A PILOT FOR A HEALTH CLAIMS SYSTEM
USING FOLATE/NEURAL TUBE DEFECTS HEALTH CLAIMS
BEING UNDERTAKEN BY
The Australia New Zealand Food Authority
Australian Food Council
Australian and New Zealand Food Industry
Commonwealth Department of Health and Family Services
and other Australian and New Zealand
food companies and organisations
and
health and welfare bodies
PROJECT DESCRIPTION
A FOLATE/NEURAL TUBE DEFECTS HEALTH CLAIMS PILOT
The Australia New Zealand Food Authority (ANZFA), the Australian Food Council (AFC), the Commonwealth Department of Health and Family Services, and other Australian and New Zealand food companies and organisations and health and welfare bodies are conducting a pilot to trial a management framework for health claims using one health claim. Health claims on food labels may help to improve diets and reduce death and illness rates.
The health claim to be trialed in the pilot describes the link between adequate maternal dietary folate intake and reducing the risk of neural tube defects (NTDS) in new-born infants.
The public health problem
Babies being born with neural tube defects (NTDS) is a significant and tragic public health problem in Australia and New Zealand. Four to five hundred pregnancies in Australia are affected each year. Up to 66 percent of these cases could be prevented by increased maternal intakes of folate one month before and three months following conception.
Currently the Food Standards Code prohibits the general use of health claims on food labels. The existing prohibition is monitored and enforced by the New Zealand and State and Territory health agencies. Health NEnisters gave the go- ahead to the folate/NTD health claims pilot in July 1998. ANZFA has amended the Food Standards Code to allow for the first time the use of folate/NTD health claims on foods. The pilot will commence in November 1998, for a period of 18 months.
What is a health claim?
Health claims are messages that make a direct link between eating a food or a nutrient in a -food and reduced risk of disease. An example of a health claim is:
Front of pack:
"A woman's diet rich in folate may help prevent spina bifida in her baby.'
Back of pack:
"Diets rich in folatel a B vitamin, before and in early pregnancy may reduce the risk e birth defects such as spina bifida in the baby. One serving e this food contains 10 % of the 400 micrograms per day intake of folate recommended for women of child bearing age.'
The proposed health claims pilot and its importance
ANZFA has proposed that a health claims pilot project be undertaken to test the use of a health claim and a management framework for health claims generally for the first time in Australia and New Zealand. This is a world first initiative in food regulation.
A common concern of many stakeholders is that the introduction of any health claims system should contribute positively to consumer understanding of good nutrition and how diet can benefit their health, with no inadvertent risk to public health. This is a common concern of many stakeholders.
Conducting a pilot using one scientifically well-substantiated health claim which has the potential to produce a measurable public health outcome within a reasonable timeframe presents the opportunity to test whether indeed health claims can benefit consumers and the industry alike.
The health claims pilot will involve the use of one health claim that makes the link between increased maternal folate consumption and a reduction in the incidence of neural tube defects. There is strong scientific evidence to suggest that many cases of neural tube defects, such as spina bifida in babies, can be prevented if women consume at least 400 micrograms of folate in the month before conception and in the first three months of pregnancy' To consume adequate amounts of folate, a folate-rich diet or a diet supplemented with folic acid tablets is important.
There is also emerging evidence that higher intakes of folate may offer other health benefits, including:
· helping to prevent heart diseases through lowering plasma homocysteine levels;
· helping to prevent certain cancers;
· potentially reducing the risk of other birth defects;
· and playing some role in reducing the risk of Alzheimers Disease.
Which foods might carry folate/NTD health claims?
Food products authorized to carry a folate/NTD health claim will be listed in a Register held by ANZFA. Entry of food products into the pilot is expected to be approved on a rolling 3-monthly basis.
Food products which may be authorised by the Australia New Zealand Food Standards Council to carry folate/ NTD health claims will be those that meet certain nutritional qualifying and disqualifying criteria.
These nutritional criteria for foods which may carry folate/ NTD health claims are based on national nutrition policy. They have been set with a view to permitting the use of folate/NTD health claims on foods which contain at least 40 micrograms of folate per serve. Foods which are not primary foods* (as listed in Standard A9) must not contain in one serving more than:
· 14g of total fat;
· 5g of saturated fat
· 500mg of sodium; or
· 10g added sugars (or honey).
*Primary foods as defined in Standard A9 are: fruit, vegetables, grains, legumes, meat, milk, yoghurt, eggs, nuts, seeds and fish.
Foods which would meet these qualifying and disqualifying criteria include certain vegetables and fruit, legumes, nuts, yeast, liver, cereals and orange juice, and many fortified breakfast cereals, breads, pasta, biscuits, extracts, fruit and vegetable juices.
