The transition period is about to end for Formulated Supplementary Sports Foods.

A Formulated Supplementary Sports Food (FSSF) is a category of food product, legislated under the Food Standards Code. The Code is developed by Food Standards Australia New Zealand, and enforced by state and territory food regulatory bodies.

The technical definition of a FSSF is a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals. [1] Or in plain English, they’re foods which are consumed by people who are engaging in physical activity and have specific nutritional requirements to support this activity.

FSSFs can be made up of ingredients such as amino acids, vitamins, minerals, protein, caffeine, electrolytes, and of course nothing on the WADA prohibited list. FSSF come in all forms: powders, bars, gels or drinks and can be consumed any time of the day, before exercise, during exercise, after exercise.

The 5 key reasons consumers take formulated supplementary sports foods are:

1. Energy source
2. Build muscle
3. Protein source
4. Exercise recovery
5. Weight control

It is estimated that around 10% of the Australian and New Zealand population regularly consume sports foods, of that 60% use sport food product in an exercise related context and 80% of those products are protein supplements. [2] Lets crunch the numbers here- 10% of the Australian population (2.5 million [3]) + NZ population (0.5 million [4]) equals approximately 3 million consumers. And of these 3 million consumers, the gym was associated as the highest area of use of sports foods. Assuming 3 million ANZ consumers visit the gym 4 times a week, and take a 30 g serve of a FSSF, that’s approximately 19 tons of FSSFs consumed per year across ANZ. That’s big business.

Before you launch your next FSSF, you need to know about how the regulatory landscape has shifted so you can adapt.

The back story: On 22 October 2019, the TGA asked the public for their view on their proposed legislative changes which would declare some FSSF, therapeutic goods. Up until this date sports products generally fell into the domain of foods, particularly the FSSF category. The TGA received 19,500 responses; clearly the topic was controversial. We have been very vocal about our views directly with the TGA, and feel strongly that the changes proposed by the TGA do not address the fundamental issues (particularly safety issues) which have plagued this category of supplements.

In September 2020 the TGA reached a decision, declaring that from 30 November 2023, certain sports supplements will be considered as therapeutic goods (medicines) moving forward, when they meet the following circumstances:

• Ingredient selection: Where a product contains:
  • A scheduled ingredient under the poisons standard (SUSMP) (NB: this document is updated frequently, so it’s important to keep an eye on this ongoing); or
  • A prohibited substances from the WADA list as at 1 March 2023; or
  • Dendrobium (Dendrobium nobile) or Methylliberine (NB: the TGA may update this list as and when they like, so it’s important to keep an eye on this ongoing); or
  • A substance with equivalent pharmacological activity to any of the above mentioned ingredients, including similar forms (e.g. active principle, precursor, derivative, salt, ester, ether or stereoisomer)
• Product form: pill, capsule, tablet (other than those containing glucose only)
• Product claims:
  • Represented (expressly or by implication) as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity; and
  • For therapeutic use or advertised in a way that is likely to be taken for therapeutic use; or
  • For uses including (but not limited to): gaining muscle, increasing mental focus, increasing metabolism, increasing stamina, increasing testosterone levels, reducing oestrogen levels or otherwise modifying hormone levels, losing weight or fat, preparing for workout, or recovering from workout.

As you can see, there are a lot of rules and references to crosscheck, and it’s easy to misinterpret where your product might sit in this new regulatory landscape.

So, where to from here:

1. Do nothing keep as is; what is the risk? The risk (and the stakes) are high; too high in our opinion to be caught out. With hefty fines and cease & desist supply notices on offer, coming under the TGAs watchful eye could easily sink a business. The culture at the TGA is such that infringement notices are enthusiastically dolled out and once the transition period has elapsed we would confidently bet that sports supplements will come under fire immediately. Further, imagine receiving a delivery of thousands of units of a new product into your warehouse, only to receive a letter from the TGA a few days later demanding that you must immediately cease supply of the product in Australia- that’s what’s at stake.
2. Modify your product to become a legitimate FSSF, in line with Chapter 2.9 of the Food Standards Code and steering clear of the Declared Therapeutic Goods Order. You might say this will dilute your messaging and formulation, but with creativity, formulation expertise and a firm grasp of the regulatory landscape, you might be surprised at how much of the original product proposition you could retain.
3. Modify your product to become a legitimate therapeutic good. This might seem like a daunting proposition, but with the right support this process doesn’t need to be bigger than Ben Hur, and you might be surprised at how much additional opportunity this could bring you!

Our last word, we get asked regularly whether a food can make health claims, or whether a food can be supplied in a tablet/ capsule format. This statement from the TGA does a good job of addressing this query “Often, claims made about a product, or the appearance of the product may suggest that it is a therapeutic good. However, the fact that health claims are made about a product does not automatically make it a therapeutic good. Nor does the fact that the product comes in capsules or powders, or is labelled as a ‘dietary supplement.” [5]

So, if you require assistance in navigating this landscape and determining if your product is a food or medicine, and to discuss the opportunities of one regulatory category over the other for your product, please get in touch.

[1] Australia New Zealand Food Standards Code. (2017). Standard 2.9.4 – Formulated supplementary sports foods. Available at: https://www.legislation.gov.au/Series/F2015L00421

[2] Food Standards Australia New Zealand (FSANZ) (2013). Sports Foods Consumption in Australia and New Zealand. September 2013). Available at: https://www.foodstandards.gov.au/publications/Documents/Sports%20Foods%20Quant%20Report.pdf

[3] Australian Bureau of Statistics (2022). National, state and territory population. March 2022. Available at: https://www.abs.gov.au/statistics/people/population/national-state-and-territory-population/mar-2022

[4] New Zealand Stats (2022). https://www.stats.govt.nz/information-releases/national-population-estimates-at-30-june-2022/#:~:text=At%2030%20June%202022%3A,37.0%20and%2039.1%20years%2C%20respectively.

[5] Australian Government, Department of Health, Therapeutic Goods Administration (2014). Food and medicine regulation; Find out if a product is regulated as a food or a therapeutic good. https://www.tga.gov.au/news/news/food-and-medicine-regulation