Supplements and nutraceuticals: why they are regulated differently

Nutraceuticals and dietary supplements occupy a unique space in global healthcare. The term "nutraceutical"—a combination of "nutrition" and "pharmaceutical"—broadly covers products derived from food sources that claim to offer extra health benefits. These products range from daily multivitamins and mineral tablets to herbal extracts, probiotics, and amino acids. While widely used to support general wellbeing, they are not regulated in the same way as conventional pharmaceuticals. Because they often sit in a grey area between food and medicine, regulators around the world have developed distinct frameworks to oversee them, balancing consumer access with the need for safety and truthful marketing.

The line between medicine and supplement

The primary distinction between a medicine and a supplement lies in the product's intended use and the evidence supporting that use. Medicines are defined by their purpose to treat, cure, prevent, or diagnose disease. Before a medicine reaches the market, it must undergo rigorous clinical trials to prove that it is safe and effective for these specific medical conditions. Supplements, by contrast, are generally intended to supplement the diet by providing nutrients that might not be consumed in adequate amounts.

A single ingredient can sometimes fall into either category depending on its dosage and presentation. For example, a low dose of a vitamin might be sold freely as a dietary supplement, while a high dose of the same vitamin formulated to treat a diagnosed clinical deficiency might be registered as a prescription medicine. The determining factor is often the manufacturer's claims. If a product is marketed to treat a specific illness, it typically crosses the regulatory line and is classified as a medicine, subjecting it to the full weight of pharmaceutical evaluation.

Why health claims are restricted

Because supplements do not undergo the same extensive clinical testing as medicines, regulators strictly limit the health claims their manufacturers can make. In many jurisdictions, manufacturers are permitted to make "structure or function" claims—such as "supports a healthy immune system" or "helps maintain joint mobility"—but they are prohibited from making disease claims, such as "cures the flu" or "treats arthritis".

This restriction exists to protect consumers. Without the burden of proving efficacy through large-scale, randomised controlled trials, supplements cannot legally claim to replace medical treatments. If a supplement manufacturer claims their product treats a disease, regulators require them to provide the same level of scientific evidence as a pharmaceutical company. Furthermore, regulators often require a disclaimer on supplement labels to clarify that the product has not been evaluated for disease treatment, ensuring that consumers do not delay seeking proven medical care for serious conditions.

The SAHPRA complementary medicines framework

In South Africa, the regulation of these products falls under the South African Health Products Regulatory Authority (SAHPRA) through its complementary medicines framework. SAHPRA defines complementary medicines as products containing scheduled substances, including vitamins, minerals, plant extracts, and animal extracts, used for maintaining, restoring, or promoting health.

Under this framework, manufacturers must register their products, but the regulatory pathway is tailored to the risk profile of the product rather than demanding the full pharmaceutical dossier required for a new drug. However, if a complementary medicine makes a disease treatment claim, or if it contains high concentrations of certain active ingredients, it may be reclassified as a conventional medicine and subject to stricter scheduling. Consumers and healthcare providers in South Africa can verify the registration status of complementary medicines by searching HealthSA, ensuring the product has been officially recorded. Registered products are also subject to South Africa's Single Exit Price framework, which aims to ensure transparent and uniform pricing across the supply chain.

Quality, safety, and manufacturing standards

While the efficacy requirements for supplements may differ from those for conventional medicines, safety and quality standards remain strict. Regulators generally require supplement manufacturers to follow Good Manufacturing Practice (GMP). This ensures that products are produced consistently, free from contamination, and accurately labelled regarding their ingredients.

Quality control is particularly important for botanical extracts, which can vary wildly in concentration depending on how the plants are grown and harvested. Contamination with heavy metals, microorganisms, or undeclared pharmaceutical active ingredients is a known risk in the broader supplement industry, making GMP compliance essential. By enforcing these manufacturing standards, regulators aim to ensure that even if a supplement does not cure disease, it will at least be safe for consumption and contain exactly what the label promises.