Where the ability of a food to meet the qualifying criteria of at least 40 micrograms folate per serving at time of consumption depends on particular storage, handling or cooking requirements, the label on the package containing the food must include a statement of those requirements.
Certain food products/categories are excluded from being able to carry the claim, even if they meet the above criteria for claimable foods, bearing in mind that the target population is periconceptional women. These exclusions are made on public health and safety grounds. The foods are: alcoholic drinks, formula dietary foods, infant formula and canned and cereal-based infant foods, and formulated supplementary sports foods.
Food labels which carry a folate/NTD health claim must also carry a message which encourages people to eat a wide variety of foods in their diet. Such a message would be "Food variety helps optimise health".
Raising awareness in the community
To ensure that health claims appearing on food products are clearly interpreted by consumers and not seen as a substitute for a healthy diet they must be presented as part of a broader healthy lifestyle information initiative. For the purposes of the folate/NTD pilot, key activities of this type include:
· establishing partnerships - a partnership between a range of health associations and community organisations willing to build folate/NTD education into their activities;
· public education - educational/promotional materials are being developed on health claims and the importance of folate in the diet, for distribution through supermarket chains and health care providers in both countries;
· logo - an ANZFA health claims logo is being developed for voluntary use on approved foods and activities associated with the pilot; and
· media communication - to raise awareness and knowledge about folate through print media; radio; and supporting messages from participating food companies through electronic and other media, and through their own product promotion materials.
Folate - a partnership approach
Partnerships with health professionals and community groups are central to the folate/NTD health claim project. Health professionals and community groups are important in broadly communicating the folate message to women of child bearing age.
Organisations which are currently confirmed partners in the alliance with ANZFA include:
· the Australian Spina Bifida Association;
· The Northcott Society;
· the Australian Nutrition Foundation;
· the New Zealand Nutrition Foundation;
· Family Planning Australia;
· the Maternity Alliance;
· the Pharmaceutical Society of Australia;
· the Pharmacy Guild of Australia;
· the Country Women's Association of Australia;
· the ACT Division of General Practice;
· Australian Lactation Consultants' Association;
· Dietitians' Association of Australia the Royal Australian College of Obstetricians and Gynaecologists; and
· the Australian College of Midwives.
Monitoring and evaluating the pilot
To assess the effectiveness of folate/NTD health claims, particularly in triggering purchasing decisions and influencing diets of target groups, market data will be gathered and analysed. The purpose of the monitoring is to establish whether women of child bearing age are selecting and consuming food products carrying health claims, and how the health claim and associated awareness raising initiatives influenced that decision.
Independent consumer research will be commissioned by ANZFA, on behalf of the folate/NTD health claim pilot, to assess the impact of the health claims in terms of the:
· awareness amongst the target population of the health claim,
· understanding of the nutrition advice being presented by the folate claim and supporting information; and
· role of the health claims in purchasing decisions.
Longer term tracking of changes in NTD prevalence will also take place to determine whether changes in dietary folate in the "at risk" population i.e. women, are having a positive health benefit.
Data on the market penetration of folate containing products will be used to assess the nutritional impact of the health claim and the fortification practices by the food industry. Data which is to be gathered to determine these fundamental questions include:
· composition of products carrying the health claim;
· market performance of the product since the health claim;
· use of the folate claim on products in terms of the number and volume of products in the market, and the wording and presentation of claims;
· and use of other nutrient claims about folate on food products.
A process evaluation of the pilot will also be undertaken to determine the overall effectiveness of the management framework for health claims trialed in the pilot, for all stakeholders involved.
An Opportunity for the Food Industry
The food industry has long argued that lifting the prohibition on health claims is a marginal extension of legislation which allows food companies to cmvey accurate information about the properties of their products and the benefits of their consumption as part of a balanced diets. As the links between diet and health become better described, consumers are seeking specific information about the health benefits of particular foods more and more, and food companies would like to be permitted to be a primary source of such information.
The folate pilot health claim system represents an opportunity not only to provide credible, substantiated information of established benefit to consumers, but also to demonstrate the manner in which health claims generally could be used responsibly by food companies as communication tools.
Ultimately, if the pilot is successful that a more general health claims system might be introduced widening the opportunities for specific product promotion.
Funding arrangements
Funds and in kind contributions for the folate/NTD health claims pilot will be provided by:
· ANZFA;
· the Australian Food Council;
· other food companies or food industry associations through direct negotiation and contribution to ANZFA;
· the Commonwealth Department of Health and Family Services;
· other individual stakeholders wishing to participate in the project;
· the Australian Supermarket Institute and major retailer members; and
· health professionals and community groups.
The pilot is being conducted as a model of government/industry/health professional/community collaboration on a public health and food regulatory initiative.