Clinical Strategy
Supplement claims substantiation means holding evidence that supports every claim on your label and in your marketing. We map each claim to the published evidence, show where it falls short, and, where it helps, design a study that closes the gap for the TGA, the FDA and the FTC.
Markets
AU · US
Timeline
From 4 weeks
You receive
A claims-to-evidence plan
Three questions. We show what your claims need before they reach a label.
Starting from this service
Your pathway
Question 1 of 3
What this covers
Every health claim needs evidence behind it, and the standard depends on the market. In Australia, listed medicines must hold evidence that supports each indication, and the TGA can ask to see it at any time. In the US, structure-function claims must be substantiated, and the FTC expects competent and reliable scientific evidence for health claims in advertising.
We start with the claims you want to make and work backwards. Each claim is mapped to the evidence for the ingredient, the dose and the form in your product, because a study on a different dose or extract rarely transfers. Where the published evidence is strong, you get a file that shows it. Where it is weak, we tell you plainly, and suggest either a narrower claim or a study that would support the one you want.
When a study is the right answer, we design it to be small, focused and useful: the right outcome measures, a realistic sample and a protocol a research partner can run. The aim is evidence that holds up on a label, not a trial for its own sake.
Evidence also protects you after launch. When a regulator, a retailer or a marketplace asks you to support a claim, the answer should be a file you can send the same day. We organise the evidence so it can be read by someone who has never seen your product, with each claim, each study and each dose lined up and easy to follow.
DSHEA status for every ingredient, with NDI questions flagged.
Panel, statement of identity and required label copy, laid out for your designer.
Claims, substantiation and the 30-day FDA notification.
Website, ads and marketplace listings checked against FDA and FTC rules.
Supplier and manufacturer paperwork reviewed against 21 CFR 111.
What an FDA inspector would ask for, and where it lives.
How it works
Every Clinical Strategy 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.
Discovery
We learn the product, where it is sold today and how you plan to sell it in the US.
Written output: Discovery notes
Validation
Each ingredient, dose and claim is checked against DSHEA, FDA labelling rules and FTC guidance.
Written output: Validation report
Scope
We set out exactly what will be prepared, by whom, and when you will have it.
Written output: Signed scope
Build
Label, claims file, notifications and marketing review, delivered to the scope.
Written output: Final compliance file
Who this is for
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
Often scoped together
TGA and FSANZ pathways for supplements, nutraceuticals, cosmetics and medical devices.
FDA and DSHEA compliance for dietary supplements and nutraceuticals.
From first idea to a specification a manufacturer can quote.
Questions
If your question isn’t here, send it with your enquiry. We reply within two business days.
It is the evidence that supports each claim you make about your supplement. Regulators expect you to hold it before the claim is made, not after. We build a file that links every claim to studies on the same ingredient, dose and form as your product.
Sponsors of listed medicines must hold evidence that supports each indication on the ARTG and certify that they hold it. The TGA publishes evidence guidelines, and it can request the evidence at any time. We organise your file to those guidelines.
Structure-function claims must be truthful and substantiated. The FTC, which oversees advertising, expects competent and reliable scientific evidence, generally meaning well-designed human studies on the product or an equivalent formula. We assess your claims against that standard.
Not always. Many claims can be supported by published studies on your ingredients at the same doses and forms. A study makes sense when you want a claim the literature does not support, or a point of difference competitors cannot copy.
It can, if it is designed around the claim you want to make. The outcome measure, the dose, the population and the duration all have to match. We design studies to answer one question well.
Yes. Nootropic and beauty supplement claims attract close attention from regulators, so we are particularly careful with wording and evidence in both categories.
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.
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.
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.
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.
Your scope
Services you add appear here and are sent with your enquiry. We reply within two business days with fixed fees.
