Sports supplements like protein powders, pre-workout capsules, or performance products may have the same target audience. But the regulations may not be the same for each of them. In Australia, sports supplements may fall under a food or therapeutic goods regulatory framework. That will depend on ingredients, claims, dosage, and presentation. This distinction is important for manufacturers, importers, and suppliers so they can follow the right requirements.
This article explains how sports supplements have become medicines as well as foods in Australia. Know when the TGA becomes involved and what businesses need to consider before importing or supplying these products.
Regulatory Body for Sports Supplements in Australia
Sports supplements in Australia may be regulated by different authorities. It depends on whether these supplements come under food or a therapeutic good. In case a product is regulated as a therapeutic good, the Therapeutic Goods Administration (TGA) is responsible for its regulation under the Therapeutic Goods Act 1989.
On the other hand, products regulated as foods must meet the applicable requirements of the Australia New Zealand Food Standards Code. This includes Standard 2.9.4, which governs formulated supplementary sports foods. Food Standards Australia New Zealand (FSANZ) develops food standards, including standards specifically relevant to formulated supplementary sports foods.
Therefore, businesses should first determine the regulatory classification of their product before identifying the requirements that apply.
Definition of Sports Supplements
The Australian definition of sports supplements differs from that of food and therapeutic goods. Let’s look into it:
Formulated Supplementary Sports Food
Sports supplements categorised as ‘food’ means a product specifically formulated to help sportspeople achieve nutritional or performance goals. Their composition covers permitted vitamins or minerals, amino acids used as a nutritive substance, any other substance used as a nutritive substance, and caffeine.
Sports Supplements
They become a therapeutic good or a medicine when they are presented in a medicinal dosage form of a pill, tablet, or capsule. Or their ingredients are high-risk for consumers. Higher-risk ingredients in sports supplements are considered when the following happens:
- Substances present in the product, irrespective of how they came, that are ‘scheduled’ in the Australian Poisons Standard (example, prescription medicine ingredients)
- Ingredients that are intentionally added to the product are classified as a substance banned for use in sport by the World Anti-Doping Agency
- Ingredients that are intentionally added to the product are substances included in a list of ‘Relevant Substances’ specified in the declaration
Regulatory Requirements for Sports Supplements in Australia
The classification as food or therapeutic medicine determines the regulations applicable to the sports supplements in Australia. Take a look here:
Sports Supplements Regulated as Foods
Sports supplements that meet the applicable food requirements are regulated under the Australia New Zealand Food Standards Code. A specific category, Formulated Supplementary Sports Foods, is governed by Standard 2.9.4. These products are designed to assist sportspeople in achieving particular nutritional or performance goals.
The standard addresses formulation and labelling requirements and allows certain products to contain higher levels of particular vitamins and minerals than may be permitted in general-purpose foods.
Products that are generally considered foods contain ingredients appropriate for foods. They are present in traditional food forms like powders, beverages, and bars. A product making a therapeutic claim won’t become a therapeutic good automatically unless other factors are satisfied.
Sports Supplements Regulated as Therapeutic Goods
A sports supplement declared to be a therapeutic good, or one presented for therapeutic use and not classified as foods are therapeutic good. Where a sports supplement is classified as a therapeutic good, the Australian sponsor must comply with applicable therapeutic goods requirements. These may include:
- Addition to the Australian Register of Therapeutic Goods (ARTG)
- Appropriate formulation
- Manufacturing compliance
- Product labelling requirements
- Evidence supporting claims
- Advertising compliance
- Ongoing post-market obligations
Therapeutic goods generally need to be entered in the ARTG before they are imported, advertised or supplied in Australia.
Process for Bringing Sports Supplements to Market in Australia
While formulated supplementary sports foods don’t have a formal registration process, sports supplements considered therapeutic goods or medicines might need listing. Consider the steps below for it:
Step 1: Ascertain Whether the Product Is a Therapeutic Good
Ingredients, claims, intended use, presentation, and dosage form will affect the classification of sports supplements. The TGA provides a decision tool to help determine whether a sports supplement may be regulated as a therapeutic good.
Step 2: Review Ingredients and Product Claims
Review the complete formulation and proposed claims to identify whether the product falls within the TGA’s sports supplement framework. Particular attention should be given to scheduled substances, relevant restricted ingredients, and substances prohibited in sport that are intentionally added as ingredients. Also, consider the claims relating to maintaining or improving performance in sport, exercise, or recreational activity.
Step 3: Choose the Appropriate Therapeutic Goods Pathway
Consider the regulatory pathway that applies if the product is a therapeutic good. Depending on the product, this may involve an applicable pathway for listed medicines or registered medicines. Ingredients, indications and risk profiles of the product decide the correct pathway.
Step 4: Ensure Manufacturing and Product Compliance
Before applying for market entry, ensure that the product meets applicable requirements. These relate to permitted ingredients and formulation, manufacturing arrangements, GMP requirements, where applicable product specifications, labelling, and evidence supporting proposed claims.
