SA stands at a critical regulatory crossroads as policymakers edge towards treating everyday natural health supplements as pharmaceutical medicines.
Applying a heavy-handed pharmaceutical model to lower-risk wellness products threatens to devastate a thriving R22bn industry, placing thousands of local jobs and small enterprises in jeopardy.
SummaryOpen the quick read
- Treating low-risk wellness supplements like prescription drugs threatens South Africa's R22bn health industry and thousands of SME jobs.
- The Supreme Court of Appeal previously ruled that non-medicinal complementary products cannot be unlawfully regulated under the Medicines Act.
- International markets such as Canada, the EU, and India successfully use distinct, proportionate frameworks for food supplements rather than pharmaceutical regimes.
- Excessive regulatory costs risk driving up consumer prices and inadvertently pushing buyers towards untraceable, unregulated grey markets.
- Industry experts urge regulators to adopt a science-based, risk-proportionate model that ensures public safety without suffocating local innovation.
For several years, SA has been edging towards a regulatory framework (some might argue 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 being made by government, and the consequence of which, if this new regulatory regime is imposed, which treats health and wellness supplements as medicines, will be devastating for a sector that contributes R22bn 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 SA 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.
SA 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.
These 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 SA must therefore confront is simple: are we regulating according to risk, or simply regulating according to category?
The SA Health Products Regulatory Authority (Sahpra) itself recognises different risk levels within complementary medicines.
Its current 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 EU 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 its regulatory authority.
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 now reviewing its framework specifically to reduce regulatory burden and improve proportionality.
SA’s own legal history should also give policymakers pause.
In Minister of Health and Another v Alliance of Natural Health Products (SA), the Supreme Court of Appeal held that the 2017 regulations were unlawful to the extent that they applied to complementary medicines and health supplements that were not actually “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.
Following 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 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 very traceable supply chains regulation is supposed to protect.
SA 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.
SA 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 now is whether regulation will protect the public while allowing a legitimate industry to grow, or whether excessive regulatory burdens will make lawful 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 SA can no longer afford to get wrong.
Dr Petrus de Kock is 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 SA