Posted 29 August 2011
Although this ruling is in my favour, it raises a few very pertinent aspects.
The substantiator is "Ms Allison Vienings from MRA Regulatory Consultants, an independent regulatory consultancy". "It added that Ms Vienings is a credible expert in the field of complementary medicine." "She added that sufficient documented evidence exists for the acceptance of the traditional use of hoodia as an appetite suppressor to claim that the product will suppress the appetite, thus resulting in a feeling of satiety which will prevent over eating and food cravings. Emphasis was placed on the fact that these claims should be (and in this instance are) made along with the statement 'Only effective when used in conjunction with a restricted or kilojoule controlled balanced diet'."
I have 6 major points to raise regarding this substantiation:
- Allison Vienings is Executive Head of SMASA (Self-Medication Manufacturers Association of South Africa) of which Clicks is a member. Can we expect her to be independent? Unlikely. For example, I laid a complaint with the ASA against Dischem for continuing to sell the scam product, Hoodia Slender Gel, in spite of repeated and numerous ASA rulings. The ASA wrote a long while ago to SMASA asking for further action. Dischem is a member of SMASA, and SMASA subscribes to the ASA code. According to my information, SMASA have not even had the decency to respond to the ASA. Clearly they have been delivered a hot potato and do not want to take action against a member.
- At what stage is a product still a traditional medicine? In this case, hoodia is ingested raw by the San people: can one still call it a traditional medicine once it is dried, pulverised, encapsulated?
- Similar to point 2 above, if the CSIR have documented the active compounds in raw hoodia, and these are absent from the dried product as in this case, can one still make traditional claims or efficacy claims for it?
- Surely one expects any pharmacist/doctor worthy of any credibility and having studied pharma 101 to know better? No actives = no efficacy.
- How can a "credible expert" argue that the claim "appetite suppressor" is valid if "these claims should be (and in this instance are) [are] made along with the statement "Only effective when used in conjunction with a restricted or kilojoule controlled balanced diet"! I scratch my …. in trying to understand how a restricted diet will validate a claim of appetite suppression? Bizarre. Inappropriate. Nonsensical.
- Knowing that there is insignificant levels of P57 and others in the Clicks Hoodia product compared to raw, has Allison Vienings opened herself up to be charged by the CPA? My understanding is that she has walked squarely into the quagmire.
Of course, I have previously pointed out that Allison Vienings substantiated Glomail Bioslim Fat Attack, a product that uses 200mg chitosan once a day to trap fat, which is physiologically baloney, and in particular when considered with the best research which showed that using 6,300 mg chitosan split over three meals a day, had a clinically insignificant effect. It is not that she may only have erred, but my arguments pointing this out and supporting my arguments with that from evidence from Natural Medicines Comprehensive Database did not dissuade her from standing firm on her pseudoscience.
Clicks Hoodia Appetite Regulator / HA Steinman / 17987
Ruling of the : ASA Directorate In the matter between:
Dr Harris Steinman Complainant(s)/Appellant(s)
Clicks Retailers (Pty) Ltd Respondent
25 Aug 2011
Doctor Steinman lodged a consumer complaint against packaging for Clicks' Hoodia Appetite Regulator.
The packaging states, inter alia, "Dietary Regulator" and that it "Helps to:
. Prevent over-eating
. Feel fuller for longer
. Control food cravings"
In essence, the complainant submitted that there is no proof that Hoodia has any efficacy at all and that the claims made require substantiation.
Furthermore, that the name Hoodia within the product name is misleading.
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 4.1 – Substantiation
. Section II, Clause 4.2.1 – Misleading claims
The respondent submitted correspondence from Ms Allison Vienings from MRA Regulatory Consultants, an independent regulatory consultancy. It added that Ms Vienings is a credible expert in the field of complementary medicine.
Ms Vienings elaborated on the historic situation in terms of regulating complementary and alternative medicines as well as traditional African medicines. She added that sufficient documented evidence exists for the acceptance of the traditional use of hoodia as an appetite suppressor to claim that the product will suppress the appetite, thus resulting in a feeling of satiety which will prevent over eating and food cravings.
