Solal Eyesight Protection, another adverse ASA ruling

,

Posted 24 January 2012

The ASA previously ruled against Solal's claims for their Eyesight ProtectionTM  product. One of the claims made for this product was   “Eyesight Protection TM” helped “protect the eyes against eye damage from UV-sun rays …”, “Minimises low-light vision loss, eye fatigue, intolerance to glare and other eye disorders” and should be used “… on a regular basis … even in the absence of symptoms …” 

In the previous ruling, the ASA concluded that Solal's expert, Dr Terry Grossman, was not a "true" expert. In this ruling, the ASA has supplied new substantiation. Still not enough to sway the ASA. Sometimes the ASA does get a ruling wrong (in my opinion), but in this instance, I think that they were again spot on. In fact, I commend the ASA on a well reasoned ruling.

Solal Technologies / JC Laithwaithe / 15765
Ruling of the : ASA Directorate
In the matter between:
Dr JC Laithwaithe Complainant(s)/Appellant(s)
Solal Technologies (Pty) Ltd Respondent

24 Jan 2012
http://www.asasa.org.za/ResultDetail.aspx?Ruling=5921

BACKGROUND
In a ruling dated 30 August 2010 under the above reference, the Directorate upheld an objection against the respondent’s advertisement for its eye protective nutrients.

The advertisement at the time was headed “Interesting facts about your health” and stated, inter alia, “FACT 1: The eye damage that causes vision loss in old age, actually starts in early adulthood, or even younger”.

The copy further stated, “Everyday sunlight exposure causes a type of damage to the eyes known as macular degeneration. This damage accumulates over time and ultimately results in reduced vision and possibly even blindness in old age (known as ARMD: Age Related Macular Degeneration). This damage begins at a young age, even in childhood, but only manifests with reduced vision in old age. To protect your eyes, adults and children should wear UV-protective sunglasses outdoors during sunny days. You also need to begin supplementation with eye-protective nutrients from early adulthood.”
Readers were encouraged to start using this product “… from early to mid-adulthood” and that the product should be “… used on a regular daily basis thereafter, even in the absence of symptoms …”

It explained how the respondent’s “Eyesight Protection TM” helped “protect the eyes against eye damage from UV-sun rays …”, “Minimises low-light vision loss, eye fatigue, intolerance to glare and other eye disorders” and should be used “… on a regular basis … even in the absence of symptoms …”

The substantiation ultimately rejected by the Directorate at this time consisted, inter alia, of verification from one Dr Terry Grossman. The Directorate rejected this verification on the basis that:

Dr Grossman sat on the advisory panel of a magazine called “Health Intelligence”, which appeared to be a magazine published by the respondent (thus negating his independence),

Dr Grossman himself was a promoter and distributor of supplements similar to those of the respondent, and thus possibly stood to benefit, even indirectly, form the acceptance of such products, and

There was nothing before the Directorate to show that Dr Grossman, a general practitioner, has attained theoretical knowledge or practical experience in the field of eye care and more particularly degenerative eye diseases which is the field to which the claims relate.

As a result, the respondent was instructed to withdraw all claims of the above nature with immediate effect. The respondent’s attention was also drawn to the provisions of Appendix F of the Code.

SUBSEQUENT TO THIS RULING
In a string of correspondence starting as far back as 29 June 2011, the respondent submitted new substantiation for the advertising and claims at issue. It also raised several issues or concerns relating to the ASA’s mandate, jurisdiction, capability and integrity. For the purpose of this ruling, however, these issues are irrelevant.

The respondent also claimed that the documentary evidence it is now relying on, was in its possession prior to publishing the advertisement at issue, as is required by the Code. It added that this “evidence” emanates from, inter alia, the Harvard School of Public Health, the Journal of American Medical Association and the British Medical Journal. Although the respondent attempted to have these published material deemed confidential, the Directorate rejected this request. Likewise other attempts to have the names of its experts kept confidential were rejected. Despite the Directorate advising the respondent of this, it confirmed that, other than documents initially market as “S1” and “S2”, it does not withdraw any of its other documentation.

In addition to this, the respondent relied on letters from a Dr Kratz, Professor Sarel F Malan, and Dr Clive Novis, arguing that these people are suitable and qualified experts in the relevant field to which the claims relate.

