Every year or so, some healthy ingredient or nutrient appears to ‘take the world by storm’. Previous hero ingredients have been antioxidants, probiotics, the protein rush and our current focus on prebiotics and other fibres. While it remains to be seen whether this will be the case with ‘adaptogens’, the volume of queries fielded by food regulatory consultants suggests that the food industry is ready to try.
This article explores what adaptogens are, what the potential regulatory paths to the Australian market are, and what regulatory barriers could get in the way, particularly if you classify your adaptogenic product as ‘food’.
Never heard of adaptogens?
Many of the plants and fungi (and – more importantly – their concentrated or refined extracts) that are marketed as ‘adaptogens’ have often been known for their health benefits for some time. A paper issued by the European Medicines Agency (EMA) in 2008 refers to “herbal medicinal products’’ and lists some products that are already well-established in the Australian market, such as ginseng (see the Committee on Herbal Medicinal Products (2008), “Reflection Paper on the Adaptogenic Concept”, European Medicines Agency). Other trending ingredients being branded as ‘adaptogens’ include ashwagandha, maca, turmeric, schisandra and certain mushrooms.. Other trending ingredients being branded as ‘adaptogens’ include ashwagandha, maca, turmeric, schisandra and certain mushrooms.
Apparently, what makes these plant products ‘adaptogens’ is whether they have an ‘adaptogenic’ effect. This effect is broadly defined as ‘stabilising physiological processes’ and the ‘promotion of homeostasis’ – but generally comes back to the concept of assisting the human body in coping with stress. It is worth noting at this point that the EMA paper concluded that more clarification and research needed to be done into the entire ‘adaptogenic’ concept, and subsequently prohibited the use of the term in pharmacological and clinical terminology until that research was done. While this prohibition appears to still be in place in Europe, the position in Australia can be quite different, depending on the regulatory classification of the ‘adaptogen’ in question.
While the global pandemic has no doubt driven up consumer demand for products that help protect their body from the physiological toll of stress, the consumer trend for their food and supplements to tackle mood and influence how consumers feel was already well established pre-COVID.
What’s your regulatory path to market?
Given that adaptogens appear to need to be orally consumed to have their desired effect, this means any product must either be legally classified as ‘food’ or as a ‘therapeutic good’ to be compliant if sold at a retail level on the Australian market.
In Australia, a lot of products are regulated as ‘therapeutic goods’ that would – in many other countries – be regulated as ‘food’ (or, at least, not regulated as ‘medicine’). These include many products marketed as adaptogens, such as complementary medicines, traditional medicines, and dietary supplements. There are regulatory benefits to being classified as a ‘therapeutic good’, particularly in relation to the powerful claims you are often able to make. In fact, in contrast to Europe, a search of the Therapeutic Goods Administration (TGA) website for ‘adaptogen’ shows it to be a permitted indication on behalf of listed therapeutic goods so long as evidence is held as to its traditional use (see the Therapeutic Goods (2021) (Permissible Indications) Determination (No.1), Table 8).
However, there are also downsides to being regulated as a ‘therapeutic good’, including: restrictions on where and how they can be sold; having to manufacture in premises audited to medicinal goods manufacturing practices; expensive and time-consuming market pre-approvals of ingredients, recipes, and claims for example. These downsides are encouraging many adaptogen product suppliers to explore the regulatory possibilities of ‘food’ in Australia. In contrast to therapeutic goods, there are fewer pre-market approvals and the manufacturing standards are much more achievable for ‘food’ products. This often makes ‘food’ a quicker or more economically viable pathway. But ‘food’ still has its own regulatory challenges – not least of which include: whether the adaptogen itself is allowed in ‘food’; and what claims can be made about it.
Is your adaptogen ‘novel’?
One of the aspects of food regulation that requires market pre-approval from Food Standards Australia New Zealand is if an ingredient is ‘novel’ or not. If an adaptogen is found by a regulator to be ‘novel’, the whole product will not be permitted to be sold in the Australian market. An application to change the Australia New Zealand Food Standards Code seeking permission for the adaptogen will be required.
Many adaptogens, such as turmeric, ginger and liquorice, are clearly not ‘novel’ (and therefore likely permitted in food) due to their long history on the Australian market. In contrast, the Advisory Committee on Novel Foods (ACNF) has found several popular adaptogens to be ‘novel’ – such as rhodiola and cordyceps mushroom – which risk being prohibited in ‘food’.
Is the very word ‘adaptogen’ a health claim?
Once you are confident that an adaptogen is permitted in food, the next question is how to compliantly market the adaptogenic properties. Any implication that a food product has an effect on the human body (including a physiological process or outcome) could be found to be a ‘health claim’, which may require either self-substantiation through a scientific systematic review or an amendment to the Food Standards Code. Once permitted, the making of a health claim on behalf of food products is still regulated (through nutritional profiling and labelling).
In fact, the very word ‘adaptogen’ could be seen by a regulator as being a health claim; although this author would argue that the word could be used on a food product if its use were strictly limited to a claim about the presence or absence of a biologically active substance (such as saying “with vitamin C”) or about a food ingredient that has associated health benefits (eg. “with whole grains”).
Next (or hopefully first) steps
Whichever path you select to take your adaptogenic product to market, hopefully this article not only demonstrates how possible it is, but also the importance in making these decisions early in the new product development process. These decisions will impact how quickly you can launch, where you manufacture your adaptogenic product, what can go in it and in what quantities, where you can sell it, and how to communicate its unique selling proposition to consumers.
As someone who has had to support a number of clients who made these decisions after going to market, this author would strongly recommend getting expert regulatory advice (as well as extensive consumer research) before launching your product into the adaptogenic market.
If you’ve any questions about the article, or any other food regulatory issue, please don’t hesitate to contact us via firstname.lastname@example.org.
This article first appeared in the January-March 2022 edition of the “food australia” journal (Vol.74(1)) published by the Australian Institute of Food Science & Technology.