Formulated Supplementary Sports Foods: Under Review

FSANZ has released a consultation paper and is requesting submissions in the first round of its review into the regulation of Formulated Supplementary Sports Foods (FSSFs).

Submissions close 6pm, 9 March 2023. Note that there will be a second call for submissions in future before any amendments to the FSC are finalised, and a further consultation paper focusing on claims will also be released as part of the review.

State of Play

In response to the recent redefinition of the scope of ‘FSSF’ products that will be treated by the TGA as medicines, FSANZ is now considering what adjustments on the food side of the food-medicine interface would be most beneficial for consumer protection and all-around clarity without unduly stifling innovation. We believe there is a strong consensus within the industry that the current regulation of supplemented or fortified foods and beverages is outdated and ill-adapted to regulate innovative food and beverage categories.

We have reviewed FSANZ's consultation paper and considered what submissions may be most valuable in shaping the outcomes of the review to the advantage of our clients. FSANZ loves to hear from industry on these reviews and to receive submissions with as much relevant data around innovation, consumer trends, and practical experiences/issues as possible. With our support, UC F&B and Health clients can make submissions that may have a material impact on the outcomes of the review.

Universal Counsel supports pro-industry (yet still appropriately consumer-protective) amendments to FSSF regulation. Through submissions made in this round and in future on behalf of our clients, we hope that to promote outcomes from this review that -

(a) avoid a narrowing of the scope of FSSFs to close this channel to currently accepted use; and

(b) expand the scope of supplemented food regulation to more closely align with consumer demand and our F&B clients' innovation aims.

Scope of the review

• Definitions - The scope of the review covers proposals for more clearly-defined relevant terms, including ‘modern’ consumer classifications as an alternative to the current ‘sports persons’. This may result in a pivot to ‘supporting performance’ or potentially even ‘health and wellness’ as a foundation of the definition of what may constitute an FSSF. This could allow for a more flexible presentation of goods in this category, which would benefit clients in seeking to expand their supplemented beverage/food offerings while maintaining brand integrity. On the other hand, many businesses would also benefit from successfully opposing a narrowing of the characterising/pre-requisite definitions for this category, which might otherwise restrict the currently broad scope of use in the food-medicine interface.

• Approach to regulation - The consultation paper proposes consideration of a potential risk-based, multi-tiered approach to regulation for supplemented food products. This could result in broader permissions for low-risk nutritive substances and tighter conditions around the use of riskier nutritive substances (particularly where that risk arises from excessive consumption through what FSANZ calls the ‘stacking’ of FSSs). We consider that this risk-based approach would likely benefit most UC F&B clients, who commonly look to use low-risk nutritive substances.

• Warnings/directions- There are also requests for comment in relation to target audiences of proposed products and whether further labelling requirements are necessary to manage risk to those demographics (with reference to current pregnant women and children consumption warnings). There are several open-ended questions for respondents around labelling of FSSFs generally and the opportunity for potentially significant changes on this front as a result. 

• Claims - Note that there will be a second, separate consultation paper and request for submissions specifically in relation to nutrition and health claims that can be made in connection with FSSFs. Submissions received in this round in response to question 19 on claims will influence the scope of the second claims-focused consultation paper, which will likely focus on outcomes to address the inconsistencies in special purpose food/FSSF claims regulation and resulting ‘grey areas’.

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Next Steps

Contact our UC F&B team at food@universalcounsel.com.au to discuss the FSANZ Formulated Supplementary Sports Food review and the potential impact on your business.

See our UC F&B unit page for more information on the F&B industry-specialised services we provide under this banner, including labelling and collateral review, non-compliance risk management, and end-to-end strategic NPD support.