Posted 03 July 2013
Kenza Health is selling the scam product, Biobust (a product that claims it can increase the size of a woman’s bust!). When the product, Crèche Guard Cough, Cold & Allergies Syrup was brought to my attention and I realised that it was a Kenza Health product, I wondered if this may also be a product that conflicts with scientific evidence, i.e., whether it may be a scam as well. So I evaluated the ingredients and compared it with credible databases of knowledge of “natural medicines”. As you will see below, this product is a mixture of herbs, and nonsense, extrapolating from evidence that don’t even exist.
Kenza Health then asks Dr David Nye, a homeopath who has supported a number of this products for which scientific evidence does not exist, in order to substantiate the product. The ASA summarises: “In most instances, Dr Nye expects the Directorate to “reasonably assume” efficacy of the various ingredients despite acknowledging in many instances that they are not present at the same levels as in the studies, and explaining that some ingredients are claimed to be effective based only on studies that were done in vitro (i.e. not tested on humans). In particular, he confirms that “Although there is no available evidence to demonstrate that the combination of ingredients can support the claims being made for the product, the sum of the indications of the ingredients does support the claims. There is no logical reason why this should not be extrapolated to the combination”.”
|Kenza Health / HA Steinman / 19189|
Ruling of the : ASA Directorate
In the matter between:
Dr Harris Steinman Complainant(s)/Appellant(s)
Kenza Health (Pty) Ltd Respondent
18 Jun 2013
Dr Steinman lodged a consumer complaint against the respondent’s advertising for “Crèche Guard Couth, Cold & Allergies Syrup”. The advertising was seen on the respondent’s website www.myhealth365.co.za/en/creche-Guard/23-creche-Guard-cough-cold-allergies-150ml.html.
It states, inter alia, that:
“Crèche Guard Cough, Cold & Allergies has been formulated with a range of herbal ingredients to assist the body to alleviate wet and dry coughs, soothe sore throats, and combat colds and flu”.
It further states, inter alia, as follows:
“Crèche Guard Cough, Cold & Allergies is a nutritional supplement that may assist the body to:
• For use in wet and dry coughs
• Help loosen mucus in the air ways
• Help alleviate upper respiratory tract infections
• Help shorten the duration of colds
• Help the body to fight allergies”.
“Has your child had any of the following symptoms?”
• Colds and flu?
• Sore throat?
• Runny Nose?
In essence, the complainant argued that the product claims that this combination of ingredients can benefit wet and dry coughs, help loosen mucus in the airways, help alleviate upper respiratory tract infections, help shorten the duration of colds, and help the body to fight allergies.
However, there is no evidence to support such claims, and using a dose this miniscule has no proven efficacy. When searching for evidence of efficacy, the complainant turned to the Natural Medicines Comprehensive Database, previously established as a reputable source of information on natural medicines. He argued that it is evident that there is no evidence that this combination of ingredients has any efficacy at all, i.e., no support that this combination of products will satisfy the claims being made for it.
The complainant added that he evaluated the claims for the individual ingredients, and found the following:
Pelargonium sidoides – Likely effective
Bronchitis: Several clinical studies show that adults and children with acute bronchitis, who take a South African geranium extract, starting within 48 hours of symptom onset, have significantly reduced symptoms compared to placebo after 7 days of treatment. This ingredient is rated as LIKELY EFFECTIVE for bronchitis, which the database defines as: “This product has a very high level of reliable clinical evidence supporting its use for a specific indication. Products rated “Likely Effective” are generally considered appropriate to recommend.” Insufficient reliable evidence to rate and preliminary clinical research suggests that taking a South African geranium extract can reduce symptoms of the common cold and produce complete resolution after 10 days of treatment, but not after 5 days of treatment
The complainant submitted that the Crèche Guard Pelargonium sidoides is not of the exact same composition/strength as that of the proven ingredient, EPs 7630.
Effectiveness: – Nil for claims listed.
Effectiveness: Nil for conditions listed
(It does make a claim for atopic dermatitis (eczema). Liquorice given orally in combination with 9 other herbs (Zemaphyte) might reduce redness and skin lesions in adults and children with nonexudative atopic eczema (12627,12628,12629). However, other research shows no effect (12630).
