The assistance of Ruth Wong, Solicitor is writing this article is appreciated.
The distinction between the regulation of therapeutic goods and food regulation has become increasingly blurred due to the prevalence of foods and drinks on the market that claim to have health benefits and nutritional qualities.
The functions of foods and therapeutic goods sometimes overlap. For example, certain foods and food components do modify physiological processes and some therapeutic goods can demonstrate properties of foods. Therefore, the regulation of these products is not always straightforward.
The overlap between therapeutic goods and foods is often described as the food-medicine interface.
In order to address the rise in products which fall within the food-medicine interface, Food Standards Australia New Zealand ("FSANZ"), an independent statutory agency responsible for developing food standards and joint codes of practice with industry, is currently developing a new food standard relating to nutrition, health and related claims to be included in the Australia New Zealand Food Standard Code ("Code").
Therapeutic Goods Act
The Therapeutic Goods Act 1989 (Cth) ("Act") provides a national framework for the regulation of therapeutic goods and sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.
The Act is administered by the Therapeutic Goods Administration ("TGA").
A 'therapeutic good' is broadly defined under the Act as a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use. 'Therapeutic use' includes use in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury, or influencing, inhibiting or modifying a physiological process.
Any product for which therapeutic claims are made must be either listed or registered in the Australian Register of Therapeutic Goods ("ARTG") before it can be supplied in Australia.
The definition of therapeutic goods specifically excludes foods.
At present, the Code prohibits therapeutic or health claims being made in relation to foods, with the exception of claims about the benefit of maternal consumption of folate to reduce the risk of foetal neural tube defects. Nutrient content claims and some health maintenance claims are permitted.
With the guidance of a policy by the Australia and New Zealand Food Regulation Ministerial Council ("Ministerial Council"), FSANZ is developing a new food standard on nutrition, health and related claims in an attempt to provide some clarity in respect of the food-medicine interface. In particular, FSANZ proposes to allow a wider range of claims to be permitted and to provide incentive for innovation, as well as providing a framework to ensure that consumers are able to make informed and healthy choices while preventing misleading claims.
The proposed standard sets out criteria for three types of claims: nutrition content claims, general level health claims and high level health claims. The type of claim determines how the claim is regulated and the evidence that is required for substantiation.
- Nutrition content claims: statements regarding the amount of a nutrient, energy or a biologically active substance in the food. Manufacturers must prove that the nutrient, substance or property is present at levels referred to in the claim.
- General level health claims: statements referring to the presence of a nutrient or substance in a food and its effect on a health function. This type of claim cannot refer to a serious disease or condition or to an indicator of a serious disease (e.g blood cholesterol). Manufacturers must use either the FSANZ Model List of pre-approved statements, provide suitable scientific texts or dietary guidelines to support the claim, or must hold scientific evidence to substantiate such claims and produce this evidence, on request, for enforcement agencies.
- High level health claims: statements referring to a serious disease or biomarker. This type of claim needs to be pre-approved by FSANZ, and approved claims are listed in the proposed standard.1
The framework builds consumer and industry confidence by including a number of safeguards to ensure that all claims are true, scientifically substantiated and not misleading. These include, for example, requirements that:
- foods allowed to carry claims meet certain eligibility criteria;
- claims meet substantiation criteria that determine the evidence required for a proposed claim; and
- claims are made in the context of total diet.
Status Of Development Of The New Standard
The development of the new standard, like all standard development work performed by FSANZ, is an open process which involves extensive public consultation, close liaison with key stakeholders and expert advisers. The most recent public consultation document, the Preliminary Final Assessment Report, closed on 16 May 2007. FSANZ is presently reviewing stakeholder comments and conducting further consultation on the few specific issues that remain. FSANZ anticipates that the final recommendations on health claims will be submitted to the Ministerial Council in May 2008.
Until this process is complete and the new standard on nutrition, health and related claims is formally adopted in the Code, claims that foods possess certain therapeutic or health benefits remain prohibited in Australia and New Zealand.
Enforcement And Prosecutions
The Code is enforced on a state by state basis in the form of the various Food Acts, which are largely replicated in each of the States and Territories. The Food Acts are administered by each State's Food Authority.
The Food Acts state that their main purposes are to apply the Code and to prevent misleading conduct relating to the sale of food. Those purposes are achieved by providing for the monitoring and enforcement of compliance with the Food Act and the Code.
The Foods Act state that a person must not sell or advertise food that is packaged or labelled in a way that contravenes a provision of the Code, or sell or advertise for sale food in a way that contravenes a provision of the Code. In NSW the maximum penalty for contravening those provisions is 500 penalty units ($55,000) for an individual and 2,500 penalty units ($275,000) for a corporation.
Trade Practices Act
Health and nutrition claims in respect of food are also governed by the misleading or deceptive conduct provisions in the Trade Practices Act 1974 (Cth) ("TPA"). The provisions prohibit a corporation from engaging in conduct that is misleading or deceptive, or likely to mislead or deceive, and making false representations in respect of goods or services.
The TPA is administered by the Australian Competition and Consumer Commission ("ACCC"). In recent years, the ACCC has targeted the fruit juice industry in respect of misleading claims about the alleged nutritional, health and therapeutic benefits of certain ingredients in fruit juices. The ACCC has pursued well known fruit juice manufacturers and distributors, such as Berri and Cadbury Schweppes, in respect of inaccurate labelling.
Court action has not been brought in many cases as a result of the parties that received letters from the ACCC putting them on notice of a breach of the TPA signing court-enforceable undertakings. Those undertakings effectively preclude them from making misleading representations in the future in respect of the product in question, and requiring them to publish a corrective notice and implement and maintain a trade practices law compliance program.
For example, Berri was investigated by the ACCC in respect of its new range of enhanced fruit juices, including its Green Zone juice product. The ACCC was concerned that Berri had misrepresented on product packaging to consumers that the Green Zone juice product contained a "shot" of both wheat grass and barley grass when this was not the case. As part of its court enforceable undertaking to the ACCC, Berri undertook to specify the quantities of "green matter" and herbal supplements in actual milligrams and volume percentage and to inform members of the Australian Fruit Association of Berri's experience and the lessons learned in marketing novel products with health related claims.
The current position can be summarised as follows:
- the Code prohibits therapeutic or health claims being made in relation to most foods;
- nutrient content claims and some health maintenance claims are permitted;
- FSANZ will submit to the Ministerial Council in about May 2008 its final recommendations on health claims that will lead to the development of a new food standard on nutrition, health and related claims; and
- until the new food standard comes into effect, there remains a risk that any health claims made with respect to food will be pursued by the ACCC or, to a lesser degree, a State Food Authority.
1 Information obtained from the FSANZ website.
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