Posted 12 February 2010
Here is part of one of the Simply Slim advertisements that have appeared in many media throughout the country. The slogan reads Simplifying Slimming Naturally. Paradoxically however several allegations have been made that it is not a natural product but contains a registered medicine.
Simply Slim epitomises the mess that has developed in the complementary and alternative medicines (CAMs) market in the absence of adequate regulatory oversight in South Africa. It was announced that the Medicines Control Council had ruled on 27 January 2010 that sales of the product should be suspended because of health risk concerns. It’s ironic then that a half-page advertorial in the Sunday Times of 31 December, 2010, in defence of the product and claiming that all the existing regulatory requirements had been adhered to, was published. (The MCC’s directive to Simply Slim was made on 2 February, 2010 and Simply Slim complied with a recall letter on 5 February, 2010.)
Throughout the advertorial in bold is a phrase: ‘Please decide for yourself!!!’ This is the crux of the matter – the reader is being invited to make decisions about legal, regulatory and pharmacological issues based on a minimal amount of information. Most persons not trained in these fields would not have the requisite background information to actually make such a decision.
The advertorial refers to the flawed Complementary Medicines Call Up Notice which has previously been argued should be rescinded. What is of note is that neither this notice nor the Medicines Act (Act 101 of 1965) even define ‘complementary medicines’ adequately. In fact the title of the call up notice is ‘CALL UP NOTICE FOR MEDICINES FREQUENTLY REFERRED TO AS COMPLEMENTARY MEDICINES . . .’ and the preamble states: ‘[t]he Medicines Control Council (MCC) has noted that there are increasing numbers of medicines frequently called complementary medicines being sold in South Africa for which claims of safety, quality and efficacy are being made without the approval of the MCC.’
The reference to category 11 is ‘Combination Complementary Medicines’ but this again falls under a heading of medicines frequently referred to as complementary medicines. Still no definition. A call up notice cannot create legal categories of medicine – this would have to be done through an amendment to the Act itself or through promulgating appropriate Regulations to the Act.
It is also clear from the notice that it is the MCC’s job to approve any claims made for safety, quality and efficacy for any medicine. There is a process by which this is done known as registration. This must not be confused with a “registry number” which is just an administrative number given to any correspondence received by the Registrar of the MCC.
A highlighted heading in the advertorial proclaims ‘The Truth Regarding Sibutramine’. (Sibutramine was allegedly found in several laboratory tests of Simply Slim.) The Beeld is quoted reporting on the European Medicines Agency stance on the risks of sibutramine and the names of South African registered medicines containing sibutramine are provided. Sibutramine is a substance which has been approved for weight loss.
The advertorial writers do not recognise that the named medicines are Schedule 5, available on prescription of a medical doctor only, and that the risks and benefits have been assessed by the MCC and continue to be assessed. In contrast, Simply Slim was not submitted for registration as a medicine. If indeed Simply Slim (or batches of it) does contain sibutramine – a Schedule 5 medicine is being illegally sold by distributors who have no medical training and no capacity to accurately assess the cardiovascular status of the purchaser.
The advertorial then addresses ‘The Synephrine Uproar’ and goes into some detail about the differences between meta-synephrine and para-synephrine, claiming that para-synephrine does not have the negative side effects associated with meta-synephrine and that Bitter Orange – the ingredient in Simply Slim contains only para-synephrine. In fact there is evidence that bitter orange contains a mixture of m- and p- synephrine, and that p-synephrine is not harmless.
The news reports of the MCC’s suspension of Simply Slim sales indicate that synephrine is also a Schedule 5 substance. Bitter orange (or Citrus aurantium) has been highlighted in a World Health Organization publication as being associated with people having heart attacks and strokes. There is even a report and a letter in the South African Medical Journal (2008) concerning the dangers of bitter orange.
An advertisement for Simply Slim in the December 2009 ‘indwe’ – the SA Express in-flight magazine – implies that the product will cause weight loss without any dietary change or exercising. A complaint was submitted to the Advertising Standards Authority about these claims, the complaint was upheld and an ad-alert was issued.
It is quite possible that Simply Slim will appeal the MCC resolution and it would be difficult to predict the outcome. How many other products containing Scheduled medicines are being sold with a false claim that they are complementary medicines or nutritional supplements?
How can the South African consumer be sure that the complementary medicines or nutritional supplements they’re buying don’t contain prescription medicines or no active substances at all?
The MCC’s resolution to suspend sales of Simply Slim is an exception. Surely every single one of these kinds of products should be independently scrutinised to protect the consumer so that it is not a case of “Please decide for yourself”. We need to have confidence that the system is functioning.
UPDATE: The marketers of Simply Slim have announced on their website that they will be launching a “new product” soon. Is this some kind of admission that their previous product did in fact have problems? Does it mean that they will not be submitting safety quality and efficacy information for the ‘old’ product to the MCC?
Will this new product be submitted for registration with the MCC in terms of quality, safety and efficacy? Will this new product be formulated and manufactured in South Africa? Or is this to be another imported product? Will the new product continue to claim ‘Simplifying Slimming Naturally’? Will the new product have had clinical trials done to prove that it works?
See also Prof. Roy Jobson’s take on this matter: Mail & Guardian Thought Leader page: http://www.thoughtleader.co.za/royjobson/2010/02/16/simply-slim-sibutramine-and-synephrine/