It also again relied, to some extent, on Dr Grossman’s verification, and advanced reasons as to why the Directorate should accept him.

COMPLAINANT’S COMMENTS
In keeping with procedure, the complainant was afforded an opportunity to comment on the evidence submitted by the respondent.

The complainant advised that she was no longer in possession of the original advertisement or her complaint, but added that the new evidence does seem substantially better. However, she made the point that there is still nothing to show that these supplements would prevent the onset of developing such eye diseases. In closing, she pointed out as follows:

“My primary concern is that the advert implies that all people should take this supplement from the age or 30 to 40 years. The significances in risk for different groups of the population suggests that some guidance should be given to helping people identify whether they in fact fall into a higher risk group (eg. family history). In this situation most of us do feel that taking this kind of supplement is a sensible measure to take”.

In commenting on the independence, credibility and expertise of the relevant experts, the complainant submitted that “Dr Clive Novis is a qualified ophthalmologist who is well respected in South Africa. I have no reason to question his credibility and expertise. I know of no reason to question his independence”. She added that she has no more information on the other sources than what was provided by the respondent.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the new substantiation the following clauses of the Code were taken into account:

• Section II, Clause 4.1 – Substantiation

• Section II, Clause 4.2.1 – Misleading claims

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

The initial ruling, inter alia, took issue with the respondent’s expert on the basis that he was not an expert in the field relating to eye care and more particularly degenerative eye diseases. When submitting new evidence, the respondent relied on more than one expert. For the sake of convenience, each expert will be discussed below:

To contextualise the matter, the Directorate had regard for the complaint initially submitted. Here the complainant took specific issue with, inter alia, the following claims:

“Everyday sunlight exposure causes a type of damage to the eyes known as macular degeneration” (arguing that the primary cause is genetic);

“This damage begins at a young age, even in childhood, but only manifests with reduced vision in old age” (arguing that medical research does not support this claim);

“You also need to begin supplementation with eye-protective nutrients from early adulthood” (arguing that there is no evidence that the respondent’s product will protect those people who are genetically predisposed, much less those who are not).

The primary question before the Directorate is therefore whether these claims are true for and whether the respondent’s product is efficacious against such damage.

Dr Clive Novis
It appears common cause between the parties that Dr Clive Novis is indeed an expert in the relevant field to which the claims relate. He is a qualified ophthalmologist, medical doctor and ophthalmic surgeon who specialises in cataract and laser surgery. The complainant agreed that he is well respected in South Africa and that she has no reason to question his credibility and expertise.

In his letter of verification, Dr Novis states:

“I have reviewed the contents of Solal Technologies advert and the product label for its Eyesight Protection Formula; and in my opinion the information contained within the advert is substantiated by the studies in the attached confidential Annexure E; the information contained in the attached article … and by those published in the medical literature …

I also wish to point out that Age Related Macular Degeneration (ARMD) does in fact affect all race groups albeit that the incidence thereof may differ from one race group to another”.

It is trite that substantiation has to be product-specific, rather than ingredient-specific. Effectively, what the Directorate requires is for an independent and credible expert to unequivocally confirm that the product, as is bought in the store, will deliver the claimed results when consumed at the recommended dose.

Furthermore, the manner in which the Directorate interprets substantiation and decides whether to accept or reject it has been the subject of a few appeals to the relevant higher committees within the ASA structures recently.

In Lifebuoy / Dettol / 14813 (27 August 2011), for example, 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, irrespective of whether or not such an expert has been accepted by the ASA before.

In another matter under reference A Vogel Neuroforce / S Kaye / 16323 (9 November 2011), the Advertising Standards Committee (the ASC) considered an appeal against a Directorate ruling which rejected an expert on the basis that he was not a suitable independent and credible expert in the field. Here the ASC emphasised the point that if an “expert” is ambivalent or ambiguous in his / her verification, it cannot be accepted.

Finally, in Clicks Slim Drops Herbal Tincture / HA Steinman / 17986 (24 October 2011), the Directorate made the following point:

“It is trite that the Directorate cannot accept ingredient based substantiation as adequate for an entire product, even more so when there is nothing to show that the levels of ingredients are adequately ingested at the recommended dose, and that the ingredients do not contra-indicate one another. In essence, what is required is unequivocal verification that the claims at issue are true for the product as a whole when used at the recommended …”

These rulings reaffirm the Directorate’s approach in requiring clear, unequivocal and product-specific verification.

