It’s important to understand how to correctly use scientific or clinical claims when advertising therapeutic goods to the public.
This information is for those involved in the marketing of therapeutic goods who use scientific or clinical representations or claims in advertisements by:
What are scientific or clinical representations?
The term ‘representation’ is broad. Representations can include warning statements, the name of a product and claims about the product (including those conveyed through pictures and videos). A ‘scientific’ or ‘clinical’ representation is one that:
Scientific studies constitute research through the systematic collection, interpretation and evaluation of data. Scientific studies can include studies conducted on animals.
The type of research most relevant to therapeutic goods is ‘clinical’ research. Clinical studies involve people and can be observation studies or clinical trials. Clinical trials are conducted to determine the safety and efficacy of therapeutic goods. Using clinical studies to substantiate claims (by way of citing such studies) will result in the advertisement being non-compliant with the Code if the studies do not meet certain standards (such as being peer reviewed, containing sufficient subject numbers, using adequate ‘blinding’ and being consistent with the broader body of evidence).
A clinical study may only be used to support a claim where the conclusions are relevant to the claim and demonstrate a clinically meaningful (not just a statistically significant) outcome. Claims based on in-vitro (‘test-tube’) evidence or animal studies are not acceptable to support clinical outcome claims in advertising.
What is an ‘implied’ citation to scientific or clinical literature?
An implied citation to scientific or clinical studies occurs when a consumer would expect a claim to be supported by specific research results. An implied citation may be a stand-alone claim or may be used in association with a statement of the therapeutic good’s indication or intended purpose.
High-level claims that imply a citation to scientific or clinical literature, such as a claim that a product has been ‘clinically proven’, are likely to give consumers the impression that the effectiveness of the advertised product has been proven beyond doubt through rigorous clinical/scientific studies. If this is not the case, the claim is misleading. Otherwise, a reference to the study or studies needs to be provided in the advertisement in which the claim is used.
Advertisers may use citations to scientific or clinical studies to provide extra support for a claim which is the therapeutic good’s indication or intended purpose. If advertisers do use citations in the advertisement, the requirements at Section 15 of the Code will apply.
‘Data on file’
Sponsors sometimes want to use their own, unpublished scientific studies to support claims. If such a study is referenced in an advertisement, the term ‘data on file’ is not sufficient to meet the Code requirements for providing enough information to allow consumers to access the study.
Tips for producing a compliant scientific claim