FSANZ shortcomings in post-marketing surveillance

By A F Zipper, C Chem, ARMIT (App. Chem.), FAIFST, FRACI (Professional Food and Pharmaceutical Services)
© Lawmedia Pty Ltd, November 2009

This article, written by prominent food technologist Anthony Zipper, highlights previous examples of Food Standards Australia New Zealand not maintaining the adequate monitoring and surveillance promised in relation to the safety effects of new food standards.

All bread in Australia (except when represented as "Organic") based on wheat or whole-wheat flour is now required by law to be fortified with Thiamin and Folic Acid. All bread (except when represented as "Organic") that uses salt in its manufacture must now also contain Iodine.

Putting aside the still not legally defined term "Organic" and Organic bread is a minor product, the majority of Australians will be consuming, without choice, bread that is fortified to cater for the potential medical requirements for a minority of the population.

Australia's partner in Food Legislation, New Zealand, will mandate fortification of Iodine only. Thiamin will be subject to a separate provision and Folate fortification has been postponed pending a further investigation.

Without discussing the ethics of these fortifications, there is a potential issue regarding the long-term effects of these three nutrients in the Australian population and the method of post-market surveillance.

As background, Thiamin was introduced in 1991 to counter the lack of Thiamin (Vitamin B1) in alcoholics which leads to Wernicke-Korsakoff syndrome (WKS); Folic Acid was introduced in September 2009 and is intended to prevent neural tube defects (Spina Bifida) in babies and Iodine, which will be introduced in October 2009, is to obviate Thyroid problems in the general population and thyroid hormone deficiency in mothers which leads to lower IQs, learning and behavioural problems for babies.

In Standard 2.1.1 of Australia New Zealand Food Standards Code (ANZFSC) there are Editorial Notes that state the fortification of bread with Folic Acid and Iodine "will be reviewed when sufficient monitoring data are available".

There are two examples of previous food fortifications to which post-market surveillance was applicable. These were the mandatory addition of Thiamin to bread and the voluntary addition of Folic Acid permitted in a range of foods in 1995.

With reference to post-market surveillance of Thiamin, L R Drew and A S Truswell in their paper "Wernicke's encephalopathy and thiamine fortification of food: time for a new direction?" published in the Medical Journal of Australia, MJA 1998; 168: 534-535, stated "The Federal Government did not set up a system to monitor the effect of bread fortification, but information is accumulating that there has been some effect".

Harper, C G, Sheedy, D L, Lara, A I, Garrick, T M, Hilton, J M, Raisanen, J in their paper "Prevalence of Wernicke-Korsakoff syndrome in Australia: has thiamine fortification made a difference?" Med-J-Aust. 1998 Jun 1; 168(11): 542-5 found "There has been a significant reduction in the prevalence of WKS in Australia since the introduction of thiamine enrichment of bread flour."

NH&MRC reported in "Nutrient Reference Values for Australia and New Zealand" published in 2006 "Since mandatory fortification of Australian bread with thiamin in 1991, WKS has become very uncommon (Truswell 2000)".

The paper "Impact of voluntary folate fortification on plasma homocysteine and serum folate in Australia from 1995 to 2001: A population based cohort study" by Siobhan Hickling, Joseph Hung, Matthew Knuiman, Konrad Jamrozik, Brendan McQuillan, John Beilby, Peter Thompson, Journal of Epidemiology and Community Health, 2005; 59 (5): 371-376 states "Voluntary fortification of foods with folate in

Australia has been followed by a substantial increase in serum folate in the general population".

However, on scrutinizing the public record of Food Standards Australia New Zealand (FSANZ), it appears that FSANZ does not appear to have conducted, sponsored or initiated research on post-market surveillance of the above two fortifications but has relied on other organisations to follow through and report results. This may be an adequate response for these previous fortifications but there is no indication that a satisfactory level of research will be conducted and by whom, for Folate and Iodine fortification in the future.

In the Final Assessment Report for FSANZ Proposal P295 of 4 October 2006 "Consideration of Mandatory Fortification with Folic Acid", many submitters strongly requested that a monitoring and surveillance system be in place prior to fortification being implemented. There is no indication that these requests have been implemented.

