What you need to know about the new TGA Legislation

Posted by Ryan Bevan in Feature Articles

Estimated reading time: 3 minutes

Your guide to the new TGA changes effect on capsulated products

Update 30th November 2023:

Check out our new TGA products, listed on the Australian Register of Therapeutic Goods:

Update 9th November 2023:

The TGA has released a statement clarifying products that will and won't be affected by the new legislation.

Update 10th October 2023:

Following notification that the TGA legislation changes have been softened, it is no longer the case that all products in encapsulated form (ie sold in a capsule) will be regulated under the TGA.

Until today, and for the past 2.75 years since the original announcement, the legislation covered all products sold in a capsule... regardless of claims made.

We've poured significant resources into being ready for this change as originally scheduled, but luckily we are flexible and can respond quickly to the latest update.

The takeaway? We're working hard behind the scenes to ensure you experience minimal disruption to your capsule purchasing experience at Bulk Nutrients.

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Hang On, What's the TGA?

A quick introduction for those not in the know...

The Therapeutic Goods Administration, commonly known as the TGA, plays a crucial role when regulating medicines and medical devices in Australia. They're the authority that ensures everything medical meets the required standards, and those standards are very high, as well as well regarded worldwide.

But the TGA's job doesn't end once a product is on the market. It also maintains an active register of approved products, ensuring any changes in formulations or changes to the way they are manufactured are registered.

In essence, the TGA ensures Australians can trust the medical products they take, knowing there's an overarching body regulating them.

What products will be affected from 30th November 2023?

Any product supplied in a capsule, that makes claims relating to performance in sport, exercise or recreational activity and includes product names, will be a therapeutic good.

Restricted claims include, but are not limited to:

gaining muscle;
increasing mental focus;
increasing metabolism;
increasing stamina;
increasing testosterone levels, reducing oestrogen levels or otherwise modifying hormone levels;
losing weight or fat;
preparing for workout;
recovering from workout

So many products will not be able to continue to be sold in Australia, as they are making these claims.

Will Bulk Nutrients stop selling its current capsule range?

As it turns out – no!

All capsulated products due to be discontinued can now be made as foods after 30th November under the amended legislation... as long as they don’t make any claims.

It's a reshuffle, but here at Bulk we're busily updating our labels, webpages and content to ensure we comply with the new ruling.

Does Bulk Nutrients have a range of TGA Listed capsules?

Yes, you better believe we do and we’ll be rolling those out in December, under the revised TGA regulation.

The products we'll have listed are:

TGA Capsule Changes Summary

As you'd expect at Bulk Nutrients, we've been working hard towards reshaping our capsulated range under the new TGA legislation. It turns out, we don’t need to change as much of the range as anticipated.

We'll be providing a great mix of products regulated under the TGA and also products as foods, so we can continue to provide our customers a great range of capsules to support your health fitness and wellbeing.

Keen to learn more about the upcoming TGA changes and how they might affect you? Keep an eye on our socials, website and emails to be the first to hear about the latest developments for TGA capsules!

Ryan Bevan

Ryan Bevan works hard to ensure strict TGA compliance, coordinating with external consultants, and managing intricate documentation - all while drawing strength from Bulk Nutrients' exceptional Quality Assurance team.

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