
Mandatory folic acid fortification: Big questions remain unanswered By Joe Lederman FoodLegal Lawyers and Consultants © Lawmedia Pty Ltd, June/July 2009 As of 13 September 2009, bread-making flour in Australia will be fortified with folic acid as mandated by the Federal Government agency, Food Standards Australia New Zealand (FSANZ). However, developments in overseas jurisdictions and new scientific evidence are raising more questions that our government agencies have yet to answer satisfactorily. The mandatory fortification of bread-making flour with folic acid became law in Australia once the amendment to Standard 2.1.1 of the Australia New Zealand Food Standards Code (‘the Food Standards Code’) as stated in FSANZ Proposal P295 was gazetted in 2007. However, there was a 2-year period to implement the new Standard and that date is fast approaching. This strategy of mandatory fortification has been a regulatory attempt to reduce the incidence of neural tube birth defects; therefore the target demographic of the increased folic acid intake is peri-conceptional women. But what about the effect on the whole population, including children, men and the elderly, who will also be consuming increased folic acid? In January 2009, this writer delivered a paper at the Deakin University International Food Law and Policy Symposium. This paper sparked a public debate with FSANZ Chief Scientist Dr Paul Brent in The Australian newspaper which which was reported in the February 2009 issue of FoodLegal Bulletin (see our article “Folic acid fortification mandate in debate”). While the Symposium paper highlighted the apparent legal and procedural deficiencies in the approval process of FSANZ Proposal P295, the main question the paper sought to address is: who would be legally accountable if mandatory folic acid fortification caused more health issues than it prevented? On Page 37 of the First Review Report for Proposal P295, FSANZ stated: Papers published since Final Assessment (see Attachment 5) on the potential risk or protective effect of increased total folate (dietary folate and supplemental folic acid) on colorectal cancer, prostate cancer, stomach cancer and breast cancer does not change FSANZ’s conclusion at Final Assessment. Current peer-reviewed evidence, in totality, does not suggest an increase in risk of colorectal, prostate, stomach or breast cancer from the increase in folic acid intakes likely from mandatory fortification. Since the 13 September 2007 amendment to the Food Standards Code, several peer-reviewed studies linking increased folic acid intake with adverse health effects have been published. The release of new studies In February 2009, a study was published in the American Journal of Clinical Nutrition revealing that a number of children with Inflammatory Bowel Disease (IBD) had high levels of folate. This brought into question the theory that children suffering from IBD were often folate deficient. In March 2009, it was reported that a study at the University of Southern California found that men who increased their daily intake of folic acid by 1mg significantly increased their risk of developing prostate cancer. It was noted in the study that this increase in folic acid was higher than normally present in commonly consumed multivitamin supplements and that consumers “must not lose sight of the safe, well-established benefits of folic acid supplementation/fortification for women of childbearing age to prevent neural tube defects”. A report on monitoring of incidence of colon cancer in Chile both before and after mandatory folic acid fortification of flour published in 2009 has provided new evidence that a folate fortification program could be associated with an additional risk of colon cancer. Changes of regulatory policy in other countries Several countries have already implemented mandatory folic acid fortification programs or are in the process of introducing one. However, the recent scientific studies have prompted a number of jurisdictions to reconsider: *Ireland: While voluntary fortification programs have reduced incidence of birth defects, a government implementation report has found that mandatory fortification would “not provide much additional protection”. Subsequently, the introduction of mandatory fortification has been put into abeyance by the Food Safety Authority of Ireland until further research on links between folate levels and cancer is available. New Zealand: The New Zealand government is taking further advice and reviewing the decision to introduce a mandatory fortification scheme. A market research survey found 87% of people in New Zealand did not want mandatory fortification to take place. United Kingdom: In 2007, the UK Food Standards Agency recommended introducing a mandatory fortification scheme. However, this introduction has been delayed due to a request by the Chief Medical Officer to review the emerging science in relation to colorectal cancer. The UK final decision is due in July 2009. Questions over enforceability of the mandatory folic acid standard in Australia* On a further note, FSANZ Proposal P295 for mandatory fortification attempted to limit the daily intake of folic acid via the fortification scheme in order to prevent people exceeding the safe upper level of intake as set by the National Health and Medical Research Council. FSANZ attempted a solution by setting a maximum level of fortification, but it appears this has placed an enormous burden on the flour millers. To accurately test the flour to ensure the folic acid levels are within the required range is an extremely costly process. The burden of the extra cost was recognised by FSANZ in its reports. The Food Standards Code is not enforced by FSANZ, which has no enforcement powers itself. The legal enforcement of the new standard is therefore the responsibility of Environmental Health Officers (i.e. food inspectors) of local municipal governments where the flour mills are located. At the Implementation Sub-Committee Stakeholder Forum held in Melbourne on 19 June 2009, it was mentioned that the accurate enforceability of this standard was very difficult. It should be noted that this concern had been brought to the attention of FSANZ during the consultation process on Proposal P295. In response to being told by the industry and State Health enforcement officers that the new food standard for mandatory fortification could not be properly enforced, FSANZ simply stated on Page 52 of the First Review Report: FSANZ considers that this is unlikely to occur based on discussions with enforcement agencies who have clarified that they do not intend to implement overly burdensome enforcement strategies. Therefore FSANZ, a body with no say in law enforcement, has created a standard which it claims will not be implemented in an “overly burdensome” way even though this standard was created to protect consumers from over-exposure to a potentially dangerous substance. The mandatory folic acid standard is an illustration of how the separation of our standard-setting agency from the enforcement process for those standards creates a situation of the law potentially creating serious health risk s without proper safeguards. The question of implementation and monitoring will, by necessity, become discretionary and subjectively enforceable. ------------------------------------------------------------------------------------------- Declaration of Interest: FoodLegal has previously advised clients who are flour millers and bakeries. However, neither Joe Lederman nor FoodLegal has 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 29 Jun 2009. 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.