The NH&MRC reported in "Nutrient Reference Values for Australia and New Zealand" published in 2006, the following quotes pertain to the Upper Level of Intake for Thiamin: "The upper level of intake of thiamin cannot be estimated."    "There are no reports of adverse effects from consumption of excess thiamine by ingestion of food."   "Existing evidence available from clinical studies as well as the long history of therapeutic use indicates that current levels of intake from thiamin from all sources do not represent a health risk for the general population."

Although there are reports of adverse reactions and sensitivities to Folic Acid and Iodine, these are representative only of the small groups who have been prescribed these nutrients for particular reasons. Until there is data resulting from the general population ingesting Folic Acid and Iodine on a regular basis, it is difficult to draw any conclusions as to what adverse effects might be found. However in "Folate fortification: potential impact on folate intake in an older population" by Flood VM, Webb KL, Smith W, Mitchell P, Bantick JM, Macintyre R, Sindhusake D, Rubin GL. published in Eur J Clin Nutr. 2001 Sep;55(9):793-800, the conclusion was: "There is unlikely to be a large increase in the proportion of older persons who are likely to consume more than the upper safety level of intake with universal folate fortification."

In August 2009, FSANZ published a Fact Sheet "Iodine sensitivities and mandatory fortification" which stated:"Various iodine-containing substances and iodine-rich foods can produce a range of adverse reactions in some people.  These people can react, sometimes severely, to iodine-containing substances such as those used in X-ray procedures, iodine-based antiseptics, and/or seafood.  Sometimes such reactions are referred to as 'iodine allergy'.  Despite iodine being common to these substances and food, the reactions observed are almost certainly not to iodine itself, but to other components bound to the iodine.  The forms of iodine used in iodised salt are too small by themselves to cause an allergic reaction. Some individuals are more sensitive to adverse reactions from high iodine intakes compared to others.  This has been referred to as 'iodine sensitivity', and is not a true allergic reaction.  These reactions only occur at very high doses that far exceed the amount of iodine that people would receive from their normal diet, even with mandatory fortification.  However, very high iodine foods and supplements, such as some seaweed and kelp products may affect sensitive individuals".

Although many other methods for ingestion of Thiamin, Iodine and Folate have been suggested for the vulnerable groups, both in Australia and overseas, it is the bread and other flour-based products of the whole population that has been selected by FSANZ to be the compromise solution, even though the majority of the population are not in need of these fortifications.

Yet the evidence shows that FSANZ has made regular promises in the past regarding monitoring and surveillance that FSANZ has failed to fulfil.

FSANZ never fulfilled their declared promise to monitor and conduct post market surveillance for previous fortifications and there is little evidence to demonstrate the FSANZ claim that the recent mandatory folate and iodine fortifications will be followed up.

Therefore one may be justifiably skeptical of FSANZ spin-doctoring on this issue having regard to FSANZ's lack of post-market monitoring & surveillance on previous fortifications of food; for instance, the 2 voluntary folate fortification as per Standard 1.1A.2 - Transitional Health Claims and the mandatory thiamine fortification of bread as per Standard 2.1 - Cereals.

In the voluntary folate case, the transitional Standard was supposed to be withdrawn after the sunset clause of 2 years of the introduction of Standard 1.2.7 (i.e. P293). Also in various documents FSANZ stated that the folate section of this Standard would be monitored with post market surveillance and then reviewed for efficacy. Every few years this voluntary folate fortification is considered and then allowed to continue without any follow-up work being presented as justification.

Also regarding the Thiamin in bread, this has continued without any further justification from FSANZ since its inception.

FSANZ has failed - and any of its promises on monitoring and surveillance are therefore difficult to take seriously.  It is imperative that FSANZ immediately publish a monitoring and surveillance plan and timetable to cover and justify the fortification of bread.

The Editorial Notes in the Flour Fortification Standard have stated that monitoring and surveillance will be undertaken and it is beholden on FSANZ to ensure that this happens.

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.