For several years, South Africa has been edging towards a regulatory framework that some might argue is a nightmare that would treat many natural health and wellness products as medicines.
Why is this relevant? It tells a story of regulatory over-reach, strange decisions by the government and the consequences of imposing this new regulatory regime, which treats health and wellness supplements as medicines. The consequences will be devastating for a sector that contributes R22 billion to the economy, with thousands of jobs at stake.
This is not a debate about whether natural health products should be regulated. They should be. The real question is whether South Africa should regulate lower-risk supplements, foods and wellness products as though they carry the same risks as pharmaceutical medicines, despite legal findings, international practice and the potential economic consequences.
South Africa has moved towards a framework that brings products such as vitamins, minerals, probiotics, amino acids, collagen, omega oils, protein powders, herbal preparations and traditional formulations into a medicines-style regulatory environment. The products are widely used for nutrition, general wellbeing and health maintenance. They should meet clear standards for quality, safety, labelling and truthful claims. But regulation must be proportionate to risk.
A vitamin C tablet is not a prescription medicine. Neither is a protein powder, magnesium supplement or omega-3 capsule. They may require oversight but that oversight should reflect what the product is, how it is used and the level of risk it presents.
That distinction matters because regulation has consequences. When lower-risk products are subjected to unnecessarily heavy requirements, compliance costs rise, smaller businesses struggle, consumer prices can increase and product choice can shrink. The question South Africa must therefore confront is: Are we regulating according to risk or simply regulating according to category?
The South African Health Products Regulatory Authority (Sahpra) recognises different risk levels in complementary medicines. Its framework identifies 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.
International practice also demonstrates that natural health products do not have to be forced into a conventional pharmaceutical model to be regulated effectively. The European Union has a dedicated framework for food supplements, including requirements covering permitted vitamins and minerals and protection against misleading information. India regulates health supplements and nutraceuticals through its food-safety framework, with specific regulations covering health supplements, probiotics, prebiotics, functional foods and related categories. Brazil similarly has a dedicated food-supplement framework under Anvisa.
Canada provides an even clearer example. Natural health products, including vitamins, minerals, probiotics, herbal remedies and amino acids, are regulated under a separate framework designed around their lower-risk nature. The system includes product licensing, manufacturing standards, labelling and adverse-reaction reporting. Importantly, Canada is reviewing its framework specifically to reduce regulatory burden and improve proportionality.
South Africa's legal history should also 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.
The significance is difficult to ignore: a regulator cannot simply use a medicines framework to regulate 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.
This is not an argument for deregulation. Unsafe products, adulterated products, unlawful medicines, misleading therapeutic claims and poor manufacturing practices must be dealt with firmly. But enforcement should target those risks directly. A handful of problematic products should not become a justification for imposing pharmaceutical-level obligations on an entire lower-risk sector.
The economic consequences also deserve serious attention. Pharmaceutical-style compliance can involve extensive technical documentation, testing, specialist expertise, registration processes and ongoing regulatory costs. Large companies may have the resources to absorb these demands. Many SMEs do not.
And the impact does not end with manufacturers. The sector supports ingredient suppliers, packaging companies, laboratories, logistics providers, wholesalers, retailers, consultants and other businesses. Higher barriers to entry could mean fewer local manufacturers, less innovation, fewer products and higher prices for consumers.
There is also a consumer-protection paradox. If legitimate products become too expensive or disappear from formal retail channels, consumers may turn to informal sellers or offshore platforms where oversight is weaker. Overregulation can therefore push consumers away from the traceable supply chains regulation is supposed to protect.
South Africa needs a different approach: regulate the risk, not the label. Products should face appropriate requirements for quality, safety, manufacturing, labelling, claims, adverse-event reporting and recalls. Stronger controls should apply where the evidence and risk justify them. Lower-risk products should not automatically be subjected to the full weight of pharmaceutical regulation.
South Africa has an opportunity to build a framework that protects consumers without suffocating SMEs, local manufacturing and innovation. The objective should not be less regulation. It should be better regulation: proportionate, lawful, science-based and fit for purpose.
The choice is whether regulation will protect the public while allowing a legitimate industry to grow or the excessive regulatory burdens will make legal products harder to produce, harder to access and harder to afford.
That is not merely a regulatory question. It is an economic and consumer-access question and one South Africa can no longer afford to get wrong.
Dr Petrus is a director at RiksRecon, a consultancy company focused on political, social and geopolitical risk analysis and advisory services. He is also a founding member of the Anti-Illicit Economy Association of South Africa. He has extensive experience in government, the private sector and civil society organisations, and often provides policy, regulatory and market-related research and advice to clients. He straddles many worlds, having been involved in and actively deployed on strategic projects in more than 30 African markets. He understands African and emerging-world realities from the proverbial pavement all the way up to the highest offices in the land.