Marika Sboros: Food is medicine, but SAHPRA treats it like a drug. Illegally.

Four years ago, the Supreme Court of Appeal ruled that SAHPRA had overstepped its powers in regulating vitamins, minerals and herbal remedies as though they were pharmaceutical drugs. Little has changed. This investigation, by freelance journalist Marika Sboros, digs into why — from a herbalist turned courtroom crusader to an industry association's uneasy truce with the regulator. This special report exists only because BizNews Community members contributed to our Commissioning Fund: proper investigative journalism like this is no longer economically viable. If you'd like to see more work like this, email the editor at alec@biznews.com to contribute..By Marika Sboros*.The big question hovering over South Africa’s natural health products industry is not whether vitamins, minerals and herbal remedies need regulation. They do, and the industry itself says so. The real question – and scandal – is what happens when a regulator treats a court judgment as a parked inconvenience rather than a solid boundary.More than four years ago in Bloemfontein, the country’s "city of roses", the Supreme Court of Appeal (SCA) told the medicines regulator it had overstepped its powers.A three-judge bench ruled unanimously. It rapped the Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) on the knuckles for regulating vitamins, minerals, herbal remedies and other natural health products as rigorously as it regulates pharmaceutical drugs.Four years on, nothing has changed. SAHPRA, under CEO Dr Boitumelo Semete Makokotlela, appears to have found ways to keep the regulatory machinery moving in the same direction, industry sources say.The SCA ruling was more than a legal victory for a beleaguered industry. The judges acknowledged a real public interest in regulating these substances. They found that SAHPRA's regulatory enthusiasm went too far, establishing a principle that reaches well beyond vitamins, minerals and herbal remedies.They gave the Health Minister and the regulator 12 months to fix the law.SAHPRA appeared to have leaned on an appeal as an automatic pause in enforcement of an invalidity ruling. It has since rolled out "transitional roadmaps" and border-control import blocks under cover of technical legal justification.On the SCA ruling, it says that the 2017 General Regulations were found unlawful but only insofar as they applied to products that don't meet the legal definition of a "medicine" or "scheduled substance". The declaration of invalidity was suspended for 12 months, and the Minister's 2023 draft amendments were meant to close that gap. The revised regulations, it says, clarify that only products meeting those legal definitions fall under the Medicines Act.A ‘wild west’ of health risks and claimsThe regulator insists it is simply following its statutory mandate to protect the public from a "wild west" of mislabelled ingredients, toxic substances and fraudulent health claims.It has left an industry worth R22-billion a year and thousands of jobs hanging in the balance.That the industry is still standing upright is due largely to Capetonian Anthony Rees and the two organisations he built — the Traditional and Natural Health Alliance (TNHA) and the Alliance of Natural Health Products (ANHP).Rees gave up his herbalist practice years ago to lobby Parliament full-time on the legislation that created SAHPRA. He has campaigned on health-freedom issues since the 1990s, co-coordinating the advocacy group PHARMAPACT since 1996.Along with other lobbyists, he helped secure the exclusion of a complementary medicines definition from the original 2014 Medicines Act amendment bill. He served on the old MCC's expert sub-committee for Western Herbal Medicines before it gave way to SAHPRA in 2017.When SAHPRA started regulating natural health products as medicines anyway, Rees founded the TNHA as a militant advocacy group and watchdog. It remains his permanent platform for lobbying and consumer education.When it was clear that individual manufacturers and retailers lacked the standing and resources to fight the state alone, he formed and chaired the ANHP as a separate, single-purpose vehicle to fund and drive litigation.The standoff has developed over decades, rooted in legal loopholes between the definitions of "food" and "medicine."From the MCC to SAHPRASouth Africa has regulated medicines since the Medicines Control Council (MCC) was established under the Medicines and Related Substances Act of 1965.Amendments in 2017 created SAHPRA as the MCC's successor, with a mandate stretching from clinical trials to radiation-emitting devices. Natural health products sat awkwardly in between.SAHPRA formally took over in February 2018. Almost immediately it placed natural health supplements under the umbrella of complementary medicines, under Category D, requiring the same onerous, costly pharmaceutical-style registration used for prescription drugs.On where food ends and medicine begins, SAHPRA says the same substance can fall into different categories depending on intended use and presentation. Turmeric in a spice jar, for example, is food; turmeric concentrated into a therapeutic capsule can become a medicine.The industry's response was the ANHA court case, with two legal outcomes in its favour, first in the Gauteng High Court in Pretoria in November 2020, followed by the SCA in Bloemfontein in 2022.Rees sees SAHPRA's conduct not as bureaucratic inefficiency. “It is defiance of the courts, a direct affront to the rule of law, and a violation of constitutional obligations," he says.He traces it to SAHPRA’s restructuring from an organ of state into a self-funded state-owned enterprise. He argues that this turned into a "revenue-hungry, rent-seeking gatekeeper". It uses border posts as "pressure points" and "weaponises" import