Posted 07 May 2013
This is a great example of how pseudoscience has been utilised, i.e., evidence from a computer model used to claim an ingredient will have a beneficial effect in humans, without proving it. A consumer laid a complaint against USN Fat Block that claims “CLINICALLY PROVEN”, “QUALITY INGREDIENTS”, and “Supports Weight Loss”. In fact, similar claims for the ingredient used, Neopuntia, was previously ruled against by the ASA. (It is clear from this that USN cannot be trusted at all.)
The ASA examined the evidence supplied by USN and agreed, there is no proof that this product works at all, and therefore ruled against the claims as well as the name of the product.
|USN Fat Block / HA Steinman / 20454|
Ruling of the : ASA Directorate
In the matter between:
Dr Harris Steinman Complainant(s)/Appellant(s)
Ultimate Sports Nutrition (Pty) Ltd Respondent
25 Apr 2013
Dr Steinman lodged a consumer complaint against the respondent’s packaging for its “FAT BLOCK” product. The packaging contains the following claims:
“EFFICIENT FAT BINDER”,
“A clinically proven dietary supplement formulated to decrease fat absorption after a meal”,
A logo featuring the words “CLINICALLY PROVEN” surrounded by “QUALITY INGREDIENTS”,
“Supports Weight Loss”.
The complainant referred to an older ASA ruling under reference Neu-U / HA Steinman / 12736 (5 February 2009), in which the ASA ruled that the respondent was unable to substantiate its efficacy claims for the product. Both Neu-U and USN FAT BLOCK contain the same ingredient.
The complainant added that he has checked the very credible scientific database PubMed, as well as the Natural Medicines Comprehensive Database and there is no evidence of a single robust, peer reviewed clinical trial showing any efficacy for this ingredient. He added that since 2009 there has not been a single study to even test the ingredient as a fat blocker or as instrumental in weight loss.
As a result, the claims highlighted above as well as the product name are misleading to consumers.
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint the following clauses of the Code were considered relevant:
• Section II, Clause 4.1 – Substantiation
• Section II, Clause 4.2.1 – Misleading claims
In its initial response, the respondent referred to two reports by TNO Nutrition and Food Research in the Netherlands which were compiled in 2001 and 2004. It argued that these reports determined and confirmed the fat binding capacity of “Neopuntia” during passage through a dynamic gastrointestinal tract, as well as its fat recovery ability.
It attached a specification sheet for Neopuntia detailing the active ingredients of the product and also made mention of a further clinical trial conducted by Bio Serae Laboratories SA during 2003, which again confirmed the fat binding qualities of the product.
It explained that Neopuntia originated from the cactus (Opuntia-ficus Indica) and has demonstrated the ability to bind fat over the years. It attached copies of the two TNO Nutrition and Food Research reports. The Directorate granted confidentiality on some of the reports in accordance with the provisions of Clause 5 of Section I.
Subsequent to this, the respondent’s representative Clear Copy, submitted an updated response, containing confirmation for the disputed claims in the form of a report from “PlantaPhile”. It argued that PlantaPhile is an established expert entity in the field of efficacy of natural products.
As such, it argued that the claims are adequately substantiated and the product name cannot be said to be misleading.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
Clause 4.1 of Section II requires advertisers to hold evidence or verification for all efficacy claims. It further stipulates that such evidence or verification shall either emanate from, or be evaluated by an independent and credible entity, which is “… an expert in the particular field to which the claims relate …”
In such cases, the Directorate has two key considerations:
Is the expert put forward an independent and credible expert in terms of the requirements of Clause 4.1 of Section II of the Code?
Does the expert expressly verify that the claims in question are true for the product advertised when used as recommended?
The respondent did not deal with the complainant’s reference to an earlier ruling against a different product which, according to the complainant, contained the same ingredient as the current “FAT BLOCK” product.
In Neu-U / HA Steinman / 12739 (5 February 2009), the Directorate considered the claims “THE LATEST WEIGHT MANAGEMENT SOLUTION” and “… in vitro tests conducted on a gastrointestinal model have shown that NeOptunia reduces fat absorption by 28,3%”. The packaging at the time also reflected the words “clinically proven fat binder”. The complainant had submitted, inter alia, that the gastrointestinal model referred to was a computer simulation, and that the product had not been tested on any living creature, be it human or animal. It is also noted that at the time, the respondent relied on a study done by Bio Serae Laboratories SA, as well as a TNO study.
The Directorate, inter alia, ruled as follows:
“The respondent appears to have extrapolated its findings and claims from the studies submitted.
In The Little Book of Big Health Secrets / Premarin / 11090 (20 October 2008) the Directorate was faced with a similar situation where the respondent relied on studies done, and submitted these studies as proof. It ruled, inter alia, as follows:
‘… in accordance with Clause 4.1.4 of Section II of the Code, the Directorate can only accept substantiation from a person or entity that is independent, credible and an expert in the relevant field to which the claims relate. It has also been ruled on several occasions that the Directorate is not a medical or scientific expert, and is not at liberty to interpret scientific documentation and research. In light of this, the Directorate is not able to scrutinise and interpret the supporting documentation submitted by the respondent. While the studies may well emanate from independent and credible experts in this field, they contain scientific information and jargon, which the ASA is not qualified to interpret. In addition, the Directorate cannot determine whether the findings communicated are scientifically significant to such an extent that they can be applied as broadly as the advertising seems to imply’.
The same approach applies here, and the Directorate is unable to interpret the scientific data submitted and draw scientific conclusions from it. What the Directorate requires is confirmation from an independent and credible expert in the relevant field that the information contained in the studies submitted supports the exact claims made for this specific product. No such verification was submitted.
