SIMPLY SLIM RECALL RAISES CONCERNS ABOUT BITTER ORANGE

The Medicines Control Council (MCC) has suspended sales of the weight loss product Simply Slim as they believe it may pose significant risks to the South African public. Simply Slim, which is being promoted and sold as a complementary herbal weight loss product, is not registered by the MCC. Sample tests revealed that certain batches of the product contained sibutramine which is associated with significant adverse effects including heart problems Sibutramine is the active ingredient of some Schedule 5 weight loss medicines registered in terms of the Medicines and Related Substances Act, 1965. Medicines containing Schedule 5 substances must be registered as medicines and may only be sold on 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. The product will be suspended 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.

An active ingredient in Simply Slim is Bitter Orange, which is now also in the spotlight. HPA Chairman Dr Alan Tomlinson has alerted HPA members to the concerns regarding Bitter Orange. "With the attention that has been given to this product, concerns about Bitter Orange have also been raised," warns Tomlinson. "Bitter orange contains synephrine, an alkaloid which may be subject to investigation. The HPA herewith alerts its members to the concerns regarding Bitter Orange. The HPA cannot prescribe to its members the action to be taken in this regard, however, you are urged to consider this information with regard to your products. "