Effectiveness: Insufficient reliable evidence to rate.
Bronchitis. Preliminary clinical research suggests thyme, in combination with cowslip (Bronchipret), relieves symptoms of bronchitis such as coughing, fever, and increased production of sputum (13557).
Effectiveness: Possibly effective
Influenza: Clinical research shows that some elderberry extracts might reduce flu-like symptoms.
The complainant submitted that this ingredient is rated as POSSIBLY EFFECTIVE which the database defines as “This product has some clinical evidence supporting its use for a specific indication; however, the evidence is limited by quantity, quality, or contradictory findings. Products rated ‘Possibly Effective’ might be beneficial, but do not have enough high-quality evidence to recommend for most people.”
The complainant stressed that one has to consider the claims in relation to the dose being used. In the studies that appear to illustrate some efficacy, 600mg – 700mg of Sambucus nigra was administered daily. The recommended dosage on Crèche Guard is a mere 167mg per day, well below the dosage that was considered “Possibly Effective”.
In conclusion, the complainant argued that there is no evidence that this combination of ingredients can support the claims being made for it. There is “nil” evidence for two of the ingredients, with some potential evidence for one claim, but at much higher doses than used in this product. There is simply insufficient or no evidence to support all the claims being made for this product.
He therefore argued that many of the claims are untrue or exaggerated and that there is insufficient evidence to support the claims, as required by Clause 4.1 of Section II. Therefore consumers are being sold a product that may not be able to support the claims being made in order to induce consumers to purchase the product.
RELEVANT CLAUSE OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint Clause 4.1 of Section II (Substantiation) was taken into account:
The respondent correctly noted that the ingredient listing and dosages indicated do not constitute advertising in accordance with the ASA Code. The definition of “advertisement” in terms of Clause 4.1 of Section I clearly indicates that advertising refers to claims that are made by the manufacturer about the product with a view to influencing consumers to purchase the product. Reference was made to the ruling of the Directorate in Lowveld Favourites Juice / MA Paige / 18564 (31 October 2011).
In respect of the remaining claims, the respondent submitted an evaluation report from Dr David Nye. It added that the ASA has previously accepted Dr Nye as a suitable expert in the field of homeopathy and natural products and reference was made of Oscillococcinum / Z Joubert & Another / 18385 (30 July 2012) and there is no reason why Dr Nye should not be accepted as an expert in the current matter concerning a natural product. His CV and evaluation report was also submitted.
Other than highlighting Dr Nye’s findings, the respondent took the time to explain what type of evidence should be accepted by the ASA. It argued that “product specific” evidence, which the ASA requires, can either be research conducted on the marketed product, or an independent evaluation of the generic data on the “active” which needs to be extrapolated to the “active” in the marketed product in the same or greater concentration, assuming that the excipient design would have no influence on the efficacy of the “Active”. As motivation, it referred to a ruling in the matter Ultimate Sports Nutrition / University of Stellenbosch (18 August 2003) as well as a ruling in the matter Herbex Slimmers for Men / Dr H Steinman / 879. It is noted that the respondent did not indicate which date this ruling was made, but its submissions suggest it was the ruling dated 15 November 2005, which accepted Dr Sandell as an expert, and found the relevant claims to be substantiated based on Dr Sandell’s verification, which in turn was based on ingredient-based research on the “active” ingredients of the product. It pointed out that Dr Nye was appointed to act as independent arbitrator in the Herbex matter, and he agreed that the approach of relying on and accepting ingredient-based evidence on the “active” ingredient was appropriate.
The summary of Dr Nye submitted as follows:
“Before assessing each constituent of the product, it is relevant to consider the types of evidence available to us. D.L.Sackett, in his extensively cited article in the BMJ 1996, states that ‘Evidence based medicine is not restricted to randomised trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.’ and ‘if no randomised trial has been carried out…..we must follow the trail to the next best external evidence and work from there’ …”
The report further states, inter alia, that clinical trials (particularly well conducted trials) are not common. Therefore “… other sources of ‘evidence’ have to be scrutinized in order to obtain a balanced picture of the medicinal use of a particular herb”. Dr Nye summarises this “other” types of evidence as follows:
Traditional usage: If a herb has been safely used for generations within a particular culture, this provides valuable, empirical information. Many modern pharmaceutical drugs have not ‘stood the test of time’ in this manner. For example, Vioxx was found to have deadly consequences after being on the market for several years, in spite of passing rigorous clinical testing by the FDA.
