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It’s been 10 years since the Medicines Control Council (MCC) announced its “call-up” of products generally referred to as “complementary medicines”. These are “natural” products which do not have to be registered as medicines, yet most make health-related claims.
The intention was for the MCC to audit these products during a six-month period in 2002. The list has grown in the past decade, with not a single product having been evaluated for safety, quality or efficacy.
But this hasn’t stopped some manufacturers and importers from claiming that their product is “registered with the MCC” – with a few falsely using their MCC “acknowledgment of receipt” number as a registration number, creating the impression that the product has the body’s stamp of approval.
In a written response to a parliamentary question, the health minister said in October 2010 that nearly 155 000 submissions for complementary medicines had been received since the publication of the call-up notice in February 2002.
As for why none had been evaluated, the minister said the guidelines were not yet in place.
The only authority which calls upon the manufacturers or importers to substantiate their product claims is the Advertising Standards Authority (ASA), and only when someone lodges a formal complaint of misleading advertising.
That person is, more often than not, Dr Harris Steinman of Cape Town, who for much of the past decade has made it his business to lodge complaints against scores of “complementary” products, mostly weight-loss ones.
Most of his complaints have been upheld by the ASA directorate, which ordered the companies to remove the misleading claims from their products’ packaging or advertising.
Last week the SA Association for Responsible Health Information (ARHIA), of which Steinman is a member, released a statement marking the 10th anniversary of the complementary medicines call-up.
“What this means is that for 10 years people making and marketing complementary medicines have done so with relative impunity, profiting off South Africans who had been convinced that they should use these products to improve their health and quality of life,” said Professor Roy Jobson of Rhodes University’s pharmacy faculty on behalf of ARHIA.
“For registered medicines, the guarantee (of safety and efficacy) comes from the MCC. But for unregistered medicines where there is no such guarantee from the MCC, pharmacists have to make the decisions as to what to sell based only on information provided by the manufacturers of the products.”
The association believed that evidence of efficacy could not be provided for most of the products on the list, “which poses a serious public health risk”.
ARHIA called on the MCC, the health minister, the Pharmacy Council, the Allied Health Professions Council and the director-general of health to collaborate in remedying this situation.
“We note that draft complementary medicines regulations were published for comment in 2011 and although they clarify to some extent how these substances might be controlled, they are silent on implementation and its time frame.”
This week yet another of Steinman’s complaints against the marketing claims of a weight-loss product was upheld by the ASA directorate.
The product is Dis-Chem Pharmacies’ Dis-Chem Gold Herbal Weight Loss Formula, which claims to be “fast acting with Hoodia and Slimaluma”.
Steinman contended that there was insufficient evidence to support the weight-loss claims of either the individual ingredients or their combination, adding that the product name implied that it had the ability to induce weight-loss, which was not true.
Steinman said not all the ingredients were herbal, and that the first peer review study on Hoodia had shown that it had no effect on weight-loss or appetite suppression.
Responding, Dis-Chem pharmacies said that based on scientific research and reports on the product’s active ingredient, it believed it to be a bona fide product and that Steinman’s complaint was unfair and unfounded.
The company submitted documentation, some of it untitled and unreferenced, purporting to prove the efficacy of ingredients such as Hoodia gordonii, guarana, kola nut, “Slimaluma” and Caralluma fimbriata extract. The directorate said it required unequivocal, product-specific verification because the weight-loss claims were made for the product as a whole, and consumers were only able to buy the whole product.
“There is nothing before the directorate to indicate that there was product-specific research or that it exists,” it said in its ruling.
“The respondent has also not submitted independent research documents as evidence that the ingredients as mentioned on the packaging are effective in the dosage used in the product, and that the said ingredients do not contra-indicate each other.”
The directorate upheld Steinman’s claim, ruling that Dis-Chem withdraw the name for its product – Gold Herbal Weight Loss Formula – as well as any references to weight loss, within three months.