Prohibition on Using 'TGA Approved' Claims in Advertising Therapeutic Goods in Australia

1. Overview and Regulatory Basis

Statements implying that a therapeutic good has been specifically approved, endorsed, or certified by the TGA — such as 'TGA approved', 'TGA certified', 'TGA listed', 'TGA registered', or equivalent phrases — are not permitted in advertisements. These claims are misleading because they suggest a higher level of pre-market evaluation than what is actually undertaken for many therapeutic goods, particularly listed medicines and exempt devices. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising The prohibition is grounded in sections of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, which require advertising to be truthful, balanced, and not misleading. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising

2. Why Such Claims Are Misleading

The TGA does not 'approve' most listed medicines or exempt goods in the same rigorous way as registered medicines. Listed medicines undergo a lower level of assessment focused on safety and quality of ingredients rather than full efficacy evaluation. Using 'TGA approved' or similar terms creates a false impression of superior regulatory scrutiny or official endorsement, potentially influencing consumer decisions inappropriately. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising Even factual references to 'TGA listed' or 'AUST L number' are restricted if they imply approval or endorsement beyond the actual listing process. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising

3. Examples of Prohibited and Problematic Claims

Prohibited or likely non-compliant claims include:

• 'TGA approved formula'
• 'TGA certified quality'
• 'TGA listed for your safety'
• 'Approved by the TGA'
• 'TGA registered therapeutic good' Claims that are generally acceptable (if accurate and not misleading) include neutral references such as 'Listed in the Australian Register of Therapeutic Goods' or 'Contains ingredients permitted by the TGA', provided they do not imply endorsement. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising

4. Consequences of Non-Compliance

Using prohibited 'TGA approved' style claims constitutes a breach of advertising rules. The TGA may take enforcement action, including requiring withdrawal or correction of the advertisement, issuing infringement notices, imposing civil penalties, or pursuing court proceedings. Repeated or serious breaches can lead to more significant sanctions. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising

5. Practical Guidance for Advertisers

Advertisers should:

• Avoid any language suggesting TGA approval, certification, or endorsement.
• Use factual, neutral descriptions of regulatory status where necessary.
• Ensure all claims are substantiated and comply with the Advertising Code.
• Review advertisements against TGA guidance before publication. For complex cases, advertisers may seek clarification from the TGA. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising

6. Related Resources

Further information is available in the Therapeutic Goods Advertising Code, related TGA advertising guidance documents, and enforcement policies. The TGA encourages advertisers to familiarise themselves with these materials to ensure ongoing compliance. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics/claim-tga-approved-must-not-be-used-advertising