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Where your supplement can launch, and in what order.

Global market analysis tells you which markets your formula can enter, what has to change for each, and the order that costs least. We compare TGA, FDA and UAE rules for your exact product and give you a written market entry order before you spend on labels or stock.

Markets

AU · US · UAE

Timeline

From 2 weeks

You receive

A written market entry order

cm

Plan your market entry.

Three questions. We show the services your next market will need.

Starting from this service

Your pathway

Your pathway

  • Recommended services appear hereWritten output

Question 1 of 3

What this covers

What global market analysis covers

Selling one supplement in several markets is rarely a matter of translating the label. An ingredient permitted in an Australian listed medicine may need an NDI notification in the US. A dose that is routine under DSHEA may be above what the TGA allows. A claim that works in Los Angeles may be a breach in Sydney. The analysis finds those differences before they cost you a reprint or a recall.


We take your formula, your claims and your commercial plan and test them against each market you are considering. For every market you get the regulatory route, the changes the formula or label would need, the evidence you would have to hold, and a realistic cost and timeline. Then we recommend an order of entry, usually the one that lets later markets reuse the most work from earlier ones.


Most of our clients are Australian brands moving into the US, or US brands entering Australia, and increasingly the UAE. We also look at whether one label can serve several markets, or whether separate artwork is the cheaper choice over time.

The analysis is written for decisions, not for a shelf. Each market is scored on the work it needs, the evidence it requires and the time it takes, so you can see at a glance why we recommend one order over another. If your plans change, the analysis gives you a clear basis to change the order without starting again.

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.

How it works

Four stages, each one in writing.

Every Global Market Analysis 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, where it is sold today and how you plan to sell it in the US.

Written output: Discovery notes

02

Validation

Each ingredient, dose and claim is checked against DSHEA, FDA labelling rules and FTC guidance.

Written output: Validation report

03

Scope

We set out exactly what will be prepared, by whom, and when you will have it.

Written output: Signed scope

04

Build

Label, claims file, notifications and marketing review, delivered to the scope.

Written output: Final compliance file

Who this is for

Market entry by category

Vitamins & Minerals

Listed medicines, from single actives to complex multis.

Probiotics

Strain selection, stability and claim wording..

Sports Nutrition

Protein, pre-workout and recovery, food or medicine.

Nootropics

Cognitive claims handled with care.

Functional Foods

FSANZ standards for foods that do more.

Beauty Supplements

Collagen, skin and hair from the inside.

A note from Amelia

“The cheapest second market is the one your first market already paid for. We plan for that from the start.”

Often scoped together

Related services

US

USA Regulatory Affairs

FDA and DSHEA compliance for dietary supplements and nutraceuticals.

From 8 weeks

AU

AUS Regulatory Affairs

TGA and FSANZ pathways for supplements, nutraceuticals, cosmetics and medical devices.

From 6 weeks

AU · US · UAE

UAE Regulatory Affairs

Product registration and labelling for the Emirates market.

From 6 weeks

Questions

What founders ask about Global Market Analysis.

If your question isn’t here, send it with your enquiry. We reply within two business days.

What is a supplement market entry analysis?

It is a written assessment of how your supplement would be regulated in each market you are considering, what would need to change, and what each entry would cost and take. It ends with a recommended order of entry, so you commit money to labels, stock and marketing in the right sequence.

The biggest difference is approval. In Australia most supplements are listed on the ARTG before sale and must use permitted ingredients and indications. In the US the FDA does not approve supplements, but the brand carries full responsibility for ingredients, claims and manufacturing. Permitted doses, claim wording and label layout also differ.

Often, yes, but rarely without changes. The formula may need an NDI check, the claims usually need rewriting as structure-function claims, and the label must be rebuilt around a Supplement Facts panel. We set out exactly what changes before you commit to a US launch.

Sometimes. Dual-market labels are possible when the formula, claims and required statements overlap enough. More often a shared design with market-specific panels is cheaper and safer. We compare both options for your product.

Most analyses are delivered from two weeks, depending on the number of markets and how complete your formula and evidence are when we start.

Further reading

Reformulating a supplement for different populations and markets

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.

Read More »

Launching and scaling a supplement brand across markets

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.

Read More »

Amazon and Shopify listings need the same review as your label

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.

Read More »

Collagen coffee: when your supplement is legally a food

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.

Read More »

Your scope

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