Complementary Medicines & Functional Foods

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Regulatory Overview

In Australia, substances that are ingested for human consumption are regulated as either ‘medicines’ or as ‘foods’.

Medicines are regulated by the Therapeutic Goods Administration (TGA).

Food regulations are determined by Food Standards Australia New Zealand (FSANZ).

FSANZ is an independent statutory agency established by the Food Standards Australia New Zealand Act 1991 (FSANZ Act) and is part of the Australian Government’s Health portfolio. FSANZ develops and administers the Australia New Zealand Food Standards Code.

The Code regulates the use of food ingredients, processing aids, colourings, additives, vitamins and minerals and it also sets the requirements for labelling.

State or territory government agencies and local councils are responsible for interpreting and enforcing the Code. FSANZ has no enforcement powers.

Food Compliance

Label Reviews

Is my ‘food’ label compliant?

All food labels require contain certain mandatory information by FSANZ and by the Competition & Consumer Act (Country of Origin information).

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Is the Country of Origin text and bar chart correct?

The Competition & Consumer Act 2010 via the Country of Origin Food Labelling Information Standard 2016 provides for mandatory country of origin labelling requirements for food that is sold in Australia.

There are different labelling requirements depending on whether the food was grown, produced or made in Australia; packaged in Australia; grown, produced or made in another country; or packaged in another country.

Most food grown, produced, made or packaged in Australia will need to carry a standard mark. There will generally be two or more marks from which to choose.

In addition to a country of origin statement, the marks include an indication of the proportion of Australian ingredients by ingoing weight through text and a bar chart.

If all of the food in a display or package was grown, produced or made in Australia, the mark will also include a kangaroo logo.

Failure to comply with the Standard is likely to contravene Australian Consumer Law (ACL) and expose a party to potential enforcement action by the ACCC.

For ‘non-priority’ foods, the requirements for standard marks and the placement of origin statements in a box are voluntary, not mandatory. Non-priority food means the following: (a) seasonings; (b) confectionery; (c) biscuits and snack food; (d) bottled water; (e) soft drinks and sports drinks; (f) tea and coffee; (g) alcoholic beverages.

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Does the label contain all FSANZ mandatory information and in the correct format?

FSANZ requires mandatory information such as lot identification, name & address of the supplier, date marking, storage instructions, directions for use, statement of ingredients, information about characterizing ingredients or components, nutrition information, advisory & warning statements and declarations etc … to be on a label and in the correct format.

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Is the label compliant with the recent Plain English Allergen Labelling (PEAL) standards?

On 25 February 2024 new requirements for allergen labelling came into force. If a food was packaged and labelled before 25 February 2024 and it complied with the previous allergen declaration requirements, then the food can continue to be sold until 25 February 2026.

The Food Standards Code now requires food and ingredients to be declared using certain required names. Individual tree nuts, molluscs and individual cereals must all be declared separately.

Declarations must be made in the statement of ingredients using bold font and a separate allergen summary statement.

Precautionary allergen labelling (PAL) includes ‘may contain’ or ‘may be present’ statements about allergens, such as ‘may contain peanuts’. They are voluntary statements and the Food Standards Code does not regulate them.

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Is the additional non-mandatory label information permissible?

Most labels make voluntary statements about their product – often regarding features, benefits, health or nutrition claims. FSANZ permits some health and nutrition content claims.

Statements that are not explicitly permissible by FSANZ may be classified as ‘therapeutic’ in nature, thereby shifting the status of the product from a ‘food’ to a ’therapeutic good’ and so require entry onto the Australian Register of Therapeutic Goods (ARTG).

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What are ‘therapeutic’ claims?

FSANZ does not permit claims that are ‘therapeutic’ in nature, which it refers to as ‘the prevention, diagnosis, cure or alleviation of a disease, disorder or condition’.

TGA further defines ‘therapeutic’ as ‘influencing inhibiting or modifying a physiological process’.

Product claims must be carefully worded to avoid being captured by the ‘therapeutic’ definition.

What is a nutrition content claim?

A ‘nutrition content’ claim is a claim about the presence of a substance in the food, such as protein, fibre, a vitamin or mineral etc …. FSANZ permits some descriptions, such ‘good source of …’ or ‘low …’ or ‘no added …’ etc …. These claims are dependent on meeting specified threshold levels per serve or per 100g/ml.
For example, to make a claim ‘good source of protein’ there must be no less than 10g protein per serve.
Note, the substance which the nutrient content claim is made about must also appear in the Nutrition Information Panel (NIP).

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What is a health claim?

A health claim is a claim stating or implying a health effect on the body, including an effect on one or more of the following: (a) a biochemical process or outcome; (b) a physiological process or outcome; (c) a functional process or outcome; (d) growth and development; (e) physical performance; (f) mental performance; (g) a disease, disorder or condition.

FSANZ permits some specific health claims which TGA would normally classify as ‘therapeutic’ and classifies them as either ‘general level’ or ‘high level’ health claims. To make a permitted ‘health’ claim, the food must meet the Nutrition Profiling Scoring Criterion (NPSC). The claim must be also accompanied by a dietary context statement.

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What is the Nutrition Profiling Scoring Criterion (NPSC)?

The NPSC is a nutrient profiling system to determine whether a food is suitable to make a health claim, based on its nutrient profile. Only foods that meet a certain score are allowed to have health claims made about them.
The score is calculated on the amount of energy, saturated fat, total sugars and sodium in the food, along with the amount of fruit, vegetables, nuts, legumes, coconut, spices, herbs, fungi, algae and seeds and in some cases, dietary fibre and protein.

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What relevance is Australian Consumer Law to the label?

Australian Consumer Law (ACL) is part of the Competition and Consumer Act 2010 (previously known as the Trade Practices Act 1974 (TPA).

It prohibits making false or misleading representations about goods. This includes claims, statements, images or graphics made on product labels.

The Australian Competition and Consumer Commission (ACCC) enforces the Competition and Consumer Act 2010.

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