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.^[1]

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')^[2] 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.

The following information relates to claims made about specific goods. In instances where the references to 'natural' are not made in the context of a direct claim about a particular good, such as when marketing goods under a company or brand name, the onus is on the advertiser to ensure the consumer is not led to the view that all the products advertised under that name have various qualities of 'naturalness' if that is not the case. This may be achieved in various ways, for example by minimising prominence of the brand name in advertisements for therapeutic goods that are not 'natural' (including on labels) or by explicitly stating the synthetic ingredients in the product.

Definition of 'natural'

Natural is defined in the Macquarie Dictionary as:

'existing in or formed by nature; not artificial'^[3] and not synthetic^[4]

Recognising that all therapeutic goods have had the raw starting material (unprocessed material) transformed through manufacturing processes into the final product (such as tablets, capsules, tinctures, topical creams and ointments, herbal extracts), as well as acknowledging that many synthetic pharmaceutical medicines are originally derived from a variety of natural sources^[5], the TGA has focussed on the processing steps involved in the transformation of the raw material to the finished good in defining the term natural when it is used in the context of promoting therapeutic goods.

Form found in nature

The starting, or 'raw material' from which the 'natural' therapeutic good (or therapeutic good ingredient) is derived must be a form physically found in nature - plants, (and other organisms that are treated as plants in the International Code of Botanical Nomenclature, such as fungi, algae and yeast), animal, marine, mineral or bacterial.

Processing/manufacturing steps

The manufacturing of the therapeutic good to produce a finished dosage form must involve 'minimal processing'. The production steps to achieve 'minimal processing' can include:

• freezing
• drying
• filtering
• grinding and powdering
• fermentation
• boiling and primary distillation
• solvent extraction
• concentration, or
• fractionation.

Same chemical identity

In addition to the 'minimal processing' requirement, the substances occurring in the starting material must:

• be chemically identical; and

must not:

• have undergone any chemical conversion or modification - for example, to become a derivative or salt form.

As a synthetic substance may be chemically identical to a naturally-occurring substance, for an ingredient to be 'natural' it must meet both the requirement to be 'minimally processed' AND the requirement to be chemically identical.

Representing a therapeutic good in its entirety as natural

Only in very limited circumstances would a claim (without qualification) that a product in its entirety is 'natural' not be misleading. For a therapeutic good to be advertised without qualification as 'natural', every ingredient in that good:

• must be only minimally processed from the form found in nature (such as a whole food or plant), AND
• must not have been transformed (for example, synthetically modified) to an extent that the ingredient is a different chemical substance.

In such cases it may be obvious to the consumer how such a product is 'natural', however the advertiser is at liberty to explain the claim further by including information drawn from the definition of 'natural' as articulated in this Guidance.

If a therapeutic good contains both 'natural' ingredients and chemically synthesised active substances (including synthetic compounds as an active ingredient or excipient), the term 'natural' may still be used. However it must be qualified to ensure the consumer would not be led to the view that every ingredient in the therapeutic good is natural. The advertiser may choose to specify which ingredients in the therapeutic good are natural or may choose to identify the synthetic 'non-natural ingredients', or both.

'Natural' references in other contexts

The TGA recognises that a number of existing businesses, particularly within the complementary medicines industry, operate under company or trading names referencing 'natural' or refer to 'natural' within brand or range names. We acknowledge that such references to 'natural' within a trading name would not by itself, automatically lead consumers to a view that all therapeutic goods marketed by that company are claiming to be 'natural'. However, the advertiser must ensure that it is clear to a consumer that a company name (and any associated taglines or logos) relate to the company and not to the specific therapeutic goods marketed under that trading name. A high degree of caution is required if the actual name of the product includes the word 'natural' as it could imply to consumers that the product is wholly natural or contains natural ingredients.

Therapeutic goods with a natural mode of action

Some advertisers use claims to the effect that an advertised therapeutic good has a 'natural mode of action'. The TGA considers that these claims will convey to the consumer a process which is, or mimics, a normal physiological process in the body. For example 'works naturally' and 'acts naturally'. It is, for example, reasonable to claim that a bulk forming laxative acts naturally to the extent that it invokes a normal physiological process. However, advertisers need to exercise caution to ensure they do not imply that the good itself is natural, if this is not the case. Advertisers should ensure that sufficient justification for making natural mode of action claims are provided to consumers, within the body of the advertisement or by reference to further information, to ensure that ordinary consumers are not misled. Further, as most medicines act on the physiology of the body, it may mislead consumers to state or imply a medicine has a natural mode of action.

Safety and efficacy

Notwithstanding that the Code prohibits claims in advertisements to the public that the advertised good is safe or free from side effects, there are risks of consumer misperceptions that 'natural' means 'safe'.

While claims that a therapeutic good is natural or that it contains natural ingredients are not prohibited, care must be taken to ensure the 'natural' qualities of the goods are not correlated, expressly or by implication, with other qualities such as safety and/or efficacy.