Herbex UltraSlim: Advertising Regulatory Board ruling

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Posted 14 May 2021

In November 2020, the Advertising Regulatory Board ruled against the claims being made by Herbex UltraSlim preventing further advertising of this product on DSTV and elsewhere. The complainant argued that there is zero evidence to show that this product has any effect on weight-loss, or any of the other claims being made for the product.

Herbex has now appealed this ruling, supplying a ‘dossier’ compiled by Dr Craig Wright, a homeopath and herbal practitioner. The original complainant argued that the dossier still did not substantiate the claims for the product. The ABR agreed.

Herewith the ruling:

Decision of the Advertising Regulatory Board

Complainant: Dr Harris Steinman
Advertiser: Newgroup (Pty) Ltd
Consumer/Competitor: Consumer
File reference: 1055 – Herbex Ultraslim – Dr Harris Steinman
Outcome: New substantiation partially accepted

Date :13 May 2021

The Directorate of the Advertising Regulatory Board has been called upon to consider new substantiation submitted by the Advertiser in accordance with Clause 4.1.7 of Section II of the Code. This new substantiation was submitted in an attempt to overturn the Directorate’s decision issued on 10 November 2020, which held that the advertiser’s claims had not been substantiated.

Background to the dispute

In its ruling dated 10 November 2020, the ARB Directorate ruled against the Advertiser’s television and website advertising. The ruling noted, inter alia, that the Complainant had presented a compelling argument to show that the advertised claims were unsubstantiated, and that neither the relevant ingredients nor the product as a whole could deliver on its promises. The ruling also recorded that the Advertiser submitted no evidence in support of its claims, despite being afforded an opportunity to do so.

New submissions by the Advertiser

In a letter dated 5 March 2021, attorneys DM Fialkov submitted that the ARB was a self- appointed regulator that purported to exercise wide-ranging powers that have enormous adverse effect on third parties while infringing on their constitutional rights. It added that the Complainant was not a “consumer”, never claimed to have bought any of its products, and as such had no standing to lodge his complaints. It requested the ARB to rule as such, and dismiss his complaint out of hand.

In addition, it bemoaned the ARB’s procedures and capacity to rule on products of this nature, arguing that the ARB was applying “… a scientific standard of proof to complementary medicines …” and that it was imposing “… an impossible standard by requiring unequivocal proof of efficacy”.

While it was not prepared to submit to the jurisdiction of the ARB, it would furnish the substantiating documents in its possession to prove that it had such evidence prior to publishing the relevant advertising.

It added that the South African Health Products Regulatory Authority (SAHPRA) provide for this product to be sold under Category D – Complementary Medicine, which means that the ARB has no say in the matter, and could not unilaterally impose its rules on such products.

The actual substantiating documents will be discussed further below.

Complainant’s views on the Advertiser’s substantiating documents

In keeping with the rules of natural justice, the Complainant was afforded an opportunity to comment on the new submissions from the Advertiser. He was asked to address the Directorate on:

1)            His status as a consumer complainant, and

2)            His views on whether the evidence complied with Clause 4.1 of Section II of the Code.

The Complainant noted that his status has been questioned several times over the past few years, and that he has consistently been regarded as a consumer complainant in terms of the Code of Advertising Practice. He is a consumer activist who, with some degree of expertise, feels compelled by duty as well as his ethics as a health professional, to protect fellow consumers who do not have the same expertise to make fully informed decisions. He has no financial interest in any company making health products, and is not acting for a competitor of Herbex.

He also addressed the Directorate in relation to his professional qualifications.

Dealing with the evidence submitted, he noted that obesity was a serious medical condition, accompanied by serious comorbidities. This makes it critical to evaluate any evidence of efficacy objectively. From this perspective, it is worth emphasising that “Big Pharma” has, to date, not been able to develop an over-the-counter product to address this problem. The fact that the Advertiser’s expert (Dr Craig Wright) feels that the evidence at hand implies that Herbex achieves this objective suggests that he is not a credible expert. He added that SAHPRA has not evaluated this product for efficacy or safety.

He explained that his initial complaint and overall view of this product was informed by information on the Natural Medicines Comprehensive Database (an entity that recently changed its name to “Natural Medicines”), which is regarded as the most authoritative resource available on dietary supplements, natural medicines, and complementary alternative and integrative therapies. This database uses a multi-disciplinary, multi- pronged approach to peer review for all content contained in the Database. The Editorial Review Board consists of practitioners from multiple disciplines including pharmacy, medicine, nutrition, research, nursing, and others. Dr Wright’s views and opinion clearly contradicts that the Natural Medicines panel of experts, which suggests that he is not a credible expert.

