Herbex and HPA’s arguments ring hollow – ASA Final Appeal Committee Ruling

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Posted 17 October 2014

regan-hpa-herbexAfter more than a year of rulings, appeals, delays, and ultimately the Final Appeal Committee (FAC), former Constitutional Court Judge, Kate O’Regan and the Committee, brought additional clarity to the ASA.  (For brevity’s sake please accept that my references below to “Judge O’Regan” refer also to the Committee.)

 

  • Herbex claimed that the original substantiation by a medical doctor that Herbex worked, should stand. Judge O’Regan showed that the doctor had misread and contradicted the very evidence that he had provided in support of his substantiation. She rejected the substantiation.
  • Herbex introduced new substantiation into the final appeal without following the correct procedure. Although Judge O’Regan did look at (and rejected the merits of!) the new “evidence” – she emphasised that it was clear the Herbex did not have the evidence to hand before they started advertising the products. This is very important, and could form the basis of complaints in future (for any CAMs).
  • Herbex claimed that its internet advertisements were not subject to the Code of Advertising Practice. Judge O’Regan dismissed this.
  • Herbex claimed that simply being a member of the Health Products Association (HPA) did not make it subject to the Code of Advertising Practice. Based on a clear reading of the HPA’s constitution, Judge O’Regan rejected this.
  •  The HPA joined the Final Appeal at a late stage and introduced the MCC’s draft Quality, Safety and Efficacy Guideline into the proceedings. This guideline was found helpful by Judge O’Regan and she used it as an argument against the HPA’s argument that the ASA should return to their “old” way of accepting substantiation upon the “say so” of an expert.
  • The HPA also introduced a document from the United States Federal Trade Commission (FTC) which Judge O’Regan indicated provided useful guidance as to the meaning of substantiation. I have read and re-read this part of the ruling many times [paragraph 42], and what strikes me is that the FTC refers to “products.” The HPA had asked that CAMs be substantiated based only on individual “ingredients.” But, of course, advertising does not refer only to ingredients, but to “products” – and consumers usually buy “products” for a particular reason, rather than just ingredients.

In summary – this is a landmark ASA ruling. Ironically, it is the HPA we must thank for having provided Judge O’Regan and the Committee with valuable information which has helped guide the decision. If the ASA ever adopts the HPA’s proposed “Code for Advertising CAMS” – the code cannot violate the principles in this FAC ruling.

The full ruling follows below.


 

Herbex / Dr HA Steinman / 20993, 20994, 20995
Ruling of the: ASA Appeal Committee
In the matter between:
Herbex (Pty) Ltd Complainant(s)/Appellant(s)
Dr Harris Steinman Respondent
22 September 2014

http://www.asasa.org.za/rulings/fac_herbex_steinman_20993-5

This appeal is against a decision of the Advertising Standards Committee dismissing three appeals brought by the Appellant, Herbex (Pty) Ltd, against three decisions of the Directorate. The three decisions of the Directorate concerned three products marketed by the Appellant: Herbex Appetite Control Tablets, Herbex Booster Eat-Less Drops and Herbex Attack the Fat Syrup (“the three products”).

Claims and marketing at issue

Herbex Appetite Control Tablets
2. According to the complaint, the following claim is made on Herbex’s website in respect of Herbex Appetite Control tablets: they “… are formulated to manage the appetite safely and naturally”, and the packaging claims that the tablets constitute an “effective weight- loss formula” and using them “manages appetite, reduces hunger pangs and cravings”. The tablets contain spirulina, garcinia cambogia (citrin), yerba maté, camellia sinensis (green tea) and ginger.

Herbex Booster Eat-Less Drops
3. According to the complaint, the following claim is made on Herbex’s website in respect of Herbex Booster Eat-Less Drops: “its main function is to balance blood sugar levels, reducing hunger pangs and positively effecting diabetes. It is also effective for nausea, indigestion and abdominal distensions”. According to the complainant, the website also claims that the Herbex Booster Range can be used in support of other Herbex weight-loss products “or can be used on their own to help you achieve your weight- loss goals”. The packaging states that the produce “reduces hunger pangs and cravings”. Herbex Booster Eat-Less Drops contain cynara scolymus (artichoke), gymnema sylvestre, trigonella foenum (fenugreek), panax (ginseng) and chromium picolinate.

Herbex Attack the Fat Syrup
4. According to the complaint, the following claim is made on the Appellant’s website in relation to Herbex Attack the Fat Syrup: “… it is a powerful herbal syrup that will help you lose weight. A few teaspoons a day will help you look your best and boost your confidence.” The product contains: agathosma betulina (buchu), camellia sinensis (green tea), garcinia cambogia (citrin), aloe ferox bitters and lemon concentrate.
History of proceedings
5. In each complaint, Dr Steinman also noted that the Appellant might seek to rely on Dr Sandell as an expert to provide substantiation for the claims made in respect of each of the three products. He said that Dr Sandell’s “position as a ‘credible expert’ was based on his registration with the Allied Health Professions Council of South Africa (AHPCSA) as a homeopath”. Dr Steinman noted that he had learnt that Dr Sandell’s registration with the AHPCSA as a homeopath had been based, not on his successful completion of examinations, but on a “letter of good standing” supported by two doctors. Dr Steinman therefore suggested that Dr Sandell could no longer be accepted by the ASA as a “credible expert”.

6. The Appellant responded to each of Dr Steinman’s complaints by lodging an evaluation of each of the products by Dr Sandell, with attached documentation. The Appellant asserted that there was no reason why Dr Sandell should not be considered a “credible expert”.

