Natural claims in respect of therapeutic goods are regulated by the Therapeutic Goods Advertising Code (No. 2) 2018 (Code). Claims (including natural claims) must not be misleading, or likely to mislead, consumers.1 Under the Code, all claims (including natural claims) must also be truthful, valid, accurate, balanced and substantiated.

On 11 June 2019, the Therapeutic Goods Administration (TGA) published guidance in relation to the use of “natural” claims when advertising medicines and medical devices to the public (TGA Guidance).2

In short, the TGA Guidance clarifies how the TGA will interpret “natural”. It provides that a consumer will understand a therapeutic good or ingredient to be natural if it:

  • is in a form found in nature;
  • has undergone minimal processing; and
  • is identical chemically to the finished ingredient or product.

If a natural claim is made and the therapeutic good or ingredient does not satisfy the above criteria, the advertiser must explain the claim in a satisfactory manner to avoid misleading consumers.

What is a natural claim? 

In the context of therapeutic goods advertising, a natural claim is a statement that a therapeutic good or ingredient is natural. Examples of natural claims are statements, such as “derived from nature”, “naturally sourced” or “100% natural”.

The TGA considers that an ingredient or product will be natural if each of the following three requirements (Natural Claim Requirements) is satisfied:

  1. Form in Nature – The original substance, from which the ingredient or product is derived, is a form found physically in nature, such as plant, mineral or bacterial.
  2. Minimal Processing – The manufacturing process involves minimal processing. Processing steps considered to be minimal include freezing, drying, fermentation, solvent extraction, fractionation and filtering.
  3. Identical Chemically – The original substance is identical chemically to the finished ingredient or product. In other words, the original substance must not undergo any chemical conversion or alterations. For example, the chemical process must not cause the original substance to have been transformed into a derivative or salt form.

Is a qualification needed? 

The TGA considers that a natural claim may be made without qualification if a therapeutic good consists solely of ingredients which satisfy the Natural Claim Requirements. In other words, a therapeutic good must comprise wholly ingredients for which natural claims could be made. However, the advertiser has discretion to provide further information on its basis for making the natural claim.

To the extent that a therapeutic good comprises natural and synthetic ingredients, a natural claim may still be made in respect of that good. However, qualification would be required to ensure that a consumer is not misled into believing, wrongly, that each ingredient is natural.

An advertiser may elect to specify those ingredients which are natural (i.e. they satisfy the Natural Claim Requirements) and those which are synthetic/artificial/non-natural (i.e. they do not satisfy the Natural Claim Requirements).

Any natural qualities which a therapeutic good may possess should not be linked, directly or indirectly, with other attributes such as safety or efficacy. Examples of problematic claims provided in the TGA Guidance include “you can trust [product name], it’s all natural” and “protect your child’s health by choosing natural”.

“Natural” product names 

The TGA acknowledges that the word “natural” is used frequently in the names of products, brands and companies, especially in the complementary medicines industry.

The use of “natural” in a company or trading name would not necessarily, in and of itself, cause consumers to believe that the company is claiming that all of its products are natural. However, a company must exercise a degree of caution to ensure that the natural descriptor is linked to the company and not to its goods.

If the name of a product includes “natural”, the company must be extremely careful to ensure that a claim is not made, by implication, that the product is wholly natural or consists of natural ingredients.

“Natural” modes of action 

If a therapeutic good is said to have a “natural mode of action”, the TGA considers that a consumer will interpret this to mean that it has a process which is, or emulates, normal physiological processes in the human body.

The focus is on the function performed by the product, rather than the composition of the product. For example, in the case of a bulk forming laxative which invokes a normal bodily process, it would be reasonable to state that the laxative has a “natural mode of action”. However, it would not be reasonable to claim that it is a “natural” product unless it satisfies each of the Natural Claim Requirements.

Alternatively, if a therapeutic good does not involve, or mimic, a normal physiological process, claims such as “works naturally” could mislead a consumer. Further, if a medicine only has an impact on the body’s physiological processes, it may be misleading to state that the medicine has a “natural mode of action”.

To the extent that a therapeutic good does have a “natural mode of action”, “works naturally” or “acts naturally”, sufficient evidence should be given to consumers in advertising to ensure that consumers are not misled as to the substance of these claims.

What about the Australian Consumer Law? 

The requirements of the Code should always be considered in parallel with the requirements of the Australian Consumer Law (ACL).

The ACL prohibits a person from making, in trade or commerce, any claim which is misleading or deceptive or likely to mislead or deceive (section 18) or which amounts to a false representation about a variety of specified matters, such as falsely claiming that a product is of a particular standard, quality, value, grade or composition when this is not the case (section 29). The Australian Competition and Consumer Commission (ACCC) published a guideline in 2006 on when descriptors, such as “natural”, may mislead a consumer in the context of food products (ACCC Guideline).3

The TGA Guidance refers to the ACCC Guideline and, in particular, a section which emphasises that a natural claim should be interpreted from the perspective of a consumer. Further, consideration should be given to the consumer’s understanding of that claim, as opposed to the understanding of a manufacturer or a food technologist. Product developers and marketing teams should bear this in mind.

The ACCC Guideline provides that, when the term “natural” satisfies a code or standard, to the extent that the consumer is not aware of this fact, the consumer may reach conclusions which are not accurate and may be misled. This principle is also applicable to natural claims in the context of therapeutic goods.

Takeaways

The release of the TGA Guidance is a timely reminder that making “natural” claims is risky and caution must be exercised. As well as considering the requirements of the Code, marketing teams must also consider the requirements of the ACL too.

Care should be taken to ensure that the use of the word natural is appropriate and to distinguish between a natural ingredient, a natural product and/or a natural mode of action. If a business wishes to make claims about the “naturalness” of a product, ingredient or process, any claim which it makes must be justified and supported by evidence.

If a natural claim is made, the TGA considers that the claim should be interpreted from the viewpoint of the consumer and not the business. Accordingly, further information should be provided with the claim so consumers can make informed decisions and to ensure that they are not misled.