Posted 05 February 2009
The advertisement is headed “THE LATEST WEIGHT MANAGEMENT SOLUTION” and states, inter alia, that “In-vitro tests conducted on a gastrointestinal model have shown that NeOptunina reduces fat absorption by 28,3%”.
It also contains a pack shot featuring the words “clinically proven fat binder”. In essence, the complainant submitted that the in-vitro study referred to was a computer assisted model and no testing was done on animals or humans to determine whether the claims apply when used by humans. In addition, no other studies have been done on this product.
|Neu-U / HA Steinman / 12739|
Ruling of the : ASA Directorate In the matter between:
Dr Harris Steinman Complainant(s)/Appellant(s)
Dr Steinman lodged a consumer complaint against a print advertisement for “Neu-U” appearing in the “PHARMED NEWS” supplement to the November / December issue of Modern Medicine magazine. The advertisement is headed “THE LATEST WEIGHT MANAGEMENT SOLUTION” and states, inter alia, that “In-vitro tests conducted on a gastrointestinal model have shown that NeOptunina reduces fat absorption by 28,3%”.
It also contains a pack shot featuring the words “clinically proven fat binder”. COMPLAINT In essence, the complainant submitted that the in-vitro study referred to was a computer assisted model and no testing was done on animals or humans to determine whether the claims apply when used by humans. In addition, no other studies have been done on this product.
There is no substantiation to verify that this product has any efficacy in terms of weight loss, slimming, obesity and the like.
RELEVANT CLAUSE OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint Clause 4.1 of Section II (Substantiation) was considered relevant.
The respondent submitted arguments on the merits of the matter, as well as a copy of the study relied on in the advertisement. In addition, it submitted copies of a pilot clinical study of Neoptunia ® on fat binding, done by Bio Serae Laboratoires S.A. in France. In its argument, the respondent clarified why the TNO in-vitro gastrointestinal model used is sufficient and effective.
ASA DIRECTORATE RULING
The ASA Directorate considered the relevant documentation submitted by the respective parties. At the outset, it must be noted that medicinal products 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. The scope of this ruling is limited to the subject matter of the complaint brought to the ASA, namely whether the claim concerning the efficacy of the respondent’s product can be substantiated. The ASA is not able or authorised to rule on the quality or safety of the product in question, and this ruling must be interpreted and applied accordingly. When read as a whole, the advertisement creates the expectation that using this product will result in weight loss. Accordingly, this expectation should be substantiated in terms of the Code. While true that the advertisement mentions a “well balanced eating plan and regular exercise”, this is suggested for “best results” (our underlining).
A hypothetical reasonable person would therefore interpret this to mean that the product will result in weight loss on its own, but that such weight loss can be optimised when including a balanced diet and regular exercise. Clause 4.1 of Section II 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”.
It further states, “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”. Because the ASA is not a technical expert body, Clause 4.1 of Section II requires it to rely on the opinion received from the “independent, credible expert”. Should the Directorate be satisfied that the relevant person or entity is indeed independent, credible and an expert in the field to which the claims relate, the Directorate will consider whether or not the expert confirms the claims in question as valid for the product as a whole, when used at the recommended dose.
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” 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.
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.
Given the above finding: The advertisement must be withdrawn;
The process to withdraw the advertisement must be actioned with immediate effect on receipt of this ruling;
The withdrawal of the advertisement must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide; and
The advertisement may not be used again in its current format until new substantiation has been submitted, evaluated and a new ruling has been made.
The complaint is upheld.