Earlier this year, the Therapeutic Goods Administration (TGA) fined the activewear brand, Lorna Jane, nearly $40,000 for alleged advertising breaches in relation to its advertising of “anti-virus activewear”. The brand claimed the clothing prevented and protected against infectious disease. You may be wondering why the TGA fined the activewear brand when activewear is not generally a ‘therapeutic good’. That is because representing a good for therapeutic use (such as “anti-virus activewear”) brings the product within the meaning of a therapeutic good under Australian laws. The advertising of therapeutic goods is subject to the regulations administered by the TGA. This article explains some of the advertising requirements that you must comply with when advertising therapeutic goods.

Regulation of Therapeutic Goods Advertising

In Australia, the TGA regulates the advertising of therapeutic goods. Under therapeutic goods laws, advertising can include a statement or pictorial representation that intends to promote the use or supply of the goods. The statement or pictorial statement may be on:

  • the label of the goods;
  • the packaging of the goods; or
  • any material you include with the package that the goods are in.

Even if your material promotes the use or supply of relevant therapeutic goods in an indirect way, this will still be an advertisement and will need to comply with relevant therapeutic goods advertising laws.

Social media posts, such as posts on Facebook, LinkedIn or Instagram, which promote the use or supply of a therapeutic good, are also advertisements. Therefore, you must comply with the rules for advertising therapeutic goods.

Certain goods are prohibited from being advertised or marketed to the public. Instead, they can only be advertised to health care professionals in accordance with the Medicines Australia Code of Conduct.

For example, medicines requiring a prescription from a doctor (products containing ingredients specified in Schedule 4 the current Poisons Standard) must not be advertised to the public.

Advertising of therapeutic goods must also comply with:

  • the Australian Consumer Law;
  • the National Health Practitioner Law (where applicable); and 
  • state and territory poisons legislation.

General Requirements

In general, an advertisement for therapeutic goods must support the safe and proper use of the product. It should not encourage inappropriate or excessive use of the good. 

Your advertisement should only contain claims that are:

  • valid;
  • accurate; and
  • substantiated.

You should also make sure your advertisement does not make a claim or representation that your product:

  • cannot cause harm;
  • has no side-effects;
  • is always effective; or 
  • is otherwise magical or miraculous.

Restricted Representations

A restricted representation is an advertisement for therapeutic goods that refers to a serious form of:

  • disease; 
  • condition; 
  • ailment; or 
  • defect. 

For example, it may refer to heart disease, arthritis or cancer.

A restricted representation may only be used in an advertisement for therapeutic goods directed to the public if the TGA has permitted or approved the use of that representation. You may need to apply to the TGA for prior approval if you want to use a restricted representation in your advertising.

The TGA has recently fined a number of other companies for advertising goods as being effective against COVID-19. This is a restricted representation and is not permitted unless the TGA has approved the product for treating or preventing COVID-19. 

Testimonials & Endorsements

In general, an advertisement for your therapeutic good must not contain an endorsement by a:

  • health professional;
  • medical researcher;
  • government authority;
  • hospital; or 
  • health facility

This includes employees or contractors of a government authority, hospital or health facility.

However, your advertisement may contain testimonials made by a person that claims to have used your good. There are a number of requirements for using testimonials in advertising for these products.

For example, a testimonial used in an advertisement for therapeutic goods must be made by a person who has used the goods for their intended purpose and is not involved in the production, sale, supply or marketing of the goods. They also cannot be an employee or officer of a corporation involved with the production, sale, supply or marketing of the goods or a health professional, medical researcher, government authority, hospital or health facility (or employee or contractor of a government authority, hospital or health facility). 

Further, a testimonial must disclose whether the person providing the testimonial has or will receive any payment, gift or other inducements for providing the testimonial.

Key Takeaways

Advertising therapeutic goods have strict regulations. Not complying with therapeutic goods advertising requirements could result in severe penalties from the TGA as well as various other consequences. Before advertising your products, you should consult a commercial health lawyer to ensure your advertising is compliant. To speak with a commercial health lawyer about advertising your therapeutic goods or making therapeutic claims, contact LegalVision’s business lawyers on 1300 544 755 or fill out the form on this page.

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