Simply Slim – ASA ruling

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Simply Slim claims to be effective for weight-loss, is registered with the MCC, is natural, and a host of other claims. A complaint was laid with the ASA against these claims. The ASA has ruled in favour of the complainant.

What is significant about this ruling is that for the first time, the ASA is specifying that Clause 4.25 of Section 1 of the Code is part of the issue: 

"Other than Dr Pretorius’ unqualified opinion, there is nothing before the Directorate to show that the levels of ingredients contained in the product are sufficient to deliver the claimed benefits, or that the ingredients would not contra-indicate one another. In addition, there is nothing to show that the product as is currently available on the market has ever been subjected to trials for efficacy or that any such results have verified the claims made." 

Till now, all the ASA required was for an "expert" to say that in his/her opinion, that the product was efficacious.

Simply

Simply Slim / HA Steinman / 15605

Ruling of the : ASA Directorate
In the matter between:
Dr Harris SteinmanComplainant(s)/Appellant(s)
Simply Slim (Pty) LtdRespondent

06 Dec 2010

http://www.asasa.org.za/ResultDetail.aspx?Ruling=5391

Dr Steinman lodged a consumer complaint against a Simply Slim Internet advertisement promoting its slimming product. The advertisement appeared on www.simplyslim.co.za.

The advertisement promotes the respondent’s slimming product with, inter alia, the following claims:
 

  • “It’s back – the Slimming product that will change your life!”
     
  • “Simply Slim is a Natural Herbal Mix capsule that can help you manage your busy life and lose weight”
     
  • “All you need to do is take one capsule daily, and maintain healthy eating habits”
     
  • “The product boosts energy levels, assists in the fat burning process is a water intake enhancer and promotes and assist [sic] your metabolic performance”.

On the “FAQ” section the following claims are made:
 

  • “Did Simply Slim receive a registry number from the MCC prior to relaunch?
    Yes. Simply Slim obtained a Registry Number 141468 for the new product from the MCC on 29 March 2010. You can view this MBR 20.8 document …”
     
  • “Do I need to exercise or follow an expensive diet-plan?
    Most of our testimonials is [sic] based on people losing weight without any strenuous excercise [sic] or following a strict diet plan. We do however recommend a healty lifestyle to assist you on your wellness journey. Best results would be achieved if taken with a kJ controlled eating plan”.

In addition to other claims of slimming and losing weight, references are made to testimonials from satisfied customers.

COMPLAINT
In essence, the complainant submitted that:
 

  • The product, which was suspended by the MCC, claims to be “back”. However there is no evidence that it is the same product which was previously available on the market as is implied by the word “back”. There is also no evidence that the “MCC is completely satisfied that the medicine is safe, effective, or of good quality.
     
  • There is no evidence that this product can lead to weight loss.
     
  • The name “Simply Slim” is misleading for this implies that the product can result in weight loss, and this is misleading.
     
  • The product claims to be safe but there is no proof that there are no known harmful effects, in fact bitter orange, which is one of the ingredients, is known to have serious side-effects.
     
  • There is no proof that the testimonials referred to are true. Furthermore, previous Simply Slim formulations were considered adulterated by the MCC due to the presence of sibrutamine, which is a scheduled substance for weight loss. Therefore, any testimonials must surely be considered not valid because the weight loss could likely be attributed to the presence of sibrutamine, and not the actual product.
     
  • There is no scientific proof that the product can boost metabolism or energy levels or assist with weight loss and detoxify the system as claimed.

RELEvANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint the following clauses of the code were taken in to account:

• Section II, Clause 4.1 – Substantiation

• Section II, Clause 4.2.1 – Misleading claims

• Section II, Clause 13 – Safety

RESPONSE
Stevan Vos Marketing Regulations Advisors, on behalf of the respondent, submitted, inter alia, that:
 

  • There are some legal and technical issues surrounding the “suspension” of the product by the Medicines Control Council (MCC). The suspension was not done in terms of authorised and prescribed provisions in terms of the Medicines Act, as a result the respondent was entitled to, and did, lodge an appeal against it, and also gave statutory notice of an intention of taking the decision on review to the High Court. The MCC advised that impugned decisions such as this are automatically suspended following the filing of a notice of appeal and the only manner in which the MCC could have kept the suspension active was to approach the High Court, which it did not do.
     
  • The impugned MCC decision applied to the Simply Slim product which was imported from China. The respondent voluntarily recalled and removed from circulation the imported product for a period of two months, and not, as the complainant alleges, because the MCC forced it to do so. The product is, however again available for purchase since 8 April 2010.
     
