Posted 23 March 2012
Prof Jobson lodged a consumer complaint against Pharma Natura’s Internet advertisement promoting its Vitaforce Nutri-B tablets. The advertisement stated, among other, “Category leader in supplement stress management" and "Nutir-B [sic] is ideal for people who lead pressurised lifestlyes or who are recoving [sic] from stress related ill health." But the company could not prove these claims and the ASA ruled against the claims.
|Pharma Nutir-B / R Jobson / 19038|
Ruling of the : ASA Directorate
In the matter between:
M R Jobson Complainant(s)/Appellant(s)
Pharma Natura (Pty) Ltd Respondent
23 Mar 2012
Prof Jobson lodged a consumer complaint against Pharma Natura’s Internet advertisement promoting its Vitaforce Nutri-B tablets. The advertisement was published at http://pharmanatura.co.za/vitaforce-NutriB.a spx.
The advertisement, inter alia, contains a table setting out the following product-related information:
“Category leader in supplement stress management
Nutir-B [sic] is ideal for people who lead pressurised lifestlyes or who are recoving [sic] from stress related ill health
Whether it is executive stress, exam stress or health related stress Nutri-B will help you cope.
Nutri-B is Halaal approved. Suitable for diabetics and suitable for vegetarians”
The complainant submitted, in essence, that claims that Nutri-B tablets are the “… category leader in supplementary stress managent” and that the product helps you recover from “… stress related ill health” or cope with “… executive stress, exam stress or health related stress” needs scientific substantiation.
The complainant also submitted that the advertisement is, at face value, in contravention of the Medicines Control Council (MCC)’s ruling dated 27 January 1984, which confirmed that “a product cannot claim to relive stress unless it is registered as a medicine and the claim has been approved by the MCC”. In this respect the complaiant refered to Guideline 1 of the Code.
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
The complainant identified the following clauses of the Code as relevant:
• Section II, Clause 4.1 – Substantiation
• Guideline 1, Clause 4.3 – Stress claims
The respondent submitted, inter alia, that:
The complaint is vexatious as it is motivated by the intention to frustrate the respondent and to ensure that it does not have the ability to respond properly (this argument appears to stem from the fact that the complainant recently lodged a number of complaints against the respondent’s advertising, all requiring a response within the short periods defined in the Code).
The complainant’s self-proclaimed crusade against companies such as the respondent is evident from his statements in an article published during 2011, dealing with the fact that the Minister of Health has appointed the complainant to serve as Council member of the Allied Health Professions Council of South Africa (AHPCSA). In this article, the complainant states that the Medicines Control Council (MCC) failure to act “… resulted in 155 000 complementary and alternative medicines being available on the market …” and that “The overarching mandate of the AHPCSA and the one I am particularly committed to myself is to promote and protect the health of the public”. In light of these statements, it is apparent that the complainant is using the ASA as a quasi regulatory authority for the purpose of determining what may or may not be said about certain products.
Matters pertaining to the regulation of complementary medicines are better left to the current regulatory authorities such as the MCC and the powers that the MCC enjoys in terms of applicable legislation. Reference was also made to a “longstanding feud” between the complainant and members of the Health Products Association (the HPA) of which the respondent is a founding member, and the argument was made that the complainant is attempting to get the ASA to deal with an issue that the MCC has not (determining what complementary medicines are allowed to claim).
It has no intention of subjecting itself to the jurisdiction of the Advertising Standards Authority as the Medicines Control Council (MCC) has already assumed control over complimentary medicines from the point of view of dealing with the said medicines as registerable medicines pursuant to the provisions of the Medicines Act. It also attached a letter from the HPA addressed to the ASA in which concern is expressed over the “onerous” standards that the ASA is imposing on such products. Seeing that the MCC has recently published draft regulations and guidelines the ASA should refrain from any investigations on such products until the relevant regulations and guidelines are finalised and formalised.
Finally, it added that it was taking legal advice concerning the institution of legal proceedings pursuant to the provisions of the Intimidation Act no. 72 of 1982 against both the complainant and the ASA.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the complainant.
Jurisdiction of the ASA
The respondent submitted that it does not recognise the jurisdiction of the ASA in this instance, and that it would regard any “…exercise of any purported jurisdiction by the ASA over the products referred to above … [as] an exercise of jurisdiction outside of the Code and contrary to the provisions of the Medicines Act and South African law in general …”
It cannot be disputed that the ASA is only empowered to consider and rule on allegations that any disputed advertising contravenes the provisions of the Code of Advertising Practice. This is echoed not only in various rulings over the years, but also in the Code itself.