Emphasis was placed on the fact that these claims should be (and in this instance are) made along with the statement "Only effective when used in conjunction with a restricted or kilojoule controlled balanced diet". Should a consumer follow this advice and follow a moderate exercise plan, weight loss will result.
Copies of chapters from supporting literature, or research articles were also submitted.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
Clause 4.1 of Section II states, inter alia, that an advertiser must hold documentary evidence to support all claims that are capable of objective substantiation. In addition, it clarifies that such documentary evidence shall emanate from or be evaluated by an independent and credible expert in the particular field to which the claims relate.
Clause 4.2.1 of Section II of the Code states, inter alia, that advertising should not contain any statement or visual presentation, which, directly or by implication, omission, ambiguity, inaccuracy, exaggerated claim or otherwise, is likely to mislead the consumer.
The packaging claims that the product "Helps" to, inter alia, "Prevent over-eating, Feel fuller for longer and control food cravings"
The respondent provided the Directorate with a report emanating from Ms Alison Vienings of MRA Regulatory Consultants. It added that Ms Vienings is a credible expert in the field of complementary medicine, which field is inclusive of slimming products as found in the matter Glomail Hoodia / Dr HA Steinman / 4522 (31 May 2006).
In this ruling the Directorate specifically accepted that MRA Regulatory Consultants qualifies as an independent and credible expert in the field to which the claims relate. There is nothing before the Directorate at present to cause it to deviate from its approach in the Glomail matter.
As such, the Directorate accepts MRA Regulatory Consultants as an independent and credible expert for the purposes of Clause 4.1 of Section II of the Code.
The only remaining question before the Directorate is whether or not the respondent adequately substantiated its claims in the manner required by Clause 4.1 of Section II of the Code?
The report from Ms Vienings of MRA states that regulatory authorities such as the European Commission: Directive on Traditional Herbal Medicinal Products, the United Kingdom's MHRA, the Australian TGA-etc. have recognised that the age-old traditional use of herbal plants/medicines has made it possible to reduce the need for clinical trials in so far as the efficacy of a medicinal product is plausible based on the basis of long standing use and experience. They allow the use of documented evidence to support efficacy or substantiate claims being made for a product.
She submits that the complainant is correct in noting that the active ingredient hoodia, does not appear in the Natural Medicines Comprehensive Database as it is classified with other traditional African medicinal plants. She further says, inter alia, "In my opinion sufficient documentation evidence exists for the acceptance of the traditional use of hoodia as an appetite suppressor, to claim that: according to traditional use the ingredient and hence the product containing the ingredient, Clicks Hoodia Appetite Regulator, will suppress the appetite, resulting in a feeling of satiety which will prevent over eating and control food cravings."
The Directorate notes that the reports from Ms Vienings relate to the ingredient contained in the product namely, hoodia. It is trite that the Directorate cannot accept ingredient based substantiation as adequate for an entire product. The Directorate can therefore not accept the substantiation submitted, as the Code requires unequivocal verification that is product specific.
In addition, the Directorate is mindful of the approach followed in Bioslim Fat Attack / Dr HA Steinman / 4740 (20 June 2006), where the Directorate also received substantiation that relied, inter alia, on the fact that the product must be used in conjunction with a diet. The Directorate ruled as follows:
"In Bioslim / Dr S Goldstein / 1122 (10 March 2005) the Directorate ruled, 'Every time the commercial makes a direct or indirect weight loss claim, the necessity of a kilojoule-controlled diet must therefore be communicated'.
In Perc Slimming / Dr H Steinman / 1679 (14 January 2005) the Directorate considered the packaging of a product which contained claims such as 'THERMOGENIC FAT-FIGHTER', 'Targets body fat', and 'Accelerated fat burners'. The Directorate ruled, 'Only one side panel carries the statement 'For optimum weight loss, a kilojoule-restricted diet with exercise is recommended.' There are no weight loss claims on the panel where this statement appears. It appears as if this statement is meant to qualify the efficacy of the product in relation to a kilo-joule restricted diet. The statement is, however, placed in such a way that it is divorced from the weight-loss claims. It is thus not made clear that the product is an aid for slimming in conjunction with a kilo-joule restricted diet'.