  • The product is manufactured with the assistance of an independent manufacturer in a good manufacturing processes compliant facility in South Africa. There is no decision by the MCC that the product is being sold unlawfully. Proper analysis and testing is conducted by Sedek Agrikem CC, an independent SANAS accredited laboratory on the raw materials. The respondent attached documentary proof from Sedek Agrikem CC in support of this submission.

In arguing the merits, the respondent essentially submitted that:
 

  • A reasonable consumer is not likely to be misled by the use of the term “back”: It is clear that the Simply Slim product, based on the original formulation, is now again available on the South African market. Sedek Agrikem CC also verifies that the currently available product is qualitatively similar to the product originally marketed.
     
  • There is no claim made that the product is “safe” as alleged by the complainant. Be that as it may, the MCC’s alleged concern about the product stemmed from the counterfeit Chinese product, which could potentially have contained sibutramine. Sedek Agrikem CC also confirms that the product currently manufactured in South Africa, does not contain any illegal, banned or scheduled substances, thus addressing this issue.
     
  • The testimonials from people who have successfully used the product were removed for reasons unrelated to the complaint. They will not be used again in future. The respondent also disputed the contention that these testimonials related to an “adulterated” version of its product.
     
  • The claim “All you need to do is take one capsule daily, and maintain healthy eating habits” is substantiated by VxPharma’s confirmation letter which the respondent attached.
     
  • The claims “Boost energy levels, assist the fat burning process is a water intake enhancer and promotes and assist [sic] your metabolic performance” as quoted by the complainant do not appear on the website.

As a note, the Directorate points out that this claim does indeed appear on the website. The full paragraph reads “Simply Slim is a natural herbal mix. The ingredients include Bitter Orange (Citrus Arantium Extract), L. Carnitine fumerate … and Evening Primrose Oil. Simply Slim is specifically formulated to help overweight NON-active people lose weight and detoxify their systems naturally. The product boosts energy levels, assists in the fat burning process is a water intake enhancer and promotes and assist your metabolic performance”.
 

  • With regard to the claims of assisting to “curb your cravings, enhance your vitality and enhance your water intake”, the respondent again relied on VxPharma’s verification.
     
  • In relation to the claimed “MCC registry number” the respondent argued that in Comfrey Capsules / The Pharmaceutical Society of SA / 9092 (29 June 2007) the Directorate ruled that “… it was clear that the [MBR] document submitted … was proof of its application … and that it was not a certificate of registration”. Given this, and given that consumers can download and view the relevant MBR 20.8 for from the respondent’s website, there is no manner in which the reference to a “MCC registry number” can be misleading and imply anything more than it actually does.

ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation as submitted by the complainant.

Voluntary undertakings
The respondent submitted that the testimonials referred to on the website in claims such as “… we have received numerous testimonials from our satisfied clients …” and “Most of our testimonials is [sic] based on people losing weight without any strenuous excercise [sic] …” were “removed from the Simply Slim website for reasons unrelated to the complaint”, and will not be used again. It requested that the Directorate accept this as an undertaking that addresses this aspect of the complaint.

While the Directorate notes that the actual testimonials have ex facie been removed, the respondent has not undertaken to remove the claims disputed. Having the actual testimonials removed would only remedy the possibility of people reading a testimonial that might not apply. This does not, however, solve the complainant’s problem.

Effectively, the claims “… we have received numerous testimonials from our satisfied clients …” and “Most of our testimonials is [sic] based on people losing weight without any strenuous excercise [sic] …” still imply that the respondent has many satisfied customers that have used its current product with success, which is what the complainant is disputing. Whether or not an interested customer is able to see the actual testimonials referred to in the above claims is immaterial, because the inferred efficacy is present in the claims themselves.

As such, the undertaking to never use the actual testimonials again does not address the concern raised, and is therefore not accepted as a resolution this specific aspect of the complaint.

Whether or not the MCC views these testimonials as relating to an “adulterated” version of the respondent as submitted by the complainant is irrelevant at this time. The fact remains that the respondent has not produced any evidence that it is in possession of testimonials that apply to the product currently on the market. It has also not undertaken to remove the claims that imply that it is.

Accordingly, the claims “… we have received numerous testimonials from our satisfied clients …” and “Most of our testimonials is [sic] based on people losing weight without any strenuous excercise [sic] …” are likely to mislead people.

These claims are therefore in contravention of Clause 4.2.1 of Section II of the Code.

Safety
The complainant submitted that the “… product claims to be safe but there is no proof that there are no known harmful effects (in fact bitter orange is known to have serious side-effects)”.

Besides arguing the merits, the respondent pointed out that its advertising does not contain “any visual presentation or any description of dangerous practices” or any situations that show a disregard for safety, which would render it in contravention of Clause 13 of Section II which deals with “Safety”. Nonetheless, it submitted a report from Sedek Agrikem CC to show that the product currently available does not contain any illegal, banned or scheduled substance, which addresses the concerns of the complainant (and the MCC).

