Substantiating health claims on food: systematic reviews and Australia's new labelling standards

Food labelling has long been a prominent and contentious health policy area in Australia, with the merits of star rating systems and country of origin labelling dominating recent debates. So it’s a little surprising then that an important new labelling standard requiring food manufacturers to substantiate their health claims with scientific evidence hasn’t attracted more attention. We asked Dorothy Mackerras, Chief Public Health Nutrition Advisor at Food Standards Australia New Zealand (FSANZ), to tell us more about the new standard and the ways in which systematic reviews have shaped and informed its development.

Food and labelling are part of a complicated legislative and regulatory jigsaw in Australia, with different federal, state and territory agencies sharing different roles and responsibilities relating to their governance. ‘It’s important to understand that food regulation in Australia involves a number of different bodies, meaning there’s often confusion about where food regulation begins and ends,’ Dorothy explains. ‘FSANZ is a bi-national Government agency with a very specific and well-defined role. We don’t cover everything to do with food and we are not responsible for food policy or enforcement, which is the responsibility of state and territory departments and food agencies within Australia and New Zealand. What we do do is develop and administer the Australia New Zealand Food Standards Code, which lists safety, composition and labelling requirements for foods.’

The new Standard 1.2.7 Nutrition, Health and Related Claims came into force in January this year, following 10 years of complex research, consultation and development. Essentially, it requires food businesses to verify any health claims they make on labels and in advertising about a food. 

‘Here in Australia and New Zealand, as in the US and Canada, we share an outlook that health claims must be based on all the evidence rather than just one study,’ Dorothy says. ‘And this is reflected in Standard 1.2.7. It sets out new regulations covering a wide range of health claims on labels and in advertising. That means all health claims are now required to be supported by scientific evidence to the same degree of certainty, whether they are pre-approved by FSANZ or self-substantiated. It’s also important to note that health claims are only permitted on foods that meet a nutrient profiling scoring criterion, so foods that are high in saturated fat, sugar or sodium are not allowed to make health claims at all.’ 

It’s easy to be confused by the volume and variety of claims encountered on a stroll down any given a supermarket aisle, so let’s take a closer look at how health claims are categorised under the new Standard and the evidence that is required to substantiate them: 

General level health claims refer to a nutrient or substance in a food, or the food itself, and its effect on health (e.g. calcium for healthy bones and teeth). They must not refer to a serious disease or to a biomarker of a serious disease. For general level health claims, food businesses can base their claims on one of the more than 200 pre-approved food-health relationships in the Code or self-substantiate a food-health relationship in accordance with detailed requirements set out in the Code. If businesses self-substantiate a relationship, then this must be notified to FSANZ. The list of notified relationships is published on the FSANZ website and can be used by enforcement agencies for monitoring purposes. However, FSANZ does not receive any dossiers of information or do any form of assessment of these relationships. 

High level health claims refer to a nutrient or substance in a food or the food itself and its relationship to a serious disease or to a biomarker of a serious disease. For example, ‘diets high in calcium may reduce the risk of osteoporosis in people 65 years and over’. An example of a biomarker health claim is: ‘Phytosterols may reduce blood cholesterol’. High level health claims must be based on a food-health relationship pre-approved by FSANZ. There are currently 13 pre-approved food-health relationships for high level health claims listed in the Code which were based on a series of commissioned reviews.

The development of these health claim categories and decisions about the evidence they require demanded lengthy and complex research and consultation on health-food relationships, with systematic reviews and Cochrane methods playing a significant role. 

'Cochrane methods and the Cochrane handbook have been very useful in this process, as has the systematic review training that a number of FSANZ staff now undertake with the Cochrane Australia training team,’ Dorothy says. ‘In terms of specific Cochrane reviews, there are a limited number that might be useful for FSANZ - such as those on calcium, folic acid and omega-3 fatty acids. In 2014, we used a Cochrane review on the relationship between sodium and blood pressure and a World Health Organization (WHO) systematic review on potassium and blood pressure to consider and prepare an updated systematic review on the relationship of both sodium and potassium to blood pressure.’

'With the Standard only enforced since January and the dust still settling, we continue to further our work on health claims,' Dorothy concludes. 'I think FSANZ, like other organisations from the NHMRC to the WHO, are contributing to something of a systematic review zeitgeist which really puts a systematic approach to evidence at the forefront.’