. Western Australian Birth Defects Registry, Women and Newborn Health Service, King Edward Memorial Hospital, Subiaco, Western Australia.

Another earlier article “Trends in neural tube defects in Australia” prepared by Paul Lancaster and Tara Hurst, AIHW National Perinatal Statistics Unit, The University of New South Wales, Australian Food and Nutrition Monitoring Unit, provided further statistics on this issue, but the data was only for 1991-1997.

Australian Bureau of Statistics (3301.0 – Births, Australia, 2009, released 03/11/10) reported that in 2009 there were 295,700 births. Thus it could be expected, using the figure of 4.6 per10,000 births, that there may have been 136 babies affected with NTD in 2009.

The total of NTDs for each year in the period 2006-2009 is required and should be currently available to determine any trends in NTD-affected pregnancies. YET THE FIGURES HAVE NOT BEEN SUPPLIED.

FSANZ stated in the undated, but known to have been issued in 1999, Fact Sheet “Folate – The Facts, A pilot health claim on food labels – To help reduce neural tube defects in babies”, that “Neural tube defects affect around 400-500 pregnancies in Australia each year” and it is assumed this number includes those pregnancies that are subject to early termination.

In a 2010 FSANZ Consumer Information publication “Addition of vitamins and minerals to food”, it was stated “We predict mandatory folic acid fortification will reduce the number of NTD affected pregnancies by 14-49 per year in Australia”.

Using the ABS birth figures for 2009 and the rate of 4.6 NTD affected births per 10,000 births, then the possible expected number of NTD affected births could have been in the range of 87-122.

Whilst it is understood that the required statistics will always lag by 1-2 years, it appears to be premature for the Media Release in January 2011 to be proclaiming “Government welcomes study on folic acid”.

The results in the MJA paper are not being disputed by FoodLegal and it is considered important that these results are published and publicised. However, what is being disputed are two important issues directly related to mandatory folate fortification:

First, it would be premature for there to be any claim about a reduction of the   number of NTDs in Australia when there is no evidence as yet presented. There appears to be an implicit conclusion supposedly drawn that the MJA results contained some positive results in regard to NTD numbers. Yet in fact the MJA paper only discusses folate level results from the general population.

Secondly, the health benefits or any adverse effects of increased folate levels in the general Australian population are not even addressed.

It is known and accepted that there is a proportion, albeit probably small, other than the NTD issue for women of child-bearing age, who suffer medical problems due to lack of folate in the diet. The 20,592 blood samples in the MJA paper were “obtained serendipitously from a population for whom a blood folate test was requested for the investigation of possible folate deficiency”, some of whom were “after the introduction of mandatory fortification”.

It had been reported in the earlier “Neural tube effects in Australia” article (referred to above) that “younger women are more likely to have NTD-affected pregnancies than older women; teenage women had the highest rate”. Although anecdotal, it is highly probable that these younger/teenage women, due to weight conscious issues, are actually less likely to eat bread (the main source of mandatory folate fortification).

With regard to all the facts available on mandatory folate fortification and its effect on the rate of NTDs and particularly as mandatory folate fortification was specifically introduced for one reason (to reduce the incidence of NTDs), FoodLegal now requests that FSANZ release the NTD rate and actual case numbers – to allow everyone to draw conclusions about the effectiveness of mandatory folate fortification. The concerns previously expressed by FoodLegal are concerns about the potential adverse impacts on a wider population outside the target group, as explained in previous FoodLegal Bulletin articles. We believe all public health measures to fortify foods consumed by the whole population should not be mandatory except where the end-benefit is far better than would be achieved by a voluntary fortification and where there are no negative impacts on other food consumers (outside the targeted consumer group).

This is general information rather than legal advice and is current as of 12 Dec 2015. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.