IT IS ALSO NOTED THAT THE ‘PILOT CLINICAL STUDY’ [i.e. The Bio Serae Laboratories Report] SUBMITTED APPEARS TO EMANATE FROM THE SAME LABORATORY THAT MANUFACTURES THE PRODUCT AND LICENSES THE RESPONDENT TO MARKET IT IN SOUTH AFRICA. Accordingly, at least so far as this study is concerned, the Directorate cannot accept the findings contained in this study at this time, as they have not been independently verified (Directorate’s emphasis).
Given the above and given the absence of independent verification of the claims in relation to the product as a whole, the advertisement is currently unsubstantiated and in contravention of Clause 4.1 of Section II of the Code”.
In its subsequent response, the respondent relied on verification from PlantaPhile, and submitted that this entity is well established as having expertise in the efficacy of natural products.
PlantaPhile in turn confirmed that:
“Opuntia [fibre] complex has been shown effective in both pre-clinical and clinical investigations to bind ingested fat, thus making it less bioavailable and prevent it from being absorbed. A fat-binding claim associated with Opuntia is therefore legitimate and substantiated. The product to which this claim relates is USN Fat Block. The only active ingredient in USN Fat Block is Opuntia. Thus, the product will deliver the advertised benefits. More specifically, the following claims can be considered adequate and truthful:
‘binds fat and thus blocks it from being absorbed / metabolised’
‘is clinically proven to decrease fat absorption after a meal’
‘supports weight management / weight loss’
The first question before the Directorate is therefore whether or not it regards PlantaPhile as a suitable independent and credible expert in the field to which the claims relate.
http://www.PlantaPhile.eu/index.html states, inter alia, as follows:
“PlantaPhile researches the variety and application of plants in folk medicines in order to make this knowledge public and thus save the wisdom of centuries-old tradition. Use of these plants imply a huge potential for application in Western natural medicine.
Publication of this knowledge sets focus points of interest from which in the long run mutual benefit will be derived for both the developed world and the indigenous peoples; locally: by establishing new economic potential, globally: through new applications for herbal preparations in modern medicine.
We work in close co-operation with local partners: botanists, doctors, healers and other plant experts, thus acknowledging and protecting intellectual property rights of indigenous peoples and ensuring maximum efficiency …
… PlantaPhile consultancy specializes in all aspects of licensing herbal products as medicines, food supplements and cosmetics. We advise manufacturers on registration of their products in European, North American and Pacific markets. We offer services ranging from feasibility studies via assembling the registration dossiers and associated documentation for traditional herbal medicines (THMP), well established use (WEU) registrations and full market authorizations (MA). We help manufacturers with placing and establishing their products in new markets, take products through the registration process according to national requirements, assist with setting up a sourcing, contract manufacturing or distribution system or finding suitable distribution partners or businesses suitable for acquisition respectively”.
From this the Directorate is not convinced that PlantaPhile qualifies as an expert in weight loss or fat absorption efficacy, which is the field to which the claims relate. PlantaPhile also does not seem to have any expertise in terms of how food, fat, and chemical products are absorbed, which is a key element insofar as the product-claims are concerned. It appears rather that PlantaPhile merely compiles information (much of which, by the looks of this summary, appears to be anecdotal) for the purpose of sharing this information. It further assists companies in the registration processes that may be required in their particular country and assists in establishing commercially viable market systems.
Furthermore, in A Vogel Neuroforce / S Kaye / 16323 (9 February 2011), the Directorate specifically grappled with what the meaning of “expert” in terms of Clause 4.1 of Section II is. It explained, inter alia, that:
“… an expert cannot be deemed an ‘expert’ in comparison to other people who are not practising in the relevant field. For example, a doctor who has just qualified as a surgeon would not automatically be deemed an ‘expert’ surgeon simply because he has the skill to perform surgery, which the average man on the street does not.
The status of ‘expert in the particular field to which the claims relate’ as required by the Code implies that the entity put up as an expert must have obtained knowledge and/or experience and/or skills that sets him apart from a general person practicing in the relevant field”.
Given that the respondent has not submitted anything to show that PlantaPhile has any expertise or experience in the field of weight loss, food and fat absorption, the Directorate is not convinced that PlantaPhile qualifies as an independent and credible expert in terms of Clause 4.1 of Section II of the Code, at least not in terms of the product claims at issue.
Finally, the Directorate also notes that there is nothing before it to show that the respondent’s product as a whole and as available in-store has ever been subjected to any kind of testing, let alone proven to be effective. All the information submitted relates to one ingredient, and there is nothing before the Directorate to show that the ingredient is actually present in the product, that it is present in a dose that was proven effective, or that the other ingredients will not impact on the efficacy at all.
The Directorate therefore does not accept the substantiation relied on by the respondent at this time, meaning that the claims are currently unsubstantiated within the meaning of Clause 4.1 of Section II of the Code.
For the same reasons, the name “FAT BLOCK” is currently unsubstantiated and in breach of Clause 4.1 of Section II.
Given the above finding:
The claims disputed, as well as the product name must be withdrawn;
The process to withdraw the claims and name must be actioned with immediate effect on receipt of this ruling;
The withdrawal of the claims and name must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide; and
The claims and product name may not be used again in their current format unless new substantiation has been submitted in accordance with Clause 4.1.7 of Section II, evaluated, and a new Directorate ruling has been issued.
The complaint is therefore upheld, and it is not necessary to consider the provisions of Clause 4.2.1 of Section II (Misleading claims) at this time.