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Bio-Strath – ASA ruling

Posted 11 March 2012

Prof Jobson lodged a consumer complaint against the Bio-Strath's website advertising (www.sanatural.co.za/bio-strath and www.bio-strath.co.za) which contained the following claims:

“Bio-Strath may be taken to: • 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 • Regulate digestion • Assist in overcoming skin complaints • Strengthen the nervous system • Combat physical and mental tiredness and nervous tension • Restore health and vitality to adults and children • Restore body vitamins where deficiency has been caused by antibiotic therapy.”

On the page dealing with “Children” it refers to “The effects of a food supplement in the behaviour of children with attention deficit disorder (ADD/ADHD) (Pädiatrie, January 1/2006)” and briefly highlights the key findings of the study. It also refers to “Bio-Strath Research” with regard to “Immune Defence/Influenza”. In many instances the claim “Full of Nature. Full of Nourishment. FULL OF LIFE” appears, as well as “NOURISH EACH AND EVERY CELL IN YOUR BODY WITH THE NATURAL VITALITY OF 61 ESSENTIAL NUTRIENTS”.

The ASA concluded, for most of the claims: ". . .  the following claims are currently in breach of Clause 4.1 of Section II of the Code" and "The respondent is therefore required to: Withdraw the advertising and claims complained of."

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


06 Mar 2012

http://www.asasa.org.za/ResultDetail.aspx?Ruling=5980


Prof Jobson lodged a consumer complaint against the respondent’s website advertising at www.sanatural.co.za/bio-strath and www.bio-strath.co.za.

In subsequent correspondence, he submitted that his original complaint should also be extended to certain print and television executions, as the same claims are made in these. He did not specifically identify any claim in relation to the print advertisement, and in relation to the television commercial he queried the validity of the implication that the product gives “joy for life”.

The website positions the product as a “… herbal wholefood supplement …” and contained the following claims:

“Bio-Strath may be taken to:

• 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
• Regulate digestion
• Assist in overcoming skin complaints
• Strengthen the nervous system
• Combat physical and mental tiredness and nervous tension
• Restore health and vitality to adults and children
• Restore body vitamins where deficiency has been caused by antibiotic therapy.”

Under the heading “Has it been researched?” it states:

“Yes. More than 36 clinical studies on Bio-Strath have proven how advantageous this product is in pregnancy, for children with poor immune systems or learning problems, athletes, people recuperating after operations or spending a long time on a sickbed, for cancer patients who receive chemotherapy and radiation, as well as for older persons with memory problems. Bio-Strath has been proven to offer excellent support in all these areas – by bring order and balance to the body.”

On the page dealing with “Children” it refers to “The effects of a food supplement in the behaviour of children with attention deficit disorder (ADD/ADHD) (Pädiatrie, January 1/2006)” and briefly highlights the key findings of the study.

It also refers to “Bio-Strath Research” with regard to “Immune Defence/Influenza”.

In many instances the claim “Full of Nature. Full of Nourishment. FULL OF LIFE” appears, as well as “NOURISH EACH AND EVERY CELL IN YOUR BODY WITH THE NATURAL VITALITY OF 61 ESSENTIAL NUTRIENTS”.

Lastly, the complainant specifically referred to the claim “Keep your family feeling inspired and invigorated. Every day, Bio-Strath helps give you the balance, energy and focus you need to live a life bursting with well-being”.

COMPLAINT
The complainant made much of the issue that the product is incorrectly presented as a food supplement. The main thrust of the argument here is that certain claims made fall within the definition of a medicine as defined by applicable legislation. As such, the respondent is misleading people.

In addition, the complainant requested substantiation for the claims listed at the beginning of this ruling. Reference was also made to the provisions of Appendix F with regard to the reference to the product’s benefit to “… cancer patients …”

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

RESPONSE
The respondent submitted a verification letter from Dr. van Velden, a list of 36 references to scientific publications or clinical studies, opinions from Mr Leonard Elliot Cohen – a pharmacist, Beatrix Brits (B.Pharm MPS), and Dr Bernard Brom (MB ChB), various testimonials from Facebook, documents titled “ATTESTATION FOR REGISTRATION” in Switzerland Bio-Strath and package inserts (for Switzerland and Australia) together with product packaging, annexed as “UK Carton.pdf”

When asked to clarify whether it would abide by Dr van Velden’s recommendations for certain amendments, it confirmed that such recommendations had already been complied with.

