18 January 2013
A complaint was laid against Créche Guard Cough arguing that there is no evidence that this product has any effect on ill children.
However the complaint was badly composed and therefore “. . . the Directorate has to decline to rule on the question of the efficacy of the respondent’s product at this time.”
Following the text of the ASA ruling, the scientific argument pointing out why this product is unlikely to have any benefit on ill children, has been added (and a new complaint laid with the ASA)
3 July 2013: Update: Results of the ASA ruling which confirms my contention that there is no proof that the ingredients, or this product, has ANY benefit.
|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
07 Jan 2013
Dr Steinman lodged a consumer complaint against online advertising promoting the respondent’s “Créche Guard Couth, Cold & Allergies Syrup”. The advertising was seen on the respondent’s website www.myhealth365.co.za.
It states, inter alia, as follows:
“Créche 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”.
In addition to this, it contains an image with the wording “SCIENTIFICALLY PROVEN OLIVE LEAF is natures’ [sic] anti-biotic”, and a link to an extract of a study published in the “International Journal of Antimicrobial Agents” in 2008.
The complainant submitted that an ordinary consumer would interpret the reference to “nature’s anti-biotic” to mean that the product will work as a general antibiotic. In addition, the abstract does not clearly communicate to an uninformed consumer that the olive lead extract referenced was only somewhat effective against organisms that are not responsible for coughs, colds, flu or allergies, and ineffective against nearly two-thirds of organisms tested. He also noted that the research was done in a laboratory, and not in humans.
He explained that this advertising is not only misleading, but potentially dangerous, as the product may possibly suppress the growth of normal, necessary microbes, resulting in an overgrowth of unwanted pathogenic microbes, resulting in disease.
With regards to a statement that “[A]ll brand names are trade marked and the individual products have MCC certificates and NAPPI (claimable from medical aid) codes”, the complainant argued that this is misleading as it implies MCC registration, which is not the case. At best, the respondent has a receipt of application for registration.
He added that the respondent should substantiate that the syrup as a whole is effective against coughs, cold and flu, and noted that, to the best of his knowledge, none of the ingredients listed have any efficacy for “allergies” as claimed. This also means that the name of the product is potentially misleading.
Finally, he referred to the fact that the respondent is continuing to market its BioBust product despite having received several adverse rulings on the basis that there is no substantiation for its efficacy, and asked for sanctions to be imposed.
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 4.2.1 – Misleading claims
• Procedural Guide, Clause 14 – Sanctions
The respondent submitted that it is rather difficult to surmise the grounds of complaint as raised by the complainant. It also noted that the Directorate did not identify Clause 4.1 of Section II (Substantiation) as relevant.
It noted that the complainant has not set out any basis for disputing the conditions with which the product is claimed to possibly assist with. Similarly, the allegation that the product is potentially dangerous (based on the presumption that microbial growth might be suppressed) is pure speculation, and irrelevant for the purpose of this dispute.
Insofar as the reference to olive leaf extract as “nature’s antibiotic” was concerned, it stated that “It has never been Kenza’s intention to imply that the product is a ‘general antibiotic’, and to ‘confuse’ consumers as the efficacy of the product, and the website will be amended accordingly …”
Insofar as the research abstract is concerned, it pointed out that there is no claim that the research was “clinical”. Scientific methods encapsulate more than only clinical trials, and even the MCC accepts evidence other than clinical data. Similarly, the ASA Code does not call for clinical data or trials. It does not believe that a reasonable person would interpret the abstract to relate to clinical trials as the complainant does.
The respondent added that the Directorate has previously established that the complainant is not permitted to lodge allergy-related claims, given his vested interest as a consultant to the Department of Health on allergy-related matters (refer Glomail Health Hoodia / HA Steinman / 9299 (5 October 200) for example). Arguments were also made as to the efficacy of liquorice against allergies.
Insofar as the potential to mislead consumers about the status of its products in terms of MCC registration was concerned, it denied any intention to mislead, thanked the complainant, and confirmed that the website would immediately be amended to address this.
Finally, in relation to the request for sanctions, it noted that this was the first complaint against its Créche Guard product. The references to BioBust rulings are of no consequence, as the Directorate held in 2008 that no sanctions were warranted. The two subsequent breach allegations by the complainant were dismissed, and this submission is merely indicative of the complainant’s harassment, rather than the respondent’s disregard for the Code.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
The respondent referred to a prior ruling wherein it was ruled that the complainant should not be permitted to lodge complaints relating to allergies.