7. In each case, Dr Sandell’s two-page opinion contained a description of the main ingredients of the relevant product and a brief description of what he claimed were their “clinically observed effects as documented in homeopathic and herbal literature”. Attached to his opinion were excerpts from the Natural Medicines Comprehensive Database (NMCD). Dr Sandell said in respect of each product that “due to the combination formulation of [the product], there is a synergistic action between the ingredients” which produces the effect which is claimed for the product. According to Dr Sandell, the synergistic effect enables the ingredients to work in lower doses than if prescribed individually. He also said that the synergy results in “fewer side effects”. He noted that synergistic effects are used in certain Western pharmaceutical medicines as well as in herbal medicines in Chinese traditional medicine. He added that herbal medicines are developed empirically and cannot be discounted as “ineffective merely because they have not been subjected to double-blind clinical studies”.

8. The NMCD was described in a review in the Journal of the Medical Library Association as “one of the most comprehensive and reliable natural medicines resources available” (See P. Peggy Hsu “Natural Medicines Comprehensive Database” in 2002 (90) Journal of the Medical Library Association 114, available on the web at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC64772/ (last accessed on 15 September 2014).). According to the review, the NMCD is written by a group of experts, whose goal is “to create an objective, reliable, scientifically investigated database, including some evidence-based natural medicines, for use by health-care professionals and patients. The data and consensus of scientific information on natural medicines has been used to create both the database and the book” (Id). The Committee notes that the Appellant, the Respondent, Dr Steinman, and the Health Products Association of Southern Africa all agree that the NMCD is a reputable publication that provides reliable information on the efficacy of natural medicines.

9. After the three complaints had been lodged, the ASA received an email message from the Registrar of the AHPCSA that stated that Dr Sandell was “registered as an acupuncturist only … and as such would not have been permitted to administer, prescribe or dispense traditional Chinese herbal medicines”. The message also stated that Dr Sandell had never been registered as a phytotherapist (herbal practitioner). The email message was provided to the Appellant to afford it an opportunity to comment. The Appellant provided a copy of the curriculum vitae of Dr Sandell and stated that Dr Sandell had previously been accepted as an expert by the ASA.

10. The ASA Directorate issued its decision in respect of the complaint against Herbex Appetite Control tablets on 2 April 2013. It noted that the Directorate had considered Dr Sandell an expert since July 2005 based on his curriculum vitae (See Herbex Nerve Tonic / MB Truter/ 940 (28 July 2005) where the Directorate found Dr Sandell to be an “independent and credible expert” on the basis of his curriculum vitae. See also Herbex Website Erroneous / HA Steinman / 10733 (15 April 2008).). However, the Directorate concluded that the email received from the Registrar of the AHPCSA constituted “new evidence” which warranted a departure from the previous acceptance of Dr Sandell as a credible expert. The Directorate reasoned that given that the ingredients of Herbex Appetite Control tablets were herbal in nature, it suggested that they fell within the realm of phytotherapy and that Dr Sandell was not qualified to comment on herbal preparations. The ASA Directorate concluded therefore that there was no substantiation of the claims made in respect of Herbex Appetite Control tablets and instructed the Appellant to withdraw the advertisement immediately. Similar rulings were issued in relation to Herbex Booster Eat-Less drops on 3 May 2013 and Herbex Attack the Fat syrup on 24 April 2013.

11. On 10 June 2013, the Appellant noted appeals against all three decisions of the Directorate to the Advertising Standards Committee. The Appellant also sought condonation for its late filing of the appeals. The grounds of appeal were that the Directorate had erred in relying on the email message received from the Registrar of the AHPC, that the Directorate should have appointed a suitable expert to assist it as an arbitrator in deciding the three matters, that the Directorate did not consider the fact that Dr Sandell had been registered by the AHPCSA as a homeopath from 1999 – 2005, and that he was also a medical doctor. The Appellant also annexed a copy of a letter from Dr Gower, the national secretary of the Homeopathic Association of South Africa, setting out the circumstances in which a homeopath could be considered an expert on herbal preparations. Dr Steinman opposed the appeals.

12. In addition to noting appeals, the Appellant also applied to the chairperson of the Final Appeal Committee, for a ruling in terms of Rule 12.19 of the ASA Procedural Guide, suspending the Directorate rulings pending its appeals. Dr Steinman opposed this application as well. The application was granted on 12 July 2013 and the Directorate rulings were suspended pending the determination of the appeals by the Advertising Standards Committee, and, if applicable, the determination of any appeals to the Final Appeal Committee. Reasons were given for the grant of the application by the President of the Final Appeal Committee.

13. On 29 October 2013, the Advertising Standards Committee (ASC) dismissed the appeal against all three rulings. It found that the Directorate had not erred in relying on the email message from the Registrar of the AHPCSA. The ASC noted that the issue relating to the appointment of an arbitrator did not relate to the issues arising on appeal, but to a different matter. The ASC found there to be nothing on the record before it that provided Dr Sandell’s response to the statement of the AHPCSA registrar. It concluded that “until such time as there is sufficient evidence to erase the concerns raised by [the Registrar or the AHPCSA] as to Dr Sandell’s expertise the committee is not in a position to accept Dr Sandell as an expert at this time.”

14. The Appellant then noted an appeal against the decision of the ASC. The grounds of appeal included the following: that the ASC erred in relying on the email correspondence from the Registrar of the AHPCSA; that the ASC erred in finding that the Dr Sandell was not a credible expert; that the ASC erred in not finding that the Directorate ought to have appointed a suitable expert to act as an independent arbitrator to assist it in deciding the complaints; that the ASC erred by in effect requiring the Appellant to “prove” the expertise of Dr Sandell when the ASA had already accepted him as an expert; that the ASC erred in concluding that a homeopath was not qualified to provide expert evidence on herbal products; and that the ASC failed to take into account the documentary evidence furnished by the Appellant.