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

At the outset, the Directorate rejects the complainant’s argument that claims such as “Keep your family feeling inspired and invigorated” and “… a life bursting with well-being” are capable of objective substantiation as envisaged by the Code.

The respondent is clearly puffing in these claims, and the Directorate does not expect it to hold independent verification for such claims. The remainder of its efficacy claims which can be regarded as capable of objective substantiation will be dealt with below.

In essence, the respondent’s substantiation is split between a verification of efficacy-type claims by Dr van Velden, and a verification of the product’s status as a food supplement by Ms Britz, Dr Brom and Mr Cohen.

Status of the product
The complainant argued at length why the product should be regarded as and registered as a medicine.

In Prozen / HPA / 9669 (7 February 2008), the Directorate, inter alia, had to consider a similar complaint. It ruled:

“… the registration of medicines per se does not fall within the jurisdiction of the ASA. It is true that Clause 4 of Appendix A [which no longer exists in the Code] requires registered medicines to advertise in line with that registration. Appendices A and F set out certain limits on the claims that an unregistered medicine can make. This does not, however, bring the enquiry as to whether a particular product must be registered within the jurisdiction of the ASA”.

Similarly, the Directorate is not able to consider whether or not the product at issue should or should not be registered as a medicine with the appropriate authorities. It would appear that the product is presented as a “… herbal wholefood supplement …” (i.e. not a medicine) and the correspondence at hand shows that the product is not registered.

The Directorate is therefore not able to consider this aspect of the complaint. The opinions from Dr Brom, Ms Britz and Mr Cohen are therefore not relevant for the purpose of this ruling.

Voluntary undertakings
Dr van Velden submitted that the following claims complained against were to be removed or amended. When explaining the change, he submitted that, inter alia, “Where medicinal claims are made in claims … I agree with the complainant that these claims cannot be substantiated, and should be removed”. He also pointed to certain claims that “… must be amended to avoid disinformation, and to reflect the true function of the product as a food supplement”.

The claims that he suggested to be removed were:

• “Regulate digestion”;
• “Assist in overcoming skin complaints”;
• “Strengthen the nervous system”;
• “Restore body vitamins where deficiency has been caused by antibiotic therapy”.

Insofar as amendments are concerned, he suggested that the following claims be amended:

“Restore health and vitality to adults and children” – To be amended to read ”Restore vitality to adults and children”;
“The 61 nutrients are regarded as essential” – To be amended to read “The 61 identified natural nutrients in the supplement are in equilibrium and well tolerated”.
“Taking the supplement will assist in nourishing every cell in your body” – To be amended to read “This supplement may assist in balancing various metabolic functions in the body”.
The ASA has a long standing principle which holds that where an advertiser provides an unequivocal undertaking to withdraw or amend its advertising in a manner that addresses the concerns raised, the undertaking is accepted without considering the merits of the matter.

The respondent confirmed that it will abide by the recommendations of Dr. van Velden. The Directorate is therefore accepting this undertaking as an adequate resolution, as it appears to address the concerns of the complainant insofar as these claims are concerned.

The undertaking is therefore accepted on condition that the claims are withdrawn or amended within deadlines stipulated in Clause 15.3 of the Procedural Guide, and is not used again in future in the current format.

Substantiation
Clause 4.1.1 of Section II states, inter alia, that an advertiser must hold documentary evidence to support all claims that are capable of objective substantiation. Clause 4.1.4 of Section II requires that documentary evidence other than survey data shall emanate from, or be evaluated by, an independent and credible expert in the particular field to which the claims relate and be acceptable to the ASA.

The respondent relied on Dr. van Velden as an independent and credible expert in the matter.

In his verification letter Dr van Velden submitted that his academic qualifications are MB ChB, M Prax Med, M Phil (Journalism). In addition, has 43 years clinical experience. He also explained that he has experience in evaluating research data because of an academic career of 26 years at the Faculty of Health Sciences of the University of Stellenbosch involving undergraduate and post graduate teaching, research and evaluating clinical medical practice.

It would appear from his letter that he based his conclusions on the 36 “SCIENTIFIC PUBLICATIONS on Bio-Strath/Strath Herbal Yeast Food Supplements” referenced in the respondent’s “Annexure C” to its response. It should be noted that the respondent did not submit these studies, only their respective titles.

