Bio-Strath – ASA ruling

Posted 17 July 2012 

In SANP “Bio-Strath” / R Jobson / 18390 (6 March 2012), the Directorate ruled, inter alia, that the claims being made for the product were not substantiated. In this ruling, the ASA reviewed new substantiation submitted and came to a different conclusion.

SANP “Bio-Strath” / R Jobson / 18390
Ruling of the : ASA Directorate
In the matter between:
Prof M Roy Jobson Complainant(s)/Appellant(s)
SA Natural Products (Pty) Ltd Respondent

16 Jul 2012

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6166

In SANP “Bio-Strath” / R Jobson / 18390 (6 March 2012), the Directorate ruled, inter alia, that the following claims were not substantiated:

• “Counteract exhaustion, fatigue and exam stress”;
• “Build resistance to colds and infections”;
• “Speed up recovery in convalescence”;
• “Improve general well-being and concentration”;
• “Provide stamina for intensive work, study and sport”;
• “Cope with stresses and strains of modern living”;
• “Combat physical and mental tiredness and nervous tension”.

This was because the expert relied upon to verify the claims did not give basis for his opinion, but merely confirmed that the claims were supported by available documentary evidence. The Directorate made the point that, in the absence of the actual research relied upon, it could not ascertain whether or not Dr van Velden’s opinion reflects the information contained in the research. As such, his opinion effectively amounted to no more than his “say-so”.

The Directorate also found against references to ADD/ADHD and “Immune Defence/Influenza”, because Dr van Velden expressed no opinion in relation to these conditions.

The respondent was instructed to remove the advertising containing the relevant claims.

SUBSEQUENT TO THE RULING
Clear Copy, on behalf of the respondent, submitted an amplified opinion from Dr van Velden as well as the studies on which his opinion is based. It argued that the Directorate interpreted the ruling of the Advertising Industry Tribunal (the AIT) in Lifebuoy / Dettol / 14813 (27 August 2011) too narrowly, thus prejudicing this industry.

In his letter, Dr van Velden submitted that scientific truths are not cast in stone, but rest primarily on the current, best available evidence according to international guidelines for research. These “truths” may be falsified by new research projects that present evidence contradicting previously accepted beliefs. However, until that happens, the best available evidence must hold. Dr van Velden also submitted that to the best of his knowledge, the quoted research has been published in peer-reviewed scientific journals. He briefly discussed the relevant research applicable to each claim, and gave his opinion on them.

Furthermore, Dr van Velden submitted that he had visited the source factory for Bio-Strath and satisfied himself as to the production levels and integrity.

RELEVANT CLAUSE OF THE CODE OF ADVERTISING PRACTICE
In light of the new substantiation Clause 4.1 of Section II of the Code (Substantiation) was considered relevant.

COMPLAINANT’S COMMENTS
In accordance with procedure, the complainant was afforded an opportunity to comment on the new documentation. The complainant submitted that he cannot accept an opinion relating the Dr Velden’s visit to the plant as he has supplied no evidence to say that he is trained in current Good Manufacturing Practice. The complainant also submitted that he will be basing his analysis of the submission on the definition of substantiation as per the Code which can be divided into three parts, namely:

• Statistically valid data
• A validated proven scientific method
• Applicable to the claim

He then proceeded to argue why the research relied on by Dr van Velden falls short of some, or all of these requirements.

ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.

At the outset it should be noted that the issue of whether or not the respondent subscribes to Good Manufacturing Practices is irrelevant insofar as this ruling is concerned, as it does not relate to any advertising disputed. The Directorate will therefore limit its ruling to the merits of the matter in relation to the claims ruled against.

It is trite that the Directorate is not expected to be a technical or scientific expert in all areas. For this reason, the Code allows for the Directorate to rely on an opinion from someone who is regarded as an independent and credible expert in the field to which the claims relate. Once the Directorate is satisfied that such an opinion has been received, the only remaining concerns would be whether or not the verification is unequivocal, and applies to the product as a whole when used at the recommended dose.

The Directorate is mindful of the fact that even experts may disagree on their interpretation of scientific data and the application of such findings. It is for this reason that the Code provides for a process of arbitration, which effectively allows for an independent expert to be selected to review the technical arguments from disagreeing parties and make a finding. The current dispute, however, is not one of arbitration in accordance with Clause 16 of the Procedural Guide.