With the recent establishment of the African Traditional Healers Council, the South African market will soon be exposed to a flood of untested traditional medicines, the clinical effects of which are largely based in folklore and tradition.
Common usage: If a herb has widespread usage in different cultures in many parts of the world, this too can provide valuable information, or “parallel evidence”. If different and widely separated cultures all employ the herb for the same or similar reasons, it is highly unlikely that this information is incorrect.
Anecdotal evidence: According to Wikipedia.org, anecdotal evidence has been defined in science as:
information that is not based on facts or careful study
non-scientific observations or studies, which do not provide proof but may assist research efforts
reports or observations of usually unscientific observers
casual observations or indications rather than rigorous or scientific analysis
information passed along by word-of-mouth but not documented scientifically
“Anecdotal evidence” can have varying degrees of formality. For instance, in medicine, published anecdotal evidence is called a case report, which is a more formalised type of evidence subjected to peer review. Although such evidence is not regarded as scientific, it is sometimes regarded as an invitation for more rigorous studies.
He then deals with the following ingredients by detailing their origin and efficacy: “Pelargonium sidoides tincture”, “Olea europea tincture”, “Glycyrrhiza glabra tincture, “Thymus vulgaris tincture” and “Sambucus nigra tincture”.
He concludes that:
“The evidence presented above for the individual ingredients supports the indications of the product, namely:
a. Alleviate wet and dry coughs
b. Help loosen mucus in the airways
c. Help alleviate upper respiratory tract infections
d. Help shorten the duration of colds
e. Help the body fight allergies
f. Soothe sore throats”.
In addition, he explains how Phytotherapists often combine herbs to obtain synergistic effects from such combinations through either Pharmacodynamic synergy or Pharmacokinetic Synergy. This allows for lower doses which still deliver efficacy.
He adds that “Although there is no available evidence to demonstrate that the combination of ingredients can support the claims being made for the product, the sum of the indications of the ingredients does support the claims. There is no logical reason why this should not be extrapolated to the combination” and concludes that:
“… the following advertised claims are substantiated and accurate for the product:
‘Crèche Guard Cough, Cold and Allergies Syrup has been formulated with a range of herbal ingredients to assist the body to alleviate wet and dry coughs, soothe sore throats and combat colds and flu’
‘Crèche Guard Cough, Cold and Allergies Syrup is a nutritional supplement that may assist the body to:
For use in wet and dry coughs
Help loosen mucus in the air ways
Help alleviate upper respiratory tract infections
Help shorten the duration of colds
Help the body to fight allergies’.
‘Has your child had any of the following symptoms?
Cold and flu?
Runny nose?’ …”
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
Clause 4.1 of Section II specifies that advertisers must hold in their possession acceptable proof that either emanates from, or was evaluated by an entity that is regarded as an independent and credible expert in the field to which the claims relate. It is also trite that substantiation should relate to the product being advertised, when consumed at the recommended dose, as this is ultimately what the consumer purchases and how it is applied.
The respondent, however, made much of the fact that the Directorate has created an expectation that ingredient-based substantiation could and should be accepted in instances where an independent and credible expert verifies the claims based on such evidence. The Directorate, however, does not agree.
Firstly, it should be noted that the examples relied on are not entirely accurately interpreted by the respondent. In Ultimate Sports Nutrition / University of Stellenbosch (18 August 2003), the Directorate ruled as follows:
“The Directorate notes that the respondent submitted published research on CLA. The Directorate would like to point out that the research appears to relate to the benefits of CLA as a generic substance and not to the respondent’s product specifically. No published material pertaining specifically to the respondent’s product was submitted in support of the claims made.
In addition, the respondent submitted documentation from Chemiphos pertaining to research conducted on the ingredients of the respondent’s products and research conducted on CLA. This documentation also appears to relate to research conducted on the benefits of the individual ingredients used as generic substances in the respondent’s products [by implication this documentation is also inadequate as it does not relate to the respondent’s product].
