The Therapeutic Goods Administration has published helpful guidance on use of the term ‘natural’ and related claims when advertising therapeutic goods to the public.
After considerable public and targeted consultation, the Therapeutic Goods Administration (TGA) yesterday published guidance on use of the term ‘natural’ and related claims (for example, ‘naturally occurring’, ‘sourced from nature’ and ‘naturally derived’) when advertising therapeutic goods to the public.
Naturally, KWM are on hand to update you on this development.
Advertisers should be aware that, when using a ‘natural’ claim, they will need to either ensure that the claim aligns with the definitions set out in the guidance or provide an appropriate explanation of the meaning of the claim in the advertisement and on the label of the product if the claim is used there.
Background
All advertising of therapeutic goods is subject to the requirements of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the Regulations). Advertising of therapeutic goods to the public must comply with the requirements of the Act, the Regulations and the Therapeutic Goods Advertising Code (No.2) 2018 (Code).
The guidance comes off the back of the TGA assuming sole responsibility for receiving and handling all complaints about advertising for therapeutic goods directed to the public from 1 July 2018, as well as enhanced sanctions and penalties for breaches of advertising legislation introduced in early 2018. An invigorated focus on therapeutic goods advertising compliance has followed, including the publication of education and guidance resources for advertisers (such as these guidelines), introduction of a new risk-based complaints handling framework and expanded TGA resources focused on advertising compliance.
The ‘natural’ claims guidance is a result of extensive public consultation on draft guidelines to support the Code as well as a more targeted consultation with industry, consumer and health stakeholders conducted throughout 2018 and early 2019.
The TGA has indicated that the published guidance is more streamlined than the versions provided for consultation and is broadly consistent with the ACCC’s guidelines about the use of natural claims in relation to food advertising.
When is it natural to use “natural”?
The Code requires that any claims made in therapeutic goods advertising must be valid, accurate, truthful, balanced and not misleading or likely to mislead.[1] Claims that a therapeutic good, or its ingredients, are ‘natural’ are subject to these requirements.
The guidance provides a framework for advertisers to assess when claims that a therapeutic good is natural or contains natural ingredients can be made without breaching the Code and is a useful indication of how TGA will interpret and assess such claims from a compliance perspective.
The TGA has focussed on the processing steps involved in the transformation of the raw material (physically found in nature) to the finished good in formulating its definition of ‘natural’ for the purposes of advertising therapeutic goods. Accordingly, an advertiser seeking to claim that a particular therapeutic good (or ingredient) is ‘natural’ should ensure that the:
- raw material from which the ‘natural’ therapeutic good (or ingredient) is derived must be in a form physically found in nature; and
- therapeutic good or ingredient must have only undergone ‘minimal processing’ from the form found in nature to produce a finished dosage form (including freezing, drying, filtering, fractionation and other identified production steps); and
- finished therapeutic good ingredient must not have become a new chemical identity (i.e. by having undergone a chemical conversion or modification).
It is clear from the guidance that only in a narrow set of circumstances would a claim that a product is in its entirety ‘natural’ (without qualification) not be misleading.
Simply because a therapeutic good contains chemically synthesised active substances as well as ‘natural’ ingredients does not prohibit use of the term ‘natural’. In that case, the term ‘natural’ must be qualified so that consumers are not led to believe that all of the ingredients in the therapeutic good are natural. Advertisers may choose to do so in a number of ways – for example by specifically identifying the natural or non-natural ingredients.
Advertisers also need to exercise caution in making any claims:
- which suggest that a product has a ‘natural mode of action’ (for example, ‘works/acts naturally’). The TGA’s guidance is that this conveys a process which is, or mimics, a normal physiological process and could imply that the good itself is natural. Advertisers are recommended to provide sufficient justification for such claims within an advertisement or by reference to further materials; or
- that mislead consumers into correlating ‘natural’ claims with other qualities such as safety or efficacy.
The TGA has indicated that it will publish specific information directed to consumers regarding the use of ‘natural’ claims for therapeutic goods in the near future, with a view to improving consumers understanding of what is required to satisfy a ‘natural’ claim.
What next?
Businesses who advertise their therapeutic goods using the term ‘natural’, or otherwise make natural claims regarding its goods or ingredients in advertising, should review their advertising (including its labelling and packaging) for consistency with the TGA’s newly published guidelines.
Our Intellectual Property team has expertise in the advertising of therapeutic goods including both medicines and medical devices. If you have any questions about the TGA guidelines, or the application of the Code generally, please get in touch to discuss how we can help.
[1] Therapeutic Goods Advertising Code (No.2) 2018, sections 9(a) and 9(b).