In addition, it appears that Dr Wright has consulted to Herbex numerous times in the past, and has compiled Herbex’s dossier for registration purposes, which casts doubt over his independence. He has no expertise in Obesity or Ayurvedic Medicine, and in some instances draws conclusions about the efficacy of certain ingredients that fly in the face of peer-reviewed published articles, as well as the Natural Medicines’ panel of experts. This too points to the fact that he is not a credible expert as required by Clause 4.1 of Section II.

Finally, the Complainant pointed out that Dr Wright’s conclusions about Health Canada’s “acceptance” of certain health claims for, inter alia, green tea products is misplaced and reflects a misunderstanding of the truth. His substantiating letter reflects the dosages of certain ingredients incorrectly, and his submissions with regards to Herbex’s compliance with SAHPRA guidelines are inaccurate. Dr Wright also fails to explain how Herbex was able to develop an effective or partially effective over-the-counter weight loss product when “Big Pharma” has not yet achieved this. A credible expert would not make such mistakes.

Application of the Code of Advertising Practice

Given the original ruling, the Directorate had to consider Clause 4.1 of Section II (Substantiation)

Decision

Having considered all the material before it, the Directorate of the ARB issues the following finding.

Jurisdiction

The original ruling in this matter dealt with the ARB’s jurisdiction insofar as it pertains to the parties. It therefore serves no purpose to restate what was said in that ruling, save to note (again) that the ARB will rule on whatever is before it when making a decision for the guidance of its members. This ruling will be binding only on ARB members and on broadcasters in terms of the Electronic Communications Act.

It should also be noted that the ARB does not purport to pronounce on the Advertiser’s compliance with the relevant legislation and regulations as enforced by the Department of Health or the South African Health Products Regulatory Authority (SAHPRA). The ARB only seeks to determine whether the advertising is compliant with its Code of Advertising Practice.

Status of the Complainant

The Advertiser argued that the Complainant was not a consumer, has never purchased any of the products against which he complains, and has never averred that he was influenced by any advertising promoting such products. It submitted that the ARB should dismiss his complaints out of hand on this basis.

The Complainant explained that he was a consumer activist who, with some degree of expertise, feels compelled by duty as well as his ethics as a health professional, to protect fellow consumers who do not have the same expertise to make fully informed decisions.

The Directorate notes as follows:

Clause 4.11 of Section I of the Code defines a “Consumer” as “… any person who is likely to be reached by or exposed to an advertisement. This includes an end consumer, user or trade customer”.

Clause 4.12 of Section I defines “Consumer complaints” as “… complaints lodged by members of the public or organisations regarding consumer related matters, concerning compliance with the Code by an advertisement or advertiser”.

There is no requirement in the Code for consumers to have purchased a product or service prior to lodging a complaint, or to actually have been influenced by the advertising. Any consumer who has a legitimate belief that an advertisement is in contravention of the Code is entitled to lodge a formal complaint with the ARB. In the absence of anything to show that the Complainant has a commercial interest, or that he represents an entity with a commercial interest in this matter (which would render his complaint a “Competitor complaint” in Clause 4.10 of Section I), there is nothing that invalidates his complaint as  a consumer complaint.

It is also accepted that certain consumers may take on a role of consumer activist, whether as a representative of an organisation or movement, or as an individual. The fact that a consumer takes such a role does not invalidate that they are, indeed, a consumer.

The Directorate is therefore satisfied that Dr Steinman is a consumer in terms of the Code.

Merits

Clause 4.1 of Section II requires advertisers to hold substantiation for all claims capable of objective substantiation. It stipulates that such substantiation must “emanate from or be evaluated by a person/entity, which is independent, credible, and an expert in the field to which the claims relate and be acceptable to the ARB”.

It is trite that the ARB requires unequivocal verification from an independent expert. Because the ARB is not a medical, technical or research expert, it has to defer to the views of a suitably qualified and experienced expert. Unlike, for instance, the SAHPRA, the ARB does not possess the requisite technical medical skills and understanding to interpret research or raw data and draw conclusions from it about which claims are proven and which are not. The ARB is still, however, expected to adjudicate on complaints brought to it against advertisements that contain objectively verifiable claims.