Mandatory folic acid fortification: Big questions remain unanswered

By Joe Lederman
FoodLegal Lawyers and Consultants
© Lawmedia Pty Ltd, June/July 2009

As of 13 September 2009, bread-making flour in Australia will be fortified with folic acid as mandated by the Federal Government agency, Food Standards Australia New Zealand (FSANZ). However, developments in overseas jurisdictions and new scientific evidence are raising more questions that our government agencies have yet to answer satisfactorily.

The mandatory fortification of bread-making flour with folic acid became law in Australia once the amendment to Standard 2.1.1 of the Australia New Zealand Food Standards Code (‘the Food Standards Code’) as stated in FSANZ Proposal P295 was gazetted in 2007. However, there was a 2-year period to implement the new Standard and that date is fast approaching.

This strategy of mandatory fortification has been a regulatory attempt to reduce the incidence of neural tube birth defects; therefore the target demographic of the increased folic acid intake is peri-conceptional women. But what about the effect on the whole population, including children, men and the elderly, who will also be consuming increased folic acid?

In January 2009, this writer delivered a paper at the Deakin University International Food Law and Policy Symposium. This paper sparked a public debate with FSANZ Chief Scientist Dr Paul Brent in The Australian newspaper which which was reported in the February 2009 issue of FoodLegal Bulletin (see our article “Folic acid fortification mandate in debate”). While the Symposium paper highlighted the apparent legal and procedural deficiencies in the approval process of FSANZ Proposal P295, the main question the paper sought to address is: who would be legally accountable if mandatory folic acid fortification caused more health issues than it prevented?

On Page 37 of the First Review Report for Proposal P295, FSANZ stated:

Papers published since Final Assessment (see Attachment 5) on the potential risk or protective effect of increased total folate (dietary folate and supplemental folic acid) on colorectal cancer, prostate cancer, stomach cancer and breast cancer does not change FSANZ’s conclusion at Final Assessment. Current peer-reviewed evidence, in totality, does not suggest an increase in risk of colorectal, prostate, stomach or breast cancer from the increase in folic acid intakes likely from mandatory fortification.

