TGA Released Guidance on Medicines’ Advertising

| By | Medicines Australia, TGA
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The TGA has released guidance on the use of ‘natural’ and related claims when advertising medicines and medical devices to the public. Here, we set out the reasons for releasing this guidance and how it was developed.

Claims that a therapeutic good is ‘natural’ or that the ingredients in a medicine or medical device are ‘natural’ are used widely in advertising directed to the public (including on the labelling or packaging).

If the advertising does not explain what the term ‘natural’ (as well as related claims such as ‘naturally occurring’, ‘sourced from nature’ and ‘naturally derived’) means in relation to the particular product being promoted, interpretations by consumers will vary, especially if ‘natural’ is used as a stand-alone claim.

Consumers need to know what a claim means or they could be misled. Misleading advertising will breach the Therapeutic Goods Advertising Code (the Code).

When advertisers use a ‘natural’ claim, they will either have to provide sufficient information to explain the claim or use it in accordance with the definitions set out in the TGA’s guidance. This will benefit consumers either through more precise advertising or, where claims are not precise, an improved understanding of what ‘natural’ claims mean. Specific information for consumers on the use of ‘natural’ claims in relation to medicines and medical devices will be published in coming weeks. This information will enable consumers to be aware, where clarifying information is not provided by the advertiser, what is required to satisfy a ‘natural’ claim.

Ensuring clarity for industry

The guidance was formulated to provide clarity to advertisers on the circumstances in which the term ‘natural’ can be used without breaching the Code. If advertisers wish to use a ‘natural’ claim that does not align with the TGA definition, sufficient explanation of the meaning of the claim must be provided in the advertisement, and on the label of the product if the claim is used there.

This guidance also provides the policy framework under which the TGA will interpret ‘natural’ and related claims when assessing advertising compliance. It should be noted that while any complaints about ‘natural’ claims about a product will be considered in the context of the guidance, the advertisers will still need to comply with all relevant aspects of the Code, including holding evidence to substantiate all (including ‘natural’) claims made in advertising. Even when the term ‘natural’ is used in a way that accords with the TGA’s definitions, the advertiser must hold evidence to be able to substantiate such claims.

Consultation

We consulted on an initial proposal for the use of ‘natural’ claims in advertising as part of a public consultation in 2018 on guidelines to support the Code. We considered the responses we received, updated our position and conducted a targeted consultation. Representative bodies of industry, consumers and health professionals were invited to provide input both on the need for clarity around the meaning of the term ‘natural’ and on the content of the proposed guidance.

While the majority of the consulted organisations were in favour of the TGA publishing guidance, there was clear input that the proposed guidance was overly complex and technical, unclear, imposed regulatory burden and was not in step with the positions articulated by other agencies (such as the Australian Competition and Consumer Commission (ACCC) and the National Industrial Chemical Notification and Assessment Scheme) or in relevant Australian court cases.

The published guidance

The published guidance has been substantially revised from the version that was the subject of the targeted consultation. We have reduced the complexity and length, and provide examples for clarification. It draws on dictionary definitions of terms and, as far as possible, is consistent with the ACCC’s guidelines about the use of natural claims in relation to food advertising, noting that there are inherent differences between natural claims in relation to foods and therapeutic goods.

Further, while the previous versions attempted to define both ‘natural’ and ‘naturally derived’, the published guidance defines only the term ‘natural’. The TGA considers that consumers are unlikely to differentiate between ‘natural’ and associated terms, including ‘naturally derived’, when these terms are used in advertisements for therapeutic goods.

SOURCE: tga.gov.au
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