TGA Advertising Code: Health Content Review
Australia's TGA Therapeutic Goods Advertising Code regulates how health products and services are marketed. Learn how to review content for compliance.
The Therapeutic Goods Administration (TGA) regulates the advertising of therapeutic goods in Australia under the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code 2021 (No. 2). Any business that advertises medicines, medical devices, biologicals, or other therapeutic goods must comply with this framework. Violations can result in infringement notices, civil penalties, and cancellation of advertising approval.
The Code applies broadly. It covers not just traditional advertisements but also websites, social media posts, influencer content, blog articles, testimonials, and any communication that promotes a therapeutic good. If your content mentions a therapeutic product and is designed to promote its use, it falls under the Code.
What the Advertising Code Requires
Permitted and Prohibited Claims
The TGA draws a clear line between what can and cannot be claimed in therapeutic goods advertising:
| Category | Permitted | Prohibited |
|---|---|---|
| Listed medicines (AUST L) | Claims consistent with approved indications on the ARTG | Claims of efficacy for serious conditions |
| Registered medicines (AUST R) | Claims consistent with approved Product Information | Off-label claims or indications not in the PI |
| Medical devices | Claims consistent with ARTG listing and intended purpose | Performance claims beyond intended purpose |
| Complementary medicines | Claims supported by evidence held by the sponsor | Unsupported therapeutic claims |
| All therapeutic goods | Factual, balanced, not misleading | Claims of cure, guaranteed results, superiority without evidence |
Specific Prohibitions Under the Code
The Advertising Code explicitly prohibits several categories of claims:
- Cure claims: You cannot claim a product "cures" a disease or condition unless the approved indications specifically support this
- Guaranteed outcomes: Phrases like "guaranteed to work" or "100% effective" are prohibited
- Superiority claims: Claims that a product is "the best" or "better than" alternatives require robust comparative evidence
- Serious disease references: Listed medicines cannot reference serious diseases, conditions, or disorders as defined in the Therapeutic Goods Regulations 1990
- Mandatory medical treatment discouragement: Content must not discourage consumers from seeking necessary medical treatment
- Testimonials for certain products: Restrictions apply to the use of testimonials in advertising prescription medicines and certain other therapeutic goods
Mandatory Requirements
Every therapeutic goods advertisement must include:
- The product name as it appears on the Australian Register of Therapeutic Goods (ARTG)
- The AUST L or AUST R number
- Required warning statements and disclaimers specific to the product
- The mandatory advisory statement: "Always read the label and follow the directions for use"
- For medicines containing certain ingredients, specific mandatory warnings (e.g., "Contains paracetamol")
High-Risk Content Areas
Social Media and Influencer Marketing
The TGA has explicitly confirmed that social media content promoting therapeutic goods must comply with the Advertising Code. This includes:
- Sponsored posts by influencers or healthcare professionals
- Product reviews that make therapeutic claims
- User-generated content that sponsors share or amplify
- Stories, reels, and short-form video content
Sponsors are responsible for advertising that is published on their behalf, including by influencers. If an influencer makes a non-compliant claim about a therapeutic good, the sponsor can be held responsible.
Website Content and SEO
Product pages, blog articles, and FAQ sections that discuss therapeutic goods are subject to the Code. Common website compliance failures include:
- Blog articles making therapeutic claims beyond approved indications
- FAQ answers that imply efficacy for conditions not covered by the ARTG listing
- SEO-optimised content that uses prohibited health claims as keywords
- Product comparison pages that make unsubstantiated superiority claims
Complementary and Alternative Medicines
Complementary medicines (vitamins, minerals, herbal products, homeopathic preparations) face particular scrutiny. Claims must be supported by evidence held by the sponsor. The TGA has increased enforcement against complementary medicines making unsupported claims, particularly for products marketed online.
Building a TGA Compliance Review Process
Pre-Publication Checklist
Before publishing any content that references a therapeutic good:
- Identify the product's ARTG entry and confirm its listing status (AUST L, AUST R, or included)
- Verify all claims are consistent with the approved indications on the ARTG
- Check for prohibited claims (cure, guaranteed outcomes, superiority without evidence)
- Confirm mandatory elements are present (product name, AUST number, warnings, advisory statement)
- Review testimonials for compliance (no testimonials for prescription medicines)
- Assess whether the content references serious diseases or conditions (prohibited for AUST L products)
- For social media content, verify compliance applies to the full post including hashtags and linked content
Ongoing Monitoring
- Review existing website content quarterly for compliance with current ARTG listings
- Monitor social media accounts monthly for non-compliant user-generated content or influencer posts
- Track TGA compliance updates and new guidance through the TGA website
- Maintain records of evidence supporting all therapeutic claims
TGA Enforcement Actions
The TGA's enforcement powers include:
| Action | Description |
|---|---|
| Compliance notice | Formal direction to cease non-compliant advertising |
| Infringement notice | Financial penalty for specific breaches |
| Civil penalty | Up to $10.5 million for body corporates; $2.1 million for individuals |
| Undertaking | Enforceable commitment to take specific remedial action |
| Cancellation/suspension | Removal of goods from the ARTG |
| Publication | TGA publishes enforcement outcomes, creating reputational impact |
How Content Review Tools Support TGA Compliance
Health and therapeutic goods companies produce significant volumes of content across websites, social media, email marketing, product packaging, and point-of-sale materials. Each piece must comply with the Advertising Code, and the consequences of non-compliance are substantial.
Content review platforms can systematically check health marketing content against TGA requirements. By configuring reviewers with the Advertising Code requirements and uploading a knowledge base containing approved indications from the ARTG, product information documents, and mandatory warning statements, teams can automate the first-pass compliance review.
AI-assisted review can flag prohibited claims such as cure language and guaranteed outcomes, verify that mandatory elements are present, check that claims align with approved indications, and identify references to serious diseases in listed medicine advertising. This provides a consistent baseline check that catches common compliance issues before they reach the TGA's attention.
This does not replace regulatory affairs review for complex or high-risk advertising, but it provides a scalable way to maintain baseline compliance across the volume of content that modern health brands produce.
This article provides general information about TGA advertising compliance and is not regulatory or legal advice. Always consult the TGA for current requirements and seek qualified regulatory advice for your specific situation.