01
AU
Supplements
Vitamins, nutraceuticals, listed medicines and functional foods.
- Pathway: medicine, food or supplement
- Ingredient and dose permissibility
- Claims, label and packaging review
- Listing, notification or registration
AUS Regulatory Affairs
TGA regulatory affairs, built to the standard.
Signature Compliance is a TGA regulatory consultant for supplement brands. We confirm whether your product is a listed medicine, a registered medicine or a food under FSANZ, then prepare the ARTG listing, label and claims file so it launches in Australia without rework.
Markets
AU
Timeline
From 6 weeks
You receive
A signed-off label and claims file
AUS
Map your Australian pathway.
Three questions. We show the services your product needs before it can be sold in Australia.
Starting from this service
Where will you sell?
Where is the product today?
What kind of product?
Your pathway
Your pathway
- Recommended services appear hereWritten output
Question 1 of 3
What this covers
What TGA regulatory affairs covers
Most supplements sold in Australia are complementary medicines. The Therapeutic Goods Administration (TGA) regulates them through the Australian Register of Therapeutic Goods (ARTG), and the route you take decides what you can claim, what evidence you must hold and how long it takes. A low-risk product is usually a listed medicine (AUST L). Products with higher-level claims may need an assessed listing (AUST L(A)) or full registration (AUST R).
Not every product is a medicine. Many protein powders, functional foods and some sports products fall under the Food Standards Code, which FSANZ sets and the states enforce. The line between food and medicine depends on the ingredients, the dose, the presentation and the claims, so we settle it in writing before anything else is done.
Once the pathway is fixed, we check every ingredient against the TGA’s permitted ingredients, choose indications your evidence can support, and review the label against TGO 92. We also check your website, packaging and social copy against the Therapeutic Goods Advertising Code, which is where most compliance problems begin. Cosmetics and medical devices follow their own routes; we handle those too, under the same scope.
US
WRITTEN OUTPUTS
INGREDIENT STATUS REVIEW
US-01
DSHEA status for every ingredient, with NDI questions flagged.
SUPPLEMENT FACTS LABEL
US-02
Panel, statement of identity and required label copy, laid out for your designer.
STRUCTURE-FUNCTION CLAIMS FILE
US-03
Claims, substantiation and the 30-day FDA notification.
MARKETING AND AMAZON REVIEW
US-04
Website, ads and marketplace listings checked against FDA and FTC rules.
CGMP DOCUMENTATION CHECK
US-05
Supplier and manufacturer paperwork reviewed against 21 CFR 111.
INSPECTION READINESS NOTES
US-06
What an FDA inspector would ask for, and where it lives.
What we cover
Supplements, cosmetics and medical devices.
Regulatory affairs for all three product categories, in Australia, the United States and the UAE. One team, one point of contact, whichever market you start in.
- Australia
- United States
- UAE
02
AU
Cosmetics
Skincare, personal care and the borderline products in between.
- Cosmetic or therapeutic: classification
- Ingredient and safety checks
- Claims, label and packaging review
- Notification or registration
03
AU
Medical devices
Devices, accessories and software that make medical claims.
- Device classification
- Pathway: inclusion, clearance or registration
- Labelling and instructions for use
- Claims and marketing review
Not sure which category your product falls into? That is the first thing we work out.
How it works
Four stages, each one in writing.
Every AUS Regulatory Affairs scope follows the same four stages. You receive a written output at the end of each, so nothing depends on memory or a phone call.
01
Discovery
We learn the product, the formula and the claims you hope to make. Nothing is assumed.
Written output: Discovery notes
02
Validation
Ingredients, doses and claims are checked against TGA and FSANZ rules, and the pathway is fixed.
Written output: Validation report
03
Scope
We confirm what will be done, by whom, and the date you will have each document.
Written output: Signed scope
04
Build
Evidence file, label review, ARTG listing and advertising check, delivered to the scope.
Written output: Final compliance file
Who this is for
Australian pathways by category
Listed medicines, from single actives to complex multis.
Strain selection, stability and claim wording..
Protein, pre-workout and recovery, food or medicine.
Cognitive claims handled with care.
FSANZ standards for foods that do more.
Collagen, skin and hair from the inside.
A note from Amelia
“Most TGA problems start in the marketing copy, not the formula. We check both before you print a single label.”
Often scoped together
Related services
US
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Clinical Strategy
Study design that supports the claims you want to make.
- ✓ A claims-to-evidence plan
From 4 weeks
Questions
What founders ask about AUS Regulatory Affairs.
If your question isn’t here, send it with your enquiry. We reply within two business days.
What does a TGA regulatory consultant do?
A TGA regulatory consultant works out how your product is regulated in Australia and prepares what the TGA expects to see. For a supplement that usually means confirming it is a listed medicine, checking every ingredient and dose, choosing permitted indications, building the evidence file, reviewing the label and lodging the ARTG listing. We also review your advertising, because that is where most breaches occur.
Is my supplement a listed medicine or a food?
DSHEA compliance means your product meets the Dietary Supplement Health and Education Act and the FDA rules built on it. In practice: every ingredient is a lawful dietary ingredient, new ingredients have been notified where required, the label follows Supplement Facts rules, claims stay within structure-function limits and the product is made under cGMP.
How long does an AUST L listing take?
The listing itself is lodged electronically and can be completed quickly once the application is ready. The time goes into the preparation: confirming ingredients, holding the right evidence for each indication and getting the label right. Our Australian scopes typically run from six weeks, depending on how complete your formula and artwork are when we start.
What is the difference between AUST L and AUST R?
AUST L products are listed medicines. They use permitted low-risk ingredients and indications, and the sponsor certifies that it holds the evidence, which the TGA can review at any time. AUST R products are registered medicines. They are fully assessed by the TGA before supply, which takes longer and costs more. Most supplements are AUST L.
Can you help if my TGA application was rejected or my product was reviewed?
Yes. Listed medicines are not pre-assessed, but the TGA runs compliance reviews after listing and can ask for your evidence or require changes. We review the TGA’s findings, identify what failed, correct the evidence, label or listing, and prepare your written response.
Do you check advertising and social media?
Yes. Every Australian scope includes a review of your website, packaging, marketplace listings and social copy against the Therapeutic Goods Advertising Code. We mark up what needs to change and explain why, so your team can write compliant copy on its own.
Further reading
Reformulating a supplement for different populations and markets
October 17, 2026
No Comments
A formula that suits young adults in Sydney may not suit older adults in Los Angeles or families in Dubai. Nutrient needs, diets, cultural requirements, climate and local rules all shift from one population to the next. Here is how we approach reformulating a supplement so it fits the people who will take it.
Launching and scaling a supplement brand across markets
October 17, 2026
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Expanding a supplement brand into a second or third country is rarely a copy and paste job. Each market brings its own rules for ingredients, claims, labels and post-market duties. Here is how we help brands sequence their markets, build once and scale without losing control of compliance.
Amazon and Shopify listings need the same review as your label
October 14, 2026
No Comments
A compliant label does not make a compliant listing. Product pages on Amazon and Shopify carry claims, images and keywords that regulators and marketplaces treat just as seriously as your pack. Here is why your listings deserve the same review as your label, and what to check before you hit publish.
Collagen coffee: when your supplement is legally a food
October 14, 2026
No Comments
Add collagen to coffee and you might think you have made a supplement. In most cases, regulators see a food. That changes the label, the ingredients you can use and the claims you can make. Here is how classification works for functional foods in Australia and the US, and why it matters early.
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