The ASA does not have jurisdiction over whether or not a product is safe in general. The only exception to this would be if an advertisement specifically claims that the product is “Safe”, in which case the ASA may, for example, require independent verification of such a claim.

While the Directorate acknowledges that reference is made to containing, inter alia, “Bitter Orange”, the Directorate could not find any specific claim that the product is “safe”, nor has the complainant identified any such claims.

Given this it would not be appropriate for the Directorate to consider this specific aspect of the complaint at this time.

“MCC registry number” and reference to being “back”
The respondent’s home page contains the large heading “It’s back – the Slimming product that will change your life!”.

Under the FAQ section another claims read as follows:

“Did Simply Slim receive a registry number from the MCC prior to relaunch?
Yes. Simply Slim obtained a Registry Number 141468 for the new product from the MCC on 29 March 2010. You can view this MBR 20.8 document under Simply Slim – Product – MCC Registry Number.”

The complainant is arguing that these claims imply that the current product has been registered and approved by the MCC, which is not the case, as the “MBR 20.8 document” is merely an acknowledgement of receipt to confirm that the respondent’s documents were submitted to the MCC, nothing more. There is also nothing to show that this is the same product as marketed before.

The respondent relied on the decision made in Comfrey Capsules / The Pharmaceutical Society of SA / 9092 (29 June 2007) where the Directorate ruled that “… it was clear that the [MBR] document submitted … was proof of its application … and that it was not a certificate of registration”. Given this, and given that consumers can download and view the relevant MBR 20.8 for from the respondent’s website, there is no manner in which the reference to a “MCC registry number” can be misleading and imply anything more than it actually does. It also relied on a letter from Sedek Agrikem CC which states that the current product is “qualitatively similar” to the original one, based on the “formulation as stated on the unit carton of the product originally introduced to the South African Market in May 2009”.

It appears that the respondent is assuming that ordinary consumers would understand the intricacies involved in submitting documentation to the MCC and having a product officially approved and registered.

Considering the history of the matter, it is significant to note that when the product was recalled in February 2010, the respondent had a prominent notice on its website that read “Following the Medicines Control Council suspension of the sale of Simply Slim Capsules in a directive issued by the MCC on Tuesday 2 February 2010, Simply Slim (Pty) Ltd has issued an Urgent Medicine Recall in terms of the MCC’s guidelines … due to certain samples testing positive for Sibrutamine, a Schedule 5 substance …”. There was also some press coverage on this issue at that time.

Given this, it is not unreasonable to expect consumers to be concerned over whether or not the MCC is satisfied that the product now for sale is safe and effective.

When confronted with the claim “Did Simply Slim receive a registry number from the MCC prior to relaunch?” and the answer “Yes. Simply Slim obtained a Registry Number 141468 for the new product from the MCC on 29 March 2010 …” such consumers may well assume that this means that the MCC is now satisfied in a manner that addresses the earlier concerns raised about the product.

In Comfrey Capsules / The Pharmaceutical Society of SA / 9092 (29 June 2007), the Directorate was faced with a question of whether or not the MBR 20.8 document is of any value in this regard. it is significant to note that the Directorate elected to obtain an official opinion from the MCC on the issue for the sake of clarity. Only once the MCC confirmed it, did the Directorate rule that “… it is clear that the document submitted by the respondent is proof of its application in terms of the Call-up Notice for Complementary Medicines – it is not a certificate of registration”.

The respondent cannot automatically assume that all consumers would be familiar enough to understand the intricacies related to MCC approval as laid out in the Comfrey Capsules ruling. Considering the fact that the MCC was previously intimately involved in having the product recalled, there is a strong likelihood that a hypothetical reasonable person would interpret this section of the FAQ to mean that the MCC has looked at the new product on the market and is satisfied that the previous concerns are no longer relevant.

It is also noted that in the opinion received from the MCC in the Comfrey Capsules matter the MCC referred to an “acknowledgement number”, and not a “registry number” as the respondent terms it. Assuming, purely for the sake of the argument and without specifically accepting this is so, that consumers would notice that the form MBR 20.8 is titled “APPLICATION FOR THE SUBMISSION IN TERMS OF THE CALL-UP NOTICE …”, this clarity at best comes after the fact, and is likely to clear up an initial impression that the MCC has “accepted and approved” the product, which is not the case.

While not pertinent at this time, the Directorate also notes that the number 141468 as quoted in the claim differs from the number 141478 that appears on the form MBR 20.8 as submitted by the respondent.

