Supplement reforms - is your product now a therapeutic good

What you need to know

• There was a declaration by the Therapeutic Goods Administration (TGA) in 2020 which determined that products for therapeutic use in sport, exercise or recreational activity which contain high-risk ingredients (e.g. products that contain substances in a schedule to the Poisons Standard or are included in the World Anti-Doping Code's Prohibited List) are therapeutic goods.
• From 30 November 2023, products that are used, advertised or presented for therapeutic use in sport, exercise or recreational activity and are in a pill, tablet or capsule form will also be classified as therapeutic goods.
• Being declared a therapeutic good means that your product must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) and must comply with the requirements of being a listed or registered medicine.
• The declaration is not the only action by regulators in the sports supplements market.  Food Standards Australia New Zealand (FSANZ) has recently announced a review of the regulatory requirements for formulated supplementary sports food products (Proposal P1010), that is, products that fall outside the purview of the TGA.

What you need to do

• If you import, supply or sell supplements or nutrients for use in sport, exercise or a recreational activity, advice should be sought in relation to any steps necessary for compliance with the therapeutic goods laws before 30 November 2023.
• If your product is now considered a therapeutic good, you will need to list or register it (depending on the ingredients and formulation) on the ARTG to comply with the law.
• It may be possible to take steps to alter the formulation or change the claims made about your product to avoid the requirement for listing/registration and corresponding obligations that apply for listed/registered medicines. You should seek legal advice on any changes that you are considering before the 30 November 2023 deadline.
• If you are interested in making comments on the FSANZ proposal, these must be filed by 9 March 2023.

The TGA's declaration

In 2020, the TGA issued a declaration clarifying the regulatory requirements regarding sports supplements. Traditionally a significant number of sports supplements had been treated as foods and not subject to the therapeutic goods laws and regulations. The declaration reclassified particular sports supplements as therapeutic goods so as to ensure these products were appropriately regulated to safeguard public health.

The first change implemented by the declaration took effect on 30 November 2020. From this date, supplements that made therapeutic claims and contained "high-risk" ingredients (eg. products that contain substances in a schedule to the Poisons Standard or are included in the World Anti-Doping Code's Prohibited List) were classified as therapeutic goods (rather than food).

From 30 November 2023, the second and more significant change takes effect. Any product in the form of a tablet, capsule or pill that makes a therapeutic claim will be considered a therapeutic good– unless the product contains glucose only.

This reclassification from food to medicine of a broad category of products is likely to have a significant impact on suppliers in this market. While the TGA did provide a three year transition period the 30 November 2023 deadline for compliance is fast approaching. To help you prepare, we set out below guidance on the scope of this aspect of the declaration, along with options to enable compliance by 30 November 2023.

What products must comply by 30 November 2023? 

In order to fall within the scope of the declaration, the product must meet the following key requirements:

1. the product must be in the form of a tablet, capsule or pill;
2. the product must be represented (expressly or by implication) as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity; and
3. when used, advertised or presented have a "therapeutic claim".

A therapeutic claim includes a claim that the product will assist with:

• 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 a workout; and
• recovering from a workout.

These listed claims are simply examples. The declaration applies to any claim that the goods are for a therapeutic use or a claim which might be taken to be to a therapeutic use.

Therefore, as of 30 November 2023, products that include the above claims (and similar) in the advertising (including on the packaging) and are supplied in the dosage form of a tablet, capsule or pill will be therapeutic goods (medicines) and required to be listed on the ARTG.

How do I comply? 

If your product is now considered a therapeutic good, you need to consider whether to list the product on the ARTG (products with higher risk ingredients may need to be registered on the ARTG rather than simply listed). To list the product on the ARTG it is necessary to comply with the listing requirements.  This includes, mandatory steps in the manufacturing process including, compliance with good manufacturing practice and particular packaging and labelling requirements.

If you do not want to list the product on ARTG or you are unable to (for example, your product is not manufactured in accordance with good manufacturing practice) you could either change the claims made about your product or the manner in which your product is delivered (that is, if the product does not contain high risk ingredients it might be able to be supplied as a powder or bar). If you are going to remove therapeutic claims from your product, be mindful that the list provided above and by the TGA are examples only.

If none of the above options are suitable, you may need to withdraw your product from the market to avoid significant penalties from non-compliance with the therapeutic goods laws.

What happens if I don’t comply?

Civil penalties (e.g. significant fines which can be up to 1.375 million for individuals or 13.75 million for companies) or criminal offences (including imprisonment) under the Therapeutic Goods Act 1989 can apply if there is non-compliance with the regime. Examples of non-compliance include failing to list a medicine on the ARTG or supplying, importing, exporting, manufacturing or advertising a medicine that is not listed on the ARTG.

For example, the TGA has recently taken enforcement action against two companies and their director and issued fines totalling to $208,000 for breach of the regime. The TGA claims that Caveman Nutrition Pty Ltd and The Cave Nutrition Store Pty Ltd advertised sports supplements and therapeutic goods that were not listed on the ARTG. The advertised goods contained Selective Androgen Receptor Modulators (SARMS), which has been linked to liver failure and increased risks of heart attack and stroke, and Cardarine, which is prohibited from sale as a Schedule 10 poison. Products containing these ingredients are required to be listed on the ARTG and there was no applicable exemption.  Therefore, the advertising for sale of these unlisted products is an offence.

But wait, there is more…

For those sports supplements that fall outside the declaration and purview of the TGA, there is still a requirement to comply with food laws.

Food Standards Australia New Zealand (FSANZ) has recently announced a review of the regulatory requirements for formulated supplementary sports food products (Proposal P1010).  Specifically, Proposal P1010 is a review of Standard 2.9.4  ('Formulated supplementary sports foods') and Schedule 29 ('Special purpose foods') of the Australia New Zealand Food Standards Code (the Code).  The review aims to gather views on how these provisions are working for all stakeholders, in order to inform FZANZ's assessment and potential amendment of the Code.

Written comments on the Proposal P1010 are due by 9 March 2023.  Interested parties should consider the proposal and file submissions.  We will keep you updated on the results of this review!

Authors: Nina Fitzgerald, Partner; and Patrick Ryan, Lawyer.