The advertiser in that matter appealed the Directorate ruling, and in Perc Slimming / Dr H Steinman / 1679 (10 March 2005) the Advertising Standards Committee (the ASC) ruled, 'MRA's substantiation can only be accepted in so far as it is clearly communicated that the product must be used in conjunction with a kilojoule controlled diet. The Committee is also of the view that in the limited instances where reference is made to use of the products in conjunction with a kilojoule controlled diet and/or exercise, this message has not been clearly and unambiguously conveyed to consumers' .
The principle established in the above rulings is that the consumer has to be clearly and unambiguously informed that the product only delivers the claimed results if it is used in conjunction with a kilojoule-restricted diet. The person purchasing the product should be made aware of this fact prior to purchase.
In the current matter, the relevant disclaimer only appears at the bottom of the back panel of the packaging under the ingredients list. Furthermore, on the bottom panel, it states, "Only effective when used as part of a kilojoule restricted eating plan and a regular exercise programme" (our emphasis), which contradicts the disclaimer and creates an ambiguous impression that the diet is not necessarily mandatory to achieve results.
In Perc Slimming / Dr H Steinman / 1679 (14 Jan 2005) the Directorate ruled, 'the target market for this product has an element of vulnerability to it.
Consumers search for a miracle weight loss product that does not require diet or exercise. In this context the conclusion that will be drawn from the packaging is that the product on its own will deliver the promised results, independent of a kilojoule controlled diet. For even better results one can diet, but this is optional'.
The product in question is similarly aimed at such consumers, and therefore all relevant facts need to be communicated to them unambiguously prior to purchase. The weight loss claims 'BIOSlim' and 'fat attack' appear on four of the six panels on the packaging, and the name 'fat attack' appears twice on the back, or fifth panel. The relevant disclaimer, however, only appears once at the bottom of the back, or fifth panel.
Given the above, the Directorate is not satisfied that the substantiation previously accepted applies in this instance. The weight loss claims are substantiated in the context of a kilojoule-restricted diet. In the advertising in issue, however, the claims are not clearly made in this context".
The significant principle established here is that if weight loss claims are claimed to be true on the basis that the product is used "in conjunction with a kilojoule restricted eating plan and a moderate exercise programme" as stated by MRA, the claims must appear in conjunction with such a notice (also refer Bioslim Meal Replacement / J Gardener / 4531 (17 March 2006) and Bioslim Once a Day / Gardener / 589 (8 March 2005) for additional explanation of why the disclaimer needs to appear whenever efficacy claims of this nature are made).
Form the examples of packaging submitted by the complainant, one can only see the front face of the packaging, which only contain the product name, and the efficacy claims, as well as an indication that there are 60 capsules in the box. No reference is made to the fact that these claims are only true when the consumer also follows a kilojoule restricted diet and moderate exercise programme. Given this, and in line with the principles established in the previous rulings referred to above, the Directorate cannot accept the substantiation at this time, because it does not accord with the likely communication to the consumer (being that the product on its own would deliver the claimed effects).
The fact that the disclaimer may appear elsewhere on the box or on the packaging insert at best serves to correct a misleading impression already conveyed by the front panel.
In light of this, the claims as they appear on the packaging at issue are currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code.
Given the above:
The claims "Helps to Prevent over-eating"; ". Feel fuller for longer"; and ". Control food cravings" must be withdrawn;
The process to withdraw the claims must be actioned with immediate effect on receipt of this ruling;
The withdrawal of the claims must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide;
The claims may not be used again in their current format.
The respondent's attention is drawn to Clause 15.5 of the Procedural Guide.
Given the above, it is not necessary to consider Clause 4.2.1 of Section II at this time.
The complaint is upheld.