In Lifebuoy / Dettol / 14813 (27 August 2011), the Advertising Industry Tribunal (the AIT) ruled as follows:

“While we accept and indeed agree that because the Directorate (or any other ASA body for that matter) invariably may not or will not have the technical expertise to evaluate technical or scientific documentary evidence, it will often be required to rely, if not heavily, upon any expert views or opinions furnished, this does not mean that the Directorate may relinquish its responsibility to ensure that sufficient documentary substantiation in fact exists to any such expert. It is accordingly required, as would any other administrative body, or a court of law, in a similar position, to assess any expert view proffered and satisfy itself as to the adequacy, at the very least, of the expert view.

In the instant case we do not believe that the Directorate did properly satisfy itself of the adequacy of the expert view and in our view did not properly apply its mind to the question of whether sufficient and adequate substantiation had been put before it to support the claims in issue.

As we have noted, Dr Jardine’s expert opinion constituted a letter comprising one paragraph in which all that he says is that he has perused the research protocol, has applied his own knowledge and understanding to the matter and that it was his opinion that the claims are substantiated. No reasons for this conclusion are provided, there is no mention of the nature of the tests conducted in the research protocol, the date when they were carried out and by whom, what methodology was used or even the results of the tests. In truth all that we are told is that in his opinion the claims are substantiated. In effect the ‘opinion’ amounts to no more than a say so by Dr Jardine that the claims are substantiated.

In our view this does not constitute a reasoned expert opinion. Even assuming that the requirements of Clause 4.1.4 may be met by the furnishing alone of an expert opinion without a copy of the supporting substantiating documents, or at the very least sufficiently detailed summary of the studies / documentation being evaluated, (in respect of which we do not express any conclusive view) the one paragraph letter from Dr Jardine does not in our view constitute adequate expert opinion for the purposes of Clause 4.1.4.

Because it does not contain any explanation of the research methodology adopted nor any explanation of the basis / grounds upon which he concluded that the results of the study support the claims in issue, it was impossible for the Directorate or indeed anyone else, regardless of their expertise or lack thereof, to in fact satisfy themselves of the soundness of Dr Jardine’s conclusions. In the result, we are of the view that the Directorate misdirected itself in taking the view that the letter constituted sufficient substantiation for the purposes of Clause 4.1.4 of Section II of the Code”.

The implication of this is that the Directorate has to interrogate the substance of substantiation, and cannot simply accept the say-so of an expert.

The bulk of Dr van Velden’s letter deals with his standing as an expert and research led by or reviewed by him, and the issue of food supplements vs. medicine. When dealing with the actual claims at issue, his verification effectively states:

“… I can unequivocally confirm that … the following claims [save the ones removed or amended above] are supported by available research on the product Bio-Strath when, taken as recommended … I am also able to confirm that the available research does indeed show that 36 clinical studies on Bio-Strath have proven how advantageous this product is in pregnancy, for children with poor immune systems or learning problems, athletes, people recuperating after operations or spending a long time on a sickbed, for cancer patients who receive chemotherapy and radiation, as well as for older persons with memory problems …”

This is not unlike “… a letter comprising one paragraph …” as referred to in the Dettol ruling above.

When considering the research titles listed by the respondent, the Directorate notes firstly that it was not supplied with copies of such research to consider and “satisfy [itself] of the soundness” of Dr van Velden’s conclusions.

Many of the research titles do not, at first glance, appear to correlate with the claims made, some appear to relate to conditions that are not listed in the complaint, some were done on mice, and others appear to merely be an evaluation of medical practitioners’ reports.

While it may well be that the documentary evidence relied on by Dr van Velden adequately substantiates the claims, the Directorate cannot, based on the principle established in the Dettol matter, simply accept his “say-so” for it. In the absence of anything beyond Dr van Velden’s confirmatory paragraph, the Directorate cannot find that the claims at issue are adequately substantiated within the meaning of Clause 4.1 of Section II of the Code.

As a result, the following claims are currently in breach of Clause 4.1 of Section II of the Code.

• “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”

It is also noted that Dr van Velden has not commented on the claims made in relation to ADD/ADHD and “Immune Defence/Influenza”. These claims are therefore equally unsubstantiated and in contravention of Clause 4.1 of Section II at this time.

The respondent is therefore required to:

Withdraw the advertising and claims complained of

Ensure that it actions the withdrawal of the claims and advertising with immediate effect upon receipt of this ruling

Ensure that the withdrawal process is completed within the deadlines stipulated in Clause 15.3 of the Procedural Guide

Refrain from using the claims and advertising at issue in future.

This aspect of the complaint is upheld.

 


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