How to start a supplement brand in Australia: the steps from idea to shelf

1. Start with the customer, the claim and the price

A supplement brand starts with a brief: who the product is for, what it should do for them, the format they will take it in and the price it has to sell at. Each of those shapes what follows. The claim does most to decide the pathway, and it decides the evidence; the format, the volume and the margin decide the manufacturer; the price sets the budget for the formula.

Design to the price from the start. As a rule of thumb from our records, divide the retail price by four or five to get the target cost of goods, packaging included, and choose the ingredients, doses and pack to meet it. A formula that can't be made at the price may have to be redesigned. More in our guide to development costs.

2. Settle the pathway: medicine, food or cosmetic

In Australia the same capsule or powder can be a listed medicine or a food, and the same cream a listed medicine or a cosmetic. Mostly, presentation decides: the claims, the name, the form, the dose, even where the product is sold. Declared goods, such as beauty supplements, are medicines whatever else applies.

The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you, so it is settled before the formula. A claim added after the formula is set can move a product from food to medicine, and with it the ingredients, the label and the regulator. Our pathways page sets out how it is decided, and the food pathway covers powders, drinks and bars sold as foods.

The rest of this guide follows a listed medicine, the pathway most supplements sold as medicines take. Foods and cosmetics are at the end.

3. Check the product can be listed

The TGA's checklist for new sponsors says a medicine is eligible for listing if it:

• contains only ingredients in the Permissible Ingredients Determination, and complies with the requirements it sets;
• uses indications from the Permissible Indications Determination, meeting any requirements they carry;
• isn't required to be sterile; and
• contains no substance in a schedule of the Poisons Standard.

Check every ingredient against the current determination before the formula is final. The third of 2026 commenced on 16 October 2026, and the TGA updates the list at least quarterly. An ingredient that isn't on it, or one wanted at a higher level, by another route or in a new role, needs its own application to the TGA first: in 2026–27 the TGA's fees are $19,826 for an IN1 or IN2 application and $33,696 for IN3 or IN4, and the law allows 40 working days for a preliminary assessment, then 70 to 180 working days for the evaluation. More in our new ingredients guide.

4. Choose claims you can hold evidence for

A listed medicine can only make therapeutic claims from the TGA's permitted indications, and they are low-level claims: "relieves throat irritation", not "reduces high blood pressure". Each indication sets the evidence the sponsor must hold, scientific or traditional, and the TGA can ask for it at any time.

Choose the indications with the formula, because the evidence has to match the ingredient, its form and its dose. A stronger claim than the permitted list allows needs another pathway, such as an assessed listed medicine (AUST L(A)) for an intermediate indication. More in our claims and indications guide and our guide to assessed listed medicines.

5. Set up as the sponsor

The sponsor is the person or company that imports, exports or manufactures a medicine, or arranges for it to happen, and is legally responsible for it in Australia. Normally, that is the brand's own company. A sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, so an overseas brand needs an Australian sponsor.

Becoming a sponsor means a TGA Client ID, through the organisation details form, then access to TGA Business Services, where listings are lodged. The responsibility stays with the sponsor when others do the work, from the formula to the manufacture. More in our sponsor guide.

6. Formulate to the claim and the price

Formulation turns the brief into three things you can act on: the formulation, its specification and a quote for making it. Every ingredient, form and dose is chosen for the claim the product needs to make, inside the rules of its pathway, and the price it has to sell at. A physical sample is approved before anything goes into production. More on how we do it on our formulation page.

7. Choose a manufacturer with the right licence or clearance

A brand doesn't need a factory of its own: a contract manufacturer can make the product. But unless a step is exempt, every step of manufacture in Australia needs a TGA manufacturing licence, and a site overseas needs a TGA GMP clearance, which the Australian sponsor holds: one for each site, per sponsor, even if the factory already supplies other Australian brands. Only Australian sites can hold a TGA licence. The standard is the PIC/S Guide to GMP, version PE009-17, since 1 September 2025.

Choose the manufacturer for the format, the volume and the cost of goods, and check that its TGA licence covers each step it will carry out in Australia, or, for a site overseas, that the site can be cleared for your product. The desktop routes to a clearance often aren't open to supplement factories overseas, which can mean a TGA inspection first. More in our guide to choosing a supplement manufacturer and our GMP clearance guide.

8. Support the shelf life

TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date. If full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence. Ongoing stability testing is mandatory and runs in real time after launch: at least one batch from each product group should go on the program each year. Our recent programs run for 24 or 36 months. More in our stability testing guide.

9. Write the label

Since 30 September 2026, a listed medicine's label follows TGO 116. One released for supply before 1 October 2031 may still follow TGO 92, or TGO 92 with some TGO 116 provisions swapped in, so a new label is best written to TGO 116 from the start.