controls, leaving companies with "extortionate" storage bills that consumers ultimately pay.Rees calls this a "quasi-legal witch hunt" that unfairly tightens and constricts an industry with "practically no reported history of harm" and leaves consumers with fewer choices.SAHPRA claims to hold ongoing talks with stakeholders. Rees says these meetings are not about dialogue. They are "full-blown theatrical productions, complete with choreographed PowerPoints, pseudo-legal jargon confetti, and enough smoke and mirrors to obscure legal reality".'Technocratic tyranny'His deeper objection is ultimately biochemical. Nutrients in natural health products, Rees argues, are building blocks intrinsic to human biochemistry; pharmaceutical medicines are designed to stimulate, suppress or alter it."Treating the two the same when regulating," he says, "is a category error."He has warned Health Minister Dr Aaron Motsoaledi that South Africa risks a slide into "technocratic tyranny" disguised as "public safety" if lawmakers do not intervene.Rees favours the US regulatory model. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, vitamins, minerals and botanicals are treated as a distinct food category rather than drugs, with no pre-market approval. The Food and Drug Administration (FDA) can only intervene after the fact if it can show a product poses an unreasonable risk.The European Union approach restricts food supplements to a positive list of approved ingredients, with health claims requiring prior scientific validation. Products making therapeutic claims must register instead as traditional herbal medicines, a route that requires 30 years of documented safe traditional use.Rees views SAHPRA's demands for technical validation, facility licensing and strict registration as closer to the EU's high-barrier model than the FDA's food-adjacent approach.A leading player in the natural health products and supplements industry is the Health Products Association of Southern Africa (HPA), founded in 1976. It is a trade body and watchdog representing more than 100 member companies across manufacturing, distribution, retail and brand ownership.HPA Chairperson Maria De Ascencao says the HPA is "fully committed to regulation of the health products industry and working with SAHPRA to find solutions”. The organisation's frustration, she says, is with the regulatory process, not the principle of regulation. Focus on consumer safety"We are simply calling for a proportionate, risk-based framework that supports consumer safety, product quality, responsible health claims and appropriate, proportionate regulatory oversight."To that end, the HPA has invested heavily in technical submissions, stakeholder forums and regulatory engagement, De Ascencao says.It advocates for a name change in SAHPRA's regulatory schedule, from Complementary Medicines to a distinct category for natural health products – a dedicated directorate similar to Health Canada's.The HPA is also committed to appropriate safety, quality and efficacy standards, and says the sector has the potential to contribute to a healthier population. It supports good nutrition, preventive healthcare and responsible supplementation and can address gaps in nutrient intake."In this respect, the sector should not be viewed simply as a commercial consumer-products industry," she says. “It can contribute to a healthier nation.”The HPA advocates for a regulatory system that distinguishes products that make "functional" health claims, De Ascencao says. She defines these as stemming from "a nutrient's scientifically supported role in maintaining health and wellness", not the disease treatment, prevention or cure claims of pharmaceutical drugs.De Ascencao likens this to the European Food Safety Authority's approach where natural health products sit somewhere between medicine and food.Low- versus high-risk health claimsThe HPA accepts that international standards and World Health Organisation (WHO) guidance offer useful benchmarks, she says. However, such benchmarks need adapting to South Africa's domestic legal framework and the actual risk profile of natural health products, “not imported wholesale from pharmaceutical regulation".Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal who also sits on three SAHPRA advisory committees, gives the claims-based distinction real texture.Manufacturers, he notes, are already restricted to low-risk claims under a detailed SAHPRA guideline. A vitamin B3 tablet, for instance, is capped at 500mg and may claim only to help metabolise nutrients, saying nothing about treating disease. Any "clinically proven" claim is automatically bumped into a stricter category.SAHPRA accepts the functional-versus-therapeutic claims distinction that TNHA and HPA argue for but says it already exists. Guideline 7.04 specifically sets permitted claims and dosage ranges for health supplements. The Guideline allows no therapeutic disease claims, and the framework is risk-based. "Supports general wellness", for example, is low risk; "helps relieve mild cold symptoms" is intermediate; "treats diabetes" or "cures cancer" is high risk.In other words, the distinction that both TNHA and HPA want written into law already exists, at least on paper, in SAHPRA's own guidelines.Despite the HPA's substantial investment in support for SAHPRA and the TNHA's ongoing lobbying, it can appear that the regulator is not listening.For consumers, the deadlock creates an unpredictable shopping environment with rapidly reducing choices. It erodes South Africans' constitutional right to take responsibility for their own health, says Rees.Shelves remain largely stocked because of the TNHA's court wins. But SAHPRA's aggressive import restrictions at the border have quietly pushed niche imported brands off the market or into long delays, leaving South Africans with domestic choice but rising costs.The controversial National Health Insurance scheme adds further threat. Signs, so far, are that the scheme will exclude traditional medicine and natural health practitioners and products from state-funded care altogether.