15. Dr Steinman opposed the appeal. He stated that there was no evidence on the record relating to Dr Sandell’s qualifications as a homeopath. Dr Sandell pointed out that the letter from the Registrar of the AHPCSA had been provided to the ASA apparently in response to a request he had made to the AHPCSA in terms of the Promotion of Access to Information Act, 2004 (PAIA), asking the AHPCSA to provide him with a copy of the records relating to Dr Sandell’s registration. Dr Steinman also analysed the documentary evidence that had been attached to Dr Sandell’s expert reports in relation to the three products and concluded that they did not support Dr Sandell’s conclusions. Dr Steinman also furnished two reports by other experts, Dr A G Parrish and Dr A L Gray, on Herbex Attack the Fat, as well as several academic articles relating to the use of dietary supplements for body-weight reduction, and a copy of regulations promulgated by the Minister of Health on 15 November 2013 relating to complementary medicines.

16. The appeal was set down for argument before the Final Appeal Committee on 19 March 2014. Just before the appeal was to be heard, as the rules provide, the Appellant lodged written argument. In its written argument, the Appellant, argued for the first time, that the ASA had no jurisdiction over the advertisements that had been the subject of the Respondent’s complaint in relation to all three products because they appeared on the Appellant’s Internet website, and the ASA has no jurisdiction over the Internet website of the Appellant.

17. On 19 March 2014, the hearing of the appeal was postponed. The Appellant was requested to lodge information to indicate whether it is a member of the Health Products Association of Southern Africa (the Health Products Association), and the terms of its membership. The Respondent was also afforded an opportunity to lodge evidence to extend the ambit of its complaints relating to the advertisements in respects of the three products to advertisements in other media. At a later hearing on 11 September 2014, this Committee ruled that it would not consider any such evidence, and would determine the appeal solely on the basis set out in the original complaints of the Respondent. Nothing further therefore need be said in this regard.

18. On 4 April 2014, the Appellant lodged a copy of the Constitution of the Health Products Association, as well as a completed application form submitted by Herbex CC, the predecessor of the Appellant for membership of the Health Products Association dated 6 January 2011. The appeal was against set down for hearing on 31 July 2014. Appellant once again lodged heads of argument. In those heads of argument, Appellant argued that properly construed the Constitution of the Health Products Association did not mean that the members of the Association were bound by the procedural and jurisdictional provisions of the ASA Code. At the hearing, the question was raised with counsel for the Appellant as to whether it would be appropriate for the Final Appeal Committee to consider the meaning of the Constitution of the Health Products Association, which itself is a member of the ASA, without affording the Health Products Association an opportunity to be heard. After taking instructions, counsel for the Appellant agreed that the Health Products Association should be given an opportunity to join the appeal and Dr Steinman did not object to this course of action. Accordingly, the hearing of the appeal was once again postponed to 11 September 2014, and the Health Products Association was invited to join the proceedings and to lodge a statement or evidence. Both the Appellant and Respondent were provided with an opportunity to respond to any evidence or statement lodged by the Health Products Association.

19. The Health Products Association lodged a statement seeking permission to intervene, as well as heads of argument and was represented before the Committee when the appeal was heard on 11 September 2014. At the start of the hearing on 11 September, the Final Appeal Committee indicated to the parties that it had convened a full panel (save for one member) to hear the appeal given the importance of the issues in the appeal. All the parties indicated they had no objection to the composition of the Appeal Committee.
Issues for decision
20. The issues that arise for decision are:

(a) are members of the Health Products Association bound by the terms of the ASA Code, including its procedures and jurisdictional provisions, or are they only bound by the substantive principles contained in the Code;

(b) how should the provisions of clause 4 of the ASA Code in relation to substantiation be interpreted and applied in relation to complementary medicines; and

(c) has the Appellant provided adequate substantiation for the three products at issue in this appeal.
(d) Are members of the Health Products Association bound by the provisions of the ASA Code, including its procedural and jurisdictional provisions?
21. The ASA Code contains a Preface, an Introduction, General Principles, provisions regulating specific categories of advertising, ten appendices regulating, in the main, specific forms of advertisement or specific industries, and a Procedural Guide, which paragraph 14 of the Preface of the Code describes as “an integral part of the Code”. The ASA also publishes guidelines that are “not part of the Code” (see Introductory section to Guidelines) which provides references to laws, rulings and procedures that are relevant to the preparation of advertising copy to assist advertisers.

22. The Constitution of the Health Products Association states that its main objectives and powers include ensuring the “high profile visibility” of the complementary and alternative medicines industry (“CAMS industry”), protecting the CAMS industry, maintaining “high ethical standards of production, quality control, marketing and advertising within the CAMS industry”, and protecting “consumers against exploitation from unethical practices”. (See section 4.2 of the Constitution of the Health Products Association).

23. Section 5 of the Constitution of the Health Products Association contains a Code of Practice. According to section 5, “[t]he vision of the Association is to present, promote and develop the CAMS industry in a professional and ethical manner” and the Code of Practice seeks to ensure “the highest standards of integrity and ethics in the dealings of members with consumers and other members”. Moreover, section 5 states that it is mandatory for members of the Health Products Association to comply fully with all aspects of the Code. Section 5.2 states that –

“Members’ advertisements, presentations at public meetings and promotional literature must not contain any descriptions, claims or illustrations that directly or by implication are misleading about the products or service. All advertisements shall conform to the ASA Code of Advertising Practice (“ASA Code”), the Consumer Protection Act, (Act 68 of 2008), and conform to the regulations of the [national Department of Health] where applicable to different classes of CAMS. For the purposes of the Code of Practice, ‘advertisement’ means the terms as defined in the ASA Code.”