In Glomail Health Hoodia / HA Steinman / 9299 (5 October 2007), the Advertising Standards Committee noted as follows:
“The Directorate has previously established that the complainant has a vested interest in matters pertaining to the regulations for labelling of foodstuffs and allergy-related claims made for products. As such, the complainant is precluded from lodging complaints of this nature”.
Upon investigation the Directorate also notes that Liqui Lean / DR H A Steinman / 4332 (30 August 2006), states:
“It is noted in this regard that the ASA has previously noted that it will not accept allergy related complaints from the complainant …
… The Directorate has previously established that the complainant has a vested interest in matters pertaining to the regulations for labelling of foodstuffs and allergy-related claims made for products. As such, the complainant is precluded from lodging complaints of this nature”.
This approach was again applied in the matter Alcat Test / HA Steinman / 12001 / 12307 (11 March 2009), and the Directorate refused to entertain the complaint, which at that point related specifically to allergy-related claims. However, the complainant appealed the decision to the Advertising Standards Committee (the ASC), who in turn ruled:
“Although the Appellant runs a consultancy business and provides services as a consultant to Phadia and other entities, which may be competitors to the Respondent, there is no information before us to suggest that he lodged the complaints in the course of his work on behalf of any of these entities or that he stood to be financially compensated for having lodged the complaints. Neither was it shown that as a result of him lodging the complaints, he stood to be rewarded with further consultancy work that he might not otherwise have obtained.
There of course may be instances where the evidence shows that an individual consumer is so closely associated with a commercial entity that s/he clearly stands to gain financially from pursuing a complaint with the ASA. But we do not believe on the evidence presented to us, that this is one of them. All that has essentially been shown in respect of his relationship with competitors is that the Appellant writes reviews for and edits in house allergy publications for some of them on an independent consultancy basis. It has not been shown, for example, that his relationship with any of them is dependent upon or predicated upon the Appellant’s views about and / or advocacy against the ALCAT test.
While the Appellant, as a result of his qualifications, expertise and involvement in the field is set apart from the average consumer and may even have a strong personal interest in the matter, this does not necessarily make him a commercial competitor. There is a distinction between a ‘consumer advocate’ or an ‘expert consumer’ and a commercial competitor acting in pursuit of a commercial interest in lodging a complaint. While a consumer advocate may pursue a personal or public cause when lodging a complaint s/he does not necessarily act in pursuit of commercial gain. Competition for commercial gain on the other hand lies at the heart of the concept of commercial competitors. It is because competitors are by and large corporate entities who are pursuing commercial interests when lodging complaints that a fee attaches to competitor complaints. Individual consumers whether acting in their own (non-commercial) personal interest or in the public interest should not be discouraged from lodging complaints because they are required to pay a fee which they very often will not be able to afford. This would be contrary to the very purpose of the Code which is to provide an accessible mechanism to the public to protect them against unscrupulous advertising.
We therefore uphold the appeal and overturn the Directorate’s ruling. The complaints are to be dealt with as consumer complaints”.
It would therefore appear that the complainant is not precluded from lodging any allergy-related complaints provided that he has no direct, or indirect commercial interest in the outcome of such a complaint.
The respondent has not put anything before the Directorate to show that the complainant stands to benefit commercially from a decision in this matter, and as such, the Directorate is bound by the ASC ruling in the Alcat Test matter to consider this as an ordinary consumer complaint.
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 may, at the discretion of the ASA, be accepted without considering the merits of the matter.
The respondent undertook to amend its advertising in relation to the claims “… OLIVE LEAF is natures’ [sic] anti-biotic” and “… the individual products have MCC certificates …”
This appears to address the concerns raised in terms of these claims, and the Directorate therefore, at its discretion, accepts these undertakings on condition that the claims as disputed are removed within the deadlines stipulated in Clause 15.3 of the Procedural Guide, and is not used again in future.
The complainant argued that the information contained under the heading “Antimicrobial activity of commercial Olea europaea (olive) leaf extract” does not explicitly inform a consumer that:
The organisms against which this extract had some efficacy do not cause colds, coughs, flu or allergies, or that the extract had very little activity against nearly two-thirds of all organisms tested, and
The research was conducted in a laboratory and not on humans.
The Directorate accepts that an average consumer might not have the scientific know-how to decipher all the information in the manner that the complainant (a trained medical expert) could. However, it should be noted that the respondent has not interpreted the material or paraphrased it in any manner for consumers. This is significant in that it means that the information contained is as it appears in the actual research, and the respondent has not ex facie put any “spin” on it.
