Supplements cover a range of products in Australia, including vitamins, minerals, sports nutrition products such as protein powders, and other goods that may improve nutrition and performance. Supplements may be regulated as either a food or a medicine in Australia, depending on whether it meets the requirements outlined in the Food Standards Code, or the Therapeutic Goods Act 1989. Determining whether a sports supplement is a food or a medicine can sometimes be complex. Manufacturers and importers of products need to know whether the products are regulated as therapeutic goods or as food because different regulatory requirements apply. Consumers may also want to check if the products they are using are classified and regulated suitably. The TGA provides a food-medicine interface guidance tool to help in determining whether a product is a medicine or a food. Some of the considerations include: - the form of the product (capsule, tablet, liquid) - whether the product contains a scheduled substance - how the product is represented, i.e. for human therapeutic use - whether people are likely to perceive the product as being for therapeutic use due to the way it is presented - the types of claims the product makes [Identifying products regulated by the TGA] Any product that is regulated by the TGA will have an ‘AUST’ number on the label. These products are regulated proportionate to their risk, approved for supply in Australia and included in the Australian Register of Therapeutic Goods (ARTG) as either registered medicines (AUST-R) or listed medicines (AUST-L). All products that meet the criteria of a therapeutic good must be included in the ARTG before they can be legally supplied. Some sports supplements on the market may be therapeutic goods but have not been included in the ARTG by the manufacturer or importer prior to supply―we may target these as part of our compliance program based on complaints and other signals we receive. For more information on the different types of medicines, including what the AUST numbers mean, visit the How we regulate medicines webpage. [Counterfeit sports supplements exist and are dangerous] Like with many other medicines and medical devices, there are unapproved, counterfeit products on the market and they can be hard to spot. A counterfeit supplement may include ingredients that are not disclosed on the label, which may be dangerous for your health, as well as: - the wrong active ingredient - no active ingredient - too much or too little active ingredient and variations across tablets and batches - substances withdrawn from sale for safety reasons - illegal prescription medicines - banned substances in sport - toxic or dangerous substances - substandard components With many supplements not falling under therapeutic goods regulation, consumers should take extra care when selecting a product. The Australian Sports Anti-Doping Authority (ASADA) published information on their website which discusses the dangers of using sports supplements and the risks involved, particularly for sportspeople. If you are concerned about counterfeit medicines, or think you have bought counterfeit goods, you can report the matter to the TGA. [Performance enhancing drugs] Performance and image enhancing drugs are becoming increasingly prevalent in Australia. Many of these products have not been approved by the TGA, while others have been approved as prescription-only medicines for specific uses. The TGA advises consumers not to use performance and image enhancing drugs unless they have been prescribed by a health professional. TGA investigations have found a number of products on the market, including: - anabolic-androgenic steroids, such as testosterone - selective androgen receptor modulators (SARMs), such as enobosarm - beta-2-agonists, such as clenbuterol - stimulants, such as amphetamines - peptide hormones, growth factors, and related peptide drugs, such as human growth hormone Not only is it illegal to supply and possess unapproved performance and image enhancing products, they may also be contaminated with unknown ingredients and toxic chemicals. [Choose products carefully] There are a few steps you can take to protect your health and safety when choosing sports supplements. For example: - don’t buy from overseas websites - look for an AUST number on the label, which confirms it is a TGA regulated product - seek advice from a health professional before using a new product - consider alternative options when aiming to enhance your fitness or physique ASADA recommends athletes only use supplements that have been tested by an independent body. https://www.tga.gov.au/media-release/sports-supplements-australia