24. Both counsel for the Appellant and for the Health Products Association argued that the import of section 5 of the Health Products Association was that members of the Association were bound only by the substantive aspects of the ASA Code, which regulate the content of advertisements, and not bound by the procedures of the ASA for handling complaints, nor, it was argued, were they subject to the jurisdiction of the ASA committees in respect of complaints received by the ASA relating to advertisements of members of the Health Products Association. Accordingly, it was argued, the ASA did not have jurisdiction to determine the complaints raised by the respondent, because the advertisements at issue had been published on the Herbex website, and not in a publication published by a member of Print Media South Africa, or the National Association of Broadcasters or any other association that is a member of the ASA. It is clear that in order to determine this appeal, we have to commence by determining whether the ASA and its committees have jurisdiction over the issues raised in the appeal.

25. Counsel for the Appellant and the Health Products Association accepted that the interpretation of the Constitution of the Health Products Association for which they contended had never previously been raised by either the Health Products Association or any member of the Health Products Association in any other proceeding before an ASA committee, despite the fact that the Health Products Association has been a member of the ASA for many years, and many of its members have appeared before committees of the ASA.

26. In interpreting section 5 of the Constitution of the Health Products Association, it should be noted, as stated in a recent Supreme Court of Appeal judgment, that –

“… in interpreting any document the starting point is inevitably the language of the document but it falls to be construed in the light of its context, the apparent purpose to which it is directed and the material known to those responsible for its production. Context, the purpose of the provision under consideration and the background to the preparation and production of the document in question are not secondary matters introduced to resolve linguistic uncertainty but are fundamental to the process of interpretation from the outset.” (See Dexgroup (Pty) Ltd v Trustco Group International (Pty) Ltd and Others 2013 (6) SA 520 (SCA) at para 16. See also Natal Joint Muncipal Pension Fund v Endumeni Municipality 2012 (4) SA 593 (SCA) at para 24.)

27. In interpreting what section 5 of the Health Products Association Constitution means, therefore, it is appropriate to look at its context, the apparent purpose to which it is directed and the material known to those responsible for its production. As mentioned above, the Constitution of the Health Products Association states that its main objectives and powers include, maintaining “high ethical standards of production, quality control, marketing and advertising within the CAMS industry”, and protecting “consumers against exploitation from unethical practices”. (See section 4.2 of the Constitution of the Health Products Association). Moreover, according to section 5 of the Constitution, the Code of Practice seeks to ensure “the highest standards of integrity and ethics in the dealings of members with consumers and other members”.

28. In interpreting section 5, it is also important to understand the nature of the ASA and its Code, given that section 5 pertinently refers to the ASA Code. There are three aspects of the ASA and its Code that are important. First, the ASA establishes a system of “self-regulation in the public interest” (See paragraph 1 of the Preface of the ASA Code). To this end, the ASA Code of Advertising Practice is the “guiding document” (See paragraph 2 of the Preface of the ASA Code) which serves as the basis for self-regulation. In this regard, too, it should be noted that membership of the ASA consists by and large of associations, and not of individual companies, whether producers, retailers or media companies. Members of the ASA include the Association for Communication and Advertising, the Association of South Africa Travel Agents, the Direct Marketing Association of South Africa, the Marketing Association of South Africa, the National Association of Broadcasters, Print Media South Africa and the Printing Industries Federation (See paragraph 3 of the Preface of the ASA Code). These associations themselves are not primarily producers or publishers of advertisements, although their members are.

29. Secondly, the ASA Code contains both substantive provisions that regulate the content and manner of advertising, as well as the procedures that govern the administration of the Code by the ASA Directorate and ASA committees, which lie at the heart of the process of self-regulation for which the ASA was established. It is not surprising then that the ASA Code does not distinguish between its substantive and procedural or jurisdictional aspects. Indeed, the Preface of the Code, as has been noted above, provides that the Procedural Guide forms “an integral part” of the Code. To ensure that the process is one of “self-regulation”, the membership of ASA committees is drawn, in the main, from member associations and all members of ASA Committees, including the presiding chairpersons of its appeal committees, are appointed by members of the ASA at its Annual General Meeting.

30. Thirdly, the ASA Code does not contemplate that only members of the ASA itself will be bound by the Code. The Preface of the Code states that the Code “binds the advertiser, the advertising practitioner and the medium involved in the publication of the advertiser’s message to the public” (Paragraph 7 of the Preface to the ASA Code), and “[a]ll entities bound by the Code shall neither prepare nor accept any advertising which conflicts with the Code and shall withdraw any advertising which has subsequently been deemed to be unacceptable by the ASA Directorate, Advertising Standards Committee, Advertising Tribunal or Appeal Committee” (Paragraph 11 of the Preface of the ASA Code). The Preface thus recognises that it is not only “members of the ASA” that are bound by the Code, but other “entities” are bound as well. It is clear, given that the ASA is a self-regulatory system that other entities must be bound through a system of contract. One of the ways in which entities that are not members of the ASA may be bound to the system of self-regulation established in the ASA Code is through their membership of a member of the ASA, although this will depend in each case on the terms of the contract between the members and the association.

31. Given the nature and objects of the ASA, it would be logical for the Constitution of the Health Products Association (and the constitutions of other members of the ASA) to provide that its members are bound by and subject to the self-regulatory system established by the ASA, of which the Health Products Association is a member. And indeed, section 5 of the Constitution states that members’ advertisements “shall conform” to the ASA Code of Advertising Practice which suggests that members of the Health Products Association are bound to “conform with” all aspects of the ASA Code.