In Crown Relocations / Elliott International / 11358 (29 July 2008), the Directorate considered a print advertisement claiming, “Voted Best Moving Company in South Africa … Focus on Excellence Awards 2007”. The respondent submitted that its claims were based on the award for “Best Removals Company” that it received from Charmont Media’s FOCUS on transport and logistics magazine, as part of the publication’s “Focus on Excellence Awards” for 2007. The complainant did not dispute this fact. It argued, however, that the research was inadequate for the claim being made. In dismissing the complaint, the Directorate held, inter alia:
“The research on which the award was based appears to have been commissioned by the relevant publication, not by the respondent. From what is before the Directorate, it appears that the respondent is the bona fide winner of the relevant publication’s award for ‘Best Removals Company’.
In addition, the print advertisement qualifies the claim ‘Voted Best Moving Company in South Africa’, by stating that the claim relates to the Focus on Excellence Awards. A hypothetical reasonable person therefore has the option of deciding whether the award referenced is reliable and significant or not. The respondent cannot logically be penalised for relying on what still appears to be a valid accolade.
Accordingly, any issue that the complainant has with the methodology and findings of the survey must be addressed with the publication…”
The significance of this finding is that the Directorate can accept that any interested consumer could establish for him or herself whether or not they believe the study reflected holds any significance. In the absence of any interpretation from the respondent, and any claims that appear to attach greater value to this study than what is pertinently stated, the Directorate cannot find that this abstract is misleading for the reasons advanced by the complainant.
The Directorate also agrees with the respondent that the comments about the product potentially being dangerous appear to be based on speculation and assumption, rather than any actual facts.
For all the above reasons, the Directorate does not share the complainant’s view that the article is misleading for the reasons advanced in the complaint. The abstract is therefore not in contravention of Clause 4.2.1 of Section II.
The respondent correctly noted that the Directorate did not call on it to supply substantiation in accordance with Clause 4.1 of Section II of the Code (Substantiation).
While true that the complainant did refer to and requested the respondent to supply substantiation for “… the claims made for each of the other components in the doses listed and also … that the syrup as a whole is effective against each of the indications: coughs, colds and allergies”, the complainant has not explained on what basis, if any, he believes that the respondent does not hold such substantiation.
In Nature’s Choice Products / Mc Cain Foods / 16283 (12 November 2010), the Directorate was faced with a similar bland allegation. It ruled as follows:
“The complainant did not clarify why it thought the claims in the respondent’s website were unsubstantiated, misleading and dishonest. The complainant simply submitted that the ASA should call upon the respondent to submit substantiation for its claims and furnish reasons why its claims do not contravene Clauses 2 and 4.2.1 of Section II of the Code. This is akin to alleging that someone had committed theft and then asking the court, in the absence of evidence, to compel the accused to prove that he did not commit such a crime.
Not only does such an approach go against the principles of natural justice, but it effectively precludes the Directorate from investigating the matter and ruling because there are no grounds of objections”.
There is nothing to show that the complainant has a basis for alleging that the respondent has not complied with the provisions of the Code.
Given the requirements for clear and concise grounds in the Code, and in keeping with the approach followed in the Nature’s Choice ruling referred to above, the Directorate has to decline to rule on the question of the efficacy of the respondent’s product at this time.
Given the respondent’s undertakings, and given that the complaint was dismissed, the Directorate does not believe it would be appropriate to consider sanctions at this time.
Subsequent ASA complaint
09 January 2013
On the Crechguard website (http://myhealth365.co.za/en/creche-gaurd/23-creche-guard-cough-cold-allergies-150ml.html) (accessed today), the following claims are being made:
Créche 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 & flu.
Créche 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?
The product contains the following ingredients:
Pelargonium Sidoides Tincture 151.9mg
Olea europaea Tincture 89.9mg
Glycyrrhiza Glabra Tincture 198.4mg
Thymus Vulgaris Tincture 55.8mg
Sambucus Nigra Tincture 55.8mg
2 – 4 years: 1.5ml 3 x per day
4 – 6 years: 2.5ml 3 x per day
6 – 12 years: 5ml 3 x per day
In essence, the product claims that this combination of ingredients can among other, benefit wet and dry coughs, help loosen mucus in the air ways, help alleviate upper respiratory tract infections, help shorten the duration of colds, and help the body to fight allergies.