Not one of the articles or study abstracts submitted by the respondent deal with, relate to, or even mention the respondent’s product. In addition, the findings or conclusions in the relevant research often relate to incidences of extensive sun-gazing and/or prolonged exposure to brightly illuminated environment (as opposed to everyday sunlight exposure). In some instances the exposure to light and its consequences were qualified to relate only to, for example “blue light exposure” and individuals with specific deficiencies in their dietary intake of specific vitamins and minerals. Some of the research articles also admit that large scale trials will be necessary before it can be stated with certainty that specific substances can reduce the incidence of ARMD and that lifestyle modification such as smoking cessation, reduction of alcohol consumption and the wearing of sunglasses may assist.

In keeping with the approach followed by the ASC and AIT in the A Vogel and Lifebuoy matters, along with the other rulings reflected above, the Directorate is not convinced that Dr Novis’ verification is sufficient. He has not addressed the concerns raised by the complainant insofar as genetic predisposition, early onset of the condition, or everyday sunlight exposure is concerned. In addition, he has not unequivocally confirmed that the respondent’s product will deliver on its implied efficacy. He merely states that the (unidentified) information contained in the advertisement is true. The leap of logic between his approval and the information contained in the evidence relied on by the respondent is not explained.

Accordingly, the Directorate is not satisfied that Dr Novis’ verification is adequate.

Prof Sarel Malan
As was pointed out earlier, part of the reasoning for rejecting the initial expert, Dr Grossman, was that he did not appear to be an expert in the relevant field.

While Prof Sarel Malan arguably qualifies as an expert pharmacist, this does not translate into being an eye care specialist. As previously noted, the advertising at issue relates to “The eye damage that causes vision loss …” and details how the respondent’s product can prevent “Age Related Macular Degeneration”.

There is nothing in Prof Malan’s CV that suggests that he has attained expert knowledge in this particular medical field.

Accordingly, the verification from Prof Malan does not appear to meet the requirements of Clause 4.1 of Section II and can therefore not be accepted.

Dr Richard P Kratz
Dr Kratz states as follows:

“Macular Degeneration is the leading cause of legal blindness. While there is no outright cure, dietary supplements have demonstrated their ability to lower the risk of developing macular degeneration. There is extensive medical literature in peer-reviewed journals supporting the use of supplements to slowing down the progression of macular degeneration.

I am familiar with this literature and the supplements listed in the SOLAL ‘Eyesight Protection’ product are cited in the medical journals …”

It is trite that the ASA requires unequivocal and product-specific verification for the claims made.

Dr Kratz merely expresses an opinion on this medical condition in general, and confirms that there is research on the issue to support the notion that supplements are of some use. He also explains that the “… supplements listed in the SOLAL ‘Eyesight Protection’ product are cited in the medical journals …”

This is not sufficient, and is a far cry from unequivocally verifying that the respondent’s product, when used at the recommended dose, will (as a matter of fact) deliver on the claims made in the advertisement. At best, Dr Kratz confirms that the concept of supplementation is regarded as beneficial, and that some studies have been conducted on the ingredients used by the respondent. He does not, however, deal with the actual claims, and does not comment on the respondent’s product or the concerns raised by the complainant on issues such as genetic predisposition or the question of early onset / use and everyday sunlight exposure.

For all the above reasons, the Directorate is not satisfied that Dr Kratz’s verification is adequate for the purpose of substantiating the claims made in the advertisement.

Dr Terry Grossman
In the previous ruling, the Directorate specifically explained why it was not satisfied with Dr Grossman. The respondent has not appealed that ruling, and instead attempted to convince the Directorate that it was incorrect in the first instance. This is not proper or permissible, as the Directorate is functus officio in this respect.

As a result, the Directorate is procedurally barred from considering Dr Grossman’s opinion in this instance.

In light of the above findings, the Directorate is of a view that the substantiation placed before it is still lacking, and therefore not acceptable.

In light of the above, the claims made in the advertisement remain unsubstantiated, and therefore in breach of Clause 4.1 of Section II. By virtue of this, the claims also remain misleading and in contravention of Clause 4.2.1 of Section II of the Code. The previous ruling therefore remains in effect, and the respondent is not allowed to use the advertisement or its claims.

,

No comments yet.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.