Clause 2.1 of Section I states, inter alia, that “The primary objective of this Code is the regulation of commercial advertising. It applies therefore (except as expressly provided further on) to all advertisements for the supply of goods or services or the provision of facilities by way of trade …”
Insofar as the respondent’s industry is concerned, only one exclusion appears relevant:
Clause 126.96.36.199 of Appendix A of the Code specifically excludes “The marketing or promotion of complementary medicines …” It is important to understand, however, that this exclusion ONLY relates to the provisions of this appendix, and not to the entire Code.
In Pretoria Civil Action & Another / City of Tshwane Metropolitan Municipality (15 November 2005), the FAC also emphasised the fact that the ASA is obliged to and entitled to rule on advertising complained of even if the advertiser does not concede to the ASA’s jurisdiction. It held:
“Even if the appellant had not appeared, after giving it an opportunity to do so, the ASA, at the request of a consumer, with due notice to the appellant could make a ruling binding on its members. The members in adhering to the ASA’s ruling would not be violating any protectable legal right of the appellant and would not commit an unlawful act. Nor would the ASA be doing so in making the ruling and nor would the consumer in asking for such a ruling. Vide Tothill vs. Gordon, 1930 WLD 99 and the ruling of this committee in National Brands Limited vs. Kwality Biscuits (Pty) Ltd”.
While the respondent may, or may not, have advertising agents that belong to a constituent member of the ASA, it may well choose to utilise a member of the ASA to carry its advertising. If this were to happen, such members, and indirectly, the respondent, would be bound by all relevant rulings. It is also clear that the ASA is required to consider all “valid” complaints.
The complaint at hand was simply one of substantiation, as detailed in Clause 4.1 of Section II of the Code. There is nothing in the complaint, or for that matter, in the provisions of Clause 4.1 of Section II of the Code, which seeks to empower the Directorate to fulfil the mandate or duties of the MCC. The provisions of Clause 4.1 of Section II (as will become more apparent below) simply require appropriate substantiation for any and all direct or implied claims that are capable of objective substantiation. This does not require consideration of whether or not the MCC has, should, or must approve the respondent’s product or register it as any type of medicine.
In light of the above, the Directorate is satisfied that it has jurisdiction over the respondent’s advertising and is entitled to receive and consider valid complaints against it.
Status of the complainant
The respondent appears to interpret the complainant’s actions as indicative of:
A crusade against so-called Complementary Medicines
Indicative of a “longstanding feud” between the complainant and members of the HPA
In support of this, it relied on a press-release of sorts, dealing with the complainant’s appointment to serve as Council member on the Allied Health Professions Council of South Africa (AHPCSA).
However, the response does not clarify why statements by the complainant such as “… 155 000 complementary and alternative medicines BEING AVAILABLE ON THE MARKET …” and “… THE ONE I AM PARTICULARLY COMMITTED TO MYSELF IS TO PROMOTE AND PROTECT THE HEALTH OF THE PUBLIC” (respondent’s emphasis) indicates a crusade or malicious intent, much less a “long-standing feud” with the HPA or its members.
In MTN / Mr I McLean (14 May 2003), the Advertising Standards Committee (the ASC) considered an appeal relating to a complaint (one of a large number of complaints) submitted by a Mr Ian McLean. At that point in time, Mr McLean advertisement lodged large volumes of complaints against cell phone advertising in particular. The ASC made the following point:
“In regard to the Respondent’s submission that the complainant ‘appears to be oversensitive’, and is not motivated by a genuine concern in respect of the relevant advertisement but is pursuing a vendetta or crusade against the cellular telephone industry, the Committee is of the view that the complaint is a valid one which needs to be considered by the Committee. The Committee is not in a position to make a ruling as to whether the Complainant could be likened to a ‘vexatious litigator’. Mr McLean appears to be a consumer activist. Without evidence suggesting otherwise the Committee cannot exclude his complaint or complaints on that basis. In any event there is doubt that the Committee can entertain such a complaint against a Complainant”.
This clearly illustrates that lodging multiple complaints (something which is not a novel occurrence at the ASA) does not automatically mean the complaints are vexatious. Any respondent making such an allegation should rely on more than simply its opinion when doing so. Considering the quotation highlighted by the respondent that the complainant wants to commit himself to promoting and protecting the health of the public, the Directorate is hard-pressed to regard this as indication of mala fides. It is also not clear why the respondent believes that the complainant has a “longstanding feud” with members of the HPA.
While perhaps true that the complainant is knowledgeable in the field of medicine (something which is arguably supported by his recent appointment to the AHPCSA by the Minister of Health), there is nothing precluding him from lodging a complaint within the parameters of the ASA Code. In lodging his complaint, the complainant complied with the relevant procedures, and his complaint is clearly related to a provision of the Code which the Directorate is able to administer.
Accordingly, the Directorate does not share the respondent’s view that the complaint is vexatious, in bad faith or designed to get the ASA to fulfil the mandate of the MCC.
