Advertising health and wellness products in Australia is a high-stakes activity. Whether you’re a startup promoting natural supplements or a global brand marketing medical devices, you must comply with strict legal rules enforced by the Therapeutic Goods Administration (TGA) and the Australian Competition and Consumer Commission (ACCC).
This guide, prepared by our eCommerce legal team, outlines the essential laws, compliance obligations, and penalties that apply when advertising therapeutic goods in Australia.
Key Takeaways
The TGA and ACCC jointly regulate health and wellness advertising.
Core legislation includes the Therapeutic Goods Act 1989 and the Competition and Consumer Act 2010.
Prohibited and restricted claims are tightly controlled – breaches can result in civil or criminal penalties.
Advertisers must use evidence-based claims and secure TGA approval for restricted representations.
Some exemptions apply (e.g. for health professionals and export goods).
Understanding Australia’s Advertising Regulators
Australia’s regulatory landscape for health product advertising is unique due to its dual oversight system:
1. TGA
The TGA is responsible for regulating how therapeutic goods, including vitamins, supplements, weight loss and detox products, and medical devices, are advertised to Australian consumers.
They enforce the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code, which outline what you can and cannot say in your ads.
2. ACCC
The ACCC enforces general consumer law under the Competition and Consumer Act 2010. It focuses on false or misleading advertising, including:
Exaggerated health benefits
Deceptive “before and after” claims
Unsubstantiated testimonials
The ACCC also works closely with professional regulators (e.g. AHPRA) to enforce advertising standards.
For a deeper dive into how consumer law affects your digital presence, read our guide on how Australian Consumer Law applies to online businesses.
Products That Trigger TGA Compliance
Your product falls under regulation if it is:
Listed or registered on the Australian Register of Therapeutic Goods (ARTG)
A health or wellness product that claims to treat, prevent, or improve a health condition
Examples of Regulated Products
Your ad likely falls under regulation if you sell or promote:
Vitamins and dietary supplements
Detox teas, shakes, powders
Weight loss products and meal replacement programs
Skincare products with therapeutic claims
Devices that claim to treat or manage health conditions
Remember: If your product is on the ARTG, your ads must comply with TGA advertising rules.
Exemptions From TGA Advertising Rules
Certain advertisements are exempt from TGA controls, including:
- Advertising directed exclusively at health professionals
- Goods not intended for human use
- Goods intended for export only
- Vaping goods (regulated separately)
Prohibited & Restricted Claims
Prohibited Representations
Some claims are banned outright unless the TGA has given express approval. These include:
“Cures cancer”
“Prevents heart disease”
“Guaranteed to work”
Scare-based or unrealistic promises
Ads must also include mandatory warnings where required.
Restricted Representations
Restricted claims can only be made with prior approval from the TGA. These include:
“Clinically proven to assist weight loss”
“Supports mental health during anxiety”
“Improves immune function during chemotherapy”
Direct-to-consumer advertising is also banned for Autologous human cell and tissue products.
This ban was introduced due to safety concerns (via the 2018 Measures No. 2 Amendment).
TGA Advertising Approval
Since 1 July 2020, most ads don’t require pre-approval, but those making restricted claims still do.
If your ad includes a restricted representation:
Apply through the TGA for approval
Do not publish until approval is granted
Maintain documentation for audits
Types of Evidence Required for Health Claims
You must hold robust evidence to support any therapeutic claims in your ads. Acceptable evidence includes:
Peer-reviewed clinical studies
Systematic reviews
Scientific literature (not just anecdotal data)
Warning: Influencer testimonials and customer reviews are not considered valid evidence under TGA and ACCC guidelines.
Enforcement & Penalties
Australia employs a graduated enforcement strategy for advertising breaches:
- Criminal offences: For contraventions of general advertising rules or prohibition notices
- Civil penalties: For advertising violations, including breaches of prohibition notices
- TGA Secretary powers: To require information, issue directions, and publish warning notices
Case Example: Peptide Clinics Australia
In 2019, the Federal Court fined Peptide Clinics Australia $10 million for unlawfully advertising prescription-only medicines directly to consumers. The company breached the Therapeutic Goods Act by making unapproved claims about treating serious health conditions such as anxiety, depression, and heart disease. This case highlights the severe penalties health and wellness businesses can face for misleading or non-compliant advertising.
Practical Compliance Tips for Health Product Advertising
To minimise risk when advertising health and wellness products in Australia, consider these practical steps:
- Review every ad against the Therapeutic Goods Advertising Code
- Use only TGA-approved indications for listed products
- Apply for approval before making restricted claims
- Keep scientific evidence on file
- Avoid exaggerated, misleading phrases
- Educate influencers and brand ambassadors
- Monitor for regulatory updates
- Build compliance costs into your marketing budget
If you advertise or promote health and wellness products in Australia, ensuring compliance with TGA and ACCC requirements is critical. Contact our legal team today for tailored advice or a review of your advertising materials.
Frequently Asked Questions
What laws govern the advertising of health and wellness products in Australia?
Advertising is primarily regulated by the Therapeutic Goods Act 1989 (administered by the TGA) and the Competition and Consumer Act 2010 (administered by the ACCC).
Are some ads exempt from TGA rules?
Yes. Ads for health professionals, export-only goods, vaping products or non-human products are typically exempt.
What are prohibited representations in health product advertising?
Prohibited representations include unsubstantiated (unproven) claims about curing serious illnesses or false and misleading statements about product efficacy. These are detailed in the Therapeutic Goods Advertising Code and supporting regulations.
Do I need approval before advertising therapeutic goods?
Most advertisements do not require pre-approval since July 2020, but advertisements making restricted representations still require specific TGA approval.
What are the penalties for breaching advertising rules?
Penalties include criminal offences, civil penalties, public warning notices, and directions to withdraw or amend advertisements. Penalty amounts can be substantial, as illustrated by recent court cases
What If You're Only Advertising Online?
If you advertise on:
Instagram or TikTok via influencers
Google Ads
Facebook/Meta
Ecommerce stores or Shopify pages
…you are still liable under Australian law. Sponsored posts, affiliate marketing, and testimonials must all follow disclosure and evidence rules.