32. However, counsel for the Appellant and the Health Products Association argued that section 5 should be given a narrow meaning to mean that members of the Health Products Association are only by bound by the ASA Code insofar as the Code regulates substantive requirements for advertisements. While linguistically on its face this interpretation may seem a possible interpretation of paragraph 5, when one looks at the context and purpose of paragraph 5 in the light of the objectives of the ASA and the provisions of its Code, the interpretation seems less satisfactory. Counsels’ interpretation requires a distinction to be drawn between the substantive aspects of the ASA Code and the procedures it puts in place to enforce the Code. Yet the ASA Code does not contemplate such a distinction. Indeed, the ASA states in clear terms that the Procedural Guide is “an integral part of the Code.” The reason for this is that the founding purpose of the ASA is to provide for self-regulation of advertising in the public interest, which requires both a set of substantive rules and a system for the enforcement of those rules, which is what the ASA Code provides. Enforcement of the Code by the Directorate and the committees of the ASA is thus central to the design and purpose of the Code. The ASA Code simply does not contemplate that its substance can be separated from its process. Members of the ASA understand and accept that principle and that principle is an important contextual consideration relevant to the interpretation of the constitutions of ASA members. Any interpretation of the constitutions of members of the ASA must where possible give effect to this principle upon which membership of the ASA is premised.

33. During the hearing, counsel for the Health Products Association could not suggest any reason why the Association would have joined the ASA other than to participate in the process of self-regulation to which the ASA is committed. He said that the Association joined the ASA in order to be able to influence its decisions, a legitimate purpose for any member of a self-regulating body.

34. We conclude therefore that properly construed section 5 of the Constitution of the Health Products Association means that members of the Health Products Association are bound to conform to the system of self-regulation of advertisements in the public interest, upon which the ASA Code is premised. The narrow interpretation of section 5 for which counsel contended is not consistent with the purpose and design of the ASA Code and cannot be accepted. Moreover, we note that the interpretation of paragraph 5 of the Constitution of the Health Products Association adopted here is consistent with the objects of the Health Products Association as identified in its Constitution. Those objectives seek to ensure that high ethical standards are embraced by its members in relation to, amongst other things, advertising and marketing, as well as seeking to protect consumers from being exploited by unethical practices.

35. In the light of the conclusion we have reached, it follows that as Herbex (Pty) Ltd is a member of the Health Products Association it is bound by the system of self-regulation provided for in the ASA Code in relation to the advertisement of its products. Counsel for Appellant correctly accepted that the definition of “advertisement” in the ASA Code includes advertisements on an Internet website and thus covers the advertisements in this appeal. It follows that it is now necessary to turn to the question whether the Appellant has provided substantiation for the advertisements at issue in this appeal.
(b) How should the provisions of clause 4 of the ASA Code in relation to substantiation be interpreted and applied in relation to complementary medicines?
36. Clause 4/p.1 of Section II of the ASA Code deals with substantiation. It provides that –

“4.1.1 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.

4.1.2 Documentary evidence, whether in the form of survey data or any other documentation, shall be up to date and current, and shall have market relevance.

4.1.3 [omitted]

4.1.4 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.”

37. The principle of substantiation contained in clause 4 of section II of the Code has two elements: first, an advertiser must be able to provide documentary evidence to support claims made in advertisements that are capable of objective substantiation; and secondly, an advertiser must have that documentary evidence in its possession before an advertisement is published. Both these elements are important in that they serve to ensure that advertisers take care, before publishing advertisements, that they can substantiate any objective claims made in advertisements.

38. The proper approach to clause 4.1.4 was considered in a recent decision of this Committee, in which the Committee noted that –

“… clause 4.1.4 of section II of the ASA Code requires, amongst other things, that the documentary evidence tendered as substantiation of an advertising claim must ‘emanate from a source or be evaluated by a person/entity, that is “independent” and “credible.”’ The requirement of credibility must, as a matter of common sense, go both to the person tendering the evidence and to the evidence itself. So not only must the person who evaluates the evidence be credible but the documentary evidence proffered must on its own terms be plausible and provide reasonable grounds for believing the statement made in the advertisement. If documentary evidence does not provide reasonable grounds for believing the advertising claim, it will not meet the standard set in clause 4.1.4.” (See Advanced Lifebuoy / Dettol / 20233 (FAC) (March 2014) at para 30).

39. In the view of this Committee when a claim is made in respect of a complementary or alternative medicine as to the effect of that product, such a claim should be understood as one that is capable of objective substantiation. The Committee notes however that there are various methods of substantiation that may be adopted. In this regard, counsel for the Appellant drew the Committee’s attention to the Guideline for “Complementary Medicines — Quality, Safety and Efficacy” published by the Medicines Control Council in November 2013 (A part of this document was attached to Appellant’s second set of heads of argument dated 25 July 2014, but also may be found on the web at http://www.mccza.com/genericDocuments/7.01_CAMs_QSE_Dec13_v2_1.pdf (last accessed on 16 September 2014)). Paragraph 5.1 of those Guidelines listed various methods whereby the efficacy of complementary medicines could be shown. It records that –

“Generally acceptable evidence in support of efficacy include:
i. Appropriately designed clinical trials using the product for which an application is being made.
ii. Appropriately designed qualitative and observational studies preferably using South African-validated instruments/methods.
iii. Published systematic reviews such as in the Cochrane database.
iv. Published clinical trials.
v. Published case reports.
vi. Evidence-based databases (e.g. Natural Medicines Comprehensive Database, Natural Standards Database).
vii. Accepted Herbal monographs or pharmacopoeiae.
viii. Monographs from any other source equivalent in standard to any of the above.
ix. In the case of homoeopathic medicines, justification of the use of the medicines from the relevant Materia Medica or Repertory listing.”

