Arcadia Home Shopping “Reduline 36” – No proof

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Posted 10 September 2013

A consumer laid a complaint with the ASA against the claims of this product. The ASA asked Arcadia Home Shopping for proof to support the claims. The ASA ruled in favour of the complainant on a number of aspects, but not all.

[note color=”#fdefb4″]Arcadia Home Shopping “Reduline 36” / K Charleston / 22018
Ruling of the : ASA Directorate
In the matter between:
Kevin Charleston Complainant(s)/Appellant(s)
 Arcadia Home Shopping (Pty) Ltd Respondent[/note]

03 Sep 2013

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6668
Mr Charleston lodged a consumer complaint against the respondent’s print advertisement appearing in the Sunday Times during March 2013.

The advertisement promotes the respondent’s “Reduline 36 LIPO-SCULPTURE CAPSULES AND DIET PLAN” as the solution to making “… all the flab around your ‘problem zones’ disappear without expensive or extensive interventions …”

Some of the claims objected to by the complainant are:

“Reduline36 capsules, used in combination with the Reduline36 kilojoule restricted diet plan, forces the fat cells in your body to literally starve”.

“The active ingredient in the Reduline36 capsules is a natural dietary fibre. Its particularly high fat absorbing capacity helps to neutralize calories from fatty foods. The natural dietary fibre forms a gel substance in the stomach, which combines with the food eaten. There the fat is absorbed and turned into an insoluble substance. These tied fats are not used in the metabolic process, but rather leave the body undigested”.

“Are Reduline36 capsules safe to use? Yes. Reduline36 capsules have been developed by a leading German laboratory”.

COMPLAINT
The complainant submitted that the reference to fat cells “literally starving” is not only contradicted by the claim that they are excreted undigested, but also not proven in any studies done on Chitosan (the active ingredient in this product). The complainant provided URLs to some studies that effectively conclude that Chitosan has no proven impact on fact absorption or weight loss.

The claims that the product is safe to use are also untrue. Chitosan is made from the outer skeleton of shellfish, and could be harmful to people with shellfish allergies.

Insofar as the claim to have been manufactured by a German laboratory was concerned, the complainant disputed this, saying that he could find no evidence thereof, but that his internet search suggests that the product originates from Eastern Europe, possible Hungary. The reference to a German laboratory is intended to mislead the consumer.

Lastly, he pointed out that the testimonials from “S Nedic” and “M Beatovic” are clearly not South African. The same advertisement and testimonials are available on http://www.vediashop.fr/productos/reduline/ and http://www.reduline.co.uk/success-stories/. This is in contravention of Clause 10.5 of Section II.

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
The complainant identified the following clauses of the Code as relevant:

• Section I, Clause 4.25 (Definitions, Scientific substantiation)

• Section II, Clause 4.1 (Substantiation)

• Section II, Clause 4.2.1 (Misleading claims)

• Section II, Clause 10.5 (Testimonials, Foreign residents).

RESPONSE
The respondent submitted the Reduline36 is a “Class III” medical devise registered in 2010 under “CE marking” with “Notified Body Number (0297)”. It is manufactured in Germany by Bmp, Bulk Medicines & Pharmaceuticals Production GMBH. A copy of the “EC-Certificate (full quality assurance system)” was submitted, as well as a letter from BMP, Bulk Medicines & Pharmaceuticals GMBH to show that they are the manufacturers of Reduline36 (which also carries the brand name “Reduzell 36”). It added that the product would not have obtained its registration if it did not comply with medical standards and manufacturing standards.

Prior to placing the advertisement, approval was obtained from the ACA Advisory Service. A copy of the relevant approval was also submitted, which states “We have perused the following advertisement … and based on the information provided to us our opinion, subject to the conditions below, is that it complies with the ASA Code”.

It added that Prof Delport of the ACA Advisory Services advised it to obtain the services of an expert to substantiate the claims made in the advertisement based on the clinical evidence (studies done on Chitosan, the active ingredient). In this regard, it submitted a condensed CV of Mr Ernst Miller, and the opinion of Dr W Niedermeyer of Germany. At the request of the Directorate, it had the original opinion (which was in German) translated. The translation was done by a sworn translator of the Cape High Court.

The package insert clearly stipulates that it contains shellfish and that people should not consume it if they are allergic. Furthermore, the advertisement clearly urges consumers to phone the respondent’s customer care helpline, or consult a doctor if they have any concerns about using the product.

