When Food Becomes a “Drug”: SAHPRA’s Regulatory Reach and the Battle Over Natural Health in South Africa

In early September 2026, veteran health journalist Marika Sboros published a pointed intervention on BizNews: “Food is medicine, but SAHPRA treats it like a drug. Illegally.” The piece lands at a moment when South Africa’s health-products regulator is under renewed scrutiny for how it draws — or fails to draw — the line between ordinary foodstuffs, nutritional supplements, complementary medicines and fully regulated pharmaceuticals.

Sboros argues that the South African Health Products Regulatory Authority (SAHPRA) continues to treat a wide range of natural and food-based products as if they were medicines, despite court rulings that limit its jurisdiction. The practical effect, she contends, is an illegal expansion of regulatory power that threatens consumer choice, a multi-billion-rand industry, and the basic principle that not every substance with a health benefit automatically falls under the Medicines and Related Substances Act.

This analysis takes Sboros’s central claim seriously, situates it in the legal and regulatory history, examines the stakes for consumers and industry, and considers the wider pattern of regulatory over-reach that appears across South African policy domains — including, not coincidentally, the ongoing struggles over cannabis and hemp formalisation.

The Legal Baseline: What Courts Have Already Said

The most important recent judicial marker is the 2022 Supreme Court of Appeal decision in the Alliance of Natural Health Products litigation. The SCA confirmed that SAHPRA’s power is confined to products that meet the statutory definition of a “medicine.” A preparation whose primary purpose is to supplement the diet or provide nutritional benefit is a foodstuff, regulated under the Foodstuffs, Cosmetics and Disinfectants Act, not the Medicines Act.

That distinction is not semantic. It determines licensing, manufacturing standards, advertising rules, scheduling, and the cost of bringing a product to market. When a regulator treats a nutritional product as a medicine, it imposes pharmaceutical-grade requirements that many small and medium natural-health businesses cannot meet. The result is either exit from the market or a shift into grey and black channels — precisely the opposite of the transparency and safety goals regulation is supposed to serve.

Sboros’s article returns to this terrain. She contends that, despite the SCA ruling, SAHPRA’s practical approach continues to sweep large categories of natural products into a medicines framework. The regulator’s borderline-product guidelines and complementary-medicines (Category D) regime still generate uncertainty. Call-up notices have been issued and withdrawn; registration of complementary medicines has been slow or non-existent; and the default posture, critics argue, remains one of suspicion toward anything that makes a health-related claim outside the conventional pharmaceutical pipeline.

Food as Medicine — An Ancient Idea Meets Modern Bureaucracy

The proposition that “food is medicine” is not a marketing slogan. It is a statement of biological fact recognised across traditional knowledge systems and increasingly supported by nutritional science. Diet influences inflammation, metabolic health, gut microbiome composition, micronutrient status and long-term disease risk. Governments worldwide promote dietary guidelines precisely because food has physiological effects.

The regulatory difficulty arises when a food or food-derived product is presented with a specific health claim. At that point the line between “foodstuff” and “medicine” becomes contested. SAHPRA’s approach, according to its critics, has been to resolve ambiguity in favour of medicine status. That resolution expands the regulator’s domain, increases compliance costs, and shrinks the space for low-risk, traditional or nutritional products that have long been available without pharmaceutical oversight.

Sboros frames this as more than bureaucratic caution. She describes it as an illegal overstep — a failure to respect the boundary the courts have already drawn. When a regulator acts beyond its statutory mandate, the consequences are not merely inconvenience for industry. They include reduced consumer access, higher prices, loss of livelihoods in the natural-health sector, and a quiet transfer of authority from democratic legislation and judicial interpretation to administrative discretion.

The Scale of What Is at Stake

The natural and complementary health sector in South Africa is substantial. Estimates cited in recent coverage place related economic activity in the tens of billions of rand. It encompasses small manufacturers, importers, retailers, traditional practitioners, and a large base of consumers who prefer nutritional and botanical approaches for general wellness or minor self-limiting conditions.

Heavy-handed classification of these products as medicines does not automatically improve safety. In many cases it simply raises barriers. Products that cannot meet pharmaceutical registration thresholds disappear from legitimate shelves or migrate to informal markets where quality control is weaker. The consumer who previously bought a straightforward herbal or nutritional product now faces either higher prices, reduced choice, or the risk of unregulated alternatives.

This dynamic is not unique to natural health. Parallel patterns appear in other domains where regulation has expanded faster than capacity or clarity. The cannabis sector offers a useful comparison. Constitutional private-use rights exist, yet commercial and traditional growers still confront complex licensing, high compliance costs and continued enforcement pressure. The result is a formal sector that is difficult to enter and an informal sector that persists. When regulation is designed or applied in ways that only well-resourced actors can navigate, the stated public-interest goals — safety, quality, access — are only partially achieved.

Ministerial Oversight and Institutional Accountability

Sboros’s piece also raises questions about the relationship between the Minister of Health and SAHPRA. Regulators are not free-floating entities; they operate under statutory mandates and executive oversight. When a regulator’s practice appears to diverge from court rulings, the political principal bears responsibility for correction or clarification.

Silence or slow response in the face of judicial limits can be read as acquiescence. It can also signal that the administrative state has developed its own institutional interests — expanding jurisdiction, standardising processes around pharmaceutical models, and treating alternative or traditional approaches as residual categories to be tightly controlled. Neither explanation is reassuring for citizens who expect regulators to stay within the law.

The broader democratic point is straightforward. Courts interpret the law. Legislatures write it. Regulators implement it within those bounds. When implementation drifts beyond those bounds, the remedy is not more discretion; it is accountability — through further litigation, parliamentary oversight, or executive instruction.

Consumer Autonomy and the Right to Choose

At the centre of the debate is a simple proposition: adults should be free to make informed decisions about low-risk nutritional and traditional products without the state treating every such choice as a pharmaceutical event.

This is not an argument against all regulation. Quality standards, truthful labelling and protection against outright fraud remain legitimate. It is an argument against the presumption that the default regulatory category for anything with a health association must be “medicine.” That presumption concentrates power, raises costs, and treats citizens as permanent patients rather than capable agents.

South Africa’s constitutional order values dignity, freedom and the rule of law. Applying pharmaceutical controls to ordinary food-derived products sits uneasily with those values when courts have already indicated that such products fall outside the medicines definition.

Looking Forward

Sboros’s article is a warning shot. It returns public attention to a conflict that litigation has not fully resolved and that administrative practice has not clarified. The natural-health sector, consumer groups and legal practitioners will continue to test the boundaries. Further court applications, parliamentary questions and industry mobilisation are likely.

For SAHPRA and the Department of Health, the constructive path is transparency and restraint: publish clear, court-compliant guidance on borderline products; accelerate or abandon unworkable complementary-medicines registration processes; and respect the distinction between foodstuffs and medicines that the SCA has already affirmed.

For the public, the issue is practical. It affects the price and availability of everyday nutritional products, the viability of small businesses, and the principle that regulatory power has limits. Food can be medicine in the oldest and most accurate sense of the term. That does not give the state licence to treat every food as a drug.

The original intervention by Marika Sboros is available here:

https://www.biznews.com/health/sboros-food-medicine-sahpra-treats-drug-illegally

The debate it has reopened will not be settled by a single article. It will be settled by whether South Africa’s institutions choose to stay inside the law the courts have already stated — or continue to test how far administrative reach can stretch before the next judicial correction arrives.