14 August 2020
What you need to know
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The interface between food and medicine has troubled regulators in recent years, as health claims are increasingly being made in relation to a broader category of products.
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Gummy lollies with claimed beneficial effects or ingredients are most likely to be regulated as therapeutic goods under the Therapeutic Goods Act 1989 (Cth), and not as food under State food legislation.
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Whether a particular gummy is in fact a therapeutic good must, however, be determined on a case-by-case basis having regard to its ingredients and health claims made.
The latest craze to hit social media is "gummy lollies" with cosmetic or other physiological effects. These gummies are being alluringly marketed as containing ingredients that are good for us (for example, vitamins), and have skyrocketed in popularity through celebrity endorsements from the likes of the Kardashian sisters, and beauty vlogger James Charles. There are now gummies which repair your hair, gummies to brighten your skin, and gummies to help you sleep, to name just a few.
The rise of these unique gummies has presented a difficult question for stakeholders globally. Are these products regulated as food or medicines?
Therapeutic good or food?
There are two different frameworks that govern foods and medicines in Australia. Determining which framework applies to a particular product is essential because of the different regulatory regimes that govern their supply. In Australia, therapeutic goods must be approved for entry in the Australian Register of Therapeutic Goods (ARTG) to be lawfully supplied in Australia. Products regarded as food – including those which make health claims – are regulated under State food legislation.
The Therapeutic Goods Act contains a definition of what constitutes a "Therapeutic Good". Goods that are represented as likely to be taken for a Therapeutic Use (that is, influencing, inhibiting or modifying a physiological process in persons), are Therapeutic Goods.
However, the Therapeutic Goods Act creates a carve-out for goods not covered by a declaration in the Declared Therapeutic Goods Order, for which there is an applicable food standard, or goods which have a tradition of use as foods in the form they are presented. In either of those cases, the goods will not be "Therapeutic Goods", even if likely to be taken for a Therapeutic Use.
In the absence of an applicable food standard, manufacturers of these innovative gummies may argue that pastilles or gummies have always been considered food and therefore, they do not fall within the definition of a Therapeutic Good. Whether such an argument succeeds will most likely turn on the ingredients in the gummy and/or the advertised benefit.
Vitamin Gummies
One interesting example is vitamin gummies. The Therapeutic Goods Administration regulates vitamins for quality and safety. The Declared Therapeutic Goods Order also currently declares goods promoted for cosmetic purposes, which are presented as being for oral consumption, as Therapeutic Goods. As a result, it is unsurprising that there are a variety of vitamin gummies currently listed on the ARTG, including hair and skin gummies.
In 2018, the regulator also conducted a targeted review of vitamin gummies listed in the ARTG to ensure that the sponsors had appropriate evidence to demonstrate their product's quality, safety, and efficacy, and compliance with the Therapeutic Goods Advertising Code 2018.
While the legal requirements to include vitamin gummies on the ARTG has not been considered judicially, a High Court decision earlier this year found that Pharmacare's vitamin gummies were "medicaments" for the purpose of determining whether they should be taxed under the Customs Tariff Act 1955 (Cth). The High Court concluded that the vitamin gummies were not "sugar confectionery" or "food preparations". Therefore, no duty was owed for the vitamin gummies.
Accordingly, it appears likely that a Court would hold that vitamin gummies should be listed on the ARTG.
Other gummies with benefits
Gummies which do not contain ingredients in the ARTG list of vitamins are likely to be more controversial. Such gummies will need to be considered on a case-by-case basis, having regard to the ingredients and any health claims made.
Final words
The vitamin market has always found it difficult to sell clinically packaged multivitamins to young adults who generally have a "see and be seen" lifestyle. Accordingly, the attraction to enter the vitamin market during its (sugar) high is understandable, but it is equally important for industry to consider the interface between food and medicine before doing so.
To assist industry in this regard, the regulator has published a "Food-Medicine Interface Guidance Tool", which it uses to determine whether or not it is responsible for regulating a particular product as a therapeutic good. While stakeholders may use that tool as a guide, it has been criticised for not being wholly accurate and therefore, it will be important to seek further advice.
For further information, please contact:
Lisa Ritson, Partner, Ashurst
Lisa.ritson@ashurst.com