Since the 13 September 2007 amendment to the Food Standards Code, several peer-reviewed studies linking increased folic acid intake with adverse health effects have been published.

The release of new studies

In February 2009, a study was published in the American Journal of Clinical Nutrition revealing that a number of children with Inflammatory Bowel Disease (IBD) had high levels of folate. This brought into question the theory that children suffering from IBD were often folate deficient.

In March 2009, it was reported that a study at the University of Southern California found that men who increased their daily intake of folic acid by 1mg significantly increased their risk of developing prostate cancer. It was noted in the study that this increase in folic acid was higher than normally present in commonly consumed multivitamin supplements and that consumers “must not lose sight of the safe, well-established benefits of folic acid supplementation/fortification for women of childbearing age to prevent neural tube defects”.

A report on monitoring of incidence of colon cancer in Chile both before and after mandatory folic acid fortification of flour published in 2009 has provided new evidence that a folate fortification program could be associated with an additional risk of colon cancer.

Changes of regulatory policy in other countries

Several countries have already implemented mandatory folic acid fortification programs or are in the process of introducing one. However, the recent scientific studies have prompted a number of jurisdictions to reconsider:

Ireland: While voluntary fortification programs have reduced incidence of birth defects, a government implementation report has found that mandatory fortification would “not provide much additional protection”. Subsequently, the introduction of mandatory fortification has been put into abeyance by the Food Safety Authority of Ireland until further research on links between folate levels and cancer is available.

New Zealand: The New Zealand government is taking further advice and reviewing the decision to introduce a mandatory fortification scheme. A market research survey found 87% of people in New Zealand did not want mandatory fortification to take place.

United Kingdom: In 2007, the UK Food Standards Agency recommended introducing a mandatory fortification scheme. However, this introduction has been delayed due to a request by the Chief Medical Officer to review the emerging science in relation to colorectal cancer. The UK final decision is due in July 2009.

Questions over enforceability of the mandatory folic acid standard in Australia

On a further note, FSANZ Proposal P295 for mandatory fortification attempted to limit the daily intake of folic acid via the fortification scheme in order to prevent people exceeding the safe upper level of intake as set by the National Health and Medical Research Council.

FSANZ attempted a solution by setting a maximum level of fortification, but it appears this has placed an enormous burden on the flour millers. To accurately test the flour to ensure the folic acid levels are within the required range is an extremely costly process. The burden of the extra cost was recognised by FSANZ in its reports.

The Food Standards Code is not enforced by FSANZ, which has no enforcement powers itself. The legal enforcement of the new standard is therefore the responsibility of Environmental Health Officers (i.e. food inspectors) of local municipal governments where the flour mills are located. At the Implementation Sub-Committee Stakeholder Forum held in Melbourne on 19 June 2009, it was mentioned that the accurate enforceability of this standard was very difficult. It should be noted that this concern had been brought to the attention of FSANZ during the consultation process on Proposal P295.

In response to being told by the industry and State Health enforcement officers that the new food standard for mandatory fortification could not be properly enforced, FSANZ simply stated on Page 52 of the First Review Report:

FSANZ considers that this is unlikely to occur based on discussions with enforcement agencies who have clarified that they do not intend to implement overly burdensome enforcement strategies.

Therefore FSANZ, a body with no say in law enforcement, has created a standard which it claims will not be implemented in an “overly burdensome” way even though this standard was created to protect consumers from over-exposure to a potentially dangerous substance.

The mandatory folic acid standard is an illustration of how the separation of our standard-setting agency from the enforcement process for those standards creates a situation of the law potentially creating serious health risk s without proper safeguards. The question of implementation and monitoring will, by necessity, become discretionary and subjectively enforceable.

-------------------------------------------------------------------------------------------

Declaration of Interest: FoodLegal has previously advised clients who are flour millers and bakeries. However, neither Joe Lederman nor FoodLegal has 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 29 Jun 2009. 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.