Food Supplements
This is where Australia surprises people. Most products (especially in tablet or capsule format) sold elsewhere as "food supplements" are regulated as complementary medicines by the TGA - not as food - and must be listed on the ARTG (AUST L) before sale. Only products presented purely as food, with no therapeutic intent, fall under FSANZ.
At Taylored Consultancy Ltd, we make this clear and stress-free. We work out which framework your product sits in, then guide you through TGA listing or food compliance so you launch on the right pathway - first time.
Clearing the path to market -
regulatory and quality expertise that gets your supplements correctly classified, listed, and ready for market.
The critical first step in Australia. We assess your ingredients, claims and presentation to determine whether your product is a complementary medicine (TGA) or a food (FSANZ).
We check your ingredients against the TGA's Permissible Ingredients Determination to confirm what's allowed in a listed medicine.
We help you list your product on the ARTG, including the sponsor's self-certification of safety, quality and efficacy.
We make sure your claims are drawn from the permitted indications list and properly held up by evidence.
A local Australian Sponsor is required to hold the listing. We help you put the right arrangement in place.
We review your labelling against the TGA medicine labelling order (TGO 92) and advertising code, or FSANZ rules for food-presented products.
Listed medicines require GMP. We help you meet manufacturing and quality expectations.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 22000 - Food safety management
HACCP - Hazard Analysis and Critical Control Points
GFSI-recognised certifications (usually BRCGS, FSSC 22000, IFS)
ISO 9001 - General quality management
It depends on your ingredients, claims and how the product is presented, not just its form. Most tablets and capsules with therapeutic claims fall under the TGA as complementary medicines, while products presented purely as food with no therapeutic intent sit under FSANZ instead. Getting this classification wrong at the start can mean redoing your entire regulatory pathway, so we assess it before anything else.
An AUST L number shows your product is Listed on the Australian Register of Therapeutic Goods (ARTG), which is the pathway most low-risk complementary medicines, including typical vitamin, mineral and herbal supplements, need to go through before sale. Listing involves sponsor self-certification against TGA requirements, including permissible ingredients and evidence for your claims. We support the full ARTG listing process, from classification through to certification.
No, ingredients used in ARTG Listed medicines must appear on the TGA's Permissible Ingredients Determination, which sets out which substances are allowed and any conditions attached to them, such as maximum quantities. If your ingredient isn't on the list, or exceeds the permitted level, your listing will be refused. We check your full formulation against the determination before you submit anything to the TGA.
Yes, ARTG Listed medicines need an Australian sponsor who takes responsibility for the product's compliance and regulatory obligations locally, and this applies whether you're an Australian business or an overseas brand entering the market. We help arrange local sponsorship arrangements as part of our Australia service, so international brands aren't blocked from listing simply because they don't have an Australian presence.
For ARTG Listed medicines, your claims need to align with the TGA's permitted indications list and be backed by the required level of evidence, and your advertising is also subject to the Therapeutic Goods Advertising Code, which restricts things like disease claims and comparative statements. We review your indications and marketing together, so your claims are approved and consistent everywhere they appear.
Labelling depends on your classification: TGA Listed medicines must comply with the medicine labelling order (TGO 92) and advertising code, while products classified as food follow FSANZ food labelling rules instead. The requirements aren't interchangeable, so a label built for one pathway won't necessarily satisfy the other. We review labels against whichever pathway applies to your specific product.
Still have questions? Contact us and we'll be happy to help.