In addition, it appears from the letter from Sedek Agrikem CC that it analysed the current product, and compared it to the “formulation as stated on the unit carton of the product originally introduced to the South African Market in May 2009”. Given that there were samples of the original product found to contain a scheduled substance which was not listed on the packaging, or “unit carton”, this does not suffice. The appropriate confirmation would be to test the original product itself and compare its contents to the current one.

Accordingly, the claim “Did Simply Slim receive a registry number from the MCC prior to relaunch?” and answer “Yes. Simply Slim obtained a Registry Number 141468 for the new product from the MCC on 29 March 2010. You can view this MBR 20.8 document under Simply Slim – Product – MCC Registry Number” is likely to create a misleading impression and is therefore in contravention of Clause 4.2.1 of Section II of the Code.

By the same reasoning, the claim “It’s back …” is currently unsubstantiated and also likely to mislead consumers into expecting that the MCC’s concerns have now been allayed and that the product has effectively been “accepted” or “approved” by the MCC, which is not the case. This claim is therefore in contravention of Clauses 4.1 and 4.2.1 of Section II of the Code.

Natural
The complainant took issue with the claim that “Simply Slim is a Natural Herbal Mix capsule …” on the basis that it contains not only natural herbs but a mix of concentrated factory derived extracts. The complainant added that L. Carnitine is not derived from herbs.

The respondent did not dispute this, and relied on an opinion from VxPharma, under the name of Dr B Pretorius to support this claim.

After detailing the ingredients contained in the product, Dr Pretorius concludes that the product is a ‘natural herbal mix”. It is noted, however, that Dr Pretorius also states that L. Carnitine fumerate as contained in this product is synthesised in the liver and kidneys and is available from red meat, dairy products and avocado.

This does not appear to correlate with the message that the product is a “Natural Herbal Mix” capsule. Neither the respondent nor Dr Pretorius has submitted any compelling argument on why the presence of this ingredient would not negate the claim made.

Given that the product does not appear to consist only of “Natural Herbal” ingredients as implied, this claim is misleading and in contravention of Clause 4.2.1 of Section II of the Code.

Claimed efficacy of the product
Here too the respondent relied on verification from Dr Benji Pretorius from VxPharma.

For the reasons set out below, the Directorate does not need to, at this time, determine whether or not Dr Pretorius and/or VxPharma qualifies as an independent and credible expert in the field to which the claims relate:

In Lifebouy / Dettol / 14813 (27 August 2010), the Advertising Industry Tribunal (the AIT) held that the Directorate cannot simply accept the “say so” of an entity put forward as an expert. The AIT held that the Directorate has to “satisfy itself that there was sufficient evidence before it showing that there is credible documentary evidence supporting the claims”.

Dr Pretorius effectively states that he consulted some literature on the topic of natural medicine, articles on obesity, “relevant key opinion leaders” and applied his own understanding based on his training and qualifications to the subject matter. He goes on to list the alleged properties and uses of the ingredients contained in the respondent’s product, and concludes that the relevant efficacy claims are substantiated “in combination of ingredients at doses included in the product”:

Other than Dr Pretorius’ unqualified opinion, there is nothing before the Directorate to show that the levels of ingredients contained in the product are sufficient to deliver the claimed benefits, or that the ingredients would not contra-indicate one another.

In addition, there is nothing to show that the product as is currently available on the market has ever been subjected to trials for efficacy or that any such results have verified the claims made. The argument made is largely that “the product contains a host of ingredients that in isolation are said to deliver specific benefits. Given that we put all these ingredients together, they are guaranteed to deliver on the promised weight loss, reduction in cravings, improved metabolic function etc”.

However, nothing before the Directorate appears to show, within the parameters of Clause 4.1 of Section II as read with Clause 4.25 of Section I (which defines the requirements for “scientific substantiation”) that this is in fact the case.

Accordingly, the respondent’s efficacy claims are currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code. By the same reasoning the name “Simply Slim”, implying weight loss, is currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code.

Given the above:
 

  • The relevant claims and advertising ruled against must be withdrawn;
     
  • The process to withdraw the relevant claims and advertising must be actioned with immediate effect on receipt of this ruling;
     
  • The withdrawal of the relevant claims and advertising must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide;
     
  • The relevant claims and advertising may not be used again in its current format until new substantiation has been submitted, evaluated and a new ruling is made.

The respondent’s attention is drawn to Clause 15.5 of the Procedural Guide.

With the exception of the dispute discussed under “Safety” above, the complaint is upheld.

The Directorate also draws the respondent’s attention to the requirements of Clause 2.3.1 of Appendix E, Appendix F, and its own undertaking to remove certain claims as recorded in Simply Slim / H A Steinman /14940 (10 February 2010).

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