An order made under section 7 of the Therapeutic Goods Act 1989 has come into force, the effect of which is to now automatically classify any “sport supplement” product in tablet, pill or capsule form as a therapeutic good (i.e. medicine), and no longer food.
This is regardless of the existence of a specific standard under the Australia New Zealand Food Standards Code (the Code) for food products expressly designed to assist sports people in achieving specific nutritional or performance goals. Essentially, the Therapeutic Goods Administration (TGA) has decided to reclassify food products as medicine based solely on their format.
An additional and immediate effect of the order under Section 7 of the Act is that imported products previously classified as “food” will be referred for inspection under the Imported Food Inspection Scheme.
This article explores whether the change is fit for purpose, and the implications of a food product transitioning to the therapeutic regulatory framework.
What are “sports supplements”?
“Sports supplements” is not a really legal term at all. Instead it is a broad term used by the TGA to capture a category of products purporting to enhance sports, fitness, or recreational performance. Many of these products were – completely appropriately – legally classified as “food”, particularly under Standard 2.9.4 of the Code (formulated supplementary sports foods). As a result, such products were legally and compliantly available through food retail channels, such as supermarkets or online, and only needed to be manufactured in accordance with food standards.
However, by reclassifying such products as therapeutic goods, they must now:
- be manufactured to medicinal standards;
- be pre-approved through listing or registration on the Australian Register of Therapeutic Goods; and
- comply with retail and marketing restrictions which apply to medicine (such as the prohibition on using social media influencers to market therapeutic goods).
The significant regulatory differences between the food pathway and the therapeutic goods pathway means that many products that were freely available to Australian consumers will now no longer be economically viable to bring to the Australian market.
Why is the TGA targeting sports supplements?
The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020 made under Section 7 by the TGA (the Order) was actually implemented in 2020, but with a 3-year transition period for products in pill, tablet and capsule form that were (and arguably still are) fully compliant with food regulations. The Order came about after 18 months of extensive consultation with both the public and key industry stakeholders, and came off the back of rising concern around the safety risks posed by some sports supplements. An increasing number of fatalities and serious health incidents had been reported both domestically and internationally in relation to such products, including incidents involving sport supplements with very high caffeine content.
The second policy reason behind this amendment to the Act is the nexus between these incidents and the otherwise healthy and frequently young consumers, who are attracted to this class of product.
It is worth noting that this reclassification of certain sports supplements based on their format alone is the second part of the Order. The first part (which took immediate effect on 20 November 2020) also automatically classified “sports supplements” as therapeutic goods, but only when they contained certain banned substances or exceeded permitted food limits for certain other substances. Given that such products would have been non-compliant foods, the need for the Order at all heavily implies that the TGA believes itself a more effective regulator of these products than food regulators. For example, in the Regulation Impact Statement, the TGA itself said:
Some companies may knowingly market supplements as food products, rather than therapeutic goods, to avoid appropriate regulatory scrutiny, even though they contain ingredients that may cause harm.
Regardless of the reasons behind the Order, at least the first part of it targeted substances that were not permitted in food products.
This second part of the Order, which took effect on 30 November 2023, ignores the content of the “sports supplement” entirely.
What categories of product are no longer legally “food” as of 30 November?
The legal theory remains that food products are excluded from the legal definition of “therapeutic goods”, especially where there is an express food standard (such as Standard 2.9.4).
It is important to note that there are no “formats” prescribed for a formulated supplementary sports food. Sports foods are commonly in powders or beverages, but can be in any format, such as confectionery, muesli bar, oil, yoghurt, or even processed meat. And, up until 30 November, they could also arguably be in pill, tablet or capsule form (or at least no such format was prohibited in food). But following the Order, any “sports supplement” product in pill, tablet or capsule form will now be automatically classified as a therapeutic good.
While other presentation factors (such as the claims being made about a product) can influence whether a product falls under the new Order, the only definitive factor in this instance is format. Certain sports food products are expressly permitted under food regulation to claim that they can “assist in the development of muscle bulk” and may be useful before, during, or after strenuous exercise. But the TGA Order expressly states that gaining muscle is a claim for a therapeutic use. So how a product is marketed does not appear to be definitive in moving a product from being a compliant food to being a non-compliant therapeutic good.
To put this in context: two products could have exactly the same ingredients and exactly the same claims, but if one is a powder… it is food. And if the other is a tablet… it is a therapeutic good. This regulatory distinction appears burdensome, confusing and unnecessary.
This is by no means the first time the TGA has attempted to regulate otherwise perfectly normal food products as therapeutic goods based solely on their format. In 2009, it previously attempted to regulate all products in tablet, capsule and pill form and intended for oral consumption as therapeutic goods under Section 7. At the time, this proposed amendment did not proceed due to the anomalies this categorisation would have on food products like chewing gum or breath mints.
However, the recent Section 7 amendment targeting “sports supplements” is the latest in the TGA’s incremental category-by-category approach to reclassifying specific ingredients as therapeutic goods based solely on their format. For example, fibre and shark cartilage – both common food ingredients – are, by virtue of Section 7, now medicine when sold in pill, capsule or tablet form.
Is the amendment fit for purpose?
It is hard to see how consuming the exact same product in powder or pill form deserves the significantly different regulatory burdens now imposed. Furthermore, it is hard to see how this amendment protects consumers from harm, given pills, tablets and capsules are in controlled quantities whereas other food formats have no such inherent controls. In fact, the whole scrutiny of sports supplements was triggered by an accidental caffeine overdose of a product in powder form.
Immediate action required
Businesses currently selling products categorised as foods that will be impacted by this declaration will be faced with three options:
- Modify their products’ format if they wish to continue selling their products as foods;
- Pursue regulatory transition to make their product compliant with the therapeutic regulatory framework; or
- Abandon the Australian market altogether.
If you have any questions about these amendments and how they apply to you, please contact our Food & Beverage team to discuss either via our dedicated email address (food@khq.com.au) or call us on (03) 9663 9877.
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