Did you know that not all natural health products and supplements have to go through the same manufacturing and testing processes as others? And that this can impact the outcomes you’re likely to get from a patient’s treatment program?
In Australia, there are two routes when it comes to supplements and other nutraceuticals:
- Products that are typically classified as foods are regulated by Food Standards Australia New Zealand (FSANZ).
- Therapeutic medicines are regulated by the Therapeutic Goods Administration (TGA) and are listed on the Australian Register of Therapeutic Goods (ARTG).
Not only do products on the ARTG need to meet strict guidelines set out by the TGA – including developing evidence to support any therapeutic claims – but TGA-approved GMP manufacturing facilities need to also ensure products go through a strict testing procedure at various points of the product journey.
Testing in food facilities
At food facilities, the ingredient arrives at the facility with a certificate of analysis (CoA) from the supplier where the CoA gets checked before the ingredient is manufactured, packed and sent out of the door.
No testing is done, unless requested.
Testing in TGA-approved, GMP facilities
In contrast, with TGA-approved GMP facilities, that same ingredient arrives at the facility with that same CoA. The ingredient then gets independently third party tested for identification, purity and microbiology. The shelf life and storage conditions are proven by stability testing.
It also gets tested in the manufacturing process.
Finally, it gets tested again before it goes to market.
These are major gates that each product in a TGA-approved GMP facility must go through before it’s allowed out the door.
The Give Back Health Promise
We take this stuff very seriously. It’s why all our products – even extemporaneous compounding ingredients – go through the same strict testing processes as all listed medicines.
As our products are held to pharmaceutical quality standards – all testing, manufacturing, packaging and release for supply processes are performed in the TGA-approved facilities and are frequently inspected and audited for quality throughout the process.
Can you tell where your supplement product is manufactured?
If you pick up a bottle of supplements look on the front of the label for an AUST Lnumber. AUST L numbers are exclusive to medicines that are listed on the Australian Register of Therapeutic Goods (ARTG). To get onto that register, a product has gone through a strict and thorough TGA regulatory process.
The TGA is known as being one of the world’s strictest and best regulatory systems in the world for nutraceuticals and other natural health products. If a product – or indeed a facility – gets their tick of approval, it’s a good sign.
If there is an AUST L number on your product, this demonstrates that its undergone strict testing and is held to the same pharmaceutical standards that Give Back Health products are held to. It means it will have been manufactured in a TGA-approved GMP facility.
This may or may not be in Australia.
However, if the product does not have an AUST L number, it could be manufactured in a food facility without the strict quality processes that you may expect your practitioner-only products to undergo.
Extemporaneous compounding ingredients, for example, and formulated supplementary sports foods and other food products aren’t classed as listed medicines. As a result, they are not required to undergo the same strict standards of testing and quality control as is carried out by TGA-approved GMP facilities.
Therefore, a company or brand selling compounding ingredients or formulated supplementary sports foods can choose whether to use a food facility or a TGA-approved GMP facility.
They may state it on their label or marketing material.
Or they may not.
It costs more and it’s not a requirement
If you’re wondering why – knowing the benefits of TGA-approved GMP facilities – a company might choose to use a food facility instead, there are a couple of key drivers.
A lot of the time it comes down to cost. Brands typically need to make sufficient sales to bankroll staff and pay company expenses. There’s also of course – in most cases – a desire for profit.
So if something doesn’t need to be done, why do it?
And there’s also the argument that by avoiding more expensive TGA-approved manufacturing facilities, cost savings can be passed on to the customer or patient.
Why do Give Back Health use a TGA-approved GMP facility?
Give Back Health products are therapeutic supplements. We have listed medicines and extemporaneous compounding ingredients in our range. We wanted them ALL to go through the same extensive pharmacopeial testing, even if it was more expensive and more than what is required by regulatory standards.
Knowing what’s in our products matters to us. Ensuring the integrity, authenticity and quality of our ingredients matters to us. We care about efficacy and we don’t want to miss something that could impede that.
Again, it comes back to quality in, quality out.
We passionately believe that you can’t introduce quality downstream. It needs to start from the top, and then testing is required throughout the entire process to ensure quality is maintained.
This is part of our positive difference. We want to raise the bar and standard in our industry. Yes, this is at a greater cost to us as a brand, but we believe in not compromising quality for profits.
People over profits.
You can rest assured that your patients are getting the highest quality ingredient that’s listed on the label which leaves you to do what you do best – optimising patient outcomes.
To summarise, when it comes to manufacturing supplements and health products in Australia, there are two options: one is a food facility with food manufacturing standards; the other is a TGA-approved GMP facility.
Products that are manufactured in TGA-approved GMP manufacturing facilities go through various testing processes throughout their journey, regardless of whether they’re listed medicines or not.
Going through these processes helps ensure quality, safety and efficacy of ingredients and the products they become part of. It means you end up with what you expected.
You’re more likely, as a result, to experience clinical outcomes because the dosage used can be compared to what’s included in the research.
And surely that’s the whole point of this all.
Wouldn’t you agree?
Feel good. Give back.
DISCLAIMER: We recommend speaking with a registered medical practitioner before taking any supplements or vitamins to ensure you don’t encounter any adverse effects or clashes with current medications you may be taking.