What is the section 7 declaration for sport supplements?
Under sub-section 7(1) of the Therapeutic Goods Act 1989 (the Act) the Secretary of the Department of Health has the authority to declare that certain goods are or are not therapeutic goods
On 23 September 2020 a section 7 declaration (the declaration) was published that declared that sports supplements containing ingredients not acceptable for food (e.g. medicinal ingredients) or that are presented like medicines (e.g. in capsules) are therapeutic goods (medicines).
Why was the section 7 declaration made?
A number of safety problems and serious adverse events have been reported internationally and in Australia associated with the use of certain sports supplements, including deaths and liver transplants.
An increasing number of sports supplements are being marketed as foods in Australia. While this is appropriate for many of these products, some actually contain ingredients that are not appropriate for food or are being presented as medicines rather than food.
In 2018 the Minister asked the TGA and Food Standards Australia New Zealand (FSANZ) to investigate options to provide greater clarity on the regulatory status of these products with the aim to improve their safe use.
The products in scope of the declaration contain medicinal ingredients that are not appropriate for food or are being presented as medicines rather than food. While these products may already be medicines in law, it appears some companies may have exploited uncertainty, potential confusion and "grey areas" by marketing these products as foods and therefore potentially avoiding appropriate regulatory oversight.
There are separate regulatory frameworks for foods and medicines with different regulatory requirements. Medicines are required to be manufactured in accordance with good manufacturing practice to ensure the quality of the product. There are also labelling, advertising and evidence requirements.
The proposed changes will not only appropriately clarify products subject to that framework, they will allow prompt regulatory action for such products including those supplied via the internet and imported into Australia.
When will the changes occur?
The declaration comes into effect on 30 November 2020 for sports supplements containing the ingredients identified in the declaration.
Sports supplements presented in the dosage form of pills, tablets or capsules (that do not contain ingredients identified in the declaration) will have 3 years to transition their medicine. The products must be compliant with the new requirements on 30 November 2023.
What products are not affected?
Products that do not make any therapeutic claims relating to sports are not affected by the declaration e.g. artificial sweeteners, meal replacement shakes.
Sports supplements that are already included as medicines in the Australian Register of Therapeutic Goods (e.g.: vitamins, minerals, herbal medicines) are not affected by the declaration.
The declaration also does not affect sports supplements that only contain appropriate food ingredients and that are presented in traditional food forms (e.g. powders, beverages, bars), such as:
- whey protein powders (as a single ingredient or with other food ingredients).
- nutrition bars
- functional foods, 'superfoods', apple cider vinegar, chia seeds
- branch chain amino acids (when presented in a food form)
What products are affected by the declaration?
The products that are in scope of the declaration include are sports supplements that make therapeutic claims and:
OR
- Contains substances/ingredients identified in the declaration:
- substances that are in a schedule to the Poisons Standard; or
- substances that are prohibited from use in sports by the World Anti-Doping Authority ('the Prohibited list') and added to the product as an ingredient; or
- relevant substances that have been specified in the declaration and added as an ingredient, namely:
- dendrobium (Dendrobium nobile);
- methylliberine
- Are presented as a tablet, capsule or pill
What happens to products affected by the declaration?
After the declaration comes into effect ( see When will the changes come into effect?) sports supplements in scope of the declaration intended to be marketed as foods will need to be changed to different product claims, ingredients, and/or dosage forms, as appropriate.
Alternatively, if the sports supplements are to be maintained on the market as medicines, the products will need to be entered in the Australian Register of Therapeutic Goods (ARTG) as a listed or registered medicine and the sponsor (the person who is legally responsible under the Act for the medicine in Australia) will need to ensure that their product meets the applicable legislative requirements for manufacturing, formulation, labelling, evidence and advertising. See the TGA website for information on listed and registered medicines.
Some manufacturers may make a business decision to withdraw their sports supplements from the market, rather than be regulated as therapeutic goods or reformulating to be regulated as a food.
