Australia – Therapeutic goods advertising: Ensuring ‘natural’ claims are not misleading


The use of the term ‘natural’ (and related terms such as ‘naturally derived’, ‘sourced from nature’, ‘all natural’) in therapeutic goods advertising is regulated by the Therapeutic Goods Administration (TGA) to the extent that the Therapeutic Goods Advertising Code (No.2) 2018 (‘the Code‘) prohibits claims from being misleading and requires claims to be truthful, valid, accurate and substantiated.

While it is ultimately the responsibility of the advertiser to ensure advertising claims are not misleading, a guideline for industry and consumers is useful to clarify the TGA’s interpretation of the meaning of ‘natural’ in the context of therapeutic goods, including how the claim will be assessed in compliance reviews.

This guidance provides information for industry on how claims about the ‘naturalness’ of a particular therapeutic good and/or its ingredients can be made without misleading consumers.

For a proportion of consumers, a claim that a therapeutic good is natural or its ingredient/s are natural will be material to purchasing choices. This may be because the consumer perceives the natural good or ingredient to be safer than another good or ingredient, or in some other way superior to a good or ingredient not represented as ‘natural’.

While it is clear that a therapeutic good cannot be ‘natural’ in the way a whole food can be, consumers are likely to reasonably understand that a ‘natural’ therapeutic good or ingredient is one that is obtained from a natural source and has undergone only minimal processing.

Providing insufficient or no information about the meaning of a claim, when the meaning is open to various interpretations (as is the case with ‘natural’ claims), will result in consumers being misled. As noted by the Australian Competition and Consumer Commission (‘ACCC’) in relation to ‘natural’ claims on food labels:

Consumers may view what is ‘natural’ differently to manufacturers and food technologists. When providing a label with a claim that the product is ‘natural’, thought should be given to what the consumer would think. In those cases where the term ‘natural’ meets a technical definition, a code or a standard, and this information is not available to the consumer, the consumer is left to draw their own conclusion and may therefore be misled.

The TGA recognises that imparting potentially lengthy explanations in an advertisement (including on the label when such claims are used in that context) may not be feasible and may detract from other important information required to be conveyed in the advertisement. Therefore the advertiser must ensure that any claims relating to the ‘naturalness’ of therapeutic goods are either consistent with these guidelines or satisfactorily explained in the advertising. This will enable consumers to have access to information that will assist them in understanding the meaning of such claims and will assist advertisers in knowing how, and in what contexts, such claims can be made and therefore avert compliance concerns…