40. In the view of this Committee, the methods for substantiation of complementary medicines listed in this Guideline provide a helpful basis for identifying what will constitute substantiation for an advertising claim relating to a complementary or alternative medicine within the meaning of clause 4 of section II of the ASA Code. Where an expert witness wishes to assert the efficacy of a natural product used in a complementary or alternative medicine, the Committee considers that reliance on one or more of the sources listed in the Medicines Control Council guidelines which support the advertising claims will in most cases provide adequate substantiation of the claim. The Committee also notes that ordinarily the mere say-so of an expert witness will not be sufficient to establish efficacy claims made in respect of a complementary or alternative medicine. More will be required. In the view of the Committee, the focus should not only be on the nature and level of expertise of the witness, but should also be on the documentary evidence that a witness provides to support his or her evidence.

41. Counsel for the Appellant drew the Committee’s attention to a report written by Dr Craig D Wright, “An overview of the history and principles of western herbal medicine.” According to this report, western herbal medicine is a “holistic, patient-centred system of medicine”. The report states that there are three basic approaches to using herbs as medicines: short-term large doses for symptomatic relief; herbal treatment for chronic conditions, often in smaller doses; and milder herbal alternatives to modern allopathic drugs. Counsel for the appellant suggested that there is a different “paradigm” applicable to complementary medicines, than that applicable to traditional medicines. He also suggested that Dr Wright’s report would assist the committee in determining how to approach the question of “substantiation” for complementary and alternative medicines. Although it is helpful to understand the approach that informs the preparation of complementary medicines, the question for the ASA in determining whether there has been a breach of clause 4 of the ASA Code is whether an advertiser had in its possession at the time an advertising claim was made in respect of a complementary medicine, documentation that supported the claim. In the view of the committee, the question of the underlying healthcare “paradigm” is not particularly helpful in answering this question.

42. More helpful in answering the question, in the view of the Committee, is the policy statement regarding advertisement substantiation of the US Federal Trade Commission (FTC) to which the Health Products Association drew the attention of the Committee (The statement was attached as annexure RA2 to the reply of the Health Products Association to the Appellant’s answer to the Health Products Association founding affidavit. The Policy Statement was issued in March 1983 and appears to be still current. It may be found on the web at http://www.ftc.gov/public-statements/1983/03/ftc-policy-statement-regarding-advertising-substantiation (last accessed on 16 September 2014). In that policy statement, the FTC states that the underlying requirement for substantiation is that advertisers “have a reasonable basis for advertising claims before they are disseminated”. The FTC notes that what constitutes “a reasonable basis” depends on a range of factors including the nature of the product and the consequences of a false claim. In this regard, and in the context of complementary medicines, the Committee notes that where there is any suggestion that a complementary medicines product may have any risk of material harm to a consumer of the product, the burden on the advertiser to substantiate claims made in respect of the products will be more onerous.

43. The Committee now turns to consider the final question in this appeal, and that is whether the Appellant provided adequate substantiation for the three products.
(c) Has the Appellant provided adequate substantiation for the three products at issue in this appeal?
44. As set out above, the appeal related to advertisements placed on its website in relation to three products: Herbex Appetite Control Tablets, Herbex Booster Eat-Less Drops and Herbex Attack the Fat Syrup. In relation to the first product, the respondent stated that the claim made is that Herbex Appetite Control tablets “… are formulated to manage the appetite safely and naturally”, and the packaging claims that the tablets constitute an “effective weight-loss formula” and using them “manages appetite, reduces hunger pangs and cravings”. The tablets contain spirulina, garcinia cambogia (citrin), yerba maté, camellia sinensis (green tea) and ginger. In relation to the second product, Herbex Booster Eat-Less Drops, the claim made was that: “its main function is to balance blood sugar levels, reducing hunger pangs and positively effecting diabetes. It is also effective for nausea, indigestion and abdominal distensions”. Herbex Booster Eat-Less Drops contain cynara scolymus (artichoke), gymnema sylvestre, trigonella foenum (fenugreek), panax (ginseng) and chromium picolinate. The claim for the third product, Herbex Attack the Fat Syrup, was that it “… is a powerful herbal syrup that will help you lose weight. A few teaspoons a day will help you look your best and boost your confidence.” The product contains: agathosma betulina (buchu), camellia sinensis (green tea), garcinia cambogia (citrin), aloe ferox bitters and lemon concentrate.

45. The Appellant responded to each of Dr Steinman’s complaints by lodging an evaluation of each of the products by Dr Sandell, with attached documentation. In each case, Dr Sandell’s two-page opinion contained a description of the main ingredients of the relevant product and a brief description of what he claimed were their “clinically observed effects as documented in homeopathic and herbal literature”. Attached to his opinion were excerpts from the Natural Medicines Comprehensive Database (NMCD). Dr Sandell said in respect of each product that “due to the combination formulation of [the product], there is a synergistic action between the ingredients” which produces the effect which is claimed for the product. According to Dr Sandell, the synergistic effect enables the ingredients to work in lower doses than if prescribed individually. He also said that the synergy results in “fewer side effects”. He noted that synergistic effects are used in certain Western pharmaceutical medicines as well as in herbal medicines in Chinese traditional medicine. He added that herbal medicines are developed empirically and cannot be discounted as “ineffective merely because they have not been subjected to double-blind clinical studies”.

46. The documentation attached by Dr Sandell was from the NMCD, which was described in a review in the Journal of the Medical Library Association as “one of the most comprehensive and reliable natural medicines resources available” (See P. Peggy Hsu “Natural Medicines Comprehensive Database” in 2002 (90) Journal of the Medical Library Association 114, available on the web at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC64772/ (last accessed on 15 September 2014)). According to the review, the NMCD is written by a group of experts, whose goal is “to create an objective, reliable, scientifically investigated database, including some evidence-based natural medicines, for use by health-care professionals and patients. The date and consensus of scientific information on natural medicines has been used to create both the database and the book.” (Id) The NMCD is also mentioned as providing “generally acceptable evidence” for efficacy claims (see discussion at para 39 above).

