Behind the counters of health shops, in the warehouses of small supplement makers and in the kitchens where families weigh up a protein powder or a vitamin C tablet, a quiet regulatory shift is working its way through South Africa. The products at stake are familiar ones: vitamins, minerals, probiotics, amino acids, collagen, omega oils, herbal preparations and traditional formulations that millions of people use every day for nutrition and general wellbeing. Under the framework the country has been edging towards, many of these everyday items would be treated as medicines, and the people who make, sell and rely on them are the ones who would feel it first.
The sector contributes R22 billion to the economy and supports thousands of jobs. Those jobs are not only in manufacturing. Ingredient suppliers, packaging companies, laboratories, logistics providers, wholesalers, retailers and consultants all sit inside the same chain. When compliance costs rise, it is the smaller businesses in that chain that struggle first. Large companies may be able to absorb pharmaceutical-style requirements such as extensive technical documentation, testing, specialist expertise, registration processes and ongoing regulatory costs. Many small and medium enterprises cannot. Fewer viable local manufacturers would eventually mean less choice and higher prices at the shelf for ordinary shoppers.
To be clear, this is not an argument against regulation. The products in question should meet clear standards for quality, safety, labelling and truthful claims. Unsafe products, adulterated products, unlawful medicines, misleading therapeutic claims and poor manufacturing practices must be dealt with firmly. The real question is whether lower-risk supplements, foods and wellness products should be regulated as though they carry the same risks as pharmaceutical medicines. A vitamin C tablet is not a prescription medicine. Neither is a protein powder, a magnesium supplement or an omega-3 capsule. Oversight should reflect what a product is, how it is used and the risk it presents.
There is also a legal question that should give policymakers pause. In Minister of Health and Another versus Alliance of Natural Health Products (South Africa), the Supreme Court of Appeal held that the 2017 regulations were illegal to the extent that they applied to complementary medicines and health supplements that were not medicines or Scheduled substances under the Medicines and Related Substances Act. A regulator, in other words, cannot simply use a medicines framework for products that fall outside the legal definition of medicines. After the judgment, Sahpra stated that draft amendments were being developed to align the regulatory framework with the court findings.
Meanwhile, the regulator’s own logic points in the same direction. The South African Health Products Regulatory Authority recognises different risk levels in complementary medicines, identifying health supplements as products limited to low-risk indications and substances, while higher-risk products may require stronger evidence. The principle is sound: the greater the risk, the greater the regulatory burden should be.
Other countries show that effective oversight does not require forcing natural health products into a pharmaceutical model. The European Union maintains a dedicated framework for food supplements, covering permitted vitamins and minerals and protection against misleading information. India regulates health supplements and nutraceuticals through its food-safety framework, with specific regulations for health supplements, probiotics, prebiotics and functional foods. Brazil has a dedicated food-supplement framework under Anvisa. Canada goes furthest: natural health products there, including vitamins, minerals, probiotics, herbal remedies and amino acids, sit under a separate framework built around their lower-risk nature, with product licensing, manufacturing standards, labelling and adverse-reaction reporting. Canada is now reviewing that framework specifically to reduce regulatory burden and improve proportionality.
There is, too, a consumer-protection paradox worth naming. If legitimate products become too expensive or disappear from formal retail, consumers may turn to informal sellers or offshore platforms where oversight is weaker. Overregulation can push people away from the very traceable supply chains that regulation is meant to protect.
The alternative is straightforward: regulate the risk, not the label. Products should face appropriate requirements for quality, safety, manufacturing, labelling, claims, adverse-event reporting and recalls, with stronger controls where evidence justifies them. The goal is not less regulation but better regulation, proportionate, lawful and science-based. Whether the framework protects the public while letting a legitimate industry grow, or makes legal products harder to produce, access and afford, is an economic and consumer-access question South Africa can no longer afford to get wrong.
The writer is a director at RiksRecon, a consultancy focused on political, social and geopolitical risk analysis, and a founding member of the Anti-Illicit Economy Association of South Africa. He has worked across government, the private sector and civil society, and on strategic projects in more than 30 African markets.