The question is whether there is any evidence to support the claims being made for this product, whether there is in fact evidence but the company is using a dose that is miniscule and has no efficacy, and whether consumers can reasonably expect to have the claims being made by this product, satisfied.
Clause 4.1 of Section II of the ASA’s Code states “Before advertising is published, advertisers shall hold in their possession documentary evidence as set out in Clause 4.1, to support all claims, whether direct or implied, that are capable of objective substantiation.”
“Documentary evidence, other than survey data, shall 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 and be acceptable to the ASA”.
I argue that this product cannot substantiate the claims being made for it, and therefore misleads consumers.
For evidence, I turned to the Natural Medicines Comprehensive Database, previously established as a reputable source of information on natural medicines.
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.
I therefore evaluated the claims for the individual ingredients. I have copied and pasted the relevant data below (the full overviews accompany this submission).
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. A specific liquid extract of South African geranium has been used (Umckaloabo, EPs 7630, Dr. Willmar Schwabe Pharmaceuticals, Germany) in most studies (14258,16641,16647,16649,16651). Some studies have also used extracts in tablet form; however, these tablet formulations have only been shown to be beneficial in adults, not in children (16641,17417).
INSUFFICIENT RELIABLE EVIDENCE to RATE
Common cold. 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 (16641).
Sinusitis. Preliminary clinical research suggests that taking a South African geranium extract can reduce symptoms of sinusitis and increase the chance of complete resolution after 21 days of treatment by 57% (16641).
More evidence is needed to rate South African geranium for its other uses.
This ingredient is rated as LIKELY EFFECTIVE which the database states “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.”
The dose EPs 7630 is for acute bronchitis, a specific extract of South African geranium (Umckaloabo, EPs 7630, Dr. Willmar Schwabe Pharmaceuticals, Germany) administered as 30 drops of solution three times daily (about 4.5 mL) or 10-30 mg tablets three times daily (30-90 mg/day) for 7 days has been used
However, Crecheguard uses Pelargonium Sidoides Tincture at 51.9mg per 5 ml = 456 mg per day.
I submit that the Crecheguard Pelargonium sidoides is not of the exact same composition/strength as that of the proven ingredient, EPs 7630, and if in fact can be shown to be the same, that the only claim that can be made is efficacy against bronchitis.
Effectiveness: – Nil for claims listed
Effectiveness: Nil for conditions listed
(It does make a claim for atopic dermatitis (eczema). Licorice 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).)
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).
Influenza. Clinical research shows that some elderberry extracts might reduce flu-like symptoms. A specific syrup formulation of elderberry fruit extract (Sambucol, Nature’s Way) 15 mL (1 tablespoon) 4 times daily seems to reduce the symptoms and duration of influenza infection when given within 48 hours of initial symptoms. Significant symptom relief seems to occur within 2 to 4 days of treatment for most patients (5260,12235). On average, this elderberry extract seems to reduce the duration of symptoms by about 56% (12235).
In another preliminary clinical study, a specific elderberry extract lozenge (ViraBLOC, HerbalScience) 175 mg taken 4 times daily for 2 days, starting within 24 hours of initial symptoms, significantly improved flu-like symptoms compared to placebo. Substantial symptom relief occurred within 48 hours for most treated patients (17022).
This ingredient is rated as POSSIBLY EFFECTIVE which the database states “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.”
However, one has to consider the claims in relation to the dose being used.
Using the maximum dose, i.e., for the oldest children (6 – 12 years: 5ml 3 x per day), it is evident that Crecheguard does not utilise the same dose as the proven ingredient Sambucol, Nature’s Way or ViraBLOC, HerbalScience.
For Sambucol, Nature’s Way, the 100 mg of Sambucus nigra is found in 10 ml of Sambucol.[i]
Recommended dose 15 mL 4 times daily = 60ml.
Therefore Sambucus nigra of 600mg per day is used to claim “Possibly Effective“
For ViraBLOC, HerbalScience 175 mg taken 4 times daily.
Therefore Sambucus nigra of 700mg per day is used to claim “Possibly Effective“
Crechegaurd dosage is 6 – 12 years: 5ml 3 x per day = 15 ml = 3 x 55.8mg = 167 mg per day.
It is therefore evident that:
I therefore argue that the claims are not only exaggerated, but in fact there is insufficient evidence to support the claims, as required by Clause 4.1 of Section II and that therefore consumers are being sold a product that may not be able to support the claims being made for it – a reason for consumers to purchase the product.