It is noted that nothing was put before the Directorate to indicate that the SAHPRA has evaluated the product and found the claims to be substantiated, which would certainly be material to this matter. Rather, the submissions state, “Ultraslim will be submitted for registration to the regulator when an appropriate call-up notice is issued by the SAHPRA”. In addition, it notes that “Herbex is in compliance with the requirements of SAHPRA for Complementary Medicines, as laid out in the Regulations and Guidelines, in particular Guideline 7.02: Complementary Medicine – Roadmap and Transitional Arrangements”.

This particular guideline (accessible at https://www.sahpra.org.za/wp- content/uploads/2021/03/7.02_Roadmap_for_CMs_Mar21_v2_2.pdf) notes, inter alia, that SAHPRA has not yet evaluated any Complementary Medicines (including products such as the Advertiser’s Herbex range) for safety, efficacy or quality.

The Directorate therefore works from the understanding that the legislated regulator (SAHPRA) has not yet considered the Advertiser’s evidence or pronounced on its advertised efficacy.

Given this, and given the requirements of Clause 4.1 of Section II as highlighted above, it is imperative that the expert utilised to substantiate the claims verifies in no uncertain terms that the claims in question are valid, supported by appropriate evidence, and that they ring true for the product as a whole and when used or consumed as recommended.

Claims in issue

The original ruling listed the following claims that appeared in the television commercial:

  • “Herbex Ultraslim a weight-loss evolution”.
  • “South Africa’s number 1 slimming brand”.
  • “25 years refining the science of weight loss”.
  • “Balances blood sugar”.
  • “Preventing belly fat”.
  • “Aids digestion to improve Gut Health”.
  • “Increases metabolism to burn fat faster”.
  • “With triple the action”.
  • “24 hour weight loss”.

In addition, it listed the following claims from the Advertiser’s website:

  • “THIS  REVOLUTIONARY  SOLUTION  WORKS  ON  YOUR  BODY  AROUND THE CLOCK TO:
  • INCREASE YOUR METABOLISM, SO THAT YOUR BODY BURNS MORE CALORIES AND FAT
  • PREVENT BLOOD SUGAR SPIKES AND DIPS, SO THAT YOUR BODY:
  • MAKES AND STORES LESS FAT
  • USES FAT FOR ENERGY INSTEAD OF STORING IT
  • IS LESS LIKELY TO STORE UNWANTED FAT AROUND YOUR BELLY AND ORGANS
  • ACTIVATE AND CLEAR A SLUGGISH DIGESTION TO MOVE WASTE THROUGH YOUR DIGESTIVE TRACT MORE EFFICIENTLY, A VITAL FUNCTION TO ENSURE THAT ALL BODILY SYSTEMS ARE WORKING OPTIMALLY”.

The parties do not appear to dispute the fact that the claims considered in the original ruling dated 10 November 2020 are capable of objective substantiation in accordance with Clause 4.1 of Section II. The most pressing question therefore is whether the advertiser has now provided adequate substantiation to satisfy the requirements of the Code.

The Advertiser relies on the opinion of Dr Craig Wright. According to its submissions, Dr Wright holds:

  • A “Master’s Degree in Homeopathy”.
  • An “MSc in Herbal Medicine”.
  • Is a “Registered Homeopath” and a “Registered Phytotherapy Practitioner” with 22 years’ “practice and teaching”.

The Directorate notes that the evidence submitted, and the opinion of Dr Wright, is silent on the following claims:

  • “Herbex Ultraslim a weight-loss evolution”.
  • “South Africa’s number 1 slimming brand”.
  • “25 years refining the science of weight loss”.
  • “With triple the action”.

In the absence of express verification from an independent and credible expert, the Directorate cannot assume that these claims are true, or that the submissions placed before it adequately prove such claims.

These claims therefore remain unsubstantiated within the meaning of Clause 4.1 of Section II of the Code.

As for the remainder of the claims, the Directorate first notes that there is nothing to show that the advertised “Herbex Ultraslim” product as a whole has ever been tested, which has resulted in Dr Wright looking at each element of the product individually. It is the Directorate’s understanding that this is standard practice within the herbal medical paradigm.

