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The Advertising Code and naming therapeutic goods

18 January 2022

Sponsors are reminded to carefully consider the application of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code (the Code) when naming therapeutic goods.

When naming products, sponsors must ensure that the full trading name of the product complies with the Code. Particular attention should be paid to Code sections 9 and 10 which specify accuracy and other requirements in advertising, including that an ad must not claim that the goods are infallible, unfailing, magical or miraculous.

All claims in an ad, including through a product name, must be valid and accurate and substantiated before the advertising occurs.

The name must not mislead or be likely to mislead a reasonable consumer.

The name of the product forms a part of the advertising because it is present:

  • on the label of the goods, and/or
  • on the packaging in which the goods are contained, and/or
  • in the advertising or marketing of the product for purchase.

Unless therapeutic goods are subject to a relevant advertising permission, the TGA advises sponsors against naming, or part-naming, therapeutic goods that expressly or impliedly make reference to:

  • a food
  • an indication
  • recreational use
  • safety
  • or make any other connotation that trivialises or exaggerates the potency of the product.

Examples include:

  • Trademark name of a Schedule 4 substance followed by (Chocolate Cooky)”
  • Trademark name of a Schedule 4 substance followed by (Girl Power MTB)”
  • Trademark name of a Schedule 8 substance followed by (Unicorn Dust)”
  • Trademark name of a Schedule 8 substance followed by (Calm)”
  • Trademark name of a product followed by (Fat Be Gone)”
  • Trademark name of a product followed by (Anxious No More)”
  • “Trademark name of a product followed by (All Natural Always)”

The TGA understands the need for products to be named in a way that distinguishes one product from another. However, sponsors are reminded that advertisements for all therapeutic goods are subject to the Act and the Code, unless specifically exempt.

The Advertising Code

Section 8 of the 2021 Code relevantly provides that advertising for therapeutic goods must satisfy that the claims in the advertisement are:

  • accurate and balanced
  • not misleading or likely to be misleading
  • substantiated.

Section 9 of the 2021 Code relevantly provides that advertising for therapeutic goods must not represent the goods to be:

  • safe, or without harm or side-effects
  • effective in all cases or to be a guaranteed cure
  • infallible, unfailing, magical or miraculous.

Section 9 also provides that advertising must not contain any statement, representation that is:

  • inconsistent with the label or intended purpose for use of the good
  • an exaggeration of efficacy or performance
  • an encouragement for inappropriate or excessive use of the goods.

The Act

Sections 42DM and 42DMA of the Act are the relevant criminal offence and civil penalty provisions for advertising therapeutic goods where the advertisement fails to comply with the Code.

Sections 42DM and 42DMA of the Act apply to advertising irrespective of whether the goods contain prescription-only substances or are entered in the Australian Register of Therapeutic Goods.

Background and medicinal cannabis products

The TGA has recently published a list of unapproved medicinal cannabis products by category of active ingredient supplied through the Special Access Scheme and Authorised Prescriber scheme. This initiative is designed to support pharmacists and prescribers in prescribing and supplying medicinal cannabis products under the active ingredient categories. These lists should be used where TGA approval has been obtained and the prescriber requires assistance in choosing a product from the correct category, or the pharmacist wishes to ensure that the product on the prescription matches the category in the TGA approval letter.

It is in that context that the TGA has observed a trend in naming conventions across a range of therapeutic goods, including medicinal cannabis products, nicotine vaping products and weight loss products. Some product names may exaggerate the efficacy or performance of a product, and potentially mislead Australians into a false sense of security about a product which has not been evaluated by the TGA.

To balance that risk against the benefits of the TGA's publications, the TGA is applying the principles of the Code when publishing trademark names of therapeutic goods, including that any claims are substantiated, truthful and balanced and not misleading. This may result in the redaction of parts of a product name where the TGA considers the name crosses these principles.

Further information

Related information on the advertising rules have been published at these webpages.