The main label carries the medicine's name, each active ingredient and its quantity, the dosage form and the quantity in the pack, and the AUST L number goes on the main label or a sticker fixed beside it. A listed medicine with two or more active ingredients, other than a sunscreen, may show them, as one block, on another part of the label instead. The label also carries the batch number, the expiry date, storage conditions, the sponsor's name and contact details, declared substances such as allergens, warning statements, directions for use and the indications. More in our labelling guide.

10. List the medicine on the ARTG

Each product is its own application, with its own AUST L number. In TGA Business Services the sponsor completes the application and validates it, then certifies that the medicine meets the requirements, submits it and pays the fee: $1,063 in 2026–27. The TGA doesn't evaluate a listed medicine before it is sold: an application that passes the system's validation is listed on the ARTG and given its AUST L number.

The listing itself is quick. The time goes into the formula, the evidence, GMP manufacturing, stability data and the label before lodging. More in our TGA listing guide and our guide to the ARTG.

11. Make, test and deliver the first batch

The first production run is made to the approved specification, release-tested, imported if it was made overseas, and delivered to the brand's warehouse or 3PL. Our minimum run is 3,000 finished retail packs per batch, and a production run takes 12 to 14 weeks once the specification is signed. More on our manufacturing page.

12. Launch within the advertising rules

Advertising is any statement, picture or design intended to promote the use or supply of the goods, including on the label and the pack. An ad must be accurate, balanced and not misleading, substantiated before it is published, and not inconsistent with the indications on the ARTG. It can't say "TGA approved".

Most ads to the public must carry the medicine's name, at least one accepted indication and "ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE". A short-form ad carries "ALWAYS FOLLOW THE DIRECTIONS FOR USE" instead, and neither applies to the label itself. Advertising directed only at health professionals, and certain others named in the Act, is outside the Code.

A paid influencer can't give a testimonial, but can endorse a product if the payment is disclosed and they aren't in a group the Code excludes, such as health practitioners. Since 1 July 2020, medicine ads in specified media haven't needed the TGA's approval before they run, though an ad that uses a restricted representation still needs the TGA's approval or permission first. Otherwise the TGA enforces after the fact. More in our advertising guide.

13. After launch

A listing comes with duties that last as long as the medicine is on the ARTG, whether or not it is selling, and some records must be kept for years after it comes off. The sponsor keeps the evidence for every claim, makes sure every step of manufacture stays licensed or cleared, keeps records, reports serious adverse reactions within 15 days, runs any recall, answers the TGA's requests and pays its charges. The annual charge, $1,566 in 2026–27, applies every year once the product has had turnover, even in a later year with no sales. Stability testing continues, and reorders follow the sales. More in our sponsor guide. Then comes the next product (extending a supplement range), and sometimes a change to this one (reformulating a supplement).

How long it takes and what it costs

Stage or fee	From our records and the TGA's schedule
Design to production order	32 days to 12 weeks, for listed medicines
Brief or formulation to dispatch	5.8 to about eight months, for listed medicines
Listing a medicine	$1,063 to apply, in 2026–27
Each year on the ARTG	$1,566 once the medicine has had turnover, in 2026–27
A new ingredient, if one is needed	$19,826 to $33,696 in TGA fees; the law allows 40 working days for a preliminary assessment, then 70 to 180 for the evaluation
The first production run	At least 3,000 finished retail packs, priced per unit on a formal quote

What holds a launch up is rarely the listing. It is a formula that won't run, an ingredient that isn't on the TGA's list, a pathway settled late, or a factory overseas without the right clearance. Our development timeline guide sets out the stages from our records, and our development costs guide what each part of the budget covers.

Foods and cosmetics

A food. 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. A food meets the Food Standards Code instead of the TGA's rules, and no food may claim to prevent, cure or alleviate a disease. A food for retail sale can't be or contain a novel food, a food without a history of human consumption in Australia or New Zealand whose safety needs assessing, unless it is listed in Schedule 25 of the Code and used within its conditions; a listing takes an application to FSANZ. More on our food pathway page and in our novel foods guide.

A cosmetic. A cream, serum or lotion is a cosmetic while its claims stay cosmetic: appearance, cleansing, odour, and protecting the skin or keeping it in good condition. A therapeutic claim, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good. A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must register with AICIS before it does. More on our skincare page and in our AICIS guide.

Where we come in

We are the product development team a new brand would otherwise have to build: one team carrying the product from the brief and the pathway through the formula, the evidence, the listing and the label to a matched, managed manufacturer and the first batch at your warehouse. We work in five steps, the Launch Engine, and each stage is a fixed fee for a defined outcome. You can stop at the end of the Design phase with no obligation to have us manage the manufacture, and the formulation is yours to take anywhere.

If you are working out whether you are ready, the readiness check takes four questions.