Dr Wright notes, inter alia, that “Herbex Ultraslim consists of 3 products that are meant to be taken together over a 24-hour period to achieve the combined results that Herbex is claiming”. These products are “Herbex Metabolic Enhancer”, “Herbex Blood Sugar Balance” and “Herbex Digestive Aid”. He adds that “… one product is taken in the morning, the other in the afternoon and the third is taken at bedtime, works overnight and produces a bowel movement in the morning, hence 24 hours”.

He provides a brief breakdown of the products’ active and inactive ingredients, summarises what the ingredients are purported to do, and explains what proof the SAHPRA would require and accept for efficacy claims.

All his submissions deal with research done on individual ingredients. These are as follows:

  • Herbex Metabolic Enhancer: Green Tea (Camellia sinensis), Ginger (Zingiber officinale Roscoe), Cayenne Pepper (Capsicum annuum L.) and Siberian Ginseng (Eleutherococcus senticosus).
  • Herbex Blood Sugar Balance: Gymnema sylvestre and Chromium polynicotinate.
  • Herbex Digestive Aid: Terminalia chebula, Terminalia bellirica, and Phyllanthus emblica L. (a combination which Dr Wright describes as a traditional Ayurvedic formula called TRIPHALA).

When concluding his submissions on the “Herbex Metabolic Enhancer” product, he notes, inter alia, that:

“Overall, the four active ingredients and their dosage – when taken together – are in line with all claims made for this product and fall within the discipline of Western Herbal Medicine, where they align with traditional uses for these herbs. One herb (C. sinensis) is present in sufficient quantity in its own right to support claims made (except ‘aids digestion’) however, its actions are added to and complemented by the three other herbs in the formula which add significantly to the overall activity of the formula. Additionally, the active ingredients and their dosage do not pose any significant safety concerns for OTC use, provided the stipulations in the PI / PIL are adhered to”.

Similarly, his concluding remarks for the “Herbex Blood Sugar Balance” product note:

“Claims for this product rely primarily on allowable claims for Chromium permitted for a health supplement by the SAHPRA in Appendix F of Guideline 7.04, supported by traditional claims for Gymnema sylvestre in Ayurvedic medicine” (his underlining).

This appendix (available from SAHPRA’s website at http://www.sahpra.org.za/wp- content/uploads/2020/07/7.04_CM_SE_Health_Supplements_Jun20_v4.pdf) provides a list of permissible claims for Chromium as an ingredient when use in “Single Substance Formulations” and “Multiple Substance Formulations” at dosages between 2,2µg and ≤ 200µg. According to Dr Wright, the Herbex product delivers 50µg daily.

Finally, when discussing the “Herbex Digestive Aid” product, he notes, inter alia, that “The compound is included in this formula for its detoxifying, digestion-normalising and weight- reducing effects, which are all traditional uses, and assist the action of the formula as a whole”. He explains that “Triphala, meaning ‘three fruits’ is one of the most famous and frequently used formulae in Ayurveda” and that its core purpose is to facilitate healthy digestion.

Nothing in his submissions suggest that the Advertiser has done any studies or tests on its complete product as sold and as consumers would ingest it. Similarly, none of the research articles and published chapters to which he refers appear to reference Herbex.

If a product is, and is advertised as, an allopathic medicine, this approach is problematic, as the allopathic paradigm requires peer-reviewed, double blind, placebo-controlled testing of the product as a whole. If the product is, and is advertised as, a herbal or homeopathic medicine, the consumer will understand that it has not been subject to the same rigorous scientific protocol.

As noted in 1059 – Sédatif PC – Dr Harris Steinman (8 December 2020):

“The Code does not dictate the medical paradigm from which such an expert should emanate, and does not prescribe the type of evidence that is needed. It simply requires advertisers to provide appropriate evidence that their product has been tested or reviewed, and that the product, when used at the recommended dose, would deliver on any claimed efficacy”.

In Faithful to Nature / Dr James Sneddon (19 July 2019) the Directorate noted, inter alia, the following:

“… it must be understood that the ARB is not mandated to regulate medicines. As things stand, there are a number of medical paradigms. The medicine that we associate with getting from the doctor is usually allopathic medicine, which finds its proof in peer-reviewed, double-blind placebo controlled testing. However, there are a number of other paradigms, including homeopathic medicines and herb based medicines. These paradigms are not tested in the same way as allopathic medicines, and therefore many consumers and medical professionals have less faith in their efficacy. However, some consumers choose to trust in these paradigms. It is not the role of the ARB to dictate which medical paradigms are correct.

