Regulations to target scam medicines

2013-11-26 00:00

THEY promise anything from miraculous cancer cures, effective weight-loss and anti-ageing fixes, but they leave consumers disappointed and sometimes even pose devastating health risks.

These are the quack formulas and “medicines” for sale in pharmacies across the country that until now have had carte blanche to make the most outrageous medical claims without any reliable scientific evidence to back them up.

But last week the Medicines Control Council (MCC) released amended regulations under the Medicines and Related Substances Act that consumer activists and experts say will clear the shelves of many scam products and their false promises.

Spoor and Fisher patent attorney Dirk Hanekom said the regulations would for the first time require the marketers of “complementary and alternative medicines” such as herbal remedies, homeopathic products and vitamins to prove to the MCC that they are safe and effective and be registered.

“By February 14, 2014, all the products across the board will have to comply with the regulations relating to labelling, package inserts and patient information leaflets and will have to contain a statement saying that the product hasn’t been evaluated by the MCC,” Hanekom said.

He said the department had prioritised certain products for registration. For example, anti-viral immune boosters, complementary medicines that promise to treat heart disease, and those relating to cancer must apply for registration within six months, while slimming products and those that claim to improve sexual performance must register within 24 months.

“The MCC will call for data depending on the level of claim,” Hanekom said. The more radical the claim, such as a claim to cure cancer or heart disease, the more evidence by way of clinical data, must be provided.

He said some products had already been ruled against repeatedly for misleading claims via the Advertising Standards Authority of South Africa (Asasa).

“The problem with that is, from a consumer perspective, it is after the fact when the product has been on the shelf, and has already been bought by a lot of consumers,” Hanekom said.

“The regulations are a hurdle that manufacturers will have to jump beforehand.”

Medical doctor and consumer activist Dr Harris Steinman, who has taken marketers who make radical claims about their products to the Asasa and won, said the regulations provided a “middle path” to cleaning up the industry that would not make everyone happy.

“Bigger producers probably won’t complain because they have had this in place all along to export their products to countries such as Australia. The people most affected will be those working in their garages,” Steinman said.

He said many of the 155 000 products on the shelves were scams that would not be able to prove their claims.

“It seems a lot of modern products will have to go off the market because the new regulations say you can only make a claim if you can prove it according to the discipline it belongs to,” Steinman said.

For example, Ayurvedic or Traditional Chinese Medicine and Acupuncture, which are registered as complementary disciplines with the Allied Health Professions Council, will only be permitted to make claims that have evidence within these disciplines.

Steinman said it seemed that products that can’t be classified under a registered discipline would then have to fall under stringent regulations governing conventional medicines.

“If this interpretation is true it is excellent news. It means the vast bulk of nonsense will be off the market because if they can’t prove the claims they can’t be sold,” Steinman said.

Consumer Fair chairperson Thami Bolani said he supported the move completely as unproven medical claims were rife and in extreme cases consumers had overdosed, developed complications and died.

“There are adverts for all sorts of cures — to improve your sex life, to fight cancer, and all of these things are unproven,” Bolani said.

Clif Johnston, vice chairperson of the SA National Consumer Union, said the unethical marketing of products had become “very pervasive” due to the loophole in the regulations.

“Safety is a fundamental consumer right and it’s important that all health products be safe, or where there are risks involved, that these are clearly and accurately spelled out,” Johnston said.

“Access to information is another fundamental consumer right, and all claims made in respect of health products need to be credible and scientifically validated.”

Homeopathic Association of South Africa president Dr Danny Pillay said any industry member that did not ensure its products were evaluated for safety, quality and efficacy, was not likely to succeed in registering them.

“The very purpose of regulation is to promote a high assurance in the quality of any product so it will very likely result in the clean-up of an unregulated industry that has prejudiced bona fide manufacturers and distributors of complementary medicine products.

“The intention of the regulator is noble and needs to be supported by all stakeholders.”

Several attempts to obtain comment from the SA Society of Integrative Medicine were unsuccessful at the time of going to print.

• Send your consumer complaints to Lyse Comins at

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