It also attached the original, and the translated versions of the two testimonials. They are indeed used in other countries as testimony of how well the product works. It added that these testimonials were also included in the documentation submitted to the ACA Advisory Services.

ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.

German laboratory
The complainant disputed the claim that the product is manufactured in a German Laboratory on the strength of his internet search, which he claims suggests that the product comes from Eastern Europe.

The complainant denied this, and submitted a letter from BMP, Bulk Medicine & Pharmaceuticals Production GMBH which “… confirm[s] that our Certificates on the Design, Manufacture and Distribution of Medical Devices … comprise of the following products … Product Category Lipid Binders Brand Name … ‘Reduline 36’ …”

This appears to negate the allegation, and appears to show that the product was indeed designed, manufactured and distributed by BMP, Bulk Medicine & Pharmaceuticals Production GMBH. The documentation also reflects the address in Parchim, Germany.

The reference to having been “… developed by a leading German laboratory” are therefore not misleading for the reasons advanced in the complaint, and cannot be said to be misleading or in contravention of Clause 4.2.1 of Section II.

This aspect of the complaint is therefore dismissed.

Testimonials
Clause 10.5 of Section II reads as follows:

“Testimonials from persons resident outside South Africa are not acceptable UNLESS their address and/or country of residence are given to the ASA or the medium involved which may decide whether such details must be used in the advertisement” (our emphasis).

The complainant did not explain on what basis he believes this clause has been contravened. He simply pointed out (correctly) that the deponents are not South African citizens. The respondent provided copies of the actual testimonials, as well as translated copies. These indicate that the deponents reside in Belgrade, Serbia.

The Directorate sees no reason at present why testimonials from foreign residents would not be permissible for this particular advertisement, and the complainant has certainly not made a case for this.

Given this, the Directorate does not believe that the testimonials used are in contravention of Clause 10.5 of Section II of the Code.

This aspect of the complaint is dismissed.

Safe to use
The advertising reads, inter alia, as follows:

“Are Reduline36 capsules safe to use?
Yes. Reduline36 capsules have been developed by a leading German laboratory. Each capsule contains natural ingredients.
If in any doubt about using Reduline36, we suggest you contact our customer service or consult your general practitioner beforehand”.

The concern for safety appears to stem from the fact that the active ingredient (Chitosan) is manufactured from shellfish, which some people are severely allergic to.

The respondent is relying on the fact that its active ingredient is disclosed in the package insert and on-pack, and that the advertising states “If in any doubt about using Reduline36, we suggest you contact our customer service or consult your general practitioner beforehand”.

Ordinarily, issues of product-safety do not fall within the jurisdiction of the ASA. However, the advertisement specifically claims that the product is safe to use. As such, this is an advertising claim, capable of objective substantiation.

The claim of safety is unqualified. In fact, the safety appears to be as a result of an apparent reputable manufacturing process, and the fact that the capsules contain natural ingredients. While the Directorate accepts that the active ingredient is disclosed in the package insert, this is not the case in the advertisement. The consequence of this would likely be that people would only realise what the active ingredient is after the product had been purchased.

Given that the respondent makes a sweeping statement that the product is undoubtedly safe, it is insufficient to expect consumers (who are uninformed about the contents of the product, beyond knowing that it contains “natural ingredients”) to be able to make an informed decision about the claimed safety. Likewise, expecting consumers to instinctively know whether or not they should consult with their GP could arguably be seen as abdication of the respondent’s duty to clear and transparent advertising. At best, the advertising suggests that there are no risks associated with taking this product, but that one could get a “second” opinion as an after-thought from one’s GP. In addition, it is noted that the respondent submitted no evidence to support its unqualified claim of safety, despite the complainant’s specific requests for it.

Given the above, the seeping, unqualified, and general claim of being “… safe to use …” is currently unsubstantiated and in contravention of Clause 4.1 of Section II of the Code.

In light of this, the respondent is instructed to:

Withdrawn the unqualified, sweeping references to the product being “… safe to use …”

Immediately action the process of withdrawal upon receipt of this ruling

Ensure that the process of withdrawal is completed within the deadlines stipulated in Clause 15.3 of the Procedural Guide

Refrain from using the unqualified, sweeping reference to the product being “… safe to use …” in its current format in future.

Substantiation of efficacy
The complainant specifically took issue with the claim that this product “forces the fat cells in your body to literally starve”, and the general efficacy claims attributed to this product, which involve the formation of a gel-like substance that absorbs the fat and is then excreted undigested.