While the complainant submitted detailed explanations on why the studies are outdated, are not statistically valid, do not use validated proven scientific method and cannot be generalised to the South African market, he did not submit anything to show why the Directorate should not accept Dr van Velden as an independent and credible expert in the field to which the claims relate. Effectively, he skipped this step, and went straight into arguing why Dr van Velden should have reached a different conclusion. Effectively, this presents the Directorate with a situation where two apparent experts have differing views or opinions. This is more a matter for arbitration than a concern that the ASA can decide on.

It is also worth noting that both the complainant and Dr van Velden agree that scientific truth may be falsified by new research that contradicts past findings. The concerns raised by the complainant are, therefore, a matter of questioning the validity of the science behind the submissions.

The Directorate’s first task is to decide on whether Dr van Velden should be accepted as independent, credible and an expert in the field. The information previously submitted by the respondent shows that Dr van Velden has his MB ChB and M Prax Med, and is a part-time lecturer at the Faculty of Health Sciences at the University of Stellenbosch. He has also acted as the Senior Lecturer at the Department of Family Medicine and Primary Care at the University. He is, inter alia, a member of the South African Medical Association (SAMA) as well as the Nutrition Society of South Africa (NCSA).

In addition, the Directorate ruling in A Vogel Alkaline Powder / K Charleston / 18429 (1 March 2012) accepted that Dr van Velden is a suitable expert “…for the purpose of verifying general, non-specialised medical claims …”

The claims above appear to fall within such “general, non-specialised” parameters, and there was nothing from the complainant to contradict the Directorate’s previous acceptance of Dr van Velden.

As such, the Directorate accepts Dr van Velden as an independent and credible expert for the purpose of verifying general, non-specialised (i.e. do not require specialist expertise or experience) medical claims.

Dr van Velden unequivocally verifies that the following references or claims are true, based on his expert knowledge and the relevant studies relied on:

• “Counteract exhaustion, fatigue and exam stress”;
• “Build resistance to colds and infections”;
• “Speed up recovery in convalescence”;
• “Improve general well-being and concentration”;
• “Provide stamina for intensive work, study and sport”;
• “Cope with stresses and strains of modern living”;
• “Combat physical and mental tiredness and nervous tension”.

The Directorate also notes that all the studies relied on by Dr van Velden were product specific.

Given this, the claims specifically listed above now appear to be substantiated within the requirements of Clause 4.1 of Section II. The original ruling is therefore overturned in this respect, and the respondent may continue using these claims.

However, the Directorate is not convinced insofar as the references to ADD / ADHD are concerned. While true that the research relied on appears to be product-specific in this regard, Dr van Velden’s verification is not unequivocal. He states as follows:

“It is well known that sound nutrition is essential for cognitive development in children. Biostrath MAY play an important role in this regard. According to the above mentioned study, Biostrath as a food supplement MAY therefore claim benefits in relation to the improvement of behaviour in children with ADD and ADHD. HOWEVER, MORE QUALITATIVE STUDIES IN THIS REGARD NEEDS TO BE DONE TO SUBSTANTIATE THESE CLAIMS. THERE ARE MANY CONFOUNDING VARIABLES THAT MAY PLAY A ROLE IN THIS REGARD”

It does not appear from the above that Dr van Velden is convinced of the implied efficacy in relation to ADD and ADHD.

The Directorate is therefore not satisfied that this amounts to unequivocal verification for the claim that Biostrath has an effect on ADD and ADHD.

The original ruling therefore remains binding and in force insofar as this claim is concerned.

Lastly, the Directorate notes that Dr van Velden did not specifically comment on the references to “Immune Defence / Influenza”. While he did refer to studies dealing with, inter alia, influenza, he did not interpret them in the context of this claim, and expressed now view on this claim. These were rather used to support some of the other claims specifically verified.

While the Directorate accepts that there is a possibility that the verification of one claim could potentially imply truth insofar as another is concerned, it is for the respondent’s expert to unequivocally state this and explain this. The Directorate cannot, in the absence of such arguments, merely accept that this is the case.

As such, the references to “Immune Defence / Influenza” are currently still unsubstantiated. The original ruling therefore remains binding and in force in this regard.

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