‘Food IS medicine’Dr Rob Verkerk, founder and Executive and Scientific Director of the Alliance for Natural Health International, brings an international perspective.Verkerk is an internationally recognised, multi-disciplinary scientist with over four decades in health, agriculture and environmental sustainability. He has spent the past two years on research, soon to be published, into how regulators worldwide draw the line between food and drugs."Food is medicine and always has been," Verkerk says. "Modern regulatory systems get the priorities backwards, rewarding treatment of disease over prevention."Regulators, he says, hold sweeping discretion to reclassify a natural product as a drug whenever it threatens patentable competitors. This gives them "a loaded gun" that lets them arbitrarily "call anything they like a drug" if it competes with licensed pharmaceuticals.Verkerk traces this to the post-World War 2 rise of a pharmaceutical "pay-to-play system" that only companies with patents and deep pockets can navigate, squeezing out unpatentable natural products by design, not genuine safety concern. "Pharmaceutical companies have shown aggressive interest in trying to rape, pillage and steal everything they can from Nature's treasure trove", Verkerk says.They have turned first-line therapists into "drug pushers for the pharmaceutical industry".He sees Health Canada's separate category for natural health products as initially a positive step that has become a "light pharmaceutical regime". It has driven roughly a third of the industry to collapse since the early 2000s.His benchmark is India, which treats traditional use itself as evidence, though he sees the same pressure to conform building there too.Omission no one wants to ownOne yawning gap runs through the entire debate is African Traditional Medicine. Its practitioners are formally recognised, yet it sits outside SAHPRA's Category D definition of complementary medicines altogether.Its medicines have demonstrated "considerable harms, especially to babies and infants", Rees notes in his February 2026 open letter to Motsoaledi. It has become a socio-political "hot potato”, he says, and remains mostly unregulated more than 30 years after the advent of democracy. He believes SAHPRA avoids regulating it "for fear of the fallout, even as herbal and nutritional products face the harshest scrutiny of any category".The omission erodes public trust in democratic institutions and constitutional rights to equality, bodily autonomy and freedom of trade, says Rees. It harms SMEs through product shortages, price increases and closures, and distorts markets by favouring "large incumbents while penalising traditional and natural health sectors".He points out that the risk profile of the CAM (Complementary and Alternative Medicine) is “extraordinarily low, safer than common foods, infinitely safer than pharmaceuticals, and almost inconsequential when compared to the genuine harms arising from certain unregulated African Traditional Medicines”.SAHPRA confirms that African Traditional Medicine is not currently regulated – the Medicines Act, which SAHPRA implements, does not expressly provide for it. However, it has "initiated a process to develop an appropriate regulatory framework" for these products, aligned with World Health Organisation guidance on traditional medicine.What South Africa stands to loseThe natural health products sector is valued at roughly R22-billion a year, with room to grow – if it survives. Among manufacturers taken to the point of collapse, GO2Pharma has faced operational paralysis and severe financial strain from regulatory compliance hurdles; Ascendis Health's manufacturing arm closed, shedding roughly 300 jobs to a facility in India.On the economic impact industry warns of, SAHPRA says it is not clear which specific requirements are considered onerous and has asked for concrete examples. It points to a Socio-Economic Impact Assessment led by the Presidency, currently underway, and a stakeholder questionnaire it ran from July 17 to August 17, 2026.SAHPRA insists that it remains committed to "evidence-based regulation, meaningful stakeholder engagement" that balances "patient safety, access and industry sustainability".That's not an answer to whether SAHPRA has assessed the cost itself, just an outsourced one..Read more:.iDexis pushes back on Sahpra’s GLP-1 recall, denies compliance breaches.The reality remains that every factory that closes takes its jobs, contracts and tax contribution with it. An industry forced into registration that it cannot survive economically does not reform. It disappears.What is not in dispute is the court record. South Africa's highest court short of the Constitutional Court has ruled that SAHPRA exceeds its lawful powers. Four years later, the regulator is undeterred.Bloemfontein is the city of roses. Four years after it delivered the cleanest legal win for natural health products, all the industry has to show for it is the regulator’s thorns..*Follow Marika Sboros on X and on Substack.Sign up for your early morning brew of the BizNews Insider to keep you up to speed with the content that matters. The newsletter will land in your inbox every morning on weekdays. Register here.Support South Africa's bastion of independent journalism, offering balanced insights on investments, business, and the political economy, by joining BizNews Premium. Register here.If you prefer WhatsApp for updates, sign up to the BizNews channel here.

Marika Sboros: Food is medicine, but SAHPRA treats it like a drug. Illegally.

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