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 Mooted regulation changes that will see South Africa’s supplements regulated as pharmaceuticals will restrict supply, force prices up and decimate up to 80 per cent of businesses in the natural products sector, industry figures indicate.
Many functional foods as well as essential fatty acids, sports nutrition products, energy drinks and processed foods such as infant formulas will also be classified as medicines under the proposal.
“We want regulation, but we want regulation that is applicable to this class of products. We don’t want them to be reclassified as medicines because they are not medicines,” said Bruce Dennison, managing director of Cape Town-based supplements manufacturer Vital Health Foods.
He said unscrupulous companies marketing weight-loss products had spurred the government into action to halt a rash of unsubstantiated health claims. “These products are not even complementary medicines, which is why we think this legislation is inappropriate.”
If the draft becomes law, those who manufacture products for the $350 million market will have to demonstrate proof of safety and efficacy to gain registration with the Medicines Control Council. Manufacturing processes will have to be authorised by a pharmacist, and advertising will also be severely restricted.
Homeopathic and flower remedies; aromatherapy oils; food supplements; and Ayurvedic, Chinese and African medicines will also be governed.
The Complementary and Traditional Medicines Stakeholders Committee (CTMSC) said the regulations favoured bigger players and were inappropriate to the botanicals industry. “We believe separate regulations should be drafted that will be relevant, fair and appropriate for complementary and traditional medicines,” they said.
The CTMSC also expressed concern about retail controls that would see health food stores forced to hire pharmacists if they wished to continue trading in botanicals.
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