47. Accordingly had the NMCD corroborated Dr Sandell’s evidence, the evidence tendered by the Appellant might well have been considered to constitute adequate substantiation for the claims made in respect of the three products. Unfortunately, however, as Dr Steinman pointed out, in many cases the NMCD does not support the claims made for the effectiveness of the ingredients of the three products asserted by Dr Sandell. So, for example, in relation to Herbex Appetite Control tablets which contain spirulina (arthrospira plantensis), garcinia cambogia (citrin), yerba maté, camellia sinensis (green tea) and ginger, Dr Sandell stated that spirulina “reduces appetite and improves fat metabolism”. To support this he attaches the relevant pages of the NMCD which state, under a heading “effectiveness”, that “preliminary research shows that taking spirulina blue-green algae does not seem to help reduce weight”. In relation to garcinia cambogia, Dr Sandell asserted that it brings about weight loss, is an appetite suppressant, that it inhibits body fat deposition, assists the satiation reflex, and that it also assists the metabolism of fat in the production of energy. The NMCD on the other hand states that –
“Taking garcinia fruit rind extract orally does not seem to help decrease weight, satiety, fat oxidation or energy expenditure in obese people. There is some mixed evidence that garcinia might reduce food intake while sustaining satiety, but it is too early to recommend for this use. There is insufficient reliable information available about the effectiveness of garcinia for its other uses.”

48. With regard to yerba maté, Dr Sandell claimed that it is a metabolic enhancer that will help metabolise fat and reduce the appetite. The NMCD states, on the other hand, that although yerba maté “taken orally might cause weight loss when used in combination with guarana and damiana”, “more evidence is needed to rate [yerba maté] for this use”. Similarly, the NMCD did not support the use of camellia sinensis for the purposes of aiding the metabolism of fat and the reduction of appetite, as claimed by Dr Sandell. Nor did the NMCD support his claim that ginger could be used as an antispasmodic or digestive aid.

49. There are therefore significant contradictions between what Dr Sandell states in his report, and the documentary evidence he produces in support of his report, in relation to the ingredients of Herbex Appetite Control tablets. As mentioned above, this Committee has recently held that clause 4.1.4 of section II of the Code requires not only that the person who evaluates the evidence be credible but also requires that the documentary evidence proffered must on its own terms be plausible and provide reasonable grounds for believing the statement made in the advertisement. In this case, the documentary evidence does not support (indeed it quite often contradicts) what Dr Sandell says in his report. The report of Dr Sandell does not therefore constitute credible evidence to substantiate the advertising claims made in relation to Herbex Appetite Control tablets.

50. The claims made for Herbex Booster Eat-Less drops are that “its main function is to balance blood sugar levels, reducing hunger pangs and positively effect in diabetes. It is also effective for nausea, indigestion and abdominal distensions”. Herbex Booster Eat-Less Drops contain cynara scolymus (artichoke), gymnema sylvestre, trigonella foenum (fenugreek), panax (ginseng) and chromium picolinate. Cynara scolymus is, according to the NMCD, possibly effective in reducing dyspepsia, nausea and abdominal pain, as Dr Sandell claimed. However, according to the NMCD, trigonella foenum, should not be used for dyspepsia, as Dr Sandell claimed, nor for the purposes claimed in the advertisement for Herbex Boostger Eat-Less Drops as it has been shown, when taken orally, to cause diarrhoea, dyspepsia, abdominal distension and flatulence. Moreover, the NMCD does not support Dr Sandell’s claim that ginseng has demonstrated anti-stress properties. While, according to the NMCD, there is some possibility that chromium picolinate may assist those living with diabetes it suggests that not all evidence is positive. In sum, although there is more support for some of Dr Sandell’s claims in relation to the ingredients of Herbex Booster Eat Less drops, in the case of one of the ingredients, the NMCD suggests that it is positively contra-indicated in respect of the advertising claims made for the product. In the view of the Comitttee, the evidence tendered by Dr Sandell in this regard, also does not constitute a “reasonable basis” or substantiation of the advertising claim within the meaning of clause 4.1.4 of section II of the ASA Code.

51. The claims made for Herbex Attack the Fat Syrup, are that it “… is a powerful herbal syrup that will help you lose weight. A few teaspoons a day will help you look your best and boost your confidence.” The product contains: agathosma betulina (buchu), camellia sinensis (green tea), garcinia cambogia (citrin), aloe ferox bitters and lemon concentrate. As mentioned in paragraphs 47 and 48 above, although Dr Sandell suggests that garcinia cambogia and camellia sinensis have effects that will result in weight loss, this is not supported by the relevant pages from the NMCD that he attached to this report. Moreover, the NMCD states that there is insufficient evidence for the effectiveness of buchu, although Dr Sandell claims that it has diuretic properties and will alleviate flatulence and bloating. The Committee notes however, that the NMCD does support Dr Sandell’s claim that aloe ferox bitters have a laxative effect. In conclusion, once again most of Dr Sandell’s claims in relation to the ingredients of Herbex Attack the Fat syrup are not supported by the evidence provided by the NMCD.

52. This analysis of the evidence presented by Dr Sandell does not require this Committee to consider whether Dr Sandell should be accepted as an expert. What is clear is that the documentary evidence he has tendered in relation to these three products does not provide a reasonable basis for concluding that the Appellant has shown that it had documentary evidence substantiating the advertising claims made for its three products at the time that the advertising claims were made.

