Posted 27 October 2011
This ruling is interesting for it brings up the issue of "scientific substantiation", "conflict of interest*", "recusal", and "a pharmacist's ethics" very clearly.
I find it unfathomable and unconscionable that Ms Allison Vienings has yet again attempted to substantiate a highly dubious product (albeit unsuccessfully) on an ingredients basis and not "whole product" basis.
Allison Vienings is a paid-up registered pharmacist with the SA Pharmacy Council and the Executive Director of the SMASA (Self Medication Manufacturers Association of South Africa).
Although Clicks is not a member of SMASA, other companies selling similar unsubstantiated medicines, e.g., Dischem, are. Therefore this can be seen as a conflict of interest. Should she not, ethically, have recused herself and not have accepted the "assignment" from Clicks to substantiate the product? Should she not at least have notified the ASA of a possible conflict of interest?
Furthermore, SMASA states unequivocally that "[S]elf-medication is the treatment of common health problems with medicines especially designed and labeled for use without medical supervision and **approved as safe and effective for such use**. http://www.smasa.cc/standardpage.php?sitecontentid=8&menuid=61&title=Overview [my emphasis]
The question is "approved (as safe and effective) by whom? and on what basis?
What is also interesting is that the "applicant" referred to in the ruling "More to Life Health (Pty) Ltd" also submitted information to substantiate the claims. If "applicant" means applicant in terms of the complementary medicines call up, it is bizarre that a non-scientific body such as the ASA, simply using logic and "common sense" could see through the non-validity of the applicant's arguments. Why did the MCC not do so at the time of the "application". If the term "applicant" refers to something else, I apologise,
What is also of interest is that More to Life Health (Pty) Ltd is the manufacturer and marketer of the Patrick Holford range in South Africa: products that are also unsubstantiated. www.holforddirect.co.za (subsequently "site under construction") However a facebook page confirms this relationship: http://www.facebook.com/holforddirect?sk=info although the More to Life Health website does not include either the Holford range or Clicks Slim Drops Herbal Tincture. (Holford products are available at both Clicks and Dischem.)
It is hard to know what is the most unethical conduct: Allison Vienings for substantiating the product (surely she knew that her report was scientfically inadequate); or Clicks for selling it knowing that it could not meet up to its claims; or More to Life Health (Pty) Ltd for submitting administrative details to the MCC (if they did); or Dischem (who caringly) sell the Holford range.
Ruling of the : ASA Directorate In the matter between:
Dr Harris Steinman Complainant(s)/Appellant(s)
Clicks Retailers (Pty) Ltd Respondent
24 Oct 2011
Doctor Steinman lodged a consumer complaint against packaging for Clicks’ “Slim Drops HERBAL TINCTURE”.
The front facia of the packaging states, inter alia, as follows:
“Weight Loss Support
A complimentary medicine that helps to:
• Increase energy to burn fat
• Control appetite”
The wording “A complimentary medicine to assist weight loss through a healthy slimming programme. Only effective when used as part of a kilojoule restricted eating plan and a regular exercise programme” appears on the side and towards the bottom of the back panel, below the “COMPOSITION” and “DOSAGE AND DIRECTIONS FOR USE”, “WARNING”, and “STORAGE INSTRUCTIONS”.
In essence, the complainant submitted that the name of the product, as well as the claims made on its packaging (that the product offers “Weight Loss Support”, “Increase[s] energy to burn fat” and “control[s] appetite” are misleading for there is no evidence in terms of the Code that the claims are possible.
The complainant pointed out that the highly regarded Natural Medicines Comprehensive Database, which is often used by practitioners of complementary medicine does not lend any credence to these claims for the individual ingredients or for the combination of ingredients.
RELEVANT CLAUSE OF THE CODE OF ADVERTISING PRACTICE The complainant identified Clause 4.1 of Section II (Substantiation) of the Code as relevant.
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. In addition, it submitted a response from the applicant of the product, More to Life Health (Pty) Ltd.
