2. Product Categories

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2. Product Categories

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Food Supplements
Australia

This section provides the regulatory definition of the food category in scope, or the appropriate food category for the product in scope. Additionally, it provides the food products that belong to this food category along with the definition and specific information on each of these types of food products.

2.1 Category Name & Definition

Category Name

In Australia, there is no separate Dietary Supplements category. Depending on the formulation, presentation (including dosage form) and indications/claims, these products are potentially regulated under one of two systems:

• As Complementary Medicines in the Therapeutic Goods category (Medicines) under the jurisdiction of the Therapeutic Goods Administration (TGA) [1], or

• As Foods under the Food Standards Code (FSC) [2] managed by Food Standards Australia New Zealand (FSANZ) [3] and regulated by the Australian state and territory food regulatory bodies.

As most 'Dietary supplements’ are taken to be:

(1) products that are intended for oral consumption and presented in the form of tablets, pills, capsules, pastilles, powders, liquids or bars, and the like, and

(2) to include ingredients such as vitamins, minerals, amino acids, herbs/botanical-derived ingredients/components, enzymes, algae/ fungi/microbes, and ingredients derived from animal sources (e.g., fish oil, shark cartilage, chondroitin), and

(3) to have claims which are therapeutic and go beyond general nutrition and health claims

then they are classified as Complementary Medicines.

There are very few dietary supplement-type products that would be considered to be foods in Australia, although there are categories such as formulated supplementary sports foods which sit at the interface with medicines. However, none of the food products can make the types of stronger claims usually permitted in overseas jurisdictions for Dietary Supplements. There is an online decision tool [4] to assist in the categorization of products, particularly those at the food-medicine interface.

Definition

The category definition has a number of components. The TGA website [5] describes complementary medicines as follows: “Complementary medicines are non-prescription medicines. They are medicines that primarily contain complementary medicine ingredients that have an established identity and tradition of use.”

Examples of complementary medicine ingredients are:

• vitamins

• minerals

• plant material

• nutritional substances

• essential oils

• microorganisms

• animal material

Complementary medicines are defined more formally in Clause 2 of the Regulations [6] as "a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use' and designated active ingredients, for complementary medicine, means 'an active ingredient, or a kind of active ingredient, mentioned in Schedule 14 (to the Regulations)."

Complementary medicines are regulated in a three-tiered, risk-based framework as described in section 2.2 below.

Note that unless exempted, complementary medicines need to be entered on the Australian Register of Therapeutic Goods (ARTG) [7] before they can be supplied for sale.

2.2 Product & Definition

1) Listed Complementary Medicines [8]

Definition

Listed Medicines are entered on the part of the ARTG [7] for listed medicines and are given a marketing approval number prefixed by "AUST L".

Specifications/Target Age

Ingredients must be drawn exclusively from a pre-approved list (refer to section "3. Compositional aspects") and have low-level indications taken exclusively from a pre-approved list (refer to section "6. Claim requirements").

Additional Information

These are assessed for quality and safety but not efficacy. Sponsors (marketing authorization holders) self-certify that they meet the legislative requirements.

2) Listed Assessed Complementary Medicines [9]

Definition

Listed Assessed Medicines are entered on the part of the ARTG [7] for listed medicines (formulation) then assessed for efficacy and given a marketing approval number prefixed by "AUST L(A)".

Specifications/Target Age

Ingredients must be drawn exclusively from a pre-approved list (refer to section "3. Compositional aspects") and can have low-level indications taken exclusively from a pre-approved list (refer to section "6. Claim requirements") in addition to at least one intermediate level claim.

Additional Information

These are assessed for quality and safety (via the usual listing application as for AUST L's). Then the products undergo pre-market assessment for efficacy, due to the use of intermediate-level claims. Sponsors (marketing authorization holders) self-certify that they meet the legislative requirements as relevant to the quality and safety aspects.

3) Registered Complementary Medicines [10][11]

Definition

Registered Medicines are entered on the part of the ARTG [7] for registered medicines following application approval and are given a marketing approval number prefixed by "AUST R".

Specifications/Target Age

Ingredients must be drawn from a pre-approved list and/or ingredients in a Schedule to the Poisons Standard (except Schedules 4, 8, or 9). The exception for Schedules 4, 8, and 9 of the Poisons Standard is in relation to restrictions on how these substances are permitted to be made available to the public. For example, Schedule 4 is 'Prescription Only' and therefore cannot be used for Complementary medicines [2].

Indications may include low, intermediate, and high-level claims (refer to section "6. Claim requirements").

Additional Information

These undergo pre-market assessment for quality, safety, and efficacy.