Food supplement registration in Australia: what applies to your product

Medicine, food or cosmetic: settle this first

The word "registration" points at three different systems, so the first question is which one your product sits in.

Your product is	Who it deals with	What is recorded
A medicine, such as most capsules and tablets with a health claim	The TGA	The product, on the Australian Register of Therapeutic Goods (ARTG), with an AUST L, AUST L(A) or AUST R number
A food, such as many protein and sports powders	The Food Standards Code, enforced by the states, territories and local councils	No product registration. In some states, the food business or premises
A cosmetic, such as a serum or a cream with no therapeutic claim	AICIS for the chemicals, the ACCC for the product	The business that introduces the chemicals, not the product

How a product ends up a food or a medicine is in our guide to the food pathway. In short, a powder, drink, bar or capsule can be sold as a food unless its presentation, or something else about it, makes it a medicine, or it is declared one. Beauty supplements are declared medicines. So are sports supplements presented for a therapeutic use, such as gaining muscle, that come as a tablet, capsule or pill or contain certain substances (sports supplements).

A supplement sold as a medicine: listed or registered

The TGA sorts complementary medicines into three tiers by risk: listed, assessed listed and registered. The TGA's own factsheet on the framework says listed medicines "can be listed in the ARTG without undergoing pre-market assessment by the TGA", while "all aspects of registered complementary medicines undergo pre-market assessment."

Topic	Listed	Assessed listed	Registered
On the label	AUST L	AUST L(A)	AUST R
Before it is sold	The sponsor certifies it meets the rules	The TGA assesses its efficacy; the sponsor certifies quality and safety	The TGA assesses it in full
Ingredients	Only those in the Permissible Ingredients Determination	The same list as listed medicines	Any complementary medicine ingredient that isn't in Schedules 4, 8 or 9 of the Poisons Standard
Claims	Low-level indications from the permitted list	Intermediate indications the TGA has assessed	Claims evaluated as part of registration

So for most supplements, "TGA registration" in everyday speech means an AUST L listing. Vitamins and herbal medicines are typical listed medicines. Over-the-counter pain relief, antihistamines and higher dose iron supplements are registered. A listed medicine's label and ads can't say it has been assessed by the TGA. The steps to a listing, from the formula to lodging in TGA Business Services, are in our TGA approval guide.

What a listing involves:

• A sponsor. The listing is applied for by the medicine's sponsor, an Australian resident or a company incorporated and doing business in Australia. An overseas brand needs an Australian sponsor (TGA sponsor).
• Permitted ingredients and claims. Every ingredient comes from the Permissible Ingredients Determination and every claim from the Permissible Indications Determination, with the evidence held for each (permitted indications).
• GMP manufacture, a TGO 116 label and stability data.
• The fees. For 2026–27 the TGA charges $1,063 to apply, then $1,566 a year once the medicine has had turnover (what it costs).

Once listed, the product shows on the ARTG with its number, and anyone can look it up (ARTG search).

A supplement sold as a food: no product registration

A food doesn't go on the ARTG and has no AUST number. It must meet the Food Standards Code, which the states, territories and local councils enforce. Sports foods follow Standard 2.9.4, and a food's claims come from the Code, not the TGA's list. No food may claim to prevent, cure or alleviate a disease.

What some states do register is the food business or its premises. Two examples from our city guides:

• Victoria. Food premises register with their local council each year, or notify it, under the Food Act 1984, depending on their class. The class is set by the riskiest activity on the premises (Melbourne).
• Queensland. Most food businesses need a licence from their local council under the Food Act 2006, including a business that manufactures food (Brisbane).

Your council confirms what your business needs.

A cosmetic: the business registers, not the product

A cream, serum or oil with no therapeutic claim is usually a cosmetic. AICIS registers businesses, not products. A business that imports cosmetics or their ingredients must register before it does, and renew for each year it keeps introducing them. For the 2026–27 registration year, registration costs $85 to $3,585, set by the value of chemicals introduced in the previous financial year. A brand that buys all its products and ingredients from Australian suppliers, and only re-sells or blends them, doesn't need to register. A product claiming to treat a condition such as acne or eczema is likely a therapeutic good, regulated by the TGA, unless excluded. More in our AICIS guide.

From our records

• Your Skin Scan: the founder, a clinical nurse consultant, wanted her own vitamin B3 (nicotinamide) product but wasn't sure which regulatory pathway applied. It became a 500 mg tablet, 120 per bottle, as a TGA-listed medicine, from first enquiry to delivery within the year.
• ATP Science's core range: four TGA-listed capsules and a food-pathway performance powder, settled product by product at the brief. Five products in production from late 2023.
• The Belly Solution: a travel gut-health powder, TGA-listed and ready for pharmacy, about eight months from formulation to dispatch.
• An international skincare brand: two supplements and a sunscreen kept compliant in Australia, with their regulatory work on a monthly retainer since 2024.