Step 5: Apply for ARTG Inclusion
Where required, the Australian sponsor must apply for the product to be included in the Australian Register of Therapeutic Goods (ARTG) through the appropriate TGA pathway. The product should not be commercially supplied unless the applicable ARTG and other regulatory requirements have been met.
Step 6: Comply with Post-Market Requirements
After market entry, the sponsor must continue to adhere to the therapeutic goods requirements that apply. This may include ongoing responsibilities that cover product quality, labelling, advertising, safety monitoring, record maintenance, and regulatory reporting. The TGA can conduct post-market monitoring, including reviewing advertising and testing products for compliance.
Document & Information Required for Sports Supplements
There is no single document checklist for every sports supplement because the requirements depend on whether the product is regulated as a food or therapeutic good. For products classified as therapeutic goods, businesses may need to establish and maintain information relating to the following:
- Complete product formulation
- Ingredient details
- Product specifications
- Manufacturing arrangements
- Applicable GMP compliance
- Stability and shelf-life information
- Proposed therapeutic claims
- Evidence supporting claims
- Product labelling
- Sponsor and manufacturer information
For standard listed medicines, the regulatory framework can rely on sponsor certifications supported by information and evidence that the sponsor is required to hold. Sports supplements regulated as foods must instead comply with the relevant food formulation and labelling requirements.
Labelling & Advertising Requirements for Sports Supplements in Australia
Sports supplements must comply with the labelling and advertising requirements applicable to their regulatory category.
Therapeutic Goods
The TGA states that the Australian sponsor is responsible for ensuring that therapeutic sports supplement labels comply with applicable requirements, including Therapeutic Goods Order No. 92 (TGO 92) for non-prescription medicines. A standard nutrition panel alone is generally insufficient for a product regulated as a therapeutic good. The label must contain the information required under the applicable therapeutic goods standards.
Sports Foods
Formulated supplementary sports foods must comply with Standard 2.9.4 and applicable general food labelling requirements. These include statements and warnings as follows:
- A statement that implies that sports food is not the sole source of nutrition. It needs to be consumed with a nutritious diet.
- It should be used with an appropriate physical training or exercise programme.
- A food with caffeine from cocoa, chocolate, decaffeinated coffee, etc., should warn “not suitable for children under 15 years of age or pregnant women. Should only be consumed under medical or dietary supervision.”
- Sports food with phenylalanine should warn “‘Phenylketonurics: Contains phenylalanine’.
- A food with caffeine from other sources should specifically mention “Contains caffeine” and the unsuitability warning for pregnant or breastfeeding women or children under 16 years of age.
Other required information relates to directions for consumption, frequency of intake, recommended one-day quantity, a nutrition information panel, and a prescribed name of “Formulated Supplementary Sports Food”. Vitamins, minerals, high carbohydrates, other substances, etc., have specific labelling provisions on the packaging to be followed.
Importing Sport Supplements into Australia
Importers should assess the regulatory status of a sports supplement before importing it for commercial supply. A product’s classification in another country does not automatically determine how it will be regulated in Australia. Importers should review product ingredients, claims and advertising, dosage form, food or therapeutic goods classification, ARTG requirements, where applicable, manufacturing arrangements, and product labelling.
A product classified as a therapeutic good requires the Australian sponsor to be responsible for ensuring that applicable regulatory requirements are met before the product is imported, advertised or supplied.
Conclusion
One important question that sports supplement regulation in Australia raises is about the product’s regulation. Is it under a food or a therapeutic goods framework? The answer can depend on the product’s ingredients, claims, presentation and dosage form. After establishing the correct classification, businesses can work with the applicable requirements for formulation, manufacturing, labelling, ARTG inclusion and continuous compliance. For manufacturers and importers, addressing classification early can help prevent unnecessary reformulation, regulatory delays, and compliance risks.
If you want proper compliance while marketing sports supplements in Australia, let Artixio’s experts help. We’ll provide high-end expertise on the subject, allowing you to import or market these correctly in the country. Reach out to us at info@artixio.com.
FAQs
Are all sports supplements regulated by the TGA in Australia?
No. Sports supplements can be regulated as either foods or therapeutic goods. Products containing ingredients appropriate for food and presented in traditional food forms may remain regulated as foods, while certain products may fall under the therapeutic goods framework.
Do sports supplement tablets and capsules require ARTG inclusion?
Sports supplements that fall within the TGA’s therapeutic goods declaration and are supplied as tablets, capsules or pills must comply with applicable therapeutic goods requirements. Where ARTG inclusion is required, the product cannot be commercially imported, advertised or supplied until it has been entered in the ARTG.
Can protein powders be regulated as food in Australia?
Yes. The TGA identifies whey protein powders and other products containing ingredients appropriate for food and presented in traditional food forms as examples of products that can be regulated as foods, provided they are not captured by the therapeutic goods framework.
What happens if a sports supplement is incorrectly classified?
Incorrect classification can result in a product being supplied under the wrong regulatory framework. The TGA monitors sports supplement advertising and conducts product testing. Non-compliance with therapeutic goods legislation can result in regulatory action, including significant penalties. The same goes for Food standards.
