“The MCC confirmed that it had not evaluated the advertiser’s application (as appears to be the case here) and had not registered the advertiser’s medicine (as appears to be the case here). By virtue of this, the MCC concluded that none of the disputed efficacy claim made by that advertiser “have been approved by the council”. As a result, the Directorate upheld the complaint, and the claims had to be removed.”
| Solal Tech – Krill Oil / K Charleston / 16710|
Ruling of the : ASA Directorate
In the matter between:
Kevin Charleston Complainant(s)/Appellant(s)
Solal Technologies (Pty) Ltd Respondent
18 Feb 2011
On 15 December 2010, the Directorate issued a ruling in the above matter, specifically concerning the standing and status of the complainant. This was largely due to the fact that the respondent allegedly had “Stylometric tests” conducted on the complainant’s complaint in this matter, and others lodged by Dr Harris Steinman, a consumer activist, and Mr Marcus Low, a representative of the Treatment Action Campaign (the TAC). According to the respondent’s tests, there was no statistically significant difference between the “stylometry” of the complainant in the current matter, and those of Dr Steinman and Mr Low. The respondent believed this to be an indication that the complainant is not acting bona fide, which would render his complaint a vexatious complaint that should not be entertained by the ASA.
The Directorate dismissed this allegation, and afforded the respondent a final opportunity to argue the merits of the matter before ruling on the issues raised by the complainant.
|Note: I want to state clearly: I did not know K Charleston and had not had any contact with him/her. Of course, as the ASA pointed out, it is not a pertinent argument anyway.|
The advertisement promotes the respondent’s “KRILL OIL (NEPTUNE-NKO) OMEGA 3” supplement as superior to “fish oil”. It offers a special promotion whereby consumers can receive “FREE VITAMIN D3 (60 tablets).
It also contains, inter alia, the claim “more than 80% of South Africans tested are deficient in vitamin D3, which is essential for heart health and significantly reduces the risk of many cancers”.
In essence, the complainant submitted that this is a clear breach of Clause 8.21.1 of Appendix A of the Code, which prohibits claims implying that there is a wide-spread vitamin deficiency that does not exist.
The complainant pointed out that no information is given about the alleged Vitamin D3 deficiency. However, according to a study done in August 2010 on 10 year old children, “Vitamin D supplementation or fortification is not warranted in healthy children living in Johannesburg”.
The complainant provided the following URL where information about the study can be found: http://www.ncbi.nlm.nih.gov/pubmed/20804632.
The complainant added that the reference to “cancers” is also a breach of Appendix F, which prohibits references to specific conditions and diseases unless the relevant product, treatment or advice is registered and approved by the Medicines Control Council (the MCC).
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE The complainant identified the following clauses of the Code as relevant:
Clause 8.21.1 of Appendix A (Vitamins and minerals) – [relates to an earlier version of the Code, which has since been amended]
Appendix F (References to diseases in advertising)
Stefan Vos Marketing Regulation Advisors, on behalf of the respondent, submitted a response, which can be summarised as follows:
The complainant’s concerns insofar as Clause 8.21.1 of Appendix A are concerned are now irrelevant, because Appendix A has been amended entirely. In addition, Clause 220.127.116.11 of the newly implemented Appendix A specifically records that “The marketing or promotions of complementary medicines and Stock Remedies as defined under Act 37 of 1947” are excluded from the provisions of Appendix A. The product in question has been submitted to the Medicines Control Council for registration as a “complementary medicine”.
It added that if the ASA were to consider the complaint in terms of the previous Appendix A, it would simply result in a brutem fulmen, and an illogical decision.
With regard to the complainant’s objection in terms of Appendix F, the respondent referred to the Directorate ruling in Solal Technologies / KM Charleston / 15601 (26 August 2010). It submitted that in this ruling, the Directorate essentially advised the complainant to consider future claims made about cancer, heart diseases and diabetes” in terms of the provisions of Appendix F.
Given that the ASA is not able to provide pre-publication advice, any guidance to parties as to which clauses could be applicable in future certainly goes beyond the scope of considering the complaint brought by the complainant. Since the Directorate cannot act as judge and jury in the matter, it is procedurally barred from considering the current complaint, which relates to the same product as previously considered and to a claim relating to cancer.
