Do I need a branded ingredient to make a claim?

No. A listed medicine's evidence can come from any sources that meet the guidelines and are relevant to the product. A branded ingredient brings studies on its own preparation, which makes the evidence for that ingredient straightforward to hold.

Can I use the supplier's studies as my product's evidence?

They can be part of it, when your product contains the same ingredient preparation, at a dose and in a form the studies support, for a similar population, and the claim is a permitted indication. The sponsor holds the evidence and certifies it, so we check the studies against the formula before the claims are set.

Can my ads say an ingredient is clinically studied?

Only in line with the body of evidence for the product, and an ad that refers to research has to identify it, the researcher and, where known, who paid for it. If the product's indications rest on traditional evidence, the ads can't imply scientific efficacy at all.

Can I put the ingredient's brand on my label?

That's set by the supplier's terms for its name and trade mark. Some brands are used under licence: AnaGain™ in Vitable's capsule is one.

Do branded ingredients cost more?

They can, and the studied dose fixes how much goes into each serve, so we cost the formula with them at the brief, against the price the product has to sell at. See what a supplement costs to develop.

Formulation

Branded ingredients in supplements: what they bring, and what the TGA expects

In short

A branded ingredient is a specific preparation: one supplier's extract, form or strain, made to a set specification and sold under a trade mark, often with clinical studies on that preparation.
The TGA's evidence guidelines expect the evidence to come from the same ingredient preparation and dosage form as the medicine. A herbal extract made a different way needs evidence that its constituent profile isn't substantially different, or a justification. So studies on one branded extract don't carry over to any extract of the same herb.
The claim still has to be a permitted indication, backed by evidence the sponsor holds. For a specific indication, the guidelines' minimum is one Category A source, such as a double-blind randomised controlled trial, or one Category B and two Category C sources.
In advertising, a scientific or clinical claim must be consistent with the body of evidence. Research an ad refers to must be identified, with the researcher and, where known, who paid for it (section 11 of the Advertising Code). The label itself is exempt from the citing rule.
From our records: affron®, KSM-66®, EnXtra®, Wellmune®, Testofen®, life's®OMEGA, VitaShine™, Eriomin®, AnaGain™ under licence, Quatrefolic® and Rocoat®, among others, in products from first launches to nine-product ranges.

Why the exact preparation matters

A listed medicine's sponsor certifies that it holds evidence for every indication (permitted indications). The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) say what makes that evidence relevant to the medicine:

The same active ingredients. The evidence should relate to the whole medicine, or include the same active ingredients. A different dose, dosage form, regimen or route needs a justification.
The same preparation. The preparations studied should contain the same ingredient preparation and dosage form as the medicine. For a herbal ingredient, a different preparation method needs evidence that the constituent profile isn't substantially different, or a suitable justification. Non-traditional solvents and extraction ratios can change the chemical profile, and standardising to a marker compound doesn't remove every difference. The TGA has separate guidance on the equivalence of herbal extracts.
The same people. The medicine's target population should be consistent with the population in the studies, unless the extrapolation is justified.

That's what a branded ingredient is for. When a product uses the studied preparation, at the studied dose, for the studied population, the studies are evidence about the product's own active ingredient. A generic extract of the same herb has to show it's equivalent, or stand on evidence of its own.

What to ask the supplier for

The full studies, not summaries: the guidelines don't accept abstracts alone, or non-clinical studies on their own, as scientific evidence.
The dose and form studied, so the formula can use the same, or justify the difference.
The population studied, to match the customer the product is for.
The specification, so the preparation in your product is the one in the studies, batch after batch.
The terms for the name. Whether the brand's name and mark can appear on your label and in your marketing is the supplier's call, set in its terms. AnaGain™, in Vitable's hair capsule, is under licence.

What the claims and the ads can say

On the label and the ARTG entry, the claims are permitted indications, and the sponsor holds evidence for each one. The guidelines warn against exaggerating the extent, nature or prominence of the effects seen in the studies, and a medicine can't advertise an indication that isn't on its ARTG entry.
In advertising, a scientific or clinical claim must be consistent with the body of scientific or clinical evidence for the goods. An ad that refers to research has to identify the researcher, the research's financial sponsor where the advertiser knows or ought to know it, and the research itself, by a citation good enough for consumers to find it. More in our advertising guide.
Traditional evidence can't be dressed as science: an indication supported by traditional evidence mustn't imply efficacy based on scientific evidence, such as "clinically tested".

Branded ingredients and the cost of goods

A branded ingredient can cost more than a generic one, and the studied dose sets how much goes into each serve. So the choice is made at the brief, with the price the product has to sell at (design to the price). Sometimes one branded ingredient carries the product, with supporting ingredients around it: EverLeanBody's capsule is built around affron® with L-theanine, lemon balm and active-form B vitamins.

From our records

EverLeanBody: a four-ingredient capsule built around affron®, a clinically studied saffron extract: 5.8 months from signed brief to dispatch. Its second product, now in development, is built on Eriomin®, a clinically studied lemon flavonoid extract.
A complex herbal capsule built around KSM-66® ashwagandha, with an evidence package covering more than 13 ingredients: 32 days from design to production order.
BWellness: a 60-tablet formula built on EnXtra®, a clinically studied Alpinia galanga extract, and sister products including an immune powder built on Wellmune® and an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3.
ATP Science: four TGA-listed capsules reformulated from scratch, one built on Testofen®, a clinically studied fenugreek extract.
Vitable: a TGA-listed capsule with more than 13 ingredients, including a clinically studied Biota orientalis extract, AnaGain™ under licence and Quatrefolic® active folate.
Arxi: a two-a-day prenatal chewable with Rocoat® coated B vitamins, to tame the taste.
Ora, our founder's own brand: around 19 natural medicines, on ingredients including affron®, KSM-66® and GutGard®.

Questions

: No. A listed medicine's evidence can come from any sources that meet the guidelines and are relevant to the product. A branded ingredient brings studies on its own preparation, which makes the evidence for that ingredient straightforward to hold.
: They can be part of it, when your product contains the same ingredient preparation, at a dose and in a form the studies support, for a similar population, and the claim is a permitted indication. The sponsor holds the evidence and certifies it, so we check the studies against the formula before the claims are set.
: Only in line with the body of evidence for the product, and an ad that refers to research has to identify it, the researcher and, where known, who paid for it. If the product's indications rest on traditional evidence, the ads can't imply scientific efficacy at all.
: That's set by the supplier's terms for its name and trade mark. Some brands are used under licence: AnaGain™ in Vitable's capsule is one.
: They can, and the studied dose fixes how much goes into each serve, so we cost the formula with them at the brief, against the price the product has to sell at. See what a supplement costs to develop.