Folic acid fortification mandate in debate

On 18 January 2009, Joe Lederman, the editor of FoodLegal Bulletin, presented a paper at the inaugural Deakin University International Food Law & Policy Symposium. His paper dealt with the decision by Food Standards Australia New Zealand (FSANZ) to introduce mandatory fortification of bread-making flour with folic acid and highlighted the lack of consumer rights in the event that a government-imposed health intervention were to injure consumers. The issue was whether, considering the success of voluntary education and fortification schemes, a mandatory, scatter-gun approach was necessary.


In the First Review Report Proposal P295 (page 22), FSANZ stated “it is not the role of FSANZ to determine whether there is a demonstrated public health need warranting mandatory fortification.” No government agency took responsibility for this policy. The Food Regulation Ministerial Council, when it asked FSANZ to review its proposal, stated that the decision was not consistent with policy guidelines but nevertheless accepted the amendment without these issues being addressed. The Standard is to be implemented from September 2009, but it ought not to be too late for the Ministerial Council to re-consider the policy of mandatory folic acid fortification of bread-making flour.

This article consists of the press release issued by Deakin University (which was picked up as a news story that The Australian reported on page 3 of its 19 January edition) and two Letters to the Editor of The Australian newspaper.

1. Article in The Australian newspaper – Published on 19 January 2009:

To see the article, click here.

2. Deakin University Media Release – Published on 18 January 2009:

Australian consumers should have the right to claim for compensation if they are adversely affected by food which has been fortified with additives by Government mandate, Joe Lederman.

Joe Lederman who was addressing an international symposium on Food Law and Policy, run by Deakin University’s Law School at the weekend, said the mandatory fortification of bread-making flour with folic acid was due to take effect from 13 September 2009, yet there were few legal safeguards in place to protect Australian consumers.

“From 13 September 2009 flour millers in Australia are required to ensure compliance with mandatory fortification of wheat flour for making bread as required under Clause 4 (2) of Standard 2.1.1 of the Australian New Zealand Food Standards Code to contain no less than 2mg/kg and no more than 3mg/kg of folic acid.”

Joe Lederman said that the legal process by which mandatory fortification is being introduced was not a thorough process and argued that current laws are inadequate to protect consumers if this government health intervention were to prove dangerous or if recent contra scientific studies were to outweigh the health benefits claimed by proponents of the mandatory fortification.

Joe Lederman said that while attempts to encourage pregnant women to increase their folate intake through folic acid supplements, along with voluntary fortification of certain foods with folic acid had resulted in a 30 percent decrease in neural tube defects among non-indigenous infants, there was no change in the rates of these defects in indigenous Australian infants. The decision to shift from fortification being voluntary to becoming mandatory was based mainly on the perception of what was needed to address socioeconomic and demographic disparities between indigenous and non-indigenous Australians.

Joe Lederman said the mandatory fortification meant that Australians would be exposed to significantly raised levels of synthetic folic acid despite recent studies suggesting elevated levels of folic acid might cause serious illness or mask other serious health conditions.

“The American Journal of Clinical Nutrition has recently warned that countries considering folic acid fortification should be cautious and research the issue carefully, yet Australia lacks the nutrition information systems that would be necessary to implement and monitor these policy-making decisions.

“There are great legal uncertainties surrounding the potential health risks and impacts of mandatory folic acid fortification for the broader public, and the limitations in existing laws on legal liability and remedies available to the injured consumer are a big concern.

“Australian consumers face a number of hurdles before a court would grant them compensation, including attributing liability, statutory limits on damages and the difficulties in launching class actions.

“The Ministerial Council or FSANZ in my view has failed to make a proper assessment as to whether mandatory fortification is the most effective public health strategy to address folate deficiency.

“We need better targeted campaigns to provide our indigenous population with the same standard of health and educational services that will ensure better diet with adequate folate, rather than just encouraging indigenous women to rely on consuming more white bread with folic acid, instead of promoting green vegetables and the folate supplements advised by most doctors.

“The health risks raised in contra scientific studies are disconcerting because excessive folate will be consumed by children, the elderly and men, all of whom have to consume folic acid but are not the targeted beneficiaries. This is a scattergun approach.”