In addition to this, the respondent argued that the provisions and scope of Appendix F should be considered within the context of the Medicines Act. This provides for products that have been submitted for registration, but have not yet been granted registration, to trade legally until such time as they are either accepted and can continue trading, or rejected, and have to discontinue. On the respondent’s interpretation of the relevant legislation, it is also required to indicate the product for the prevention of cancer, or face statutory penalty for deviating from its packaging insert. The implications of this is that it is not subject to the provisions of Appendix F by virtue of the fact that it has applied for registration with the MCC.
Appendix F does not state that advertisers may not make certain claims “unless the product is registered”. This means that provided that an advertiser is acting within the parameters of the law and any relevant regulations and call up notices or applications for registration, it is entitled to make such claims. The reference to “cancer” as contained in the advertisement appears as a preventative claim, not a curative one, and is therefore not prevented by Appendix F. Much like hearing aids are advertised for structural or organic defects of the ears, they are not required to be registered by the MCC, likewise for prescription glasses.
In support of its arguments, the respondent submitted an opinion titled “INTERPRETATION OF THE ASA CODE – MEDICINAL AND RELATED PRODUCTS AND ADVERTISEMENTS CONTAINING HEALTH CLAIMS”. This opinion was drafted by Advocate René Doms. The respondent added that Advocate Doms was previously Director of the Inspectorate of the MCC, and as such his opinion weighs in as both a legal and an MCC expert opinion.
The opinion is dated 20 June 2008, and deals largely with Advocate Doms’ view on the intention and scope of the previous Appendix A. it also passes some comments on the applicability of Appendix F in a manner similar to the respondent’s arguments. The opinion concludes that the responsibility for dealing with any suspicious claims made in advertising for products in this industry falls squarely on the Department of Health and the MCC, and this duty cannot be delegated to the ASA by virtue of these appendices.
ASA DIRECTORATE RULING
The ASA Directorate considered the relevant documentation submitted by the respective parties.
Is the Directorate able to consider this matter at this time?
The respondent argued that the Directorate is procedurally barred from considering this matter by virtue of the fact that in another ruling, referenced as Solal Technologies / KM Charleston / 15601 (26 August 2010), the Directorate effectively advised the complainant to consider future claims about, inter alia, cancer in terms of the provisions of Appendix F.
It argued that the ASA’s mandate is limited to the consideration of complaints brought to it, and it is inappropriate to offer such guidance on future complaints, and then preside over such complaints as well.
In Solal Technologies / KM Charleston / 15601 (26 August 2010), the Directorate considered a complaint concerning the same parties for the respondent’s Vitamin D3 supplement, which is one of the products promoted in the current advertisement.
After ruling that the respondent was unable to substantiate some of the claims made, the Directorate noted as follows:
“For the guidance of the RESPONDENT, (our emphasis), the Directorate also draws attention to the provisions of Appendix F in relation to the claims made about cancer, heart diseases and diabetes in the advertisement. As no complaint was made against these claims, however, the Directorate will not consider them at this time”.
The “advice” objected was therefore clearly offered to the respondent, and not to the complainant as alleged.
Notwithstanding this, the Directorate does not agree that offering such guidance, in a bona fide attempt to assist the respondent in its endeavours amounts to pre-approval, or pre-disapproval. Neither can such guidance be misconstrued as advising complainants how to complain in order to be successful, as the respondent appears to suggest.
It is noted, as a peripheral fact, that the ASA has been offering such guidance to advertisers for a substantial period of time. A cursory search on the ASA’s electronic archives reveals that as far back as 2004, the Directorate issued rulings with such additional advice (refer Arthrochoice / Nutrilida / 1405 (26 August 2004) for one such example).
In fact, in a later ruling on the same Arthrochoice matter, the Directorate ruled as follows:
“The ruling of 26 August 2004 stated ‘However, for the guidance of the respondent, the Directorate notes that Clause 1 of Appendix F lists certain diseases which may not be mentioned in advertising without full product registration with the Medicines Control Council (MCC).