The respondent submitted various articles and studies done on Chitosan, as well as the CV of Mr Ernst Miller and a report from Dr W Niedermeyer.

As Mr Miller did not ex facie express an opinion on this matter, and does not appear to have verified any of the claims at issue (the respondent merely submitted his CV), the Directorate did not consider this particular document at the time.

The English translation of Dr Niedermeyer’s evaluation report (dated 20 July 2009) is titled “Clinical evaluation in accordance with § 5 MPG [Medical Products Law] in connection with Appendix X of the Council Directive 9./42/EEC dated 14 June 1993 concerning medical products”. Beneath this, a sub-heading “For the product Reduline 36®” appears, along with the wording:

“Lipid binder in support of:

• the treatment of excess weight
• weight control
• the reduction of lipid and cholesterol absorption from foods”.

The Directorate also notes that the report appears to contain various attachments (A, B, C, D, E, F, F1, F2, F3, F4, F5 and G), which do not appear to have been submitted by the respondent.

The entire report then appears to deal exclusively with Chitosan as an ingredient. The information is contained under headings such as “What is chitosan?”, “General information on chitosan”, “Chitosan’s mechanism of action” and “Clinical trials with chitosan”. Similarly, the conclusion reads as follows:

“The efficacy of chitosan, based on lipid-binding principles, has been a long-standing successful system in protecting the body from superfluous lipid absorption. The consequential breakdown of fat from the body’s depot supports weight reduction …

This Clinical Evaluation demonstrates that, in the intended posology [sic], chitosan is suitable ‘for the supportive treatment of obesity’ and therefore also ‘for weight-control purposes within the scope of a reduction diet’ … The ‘reduced absorption of dietary fat from food’ is also proven …

Chitosan can therefore be safely taken for the intended purpose within the framework of recommended use”.

The Directorate has several difficulties with the respondent’s substantiation.

Firstly, all the evidence relied on appears to relate only to the active ingredient Chitosan, as opposed to the respondent’s Reduline36 product as a whole. This means that there is currently nothing before the Directorate to show that the respondent’s actual product, as sold, and if consumed at the recommended dose, would deliver on the claims made.

In Solal Breast Protection Formula / R Jobson / 18707 (15 February 2012), the Directorate discussed at length why it requires product-specific evidence as opposed to ingredient-based and/or anecdotal evidence. The point was made that advertisers market their products by name, and encourage consumers to purchase such products (not the individual ingredients) and consume the product at a specific dose, with an overwhelming impression that the product has been proven to work. The Directorate also pointed out that substantiation is required to have “market relevance”, and in order to do this, the product, as a whole, as sold in the market, needs to have been proven effective. After listing examples where this approach was affirmed and reaffirmed (dating back to 2003), the Directorate noted that:

“The reason for adopting a product-specific approach rather than an ingredient-based one is self-evident: Medicinal products (including such products collectively known as complementary and alternative medicines) cannot be treated as an ordinary general commodity. They have the potential for harmful as well as beneficial effects and can cause serious problems if not used safely. For this reason, there are specific regulations that strictly control the advertising and promotion of medicinal products. In general, the ASA does not concern itself with regulatory requirements to the level that the Department of Health or MCC would. The ASA can only consider whether or not the claim made for such products are substantiated, or potentially breach any of the other relevant provisions of the Code”.

While there was one study done on what appears to be a complete product, it does not appear to be the respondent’s product, but rather one called “LipoSan UltraTM”.

Secondly, the respondent has not argued, or submitted any documentation to illustrate why the Directorate should accept Dr Niedermeyer as an independent and credible expert in the field to which the claims relate. The consequence of this is that even if Dr Niedermeyer’s verification applied to the respondent’s actual product (which does not appear to be the case), there is nothing to convince the Directorate that Dr Niedermeyer is a suitable expert in terms of Clause 4.1 of Section II of the Code.

For all the above reasons, the Directorate is not satisfied that the respondent has submitted adequate substantiation to show that its product, when bought and consumed at the recommended dose, would deliver on the efficacy claims disputed by the complainant. The respondent’s advertisement is therefore found to be in contravention of Clause 4.1 of Section II of the Code.

In light of this, the respondent is instructed to:

Withdrawn the disputed advertisement

Immediately action the process of withdrawal upon receipt of this ruling

Ensure that the process of withdrawal is completed within the deadlines stipulated in Clause 15.3 of the Procedural Guide

Refrain from using advertisement in its current format in future.

The complaint is partially upheld.
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