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Frequently asked questions: sports supplements proposal and consultation
To be read in conjunction with the consultation paper on the proposed clarification that certain sports supplements are therapeutic goods.
The TGA is currently conducting a public consultation on a proposal to clarify that sports supplements containing ingredients not acceptable for food (e.g. medicinal ingredients) and/or that are presented like medicines (e.g. in capsules) should be regulated as medicines.
The current consultation on sports supplements is a consultation to obtain stakeholder feedback and no decision has been made by the Government on any reforms to the regulation of sports supplements. A decision will not be made until after a thorough assessment of the regulatory impacts and completion of a regulation impact statement.
If the proposal goes ahead, there will be a transition period of 2-3 years. This means that products that are not included in the Australian Register of Therapeutic Goods and which are actually medicines would not be removed from shelves straight after any regulatory changes. They would have significant time to transition to being include in the Register as medicines based on the claims made and supporting evidence. Please visit the TGA website for information on listed and registered medicines.
Six weeks is the standard period for a public consultation on a proposal of this type. The consultation opened in late October and does not close until 3 December. The TGA wrote to almost 100 companies, individuals and organisations in late October and the first few days of November to alert them to the consultation and encourage submissions.
The consultation period is open for six weeks, from 22 October to 3 December 2019. There are no plans to extend the consultation period, so have your say today by making a submission.
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 and/or are being presented as medicines rather than food.
A number of safety problems and serious adverse events have been reported internationally and in Australia associated with the use of certain sports supplements. These include deaths in Australia and internationally due to sports supplements containing DMAA and dinitrophenol and emergency hospitalisations of high school students in Queensland in 2018. There are Australian case reports of at least six liver and kidney transplantations being required due to sport supplement consumption, and the death of a WA woman following high-level protein supplement use. A recent Australian army study of over 2000 service men and women taking sports supplements regularly found that as many as one in six had suffered adverse events from the supplements (palpitations, tremors, tingling, numbness, headache, pain, dizziness, anxiety) with "thermogenic fat burner" supplements a particular concern.
In 2016, the life science company LGC conducted the Australian Supplements Survey which analysed 67 common supplement products in Australia. They found one in five products contained one or more substances banned in sport. Importantly, none of the products identified listed any banned substances on their ingredients list.
More recently, a study by New Zealand's Otago University's Department of Physiology found that over 5% of 116 of sports supplements available in Australia had banned substances.
A national roundtable was held in 2018 with Commonwealth, state and territory governments, health professionals and industry representatives to identify measures to improve the safe use of these products. Following the forum, the Minister asked the TGA and Food Standards Australia New Zealand to investigate options to provide greater clarity on the regulatory status of these products with the aim to improve their safe use.
State and Territory Governments have also been involved in policy discussions around this issue, with options discussed by jurisdictions at the July 2019 meeting of the Food Regulation Standing Committee's Implementation Subcommittee. In addition we wrote directly to several dozen major sports supplement suppliers in late October and early November advising them of the consultation and inviting their feedback.
The types of products that are intended to be captured by the proposal include:
- Sports supplements that contain undeclared ingredients that pose a risk to consumer safety (e.g. prescription medicine ingredients or substances banned in sport by the World Anti-Doping Agency).
- Sports supplements that make therapeutic claims appropriate for medicines and that are presented as medicines (e.g. tablets and capsules).
While the proposed declaration would clarify the status of a large number of products, it is not anticipated that there would be high regulatory impacts on Australian businesses. The products in scope are a limited number of products which are currently claiming to be foods and which should be classified as complementary medicines by virtue of their therapeutic claims, composition or dosage forms rather than foods. However, a Government decision will not be made on any changes to the regulation of sports supplements until after a thorough assessment of the regulatory impacts and completion of a regulation impact statement.
The products in scope of the proposal contain medicinal ingredients that are not appropriate for food and/or are being presented as medicines rather than food. These products are already medicines in law, but 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. The current situation is detrimental for the health and safety of those who are using such products.
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 ensure all Australians accessing sports supplements can be assured of their safety and quality.
No decision has been made by the Government on any reforms to the regulation of sports supplements. If the proposal goes ahead, there will be a transition period of 2-3 years. This means that products (which are actually medicines but are not currently included in the Australian Register of Therapeutic Goods) would not be immediately removed from shelves but would have significant time to transition to inclusion in the Register either as listed or registered medicines based on the claims made and supporting evidence. Please visit the TGA website for information on listed and registered medicines.
If the proposed changes go ahead, sports supplement products that contain ingredients appropriate for foods and that are presented as foods will be able to be continue to be supplied as foods. Where a product contains a substance that is harmful or banned and would affect consumer safety, a manufacturer would need to reformulate the product before it could be sold.
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.
The proposed reforms do not affect sports supplements that contain only appropriate food ingredients and are currently presented as foods, e.g. functional foods, 'superfoods', apple cider vinegar and chia seeds. These will continue to be regulated as foods.
Herbal products that make therapeutic claims (for example: gut health, stress management, sleep aids) are already regulated as medicines. The proposed sports supplements declaration would not affect these products.
Vitamin and mineral supplements that contain low-risk ingredients are already regulated as medicines. The proposal would not affect these products.
Sports supplements that contain only appropriate food ingredients and are presented as foods will continue to be regulated as foods, such as a product that contains whey protein powder (as a single ingredient or with other food ingredients).
Nutrition bars that only contain ingredients appropriate for food will not be affected.
The proposal is not intended to apply to food products that only make claims for dietary weight management, for example: some meal replacement shakes or bars would not be affected.
The TGA advises consumers to 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 proposed changes would enable the Government to take more rapid and decisive action against inappropriate products advertised on-line. For example, last year Australian Border Force working in collaboration with the TGA seized over a million doses of illegal products in several hundred shipments.
We encourage all interested parties to respond to the consultation and raise their concerns with the TGA, so that all views can be considered in informing any clarification on the regulatory status of sports supplements.
You can make a submission to the public consultation by following the links on the consultation web page on the TGA website. Your submission may be as brief or as detailed as you wish. Your submission will be reviewed and considered by the Australian Government in its decision on whether or not to make the declaration.
Yes, independent expert consultants will 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. Your submission to the consultation will help inform statements on the impact the proposed declaration may have on you or the organisation you represent.
Unless if the submitter requests confidentiality, submissions to the consultation, the Government's consideration of the submissions and any proposed Government action will be published on the TGA's website. The TGA has a number of email lists to which you can subscribe to receive updates by email.