Competence of the ASA
The respondent appears to believe that the ASA cannot, and should not consider claims and advertising relating to complementary medicine because it does not have the expertise to do so.
The principles of Clause 4.1 of Section II have been explained in ASA rulings in great detail over the years. In effect, it requires advertisers to hold verification for any and all direct or implied claims that are capable of objective substantiation. In addition to this, it stipulates that such evidence should either emanate from, or be evaluated by an independent and credible expert entity. It is also trite that the ASA requires such verification to be product-specific and unequivocal in nature.
The one main reason for the requirement of independent and credible expert substantiation is because the ASA is clearly not a technical expert body. As such, the Code allows for the ASA to consider and accept verification from someone who is, provided that a proper interrogation of such verification and supporting literature occurs (refer the ruling of the Advertising Industry Tribunal in Lifebuoy / Dettol / 14813 (27 August 2011) for more thorough explanation).
If anything, the fact that the MCC is charged with determining whether a product should be registered as a medicine (presumably by, inter alia, evaluating the supporting evidence and claimed efficacy) does not preclude the Directorate from discharging its onus in terms of considering whether the respondent has adequate substantiation as required by Clause 4.1 of Section II.
By virtue of the fact that the respondent is making use of efficacy claims in its advertising, the provisions of the Code apply. At best, there could perhaps be an argument of concurrent jurisdiction, but this does not prevent the ASA from exercising its discretion and fulfilling its mandate by ruling on the matter. The dispute before the ASA is NOT whether or not the product (or in this instance products) should be registered, but simply whether it can prove its efficacy claims made in its advertising.
As such, the Directorate is satisfied that it is competent and empowered to consider the complaint currently before it within the parameters of the Code.
Guideline 1 (Medicines)
The complainant submitted that the advertisement is, at face value, in contravention of the Medicines Control Council (MCC)’s ruling dated 27 January 1984 which confirmed that “a product cannot claim to relive stress unless it is registered as a medicine and the claim has been approved by the MCC”.
At the outset, it has to be pointed out that the guidelines contained in the Code serve as just that – guidelines. In fact, the opening page of the section containing the guidelines states as follows:
“These Guidelines are not part of the ASA Code but relate to laws, rulings and procedures that can affect the preparation of advertising copy.
It must also not be taken for granted that the laws listed have not been amended and users are advised to study the full implications of the particular law before proceeding. The entry will, at least, identify the existence of the law and its number”.
From this it is clear that the Guidelines section of the Code is not intended to be regarded as substantive, binding rules, but rather as useful guidelines. This approach was also noted in Siluet 40 Massage Contour / Dr HA Steinman / 8103 (11 January 2007), where the Directorate ruled that “Although the provisions of the Guideline are not binding, it does serve the purpose of guiding advertisers on how to prepare their advertising”. This principle was also affirmed in Pharmaton / M R Jobson / 18624 7 December 2011).
While the Directorate accepts that the complainant intended for the guideline to be supportive of its argument, it deserves mention that a ruling will not find an advertiser in contravention of a guideline, due to the above circumstances. The only remaining question is therefore whether or not the advertising at issue contravenes Clause 4.1 of Section II.
Clause 4.1 of Section II states, inter alia, that “Before advertising is published”, 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. In short, the respondent is required to, in terms of the Code, have adequate substantiation on hand before publishing its advertising. It is also trite that such substantiation has to be product-specific and unequivocal.
The only question before the Directorate is whether or not the respondent has proof that its products, as available on the market and when consumed at the recommended dosages, will deliver the claimed results. It should also be proven that the respondent’s product is indeed the “Category leader in supplement stress management” as contended by the respondent.
In Vodacom 4U / MTN / 10575 (8 April 2008), the Directorate ruled as follows:
“The Directorate notes, however, that in terms of its procedures, an advertiser is given an opportunity to respond to a complaint in full. Should an advertiser raise a preliminary issue such as the one raised by the respondent, it must also address the merits in the alternative, so as to cover the possibility that the preliminary point might be dismissed. If the advertiser fails to also address the merits of the matter, it runs the risk of having its point dismissed and then leaving the issue to be decided without its comments”.
The Code specifically requires all advertisers to have in its possession all documentary evidence before advertising, so that when a complaint is made against it, it can submit such evidence in a short space of time. The respondent, however, did not address the merits of the matter and did not tender any documentary evidence to support the claims made in its advertising.
Accordingly, the respondent’s claims for the Vitaforce Nutri-B tablets, as recorded above, are unsubstantiated and therefore in contravention of Clause 4.1 of Section II.
Given the above:
The claims quoted at the beginning of this ruling, made in relation to the respective products, 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 until new substantiation has been submitted, evaluated and a new ruling is made in terms of Clause 4.1.7 of Section II of the Code.
The respondent’s attention is also drawn to Clause 15.5 of the Procedural Guide.
The complaint is upheld.