Mandatory folic acid fortification: Big questions remain unanswered
By Joe Lederman 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.
FoodLegal Lawyers and
Consultants
© Lawmedia Pty Ltd, June/July 2009
This is general information rather than legal advice and is current as of 30 Oct 2021. 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.