Clause 4.1 of Section II requires that the documentary evidence should emanate from or be evaluated by a person/entity, which is independent, credible, and an expert in the particular field to which the claims relate. The Directorate requested the respondent to submit the research documentation from Chemiphos to a person or entity which is independent, credible and an expert in the particular field to which the claims relate, and in doing so, have the relevant claims independently verified. The respondent failed to submit such verification. [at best, this suggests that the Directorate would be willing to consider this evidence IF it was independently verified. This does not automatically imply that the Directorate would have accepted it]
The Directorate concludes from the respondent’s submissions that the claims made in the advertisement appears, ex facie, to be neither substantiated by research conducted on the respondent’s products specifically, nor independently verified by an expert in the particular field to which the claims relate. The advertisement is therefore in contravention of Clause 4.1 of Section II”.
The portions of material importance are:
“… The Directorate would like to point out that the research appears to relate to the benefits of CLA as a generic substance and not to the respondent’s product specifically. No published material pertaining specifically to the respondent’s product was submitted in support of the claims made”. Clearly this was highlighted as a problem by the Directorate, yet the respondent appears to ignore this.
“… This documentation also appears to relate to research conducted on the benefits of the individual ingredients used as generic substances in the respondent’s products”. Again, by making this point, it suggests that this documentation was also regarded as inadequate, as it does not relate to the respondent’s product, and the Directorate could therefore not simply assume that it would apply similarly and appropriately to the respondent’s product.
“… The Directorate requested the respondent to submit the research documentation from Chemiphos to a person or entity which is independent, credible and an expert in the particular field to which the claims relate, and in doing so, have the relevant claims independently verified. The respondent failed to submit such verification”. At best, this suggests that the Directorate would be willing to consider this evidence IF it was independently verified. This does not automatically imply that the Directorate would have accepted it, and certainly does not suggest that this would have remedied the previous two concerns highlighted.
Insofar as the Herbex ruling is concerned, it should be noted that a recent ruling (refer Herbex Appetite Control Tablets / HA Steinman / 20993 (2 April 2013) for details) found that the Directorate would no longer accept Dr Sandell as an expert. This was predominantly because of comment from the Allied Health Professions Council that “The AHPCSA is further of the opinion that since Dr Sandell is not, nor ever was, registered as a phytotherapist (herbal practitioner), he is not qualified to comment on herbal preparations since these would also not have formed part of his legal scope of practice”. Dr Sandell had also submitted ingredient-based verification as opposed to product-specific substantiation.
The finding relates to the “expertise” portion of the Code’s requirement for verification from an independent and credible expert. Until receiving the AHPCSA letter, it would appear that the ASA never contemplated whether or not Dr Sandell was a “phytotherapist” or herbal practitioner. It is possible that at the time the Directorate was not aware that such a distinction existed or that it would be relevant. When the AHPCSA expressly pointed out that he was not, and was accordingly not “… qualified to comment on herbal preparations since these would also not have formed part of his legal scope of practice”, the Directorate pointed out that the Herbex product was a herbal preparation, which would presumably require (at least) express verification from a herbal practitioner, or phytotherapist.
Clause 4.1 of Section II of the Code expressly requires verification from an independent and credible expert “… in the field to which the claims relate …” Based on the AHPCSA letter, it appeared that Dr Sandell was not an expert “… in the field to which the claims relate …”
While the Directorate accepts that the Herbex finding has since been appealed, the fact remains that at present, it does not serve the respondent’s purposes. More importantly, Dr Sandell had also submitted ingredient-based verification as opposed to product-specific verification. Given that his suitability as an expert has since been questioned, this tendency to submit ingredient-based evidence is arguably also in question.
In recent times, the Directorate has had to refine its approach on substantiation to an extent that it is compelled to critically evaluate the evidence submitted, and satisfy itself of the accuracy thereof. In Lifebuoy / Dettol / 14813 (27 August 2011), the Advertising Industry Tribunal (the AIT) specifically made the point that the Directorate has to interrogate the substance of the evidence provided and that of the expert relied on, and should not blindly accept the say-so of an expert (even if the standing of the expert is not in question).
