Selling in Australia and the US from one formula

A single formula that sells in both Australia and the US is one of the most common goals we hear from founders. It makes sense. One supplier list, one production run, one product story. The catch is that TGA vs FDA supplement requirements differ at almost every step, and a formula built for one market often needs rework before it can enter the other.

The good news is that the overlap is bigger than most people expect. If you design for both markets from the start, a shared formula is very achievable. If you design for one and bolt the second on later, you tend to pay for it twice.

Two systems built on different ideas

Australia treats most supplements as complementary medicines. If a product is presented as a medicine, it has to be included on the Australian Register of Therapeutic Goods before supply, and most are listed under the AUST L pathway. Ingredients and claims are controlled by lists the TGA publishes.

The US takes a different route. Under the Dietary Supplement Health and Education Act of 1994, known as DSHEA, supplements are regulated as a category of food. The FDA does not approve supplements before they go on sale. Instead, the brand is responsible for making sure the product is safe, properly labeled and not making disease claims.

So one system is permission-based, with lists you must match. The other is responsibility-based, with rules you must not break. That difference explains most of the friction a dual-market brand runs into.

Where TGA vs FDA supplement requirements split

The gaps tend to cluster in four places.

• Ingredients. Australia allows only ingredients on its permissible ingredients list, at set forms and limits. The US allows dietary ingredients that were marketed before October 1994, plus newer ones that have gone through the New Dietary Ingredient notification process or are otherwise lawful. An ingredient that is common in the US may simply not be available for an Australian listed medicine.
• Doses. Australian limits can cap an ingredient below what US brands commonly use, and some vitamins and minerals trigger extra warning statements above certain levels.
• Claims. Australian listed medicines must use permitted indications, word for word. US supplements use structure/function claims, written by the brand, notified to the FDA and paired with a mandatory disclaimer.
• Labels. The Australian label follows the TGA’s labeling order for non-prescription medicines. The US label uses a Supplement Facts panel with its own format, order and type-size rules.

Each of these can be solved. None of them solves itself.

Designing the formula for the stricter rule

The most practical approach is to build to the tighter requirement on each point. In most cases that means starting from the Australian permissible ingredients list, since it is the narrower gate, then confirming each ingredient is also lawful in the US.

Doses work the same way. If Australia caps an ingredient at a lower level, that lower level becomes your shared dose, provided it still has evidence behind the benefit you want to talk about. A dose that is permitted in both markets but too low to support a claim in either is not a win.

Excipients need the same check. Capsule shells, flow agents, colors and flavors all count as ingredients in the eyes of a regulator, and they do not always match across borders.

One formula, two labels

Even with an identical formula, you will almost always need two labels. Dual market supplement labeling is rarely a single design with a sticker on it. The panel formats, required statements, claim wording and sponsor details differ enough that most brands print market-specific packs from a shared visual identity.

Plan for that early, because packaging lead times and minimum order quantities affect your launch budget more than most founders expect.

Manufacturing that satisfies both regulators

Australian listed medicines must be made by a manufacturer that meets the TGA’s good manufacturing practice requirements. Overseas sites need GMP clearance before their product can be supplied in Australia. US supplements must be made under the FDA’s current good manufacturing practice rules for dietary supplements.

A single manufacturer can satisfy both, but not every one does. If you want to sell Australian supplements in the USA, or bring a US product into Australia, ask your manufacturer early which approvals they hold and for which product types. It is one of the fastest ways to narrow a shortlist.

Planning a multi market supplement launch

The order of operations matters. We suggest settling the regulatory picture before formulation work goes too far:

1. Map every ingredient against both markets.
2. Set doses that work under both sets of limits and still match the evidence.
3. Draft claims for each market separately, starting from what each system allows.
4. Confirm a manufacturer that can produce for both destinations.
5. Build two compliant labels from one brand system.

Founders who want to export supplements to the USA from Australia often find that the formula transfers cleanly, while the claims and labels need the real work. That pattern holds in our experience, including on our own dual-market case studies.

What one formula really buys you

A shared formula is a smart goal, but it is a design decision, not a shortcut. Once you have mapped the TGA vs FDA supplement requirements side by side, the trade-offs become visible and manageable. It saves money on sourcing, production and testing. It does not save you from doing the regulatory work in both places.

The brands that pull it off do one thing differently. They treat both markets as day-one markets, even if one launches a year later. That single choice keeps them from building a product that fits one country perfectly and the other not at all.