The risk of TGA regulation when making health claims about products 5 min read
A recent set of infringement notices issued by the Therapeutic Goods Administration highlights the importance of businesses carefully scrutinising all claims made about any health-related benefits of their products.
- Activewear company Lorna Jane has been issued with three infringement notes totalling $39,960 by the Therapeutic Goods Administration (TGA), for alleged unlawful advertising claims in relation to COVID-19.
- The TGA alleges that Lorna Jane claimed on its website that its 'anti-virus activewear' prevents and protects against infectious diseases, implying that Lorna Jane's products were effective against COVID-19.
- The TGA took the view that Lorna Jane had represented these products were for therapeutic use and should therefore be classified as 'therapeutic goods'. As such, the TGA considered that Lorna Jane was required (and failed) to register the relevant products with the TGA before supplying or advertising them in Australia.
- The TGA also noted that COVID-19 representations about therapeutic goods are illegal without prior TGA approval.
Lorna Jane released a range of 'LJ Shield exclusive technology' sports clothing ('activewear'). Its website stated that:
- the LJ Shield fabric treatment 'keeps you protected from viruses and germs';
- 'LJ Shield breaks through the membrane shell of any toxic diseases, bacteria or germs that come into contact with it, not only killing that microbe but preventing it from multiplying into any more'; and
- 'Any bacteria that comes in contact with the fabric is terminated when it comes in touch with the LJ Shield particles'.
The TGA is responsible for ensuring that 'therapeutic goods' available for supply in Australia are safe and fit for their intended purpose and are advertised in accordance with specific requirements. Those requirements are above and beyond obligations under the Australian Consumer Law.
The definition of 'therapeutic goods' in the Therapeutic Goods Act 1989 (Cth) (TGA Act) is relatively broad and is not limited to medicines / pharmaceuticals or medical goods. For example, 'therapeutic goods' can also include goods that are represented in any way to be, or that are likely to be taken to be (because of the way in which the goods are presented or for any other reason), for 'therapeutic use'.1
The definition of 'therapeutic use' in the TGA Act is also similarly broad, and includes uses in connection with (among other things) preventing, diagnosing, curing or alleviating a disease, or influencing, inhibiting or modifying a physiological process in persons.2
This means that advertising statements which represent that goods can cure a disease or prevent transmission of a disease between people are likely to be considered a representation that the goods are for therapeutic use.3
Goods like cosmetics and food are (for the most part) regulated separately to the TGA regime, but there may be circumstances where they are also considered to be therapeutic goods.4
For example, a cosmetic may be a therapeutic good depending on its ingredients, how it is administered and if therapeutic claims are made on the product label or in advertising.5 A statement that a skin cream is 'anti-ageing' is likely to be a therapeutic claim, however a statement that the cream 'covers up age spots' may not be regarded as a therapeutic claim and is more likely to be understood as a cosmetic claim. Whether a claim is therapeutic in nature turns not only on the wording, but the context in which the claim is made.
Another example is toothpastes and gels, which would not ordinarily be considered therapeutic goods, however desensitising toothpastes or toothpastes marketed as having desensitising properties would be treated as a therapeutic good.
Similarly, making therapeutic use representations for a food product might lead a consumer to think the product is for therapeutic use, resulting in it being regulated by the TGA. The TGA's website states the following:
… a sachet of probiotic powder might be marketed as a food but other factors such as claims about its health benefits, warning statements or a dosage regime may lead consumers to believe it is a therapeutic good.6
For example, statements that a probiotic powder enhances a person's immune system to defend against disease would be a therapeutic one, while advertising statements limited to describing the powder's taste without any references to a dosage regime or health benefits may not be a therapeutic claim.
If an advertiser's claims are caught by the definition of therapeutic goods, that advertiser must comply with specific advertising obligations in the TGA Act and the Therapeutic Goods Advertising Code (No 2) 2018 (the Code), including that the therapeutic goods:
- must be registered with the TGA for inclusion in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied or advertised in Australia;7
- must not be promoted as being safe, harmless or without side-effects; and
- must not be promoted using 'restricted representations' unless the TGA provides prior formal approval or permission. 'Restricted representations' are advertising representations about serious forms of a disease, condition or ailment (such as representations regarding COVID-19).8
Contraventions of the TGA Act can result in maximum civil penalties of $10.5 million for companies and $1.05 million for individuals.9 There are also criminal sanctions where reliance on advertising is likely to result in harm to any person or where there is intentional non-compliance.10
The TGA's action against Lorna Jane illustrates that in the current environment, there is likely to be considerable regulatory scrutiny of advertising claims about the medical or health benefits of products (in relation to COVID-19 and otherwise).
There are many goods that could potentially be regarded by the TGA as falling within the definition of a 'therapeutic good' (and thereby attracting the strict advertising requirements of the TGA Act and the Code) if advertised or presented in a certain manner.
For example, in April 2020 the TGA also issued celebrity chef Pete Evans' company with $25,000 in infringement notices for claiming that a light-emitting 'BioCharger' device could prevent coronavirus as well as 'restore strength, stamina and mental clarity'.
Companies should be vigilant about the advertising claims made about their products and ensure they seek legal advice before making any representations about health benefits or therapeutic uses of products that are not listed on the ARTG.
TGA Act, s3 definition of 'therapeutic goods'.
TGA Act, s3 definition of 'therapeutic use'.
See TGA, 'Advertising interface products' (16 July 2020).
s42DL(12), TGA Act.
s42DD, TGA Act.
s42DLB, TGA Act.
s42DL, TGA Act