How are retail shops affected by the declaration?
Sports supplements that contain ingredients appropriate for foods and that are presented as foods will be able to be continue to be sold as food at retail stores.
Sports supplements that are in the presentation of a tablet, capsule or pill (but do not contain ingredients identified in the declaration) can continue to be sold from retail stores until the end of the 3 year transition period (29 November 2023). However, from 30 November 2023, these products need to be included in the ARTG to continue to be legally sold in their current presentation.
The declaration clarifies that from 30 November 2020 it is illegal for retailers to sell sports supplements that contain the ingredients identified in the declaration, if these are not included in the Australian Register of Therapeutic Goods as listed or registered medicines. Note that the TGA does not anticipate forcibly removing these products from store shelves. However, retailers must be aware of their responsibilities under their relevant state and territory laws.
What about supply and advertising of affected goods?
When the declaration comes into effect (see When will the changes come into effect?), sports supplements in scope of the declaration will not be able to be released for further supply by the person (a manufacturer, owner or supplier of the product) who is considered to be the sponsor of the product under the Act (see Role of the sponsor) until the product is compliant with the relevant legislative requirements. From the date of effect, anyone advertising the product must also comply with relevant legislative requirements relating to advertising (see Advertising hub).
Can food sports supplements still make health claims relating to performance in sport?
Yes.
Foods that are compliant with the relevant food standards can still make the health claims permitted by those standards.
It is accepted that there is some overlap between therapeutic indications that medicines can make and health claims that foods can make. The intent of the declaration is not to stop foods making health claims relating to sports performance. Rather, it is clarifying that products that make claims (therapeutic indications) relating to sport and contain medicinal type ingredients and/or are presented as medicine are appropriately regulated under the regulatory framework for medicines.
How will the declaration affect sports supplements being imported into Australia from New Zealand?
When the declaration comes in to effect, sports supplements declared to be therapeutic goods will not be eligible to be imported into Australia under the New Zealand Australia Free Trade Agreement (NAFTA).
Will consumer choice be restricted?
Consumers will continue to be able to access products that contain ingredients appropriate for foods and presented as foods, as well as sports supplements currently being supplied as medicines. Consumers may see changes to some sports supplements on the market in relation to their formulation, claims, labelling and advertising. If manufacturers choose to have their products TGA listed, consumers would be able to select these supplements without a prescription or need to see a pharmacist. The retail businesses that sell sports supplements currently are also able to sell listed medicines without any specific licences being required by those businesses.
How will the declaration affect internet purchases of sports supplements and imported sports supplements?
The TGA advises consumers to only use products that are regulated by the TGA, rather than purchasing goods over the internet, as the safety of these goods cannot be guaranteed.
The declaration enables the Government to take more rapid and decisive action against inappropriate products advertised on-line and imported in to Australia. For example, last year the Australian Border Force working in collaboration with the TGA seized over a million doses of illegal products in several hundred shipments.
What consultation occurred prior to making the declaration?
State and Territory Governments and other Government agencies such as Food Standards Australia New Zealand, Sports Integrity Australia and Australian institute of Sport have been involved in policy discussions around the declaration.
Over the last 18 months, the Government has consulted with a range of stakeholders in relation to the regulation of sports supplements. For more information refer to:
Did the TGA produce a Regulation Impact Statement?
Yes, independent expert consultants were engaged by the TGA to contribute to the drafting of a Regulation Impact Statement (RIS) to describe and quantify the impact of the proposed declaration on parties including consumers, small businesses, industry, health professionals, athletes, and other groups that may be affected, as is required by Government before any decisions of this nature are taken.
The Regulation Impact Statement for Sports Supplements is available on the TGA website and is also available on the Office of Best Practice Regulation website.
Did the TGA notify members of the World Trade organisation?
Yes. The TGA notified the World Trade Organisation of the proposed reform and provided member states 60 days to comment. No comments were received.