Bio-Strath – ASA Ruling

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Dr Gosling lodged a consumer complaint against a Bio-Strath Elixir print advertisement that was published in the Weekend Argus newspaper during August 2008. The advertisement states, inter alia, “76% Improvement in ADD/ADHD symptoms”.

Irma Scutte Bio-Strath / J Gosling / 11936

Ruling of the : ASA DirectorateIn the matter between:
Dr John Gosling Complainant(s) / Appellant(s)
SA Natural Products (Pty) Ltd Respondent

21 Jan 2009

Dr Gosling lodged a consumer complaint against a Bio-Strath Elixir print advertisement that was published in the Weekend Argus newspaper during August 2008. The advertisement states, inter alia, “76% Improvement in ADD/ADHD symptoms”.

COMPLAINT

The complainant submitted that this claim is misleading and unsubstantiated. The respondent’s website shows that the study was done on 18 children. This is too a small number of children to draw conclusive proof. In addition, the website states 12 out of 18 children showed improvement, which makes it 66% improvement and not 76% as stated in the advertisement.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE

In light of the complaint the following clauses of the Code were taken into account:
• Section II, Clause 4.1 – Substantiation
• Section II, Clause 4.2.1 – Misleading claims

RESPONSE

The respondent submitted that it sponsored the study which was done is Switzerland and was published in a Swiss Journal Pädiatre 1/2006, and not in a Finnish Journal. The study involved 18 children of which 12 showed benefits on ADD/ADHD symptoms. All 18 children had a benefit in general health, well being and concentration. The children were tested with an Integrated visual and Auditory Continuos performance test (IVA CPT) by Joseph QA Sandford Ph.D and Ann Turner, M.D., Richmond USA. 116 statistically significant parameters were tested and 93 were positive while 23 were neutral or negative. The 76% is calculated from this relation and not the number of children. In support of its argument, the respondent attached an approval document to the study from the Ethical Medicinal Commission of the Canton of Wallis in Switzerland and the independent outsourced study referred to in the advertisement.

ASA DIRECTORATE RULING

The ASA Directorate considered the relevant documentation submitted by the respective parties. At the outset, it must be noted that medicinal products cannot be treated as an ordinary general commodity. They have the potential for harmful as well as beneficial effects and can cause serious problems if not used safely. For this reason, there are specific regulations that strictly control the advertising and promotion of medicinal products.

The scope of this ruling is limited to the subject matter of the complaint brought to the ASA, namely whether the claim concerning the efficacy of the respondent’s product can be substantiated. The ASA is not able or authorised to rule on the quality or safety of the product in question, and this ruling must be interpreted and applied accordingly. Because the ASA is not a technical expert body, Clause 4.1 of Section II requires it to rely on the opinion received from the "independent, credible expert".

Should the Directorate be satisfied that the relevant person or entity is indeed independent, credible and an expert in the field to which the claims relate, the Directorate will consider whether or not the expert confirms the claims in question as valid for the product. The respondent appears to have extrapolated the findings from the study submitted. In The Little Book of Big Health Secrets / Premarin / 11090 (20 October 2008) the Directorate was faced with a similar situation where the respondent relied on studies done, and submitted these studies as proof. It ruled, inter alia, as follows: “… in accordance with Clause 4.1.4 of Section II of the Code, the Directorate can only accept substantiation from a person or entity that is independent, credible and an expert in the relevant field to which the claims relate.

It has also been ruled on several occasions that the Directorate is not a medical or scientific expert, and is not at liberty to interpret scientific documentation and research. In light of this, the Directorate is not able to scrutinise and interpret the supporting documentation submitted by the respondent.

While the studies may well emanate from independent and credible experts in this field, they contain scientific information and jargon, which the ASA is not qualified to interpret. In addition, the Directorate cannot determine whether the findings communicated are scientifically significant to such an extent that they can be applied as broadly as the advertising seems to imply”.

The same approach applies here, and the Directorate is unable to interpret the scientific data submitted and draw scientific conclusions from it. What the Directorate requires is confirmation from an independent and credible expert in the relevant field that the information contained in the study submitted supports the exact claims made in the advertising, and can be applied as broadly as the advertisement appears to suggest.

It is also noted that the research article makes no mention of the figure 76%, and the Directorate cannot simply assume that the respondent correctly calculated this figure or is applying it appropriately. In light of the above, the claim “76% Improvement in ADD/ADHD symptoms” is currently unsubstantiated, and therefore in breach of Clause 4.1 of Section II.

Given the above: The claim must be withdrawn;
The process to withdraw the claim must be actioned with immediate effect on receipt of this ruling;
The withdrawal of the claim must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide; The claim may not be used again in its current format until new substantiation has been submitted, evaluated and a new ruling is made.

The respondent’s attention is drawn to Clause 15.5 of the Procedural Guide. 

The complaint is upheld.

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