When a pre-workout becomes a sports food

If you are planning to create your own pre-workout brand in Australia, the first question is not flavor or stim level. It is whether your product is a food or a medicine. Sports supplement regulation in Australia changed significantly when the TGA declared certain sports supplements to be therapeutic goods, and many products that were once sold as foods now sit under medicines law.

The difference matters enormously. A food follows the Food Standards Code. A medicine must be included on the Australian Register of Therapeutic Goods before supply. The format, ingredients and presentation of your product decide which world you are in.

What changed in sports supplement regulation in Australia

The TGA’s declaration took effect on 30 November 2020. It brought certain sports supplements under therapeutic goods regulation, with a transition period that ended on 30 November 2023 for some products.

According to the TGA, a sports supplement is regulated as a therapeutic good if it:

• Is presented in a medicinal dosage form, meaning a pill, tablet or capsule.
• Contains any substance included in the Poisons Standard, however it got there.
• Contains an intentionally added substance that is banned in sport by the World Anti-Doping Agency.
• Contains an intentionally added substance from the declaration’s list of relevant substances.

Products with appropriate ingredients presented as food, such as protein powders, bars and many powdered pre-workouts, remain regulated as food.

How a pre-workout becomes a sports food

Here is the thing. Many pre-workouts sit right on this line. A single ingredient or a switch to capsules can move a product from food to medicine.

So when a brand wants its pre-workout to be sold as a food, the work is about keeping it clearly within food territory. That usually means:

• A food format. Powders and ready-to-drink formats are generally treated as foods, while capsules and tablets are not.
• Food-permitted ingredients. Every ingredient must be allowed in food under the Food Standards Code, including novel food rules for less established ingredients.
• No scheduled or prohibited substances. Anything in the Poisons Standard, on the WADA prohibited list or on the TGA’s relevant substances list moves the product toward medicine regulation.
• Food-style presentation and claims. Marketing that sounds therapeutic can blur the line, even if the formula is clean.

The role of Standard 2.9.4

Many sports foods in Australia are regulated as formulated supplementary sports foods under Standard 2.9.4 of the Food Standards Code. This standard sets out what these products can contain, at what levels, and what must appear on the label, including mandatory advisory statements.

FSANZ compliance for a pre-workout means checking each ingredient and amount against the standard and the wider code, not just the headline actives.

Common reasons pre-workouts get reclassified

When we review pre-workout formulas, a handful of issues come up again and again.

A stimulant ingredient that is popular overseas turns out to be a scheduled substance or on the relevant substances list. A product originally sold in capsules for convenience falls inside the declaration. A botanical ingredient is not permitted in food. Caffeine levels or sources raise questions, especially given restrictions on highly concentrated caffeine products in food.

Any one of these can mean the product is no longer a food.

Ingredient sourcing adds another layer. A raw material can carry trace contamination with a scheduled or prohibited substance, and the TGA’s criteria for scheduled substances apply however the substance got into the product. Supplier documentation and testing are part of keeping a sports food on the food side of the line, and they matter to athletes who are subject to anti-doping rules as well. At that point, the brand either reformulates or takes on the obligations of a therapeutic good.

Reformulating to stay a food

Our case study on a reclassified pre-workout shows how these questions play out on a real formula, and how much of the outcome is decided by format and ingredient choices made at the very start.

Choosing your path deliberately

Some brands actively want to be a therapeutic good, for example to make specific claims or use ingredients only permitted in medicines. That is a legitimate choice, but it comes with listing requirements, GMP-licensed manufacturing and advertising rules under the Therapeutic Goods Advertising Code.

Most new founders working out how to start a pre-workout company prefer the food route for speed and cost. Under sports supplement regulation in Australia, that route is open to a well-designed powder with food-permitted ingredients. If that is your plan, design the product for food status from the outset rather than trying to retrofit it later.

Questions to answer before you formulate

Before you brief a manufacturer, work through these questions:

1. What format will the product take, and is that format compatible with food status?
2. Is every ingredient permitted in food in Australia, at the level you want?
3. Does any ingredient appear in the Poisons Standard, on the WADA prohibited list or on the relevant substances list?
4. What claims will you make, and do any sound therapeutic?
5. Does the label meet Standard 2.9.4 and the wider Food Standards Code?

Clear answers to those questions settle most classification questions before they become problems.

The right category, from day one

Sports supplement regulation in Australia rewards founders who decide their category early. A pre-workout designed as a sports food from the first draft avoids the costly scramble of reformulating after a regulator or retailer raises concerns.

Health supplement regulations in Australia can feel layered, with two regulators and two sets of rules for products that look alike on the shelf. But once you know which side of the line you are building for, the path becomes much clearer, and your launch becomes far more predictable.