Osteoarthritis is listed as one of these diseases. Any advertising claim referring to this disease should therefore be supported by registration of the product with the MCC.’
Whilst the Directorate provided guidance with regard to the use of the term ‘Osteoarthritis’ in the 26 August 2004 ruling, it did not rule against the use of the term as the complainant had cited the incorrect Clause for which there is no corresponding clause in the Code”.
As a result of this, the Directorate considered a subsequent complaint by Nutrilida in relation to “Osteoarthritis” as a new complaint. It is significant to note, however, that it was still the Directorate who determined whether or not the “new” complaint was valid.
Another important fact is that over the years, references to diseases in advertising have become one of a number of growing concerns. Such claims are often used to promote products, spiritual healers, miracle potions and the like. In an effort to assist advertisers, and offer guidance that may, or may not prevent further disputes, the Directorate has, on numerous occasions dating back several years, opted to make mention of other potentially applicable requirements of the Code (including, but not limited to those contained in Appendix F) when an opportunity presented itself.
The respondent’s original advertisement had clear, and emphasised statements referring to the link between Vitamin D deficiency and “cancer, diabetes, osteoporosis, kidney disease, depression, obesity and heart disease …”. Many of these diseases are listed in Appendix F, which is why the Directorate referred the respondent to this appendix for future guidance.
While true that the Directorate is not at liberty to extend the grounds of a complaint and rule on issues or concerns not specifically raised by the complainant (refer Sunlight Dishwashing Liquid / Ajax Dishwashing Liquid / 14034 (27 November 2009) ruling of the Advertising Industry Tribunal for example), it cannot be argued that such guidance as currently objected to is equal to extending the grounds of the complaint and ruling on such extended grounds in a manner that prejudices the respondent. As such the Directorate did not venture beyond the limitations of its duties and jurisdiction.
The Directorate did not expand on the complaint before it in offering such guidance to the respondent. More importantly, it expressed no view in terms of Appendix F other than drawing the respondent’s attention to the fact that this appendix may likely be applicable and worth consulting for all future advertising. This can be likened to traffic authorities advising all motorists to drive within the speed limits over the festive season. Such general advice cannot be regarded as a charge or allegation that all motorists are guilty of speeding.
From the previous ruling it is clear that the Directorate had not yet applied its mind to the question of whether or not the respondent’s advertising was in breach of Appendix F. When offering this advice to the respondent, the Directorate specifically noted that “… As no complaint was made against these claims, however, the Directorate will not consider them at this time”. From this it is clear that the Directorate is not acting as “judge and jury” as suggested by the respondent. Had this been the case, it would have negated the need for a subsequent investigation as well as this ruling.
Lastly, the Directorate also points out that the respondent was afforded ample opportunity to consider and respond to the complaint.
The significance of this is that the requirements of the audi alteram partem rule were met.
the “advice” objected to was offered to the respondent and not the complainant as alleged,
the Directorate ruling which offered this guidance expressly noted that the Directorate would not consider Appendix F because no complaint had been made against the relevant claims, and
the respondent was afforded sufficient opportunity to argue the merits,
the Directorate is satisfied that it is entitled to consider the matter and rule on the merits.
Merits of the matter
At the outset, the Directorate points out that while the respondent raised an interesting question insofar as whether the now defunct Appendix A effectively allows products that have been submitted for registration, but have not yet obtained official registration, to make claims such as those listed in Appendix F, this issue is now moot, as Appendix A has been amended entirely, and no longer contains the provision relied on by the respondent for this argument
It is also noted that the newly implemented Appendix A is indicated as belonging to, and having been implemented by the “Department of Health: Medicines Control Council (MCC).
The respondent correctly pointed out that Clause 18.104.22.168 of the current Appendix A specifically excludes, inter alia, “complementary medicines” from the scope of Appendix A. The logical implication of this is that the Directorate cannot at this time consider the complainant’s objections insofar as they relate to Appendix A because:
(Clause 10 of the now obsolete Appendix A dealt with “Registration”
and specifically stated that “In respect of products registered with the Medicines Control Council only those claims approved by the said Council may be advertised”. It also stated that for medicines that have been called up, but not yet registered, claims “… shall be limited to those submitted … in the application … provided that such claims comply with the other provisions of the ASA Code”.
