How Traditional and Herbal Medicines Are Regulated

Traditional, complementary, and herbal medicines are used by a significant portion of the global population for primary healthcare and general wellness. The World Health Organization (WHO) broadly defines traditional medicine as the sum total of the knowledge, skills, and practices based on indigenous theories and experiences, used to maintain health and treat physical or mental illness. Derived from plants, minerals, or animal sources, these products occupy a unique space in global healthcare. Because they are often perceived as natural, there is a common misconception that they are inherently safe and free from side effects. However, like any substance with biological activity, they carry risks of adverse effects, interactions with conventional medicines, and quality issues such as contamination. Regulating these diverse products presents a distinct challenge for health authorities, who must balance cultural accessibility and traditional practices with the scientific need to protect public health.

The WHO Traditional Medicine Strategy

The World Health Organization recognizes the widespread use of these therapies and has developed a framework to guide member states. The WHO Traditional Medicine Strategy aims to support countries in developing policies that ensure the quality, safety, and effectiveness of traditional and complementary medicines. Rather than acting as a global regulator, the WHO encourages nations to integrate traditional medicine into their national health systems where appropriate, while building an evidence base for safety.

A major focus of the strategy is helping countries establish regulatory frameworks, promote research, and standardize terminology. Because a single plant can contain hundreds of active chemical compounds, standardizing extracts and applying conventional clinical trial models to traditional remedies is methodologically difficult. This complexity prompts the WHO to provide specific guidance on evaluating traditional medicine evidence, moving away from a one-size-fits-all approach while maintaining rigorous safety standards.

Diverse Global Regulatory Approaches

The regulation of herbal and traditional medicines varies widely between jurisdictions. In some countries, such as the United States, many herbal products are regulated as dietary supplements rather than medicines. This means they do not undergo the same rigorous pre-market approval process for efficacy as conventional pharmaceuticals, and regulators primarily rely on post-market surveillance to identify and remove dangerous products.

In contrast, the European Union has established a specific regulatory pathway for traditional herbal medicines. This allows products to be registered based on their historical traditional use rather than requiring full clinical trials, provided they meet strict manufacturing safety and quality standards. This diversity in regulation means that a product available over-the-counter in one country might be restricted, require a prescription, or be banned in another, creating a fragmented global landscape for consumers and practitioners.

Complementary Medicines in South Africa

In South Africa, these products are classified as Complementary Medicines and fall under the jurisdiction of the South African Health Products Regulatory Authority (SAHPRA). Historically, many of these products existed in a regulatory grey area, but SAHPRA has been actively working to bring them into a formalized framework through a "call-up" process. Under this process, specific categories—such as herbal preparations, homeopathic products, and certain dietary supplements—are progressively required to be assessed, quality-tested, and registered.

While acknowledging traditional use, SAHPRA requires evidence of quality and safety, and mandates that health claims be substantiated. Consumers in South Africa can check the registration status of a complementary medicine by searching for its registration number or using tools like HealthSA to verify if a product has been officially evaluated by the regulator.

Safety, Quality, and Pharmacovigilance Challenges

Ensuring the safety and quality of herbal medicines is uniquely complex. Because the raw materials are agricultural products, they are subject to variability in active ingredients due to soil conditions, climate, harvest times, and processing methods. There are also well-documented risks of contamination with heavy metals, pesticides, or microorganisms, and instances of adulteration