Ms Vienings elaborated on the historic situation in terms of regulating complementary and alternative medicines in South Africa by the Medicines Control Council. She added that in the light of lack of guidance from MCC which the only body that is legally empowered to asses and comment on the quality, safety and efficacy of a medicine, account must be taken of all the available examples to evaluate the ingredients and claims for complementary medicines fairly. She also stated that nowhere on the packaging where it is claimed that the product on its own would result in weight loss. She referred to an article that was published in the 17 November 2006 issue of The New England Journal of Medicine titled “Combining Lifestyle Modification and Diet Pills May Help Weight Loss” as proof that the weight loss claims for a product should be acceptable if qualified by the emphasis that such product is “Only effective when used as part of a kilojoule restricted eating plan and a regular exercise programme.
Ms Vienings also submitted copies of chapters from supporting literature, or research articles. She effectively argued that the product contains ingredients which have been documented to increase the metabolic rate, which results in fat being broken down into energy and ingredients that provide for optimal insulin function and increase post-meal satiety.
The respondent also submitted correspondence from Mr Tony Hicks, the applicant for the product in question, and the founder and Director of More to Life Health (Pty) Ltd. Mr Hicks effectively points out what Ms Vienings has to say, and emphasises that the product is not sold as, or claimed to be able to result in weight loss on its own. There is clear mention that it is only effective when used “… as part of a kilojoule restricted eating plan and a regular exercise programme …” An eating plan is also referenced on the packaging and included in the pack.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
While the Directorate notes that the complainant also took issue with the name “Slim Drops”, arguing that it implies weight loss, the Directorate has to firstly determine whether the efficacy claims made are adequately substantiated. Should this be the case, it stands to reason that the name is appropriate.
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.
The packaging claims that the product is a complementary medicine that helps to “Increase energy to burn fat” and “Control appetite”.
The respondent provided the Directorate with a report emanating from Ms Alison Vienings of MRA Regulatory Consultants.
In Glomail Hoodia / Dr HA Steinman / 4522 (31 May 2006), 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. More recently, in Clicks Hoodia Appetite Regulator / HA Steinman / 17987 (25 August 2011), this approach and acceptance was again reinforced.
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?
Ms Vienings’ substantiation is effectively based on the fact that the ingredients contained in the product have been documented to increase metabolism, which in turn increases the breaking down of fat and feelings of satiety. She also emphasised the fact that these claims are true when the product is used in conjunction with a kilojoule restricted diet and exercise, a fact which is stated on the packaging.
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 dose (which in this case is indicated as “…up to 30 drops in a full glass of water before breakfast and again before lunch …” and “Up to 60 drops daily” with an express warning to not exceed the recommended dosage.
While not pertinent at this time, the Directorate notes that there is a substantial margin for difference when consumers are able to consume “Up to 60 drops daily”, implying anything from 2 to 60 drops. Ms Vienings does not deal with this and does not verify that even at the lowest practical dose would the product deliver the claimed results.
The letter from More to Life Health (Pty) Ltd is of no additional value in this regard.
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). A similar approach was also followed in Clicks Hoodia Appetite Regulator / HA Steinman / 17987 (25 August 2011).
From the examples of packaging submitted by the complainant (in the form of a photograph of the pack on shelf), one can only see the front face of the packaging, which only contains the product name, and the efficacy claims, as well as an indication that the volume contained within the packaging is 50ml. No reference is made to the fact that these claims are only true when the consumer also follows a healthy slimming programme, a kilojoule restricted diet and moderate exercise programme. This is only mentioned on the side and back panel, and are, at best, only able to clarify or possibly even contradict the initial impression created that the product on its own is able to deliver the claimed results. 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.
By the same reasoning, the Directorate agrees that the name “Slim Drops”, which implies that the product (on its own) would result in slimming would be problematic, and is currently unsubstantiated.
Accordingly, the respondent’s use of the word “Slim” as part of the name of its product, the efficacy claims of “Weight Loss Support” and the ability to Increase energy to burn fat” and “Control appetite are currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code.
Given the above:
The name and claims objected to must be withdrawn;
The process to withdraw the name and claims must be actioned with immediate effect on receipt of this ruling;
The withdrawal of the name and claims must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide;
The name and claims may not be used again in their current format.
The respondent’s attention is drawn to Clause 15.5 of the Procedural Guide.
The complaint is upheld.