Creatine Supplements in Australia: food or medicine?

Written by Cassie, registered pharmacist
Founder of Clean Green Safe

If you’ve stood in a supplement aisle wondering why two tubs of creatine look so different, you’re not alone. Creatine can reach Australian shelves through two different regulatory pathways, and once you know where to look, the label tells you which one a product took.

Two pathways to the shelf

In Australia, a sports supplement is regulated either as a food or as a medicine. Which one comes down to three things: what’s in it, what form it takes, and what it claims to do.

• As a food: creatine powders are commonly sold as formulated supplementary sports foods under Standard 2.9.4 of the Australia New Zealand Food Standards Code.
• As a medicine: creatine sold as a tablet, capsule or pill with claims about sport or exercise performance is a therapeutic good. These products need to be entered on the TGA’s Australian Register of Therapeutic Goods (ARTG) before they can be supplied.

This changed in November 2020, when the TGA declared certain sports supplements to be therapeutic goods. Tablet, capsule and pill products without higher-risk ingredients were given until 30 November 2023 to come into line.

How to tell from the label

Turn the product around and look for these signs.

• An AUST L number tells you it’s a listed medicine on the ARTG.
• The words “formulated supplementary sports food”, a nutrition information panel and the statement “Not suitable for children under 15 years of age or pregnant women: Should only be used under medical or dietetic supervision” tell you it’s sold as a food.
• If a creatine capsule or tablet makes performance claims but has no AUST L number, it’s worth a quick check on the ARTG.

What each pathway checks

The two pathways offer quite different levels of protection, and it’s worth knowing why.

A listed medicine has to be made by a TGA-licensed manufacturer under pharmaceutical Good Manufacturing Practice. That includes testing the raw ingredients and each finished batch against set specifications. Its ingredients must be permitted at permitted amounts, the sponsor’s name sits on a public register, and the TGA can review the product at any time after it’s listed.

Meeting these standards costs a sponsor more, and that can show up in the price. What it gives you is a stronger safeguard that what’s on the label is what’s in the bottle.

A sports food is made under food safety rules rather than pharmaceutical manufacturing standards, and state and territory food regulators enforce the Food Standards Code. That doesn’t mean a sports food is poor quality, but there are fewer formal checks that the contents match the label, and there’s no public register entry to look up.

Listing is about quality and safety. It isn’t an assessment of whether a product works, so neither pathway is an endorsement.

Creatine monohydrate and other forms

Creatine monohydrate is creatine bound to one molecule of water. By weight it’s about 88% creatine, so 3.4 g of creatine monohydrate gives you about 3 g of creatine. Most of the published safety information is about this form.

You may also see creatine hydrochloride or creatine ethyl ester. When a label lists a compound form, it’s worth checking whether the amount shown is the whole compound or the creatine within it, just as you would with minerals listed as salt forms.

Amounts on the label

Creatine isn’t an essential nutrient, so there’s no NHMRC daily nutritional target for it. Instead, the label shows an amount per serve and, for sports foods, a recommended amount per day.

If creatine is sold as a sports food, the Food Standards Code (Schedule 29) caps it at 3 g in a one-day quantity. So a sports food’s daily directions shouldn’t add up to more than 3 g of creatine. A listed medicine follows the TGA’s rules instead, so its daily amount can differ.

If you’re unsure what amount is right for you, your pharmacist or a sports dietitian is a good person to ask.

If you compete in tested sport

If you’re covered by the World Anti-Doping Code, you’re responsible for anything found in your body, including something present in a supplement without being declared. Batch-tested products carry a lower risk of contamination, though no test can rule it out completely. Sport Integrity Australia’s app lists batch-tested products, and it’s a good habit to check before you buy.

How Clean Green Safe can help

When you scan a creatine product, Clean Green Safe checks any AUST L number against the ARTG, or shows a Food (FSANZ) tag if it’s sold as a sports food, and shows the amount of creatine declared per serve. Anything the label doesn’t declare is shown as No data, so you always know what’s been confirmed and what hasn’t.

ABOUT THE AUTHOR

Cassie, registered pharmacist

Cassie is a registered pharmacist, a parent and the founder of Clean Green Safe. With a background in Australian supplement regulation across the TGA, FSANZ and NHMRC, she built Clean Green Safe to help people understand what’s really in their supplements, and how it all adds up across everything they take.