53. The Appellant sought to lodge further substantiation during the appeal process. It is clear that advertisers are ordinarily required to have substantiation for advertising claims made in respect of their products prior to the advertisements being published. Save in the special circumstances contemplated in clause 4.1.7 of the Code, which permits an advertiser to provide new substantiation to the Directorate upon payment of a prescribed fee, in circumstances where the Directorate has rejected substantiation previously provided by an advertiser, advertisers will not ordinarily be permitted to lodge further substantiation of an advertising claim upon appeal, particularly where that substantiation did not exist at the time the advertisement was placed. It is not necessary in these proceedings to consider whether substantiation tendered in terms of clause 4.1.7 needs to have been in the possession of the advertiser at the time the advertisement was published. What is clear, given the wording of clause 4.1, is that substantiation provided after the date of the advertisement is not ordinarily permissible. We do not need to decide here whether such substantiation should ever be admitted on appeal. At best for the appellant, its further substantiation would only be permitted to substantiate its advertising claims, if it provided clear and unequivocal substantiation for the claims made.

54. In this case, the Committee notes that the additional substantiation was apparently acquired after the advertisement was placed, which means that ordinarily it could not be used to substantiate the claims made in the advertisement at issue. Nevertheless, the Committee has considered the reports provided by Dr Nye in relation to all three products, as well as that of Dr Lewis in relation to Herbex Attack the Fat Syrup and Herbex Booster Eat-Less Drops, as well as Dr Curtolo’s report on Herbex Attack the Fat syrup.

55. In relation to all three products, Dr Nye provided a more comprehensive report than that furnished by Dr Sandell. To his reports, he annexed many of the pages from the NMCD relating to the ingredients of the three products, which do not, in the main, support the advertising claims made in respect of the products, as mentioned above. Dr Nye does not acknowledge the apparent lack of fit between his views and the documentary evidence from the NMCD which he annexes to his reports, nor does he explain it. In the view of the Committee, that lack of fit raises concerns as to the plausibility of his report, particularly as the inconsistencies are not explained by Dr Nye. Dr Lewis merely supports the reports of Dr Nye and Dr Sandell in relation to Herbex Attack the Fat syrup and Herbex Booster Eat-Less Drops and says that they are correct, without any substantial independent reasoning being provided, although she provides several references to the literature. Nor does she explain the inconsistencies between the NMCD references attached to both reports and the conclusions reached in the reports.

56. Dr Curtolo also supports the claims made for Herbex Attack the Fat syrup, although she provides more considered reasoning and is less convinced that the product will have, without more, the effects claimed for it. She concludes in relation to Herbex Attack the Fat syrup that it “will have a therapeutic effect, regardless of the low doses of the individual herbs, if administered in conjunction with suitable dietary adjustments and physical exercise”. The Committee notes in this regard that “suitable dietary adjustments and physical exercise” might, without more, result in weight loss. She adds that the manufacturer should consider “reviewing the product ingredients as a more suitable weight loss mixture can be formulated”. In the view of the Committee, Dr Curtolo’s report does not constitute a persuasive substantiation of the advertising claims made for Herbex Attack the Fat syrup.

57. Accordingly, the Committee is not persuaded that the additional substantiation furnished by the Appellant can be described as providing a clear and unequivocal substantiation for the advertising claims made in respect of the products. Given that it was not in the possession of the appellant at the time the advertisements were placed it cannot be used to substantiate the claims belatedly.

58. In conclusion, the Committee concludes that Appellant did not have in its possession at the time that the advertisements were published in respect of the three products documentary evidence which substantiates the objective claims made in respect of the three products as required by clause 4 of section II of the ASA Code. Accordingly, the appeal lodged by the Appellant against the decision of the ASC falls to be dismissed.

59. The Committee records that given its conclusion arising from its analysis of the evidence provided by the Appellant purporting to substantiate the advertising claims made in respect of the three products, it has not been necessary for the Committee to consider the claims made by the Appellant, and its experts, relating to the “synergetic effects of natural ingredients.” As far as the Committee understands the Appellant’s argument in this regard, the principle of “synergy” suggests that natural ingredients, when combined, have an effect that means that dosages of the relevant natural ingredients can individually be lower than ordinarily required to produce the desired outcome. In the view of the Committee, the evidence before it suggests that synergistic effects cannot be asserted for all combinations of natural ingredients in all circumstances, but rather that individual combinations and dosages require individual investigation to determine whether synergistic effects occur. No more need be said in this regard as it is not an issue that needs to be determined finally now.

60. The Committee concludes that Appellant’s appeal against the decision of the Advertising Standards Committee fails in respect of all three advertisements. No order is made as to costs.

Members of this Final Appeal Committee (FAC):

  1. Nkwenkwe Nkomo (see https://en.wikipedia.org/wiki/Nkwenkwe_Nkomo and http://whoswho.co.za/nkwenkwe-nkomo-5350)
  2. Mike Gendel (see http://www.gendel.com/#about_us – “senior Management team”)
  3. Dianne Terblanche is listed as the Executive Chairperson for the National Consumer Tribunal (falls under the Credit Regulator). Also see https://za.linkedin.com/in/drterblanche
  4. John Little (see https://za.linkedin.com/in/johnlittleatjohannesburg, http://www.observatoryinternational.com/uk/people/john-little/)
  5. Dimakatso Qocha (she is the Deputy Executive Director for the National Association of Broadcasters (NAB).) NAB = National Association of Broadcasters (see www.nab.org.za) ACA = Association for Communication and Advertising (see www.acasa.co.za)

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2 Responses to Herbex and HPA’s arguments ring hollow – ASA Final Appeal Committee Ruling

  1. thabo 19 January, 2015 at 6:32 pm #

    Good day
    Why is herbex flighting TV adverts again in January 2015?

    • Harris 19 January, 2015 at 7:48 pm #

      @Thabo
      The ASA rulings are only against the products complained about. So a company selling scams can simply start selling a different scam. Herbex, Homemark and others are companies that do this. The TV adverts being shown are for for a different product and a complaint has been laid with the ASA against this advert. They have not ruled yet.

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