The respondent has not submitted any of the studies or literary texts relied on (which already poses a problem for the Directorate, as it cannot satisfy itself that the results of these studies appear to correlate with what Dr Nye is saying). In a recent ruling by the Final Appeal Committee (the FAC), the point was again made that the ASA cannot simply take judicial notice of everything an expert says without interrogating the substance. The FAC specifically noted that:
“The requirement of credibility must, as a matter of common sense, go both to the person tendering the evidence and to the evidence itself. So not only must the person who evaluates the evidence be credible but the documentary evidence proffered must on its own terms be plausible and provide reasonable grounds for believing the statement made in the advertisement. If documentary evidence does not provide reasonable grounds for believing the advertising claim, it will not meet the standard set in clause 4.1.4”.
In most instances, Dr Nye expects the Directorate to “reasonably assume” efficacy of the various ingredients despite acknowledging in many instances that they are not present at the same levels as in the studies, and explaining that some ingredients are claimed to be effective based only on studies that were done in vitro (i.e. not tested on humans). In particular, he confirms that “Although there is no available evidence to demonstrate that the combination of ingredients can support the claims being made for the product, the sum of the indications of the ingredients does support the claims. There is no logical reason why this should not be extrapolated to the combination”.
In Slimbetti Active Xtreme / R Jobson / 20982 (28 February 2013), evidence (also verified as accurate by Dr Nye) was rejected on, inter alia, the following grounds:
Unlike what was the case in the Oscillococcinum matter referred to by the respondent, the research and articles relied on in the Slimbetti matter did not relate to the product as a whole, but only to some of its ingredients. This is also the case here,
Dr Nye admitted that no studies had been done on the combined efficacy (if any) of the two main ingredients (which appeared to be the “active” ingredients), which again negated any argument of having product-specific substantiation.
In addition to the reservations the Directorate holds over the applicability of the substantiation, it is further noted that the ruling in the matter Solal Breast Protection Formula / R Jobson / 18707 (15 February 2012), the Directorate discussed at length why it requires product-specific evidence as opposed to ingredient-based and/or anecdotal evidence. The point was made that advertisers market their products by name, and encourage consumers to purchase such products (not the individual ingredients) and consume the product at a specific dose, with an overwhelming impression that the product has been proven to work. The Directorate also pointed out that substantiation is required to have “market relevance”, and in order to do this, the product, as a whole, as sold in the market, needs to have been proven effective. After listing examples where this approach was affirmed and reaffirmed (dating back to 2003), the Directorate noted that:
“The reason for adopting a product-specific approach rather than an ingredient-based one is self-evident: Medicinal products (including such products collectively known as complementary and alternative medicines) 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. In general, the ASA does not concern itself with regulatory requirements to the level that the Department of Health or MCC would. The ASA can only consider whether or not the claim made for such products are substantiated, or potentially breach any of the other relevant provisions of the Code”.
From the above, it becomes clear that the substantiation is not acceptable for the following reasons:
The respondent did not submit any of the studies or literature relied on by the Dr Nye (meaning that the Directorate cannot satisfy itself that these corroborate what Dr Nye is saying),
The respondent and Dr Nye conceded that no test results exist for this product as a whole as sold to the public and at the recommended dose,
The respondent and Dr Nye indicated that there is no evidence to prove as a matter of fact that the combination of ingredients as is done for this product will deliver the claimed results. Effectively, the ASA is asked to “reasonably assume” that this is the case.
Given the above, the Directorate does not accept the substantiation relied on by the respondent, and accordingly finds the claims unsubstantiated and in contravention of Clause 4.1 of Section II of the Code.
In light of the above finding, the respondent is required to:
withdraw the disputed claims in their current format;
action the process to withdraw these claims with immediate effect on receipt of the ruling;
complete the withdrawal of the claims within the deadlines stipulated by Clause 15.3 of the Procedural Guide; and
refrain from using the claims again in their current format unless new substantiation has been submitted, evaluated, and accepted by way of a subsequent Directorate ruling.
The complaint is upheld, and the respondent’s attention is specifically drawn to the provisions of Clause 15.5 of the Procedural Guide, which requires offending claims to be removed from any media in which they appear.