Applying the Therapeutic Goods Advertising Code in Australia

1. Purpose and Scope

The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) establishes mandatory standards for advertisements of therapeutic goods directed to consumers. It applies to all forms of consumer advertising, including print, broadcast, online, and point-of-sale materials, ensuring promotions are truthful, balanced, and not misleading. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code The Code does not apply to advertisements directed exclusively to health professionals. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code

2. Core Principles

Advertisements must:

• Be truthful and not misleading
• Present claims in a balanced way
• Be substantiated by evidence
• Use clear and comprehensible language
• Not arouse undue fear or exploit consumers' concerns
• Not disparage or denigrate other goods or services These principles underpin all specific requirements in the Code. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code

3. Restricted and Prohibited Representations

Restricted representations (e.g., serious diseases or conditions) require TGA approval or specific permissions before use in consumer advertising. Prohibited representations (e.g., claims to cure/prevent serious diseases listed in Schedule 1 of the Code) are not permitted under any circumstances. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code

4. Specific Requirements

• Testimonials: Must be genuine, current, and not misleading; must disclose any valuable consideration received.
• Comparative advertising: Must be factual, verifiable, and not misleading.
• Scientific or technical terms: Must be used accurately and not in a way that misleads consumers.
• Before/after images: Must be genuine and representative; disclosure of any manipulation required.
• Free trials/offers: Must clearly state all terms and conditions. All claims must be supported by appropriate evidence held by the advertiser. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code

5. Practical Application and Compliance Tips

Advertisers should:

• Match claims exactly to permitted indications (for listed goods) or approved indications (for registered goods)
• Use plain language suitable for the general public
• Include mandatory statements where required (e.g., 'Always read the label')
• Review materials against the Code checklist before publication
• Maintain records of evidence substantiating claims Non-compliance may result in enforcement action by the TGA. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code

6. Related Guidance

The TGA provides additional guidance on specific topics such as influencer advertising, social media, testimonials, and restricted representations to assist in interpreting and applying the Code. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code

7. Enforcement and Consequences

The TGA monitors compliance and may take action for breaches, including requiring corrective advertising, issuing infringement notices, or pursuing civil/criminal penalties under the Therapeutic Goods Act 1989. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code