The ARB will ask itself:

  • Is it clear to the consumer what type of medicine they are taking / what paradigm they are subscribing to?
  • Are the claims for the product true in the context of that paradigm?”

The same test therefore finds application in the matter at hand.

The original 1055 – Herbex – Dr Harris Steinman ruling of 10 November 2020 noted that “… the Complainant appears to accept that the product is a natural product, and as such needs to have proven efficacy within the natural paradigm”.

However, unlike in Faithful to Nature, the current advertising does not alert consumers to the fact that this is a herbal product, and that it therefore must be understood within that paradigm. The Complainant, a trained medical doctor who scrutinised the ingredients realised this, but it is doubtful whether consumers who see a 30 second commercial or the relevant webpage (https://herbexhealth.com/ultraslim/) would realise that this is the case, especially given the distinct absence of any overt reference to the herbal or alternative nature of the product. Unlike many products in this space, the packaging is not especially “nature” centred, and the ingredients are not named in the advertising. The herbal or natural nature of the product is not regarded as a selling point, and the advertising is largely silent in this regard.

Had this been made clear, consumers would be able to make an informed choice, based on whether they subscribe to such paradigms. Presumably, consumers who do not, would realise that this product does not fit within their chosen paradigm.

However, in the context of the advertising, consumers are likely to believe that the product is an allopathic medicine or remedy. This is a combination of the failure to allude to the ingredients and herbal nature of the product, and statements such as “refining the science of weight loss”, which consumers would understand to refer to more mainstream scientific paradigms. The likely expectation would therefore be that the claims have been proven to be true within that paradigm. This does not appear to be the case.

In addition to this, and within the context of the herbal paradigm, the Directorate has reservations about a discrepancy between Dr Wright’s opinion, and the overall communication in the advertising. Dr Wright points out that:

“Herbex Metabolic Enhancer should be used as an adjuvant to a slimming regime and is intended to help a healthy person to manage their weight. It should not be used to treat obesity, or any of the diseases associated with obesity, and should not be taken by men with a BMI of less than 18.5” (underlining added).

He adds that “Green tea [one of the active ingredients in the Metabolic Enhancer product] has recognised traditional use ‘as an adjuvant to slimming regimes’ in the European Union”.

He does not, however, elaborate on what would constitute a “slimming regime”. Presumably, this refers to consuming such an “adjuvant” in combination with sensible, healthy eating and moderate exercise, as is generally recommended by healthcare experts.

However, none of the advertisements at issue make any reference to a weight loss or slimming “regime”, the fact that this product is not intended to assist obese people, or an apparent need to eat healthily and exercise. The television commercial simply presents this product as the culmination of years of “… refining the science of weight loss …” while promoting the claimed efficacy of this “… all new Ultraslim weight loss system”, which offers “24 HOUR WEIGHT LOSS”, resulting in a “… healthier, slimmer you”.

By omitting this context, consumers are not presented with the complete picture telling them that this herbal product is purported to cause weight loss in healthy (non-obese) people when used in conjunction with whatever constitutes a “slimming regime”. They are simply told that consuming this product alone would result in weight loss. The Directorate acknowledges that some pages on the Advertiser’s website recommend an increased water intake and regular exercise. However, because Dr Wright appears to be of the opinion that the product would / should work in conjunction with a “slimming regime”, this context needs to be communicated wherever efficacy and weight loss claims are made.

All these factors combined means that there is a disconnect between the general advertising communication and the evidence submitted by Dr Wright. Consumers are firstly not informed that this is a herbal product, which subscribes to an alternative medical paradigm and is subject to different thresholds of evidence. They are also not informed that it needs to be consumed in conjunction with a “slimming regime”, and is only aimed at assisting non-obese consumers. They are merely presented with a product, and told that, if they consume this product, it will, inter alia, increase their metabolism, burn calories and fat, regulate blood sugar levels, improve digestion and result in weight loss. This is incongruent with the evidence and Dr Wright’s opinion.

Given this, the claims in the context of the advertising before the Directorate have not been substantiated.

Members of the ARB are therefore advised to refrain from accepting advertising for this product making the claims listed above on the following understanding:

The following claims are unsubstantiated:

  • “Herbex Ultraslim a weight-loss evolution”.
  • “South Africa’s number 1 slimming brand”.
  • “25 years refining the science of weight loss”.
  • “With triple the action”.

The remaining claims are substantiated within the context of a herbal paradigm, which must be communicated, and a slimming regime, which must be communicated.

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