“The new Food Standard introducing mandatory fortification should be accompanied by a legal right to compensation should scientific consensus show in the future that they got it wrong.”

3. Letter to the Editor of The Australian from FSANZ Chief Scientist – Published on 20 January 2009:

Folic acid in bread
Food lawyer Joe Lederman (“Lawyer warns on folic acid mandate”, 19/1) is wrong in saying that Food Standards Australia New Zealand hasn’t conducted a proper safety assessment of the risks of adding folic acid to bread. His assertion that, as the problem of neural tube defects largely occurs in the indigenous population, other solutions should be found is also incorrect.

If women consume sufficient folic acid prior to conception and during pregnancy, it is a proven fact it will decrease the cases of birth defects such as spina bifida in their babies. This isn’t just an indigenous health issue but one that can affect families from all walks of like. Folic acid mandatory fortification has been developed to reduce the risk of neural tube defects in all babies born, especially in those 40 per cent of pregnancies that are not planned.

Mandatory fortification has been used safely in the US and Canada for over 10 years and has successfully reduced the incidence of neural tube defects in those countries. The food industry in Australia and New Zealand has been adding folic acid to foods on a voluntary basis for many years with no observed ill effects.

In developing the requirement to add folic acid to bread, which will come into force in September 2009, FSANZ assessed the possible negative effects of folic acid on public health and safety. The risk assessment and the scientific literature were peer reviewed by a number of national and international experts and, based on the weight of the evidence at the time, FSANZ concluded that it was safe to proceed. Since completing the standard, no new evidence has emerged which would change that conclusion.

Dr Paul Brent
Chief Scientist
Food Standards Australia New Zealand

4. Letter to the Editor of The Australian from Joe Lederman – Published on 22 January 2009:

Mandatory folic acid
Food Standards Australia New Zealand chief scientist Dr Paul Brent (Letter, 20/1) does not assure consumers in relation to mandatory folic acid fortification of flour. My presentation at Deakin University’s International Food Law Symposium meanwhile argued for compensation rights to overcome government claims for statutory immunity:

  • Voluntary folate fortification campaigns targeting pregnant women have been successful in reducing neural tube defects (NTD) in infants by 10-30%. The issue is the change to mandatory fortification that may deliver excessive levels of folate to children, elderly people and males, none of whom will derive any proven health benefit.
  • I do not argue against the science supporting folate fortification; however prevailing scientific opinion in the health area regularly changes. Scientific consensus can change, such as the recent linking of high-ethanol mouthwashes to oral cancer. Government health interventions can result in injury, such as occurred in the human growth hormone programs of the 1960s. Notwithstanding mandatory fortification in the USA, the American Journal of Clinical Nutrition recently cautioned authorities regarding excessive folate consumption.
  • Dr Brent states that high NTD rates among indigenous Australians were not the catalyst for mandatory fortification. However, FSANZ’s reports repeatedly refer to high rates of NTDs among indigenous Australians while admitting that data on patterns of bread consumption do not demonstrate that mandatory fortification would reach indigenous Australians. Yet, passionate advocates of mandatory fortification maintain that mandatory fortification is the solution to counter NTD prevalence among indigenous Australians.
  • In the First Review Report Proposal P295 (page 22), FSANZ stated “it is not the role of FSANZ to determine whether there is a demonstrated public health need warranting mandatory fortification.” No government agency took responsibility for this policy. Satisfactory monitoring regimes are yet to be put in place. Here indeed is a case of the government scientific assessors taking no responsibility for any resulting failure.

Joe Lederman


Declaration of Interest: FoodLegal has previously advised clients who are flour millers and bakeries. However, neither Joe Lederman nor FoodLegal has had discussions with, nor been briefed by, nor been retained by, any flour miller or bakery group or association in connection with Joe Lederman raising these issues in the public domain. Joe Lederman has raised these issues in the context of his own independent examination of the issues of compensation for consumers from governments when scientific consensus changes in relation to a food standard. The mandatory folic acid fortification standard was used as a case study because of Joe Lederman's deep knowledge of the administrative processes and his analysis of all the Reports provided on this issue by FSANZ.

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.