Using 'natural' claims in therapeutic goods advertising

If you want to use natural claims, you need to consider the following:

• understand the TGA's meaning of 'natural' in the context of therapeutic goods, their ingredients and their manufacture.
• be clear on what an entirely natural therapeutic good would require to be compliant.
• understand how to use qualifiers if your therapeutic good contains some natural ingredients.
• know what you can say if natural claims are directed at your company or brand name and not the therapeutic goods.
• ensure you use ‘natural mode of action’ claims appropriately.
• ensure all natural claims are compliant with other areas of the Code and Act too. Pay particular attention to implied safety and efficacy.

Many medicines are derived from a variety of natural sources, so the TGA focuses on the processing steps from raw material to finished good in defining the term natural when used in the context of promoting therapeutic goods.

An advertiser seeking to claim that a particular therapeutic good is 'natural', should ensure:

• the starting or 'raw material' for the natural therapeutic good must be a form found in nature
• the therapeutic good or ingredient must have only undergone 'minimal processing'
• the finished therapeutic good product must not have become a new chemical identity.

Raw material is derived from forms found in nature

The raw material from which the 'natural' therapeutic good or ingredient is derived must be a form physically found in nature such as:

• plant 
• fungi
• animal
• mineral
• bacterial.

Minimal processing or 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 include:

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

Chemically identical

Starting substances must be chemically identical. 

They must not have undergone any chemical conversion or modification, such as being made into 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.

Example of natural Vitamin E

• Vitamin E (d-alpha-tocopherol) isolated from soybean is natural.
• The derivative, d-alpha-tocopheryl acetate, produced via chemical modification of vitamin E from soybean, is not natural, nor is the totally synthetic dl-alpha-tocopheryl acetate.

Example of synthetic vitamin C

• Synthetic vitamin C cannot be described as natural because while chemically identical to vitamin C derived from plants (food), it has not been minimally processed.
• Plant (or food) derived vitamin C can be described as natural where it has only undergone extraction and drying (minimal processing).

Without a qualifier, for an entire therapeutic good to be ‘natural’ and compliant it would require that every ingredient: 

• be only minimally processed from the form found in nature
• must not have been transformed – such as synthetically modified – to an extent that the ingredient is a different chemical substance.

Using qualifiers

If a therapeutic good contains both natural ingredients and chemically synthesised ingredients (including actives or excipients), the term natural may still be used if you use a qualifier. 

You can do this by disclosing which ingredients in the therapeutic good are natural, or identify the synthetic ingredients, or both.

Example of entirely natural therapeutic good not needing a qualifier

Dried, powdered and encapsulated turmeric root

• Natural turmeric does not contain artificial colours, chemical preservatives or any other synthetic ingredients.

Example of qualifiers for therapeutic goods containing both natural and synthetic ingredients

• [product name] contains 60% natural [name of ingredient]
• [product name] contains natural [name of ingredient], preserved with sodium benzoate
• [product name] contains [name of ingredient], a natural active ingredient
• [product name] contains the natural active ingredients [name of ingredients].

Many existing businesses operate under company or trading names referencing 'natural' or refer to natural within brand or range names. 

References to 'natural' within a trading name may be compliant providing that it is clear to a consumer that the company name (and any associated taglines or logos) relate to the company and not to the therapeutic goods marketed under that trading name. 

This may be achieved in various ways, for example:

• by minimising prominence of the brand name in advertisements for those goods that are not ‘natural’ (including on labels) 
• by explicitly stating the synthetic ingredients in the product.

Using ‘natural’ (or similar word) in the name of a product implies to consumers that the product is wholly natural or contains natural ingredients. 

This is compliant only if the entire product:

• has starting or 'raw material' from a form found in nature
• must have only undergone 'minimal processing'
• all ingredients must not have become a new chemical identity.

Consumers easily mistake that 'natural' means 'safe'. 

Advertisers must take care to ensure natural claims are not linked, expressly or by implication, with qualities such as safety or efficacy or imply that they are safer or more efficacious than other therapeutic goods.

It is prohibited for any advertisement to say or imply that the product is safe or free from side effects.

Examples of inappropriate safety and efficacy claims

• protect your child's health by choosing natural
• nature knows best
• no synthetic ingredients - you can rest assured
• you can trust [product name], it's all natural.