Taking the pain out of therapeutic goods regulations 

 October 1, 2019

By  Jennifer - Skincare Business Foundations

Recently I went to Sydney for a regulatory workshop at the TGA, because yes - I am a total compliance nerd and LOVE learning everything I can about regulations. Here are some of my key takeaways I want to share because it's so important.

If you're new to making skincare and haven't heard of the TGA (Therapeutic Goods Administration) - basically they are the regulator for any therapeutic goods in Australia. This includes prescription medication as well as complementary medicines such as homeopathic and aromatherapy products.

Unless you’re listed or registered on the Australian Register of Therapeutic Goods (ARTG), you can’t make any therapeutic claims about your products. This means that you can’t say a product will prevent or treat a disease or illness, or affect the structure or functions of the body, e.g. heals a certain condition or controls sweat.

My top 5 tips to help you comply with the Therapeutic Goods Act 1989
1. Stick to making acceptable claims

If you look at the definition of a ‘cosmetic’ (which is very superficial) and stick within those boundaries for labelling and advertising a cosmetic product, then you shouldn’t have any issues with the TGA. Sounds so simple doesn’t it?

2. Refer to the cosmetics claims guidelines

Although the Australian cosmetic claims guidelines from the TGA are now an archived document, they still give you an idea of the things you can and can’t say. However please note they contradict more recently introduced legislation, so they can’t be relied upon 100%.

3. List therapeutic goods with the TGA

If you believe you have an excellent eczema cream or something similar and want to be able to make therapeutic claims about it – rather than trying to work out how you can ‘bend the rules’ in terms of what you say about the product, why not look into listing it with the TGA as a complementary medicine. Cost is ~$800 and there’s an annual fee of ~$1000. If you’re serious about the product then it will be worth it.

4. Be careful with testimonials

Yes, testimonials (and your ‘About’ page) are classified as advertising so you can’t include therapeutic claims in them. The TGA states that ‘advertisers are responsible for ensuring the compliance of any testimonials that are publically posted to by third parties to Facebook, Twitter, Instagram or any other social media accounts where the advertiser has control of the content. Non-compliant testimonials must be removed.’

5. Ask for help

If you want clarification on whether a certain claim you want to make is cosmetic or therapeutic, you can try your luck in the Natural Skincare Makers Australia group or speak to a consultant like myself.

As you can probably tell, I feel very strongly about the fact that if we as an industry (particularly handmade skincare) want to be taken seriously, we need to follow the relevant regulations. I see so many brands that have products for healing eczema when they shouldn’t, because they aren’t on the ARTG. At the TGA workshop, when I spoke to someone from their advertising compliance area about the Makers group and how we’re trying to educate people about TGA compliance, she very emphatically said that was a great thing – so I guess they are tired of seeing it too.

The TGA is not someone you want to have on your case and there are penalties for non-compliance. In fact, the TGA has recently made it even easier to report illegal advertising about therapeutic goods (e.g. where therapeutic claims are made about a product that isn’t on the ARTG) by adding an online complaint form to their website. The TGA will start publishing details of complaint investigations which wouldn’t be good for any business involved.

Not only that, we always want to do the right thing by our customers and our competitors. You might think therapeutic goods regulations are unfair or over-the-top, but they are there to protect consumers. It’s not fair to your customers to make therapeutic claims when you haven’t gone through the right process (these claims aren’t to be made lightly as we are talking about medical conditions, and we aren’t health professionals ourselves). It’s also not fair to your competitors who have therapeutics goods and have followed the right process by getting listed on the ARTG.

I hope this has made things a bit clearer for you, and not the other way round. Essentially you can’t do or say anything to give the customer the impression your product is a therapeutic good unless it’s on the ARTG.

To learn more about how to make compliant cosmetic claims, I’ve created an affordable and easy-to-read guide to cosmetic vs therapeutic claims.

If there’s only one thing you take away from this, let it be my motto when it comes to compliance: “If in doubt, leave it out”.


About the Author

Hi, I'm Jennifer - cosmetic regulatory consultant for Australian skincare brands. After running my own skincare business, and having a 10-year+ corporate background in risk management, auditing and compliance, I decided to combine my business know-how and industry knowledge to help others build a solid business foundation.
Since 2018, I've been supporting skincare brand owners with friendly expert advice and time-saving regulatory guides. And my signature course on how to start a skincare brand in Australia.

Jennifer - Skincare Business Foundations

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