Issued by the Department of Health
5 February 2010
It has come to the attention of the Medicines Control Council that the weight loss product SIMPLY SLIM may pose significant risks to the South African public. For this reason the Medicines Control Council (MCC) resolved to immediately suspend the sale of SIMPLY SLIM weight loss products in the country until further investigations and review can be completed. This decision was made during its meeting on 27 January 2010.
SIMPLY SLIM is a weight loss product that is not registered as a medicine by the MCC as it is being promoted and sold as a complementary herbal weight loss product. It is being sold at various retail outlets including health shops and pharmacies and is being actively marketed to consumers as a weight loss product.
After careful review of available evidence the Council concluded that the risks associated with the use of weight loss medicine SIMPLY SLIM are greater than the benefits and that the product needs to be registered as a medicine before it can continue to be sold. Council based its decision on the outcome of an investigation it conducted on the product SIMPLY SLIM. Samples of the product were collected from various suppliers and tested at reputable laboratories. The testing of certain batches revealed that the product contained sibutramine, which is the active ingredient of some Schedule 5 weight loss medicines registered in terms of the Medicines and Related Substances Act, 1965. In addition, the active ingredient of SIMPLY SLIM is bitter orange, the principal active chemical ingredient of which is synephrine, which is also a Schedule 5 substance. Medicines containing Schedule 5 substances must be registered as medicines and may only be sold on a prescription from a doctor and used in patients under the personal supervision of the doctor. Sibutramine is not listed among ingredients reflected on the product packaging of SIMPLY SLIM and is associated with significant adverse effects including heart problems.
In addition, Council has received a number of product complaints from members of the public. These complaints ranged from patients experiencing nausea, headaches, psychological effects and cardiovascular events.
Based on these findings, the MCC resolved to suspend the sale of SIMPLY SLIM until more complete supportive data on the safety, quality and efficacy of the medicine has been submitted by the manufacturer and evaluated by the Council. Only if the MCC is completely satisfied that the medicine is safe, effective, of good quality and therefore in the public interest will it allow the product to be registered and sold in South Africa.
Mrs Mandisa Hela, Registrar of Medicines, reminded the public that "the Medicines Control Council is the statutory body ultimately responsible for ensuring that all medicines and medicinal products available on the South African market are safe, effective and of good quality and that their availability should be in the interest of the public."
For more information please contact Fidel Hadebe on 079 517-3333.