By the respondent’s reading, this would mean that any product making claims such as those listed in Appendix F would be entitled to make such claims even if the product has only been submitted for registration in compliance with the Call-Up notice, but has not yet been registered.)
The specific clause identified by the complainant (Clause 8.21.1 of the defunct Appendix A) no longer exists, and
The current Appendix A specifically excludes products such as the respondent’s
In light of this, the Directorate will not rule on the complaint in terms of the objection in relation to Clause 8.21.1 of the obsolete Appendix A.
It is significant to note, however, that while the newly implemented Appendix A, which was clearly compiled and introduced with the full knowledge and approval of the MCC, has now taken effect, the MCC have not made a single change to Appendix F as contained in the Code.
Appendix F is also listed as belonging to and having been implemented by the “Department of Health” Medicines Control Council”.
The only logical explanation for this can be that the MCC did not intend for Appendix F to be changed at this time. Consequently, there is no reason why Appendix A should counteract any of the provisions of Appendix F (or any other portion of the Code for that matter).
The respondent submitted a lengthy argument about the intention of and logical interpretation of Appendix F with strong reliance on legislation governing, inter alia, the sale and registration of medicinal products. Given that the ASA does not administer any legislation in this regard, the Directorate can only consider the wording and implications of Appendix F as contained in the Code.
The respondent’s argument appear to essentially be that its products are exempt from the provisions of Appendix F because it is still legally permitted to sell its product despite the fact that no registration has been granted. In doing so, it is obliged to make claims in line with those listed on its application for registration.
Such an interpretation is not, however, borne out of the wording of Appendix F.
Clause 1 of Appendix F states, inter alia, “Advertisements should not make or offer products, treatments or advice for any of the following illnesses or conditions unless recommendations accord with a full product registration by the Medicines Control Council (MCC)… The diseases to which no reference may be made are…Cancer”.
It does not limit its scope to references to diseases in advertising by products other than registered medicines or medicines that have applied for registration as the respondent seems to suggest.
Similarly, it does not distinguish between medicines (registered or not) and other different product categories. It clearly refers to “products, treatments or advice” in a general manner, which would suggest that ANY product, treatment or advice.
In Comfrey Capsules / Pharmaceutical Society of SA / 9092 (21 June 2007), the Directorate obtained an opinion from the MCC on the acceptability of that advertiser’s claims to treat, inter alia, diabetes, asthma, cancer, and other conditions listed in Appendix F.
The MCC confirmed that it had not evaluated the advertiser’s application (as appears to be the case here) and had not registered the advertiser’s medicine (as appears to be the case here). By virtue of this, the MCC concluded that none of the disputed efficacy claim made by that advertiser “have been approved by the council”. As a result, the Directorate upheld the complaint, and the claims had to be removed.
This further supports the argument that the intention and implication of Appendix F is to prevent any products, treatments or advice on the listed conditions unless the MCC has granted formal approval.
The respondent’s “KRILL OIL (NEPTUNE-NKO®) OMEGA 3” and “VITAMIN D3” are clearly “products” for the purposes of this clause. The respondent’s argument, if it were accepted, would lead to the untenable situation where Appendix F can prevent for example, a candy manufacturer from claiming that its product can prevent/treat/cure cancer, but could not stop an unregistered “medicine” or “complementary medicine” (with absolutely no active ingredients or efficacy) from claiming to prevent/treat/cure a listed illness. This is clearly contrary to the wording of Appendix F as well as the precedent established in the Comfrey Capsules matter. The respondent’s argument is therefore rejected.
By the respondent’s own version, it is making a “preventative claim” in relation to cancer, which is a condition listed in Appendix F, and as such can ONLY be referred to when such a reference “… accord[s] with a full product registration by the Medicines Control Council (MCC)”. The respondent also confirmed that its product is not yet registered by the MCC.
In light of the above, the respondent’s advertisement contravenes Clause 1 of Appendix F.
Given the above:
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;
The advertisement may not be used again in their current format in future.
The respondent’s attention is drawn to Clause 15.5 of the Procedural Guide.
The complaint is partially upheld.