Short answer: usually yes for vitamins and most supplements — they're therapeutic goods that must be on the ARTG (typically as a listed AUST L medicine) before sale. Protein powders are often regulated as food by FSANZ instead. And many "nootropics" contain ingredients that are scheduled or simply not permitted in a listed medicine, so they may not have a legal supplement pathway at all. It depends on the product and its ingredients.
The recurring trap is assuming "it's just a supplement, so there's nothing to do." In Australia, most supplements are regulated as medicines, not food — the full framework is in our guide to selling supplements into Australia.
Do vitamins need TGA approval?
Generally yes. Most vitamins and minerals are therapeutic goods and need an ARTG entry — almost always a listed medicine (AUST L) — before they can be sold. That means using only ingredients on the Permissible Ingredients list at permitted doses and only permitted-indication claims (see AUST L vs AUST R). "Approval" for a listed product is really self-certified listing, not pre-market evaluation.
What about protein powder?
This is the grey zone. Many protein powders and sports-nutrition products are regulated as food under the FSANZ Food Standards Code — as formulated supplementary sports foods — not as TGA medicines. But the line depends on composition and claims: certain sports supplements have been declared to be therapeutic goods (and so regulated by the TGA) when they carry higher-risk ingredients or therapeutic claims. If your protein product adds actives or makes therapeutic claims, it can tip over into the TGA's remit.
What about nootropics?
Treat this one carefully: "nootropic" is a marketing term, not a regulatory category. Australia has no "nootropic" classification, so there is no blanket legal status — it depends entirely on the specific substance, and it varies widely. Many ingredients sold as nootropics are scheduled under the Poisons Standard (some prescription-only), and some are outright prohibited: for example, phenibut has been prohibited in Australia since 2018, and SARMs are prohibited imports and are not on the ARTG as supplements.
So you cannot assume any given nootropic ingredient is lawful to sell as a supplement here. Each one has to be checked, by name, against the current Poisons Standard (SUSMP) and the ARTG — the first question isn't "how do I get approval", it's "is this exact ingredient even permitted?" An ingredient lookup is a fast first check.
How do I tell if my product is a food or a medicine?
It comes down to how the product presents and what it claims — the food–medicine interface is decided by composition, presentation, and claims, not by what you call it. Therapeutic claims and certain ingredients push a product toward the TGA; a conventional food form with only nutrition content tends toward FSANZ. Getting this wrong at the start means building toward the wrong regime entirely.
What happens if I sell without approval?
Selling a therapeutic good that isn't on the ARTG — or one with non-permitted ingredients or off-list claims — exposes you to TGA compliance and enforcement action, from cancellation and recall through to court. According to the TGA, penalties can reach civil penalties of up to around $11 million for a corporation for unlawful advertising, and criminal penalties of up to 5 years' imprisonment or 4,000 penalty units (a Commonwealth penalty unit being $210 as at 2025) — after you've already invested in the launch. The cheap version is checking ingredients and claims before you commit to a formulation: start with a free label checklist for your product type and markets.
Last reviewed: June 2026. This article is general information, not legal or regulatory advice; Australian rules (TGA and FSANZ) are detailed and change over time. Verify current requirements with the TGA, FSANZ, or a qualified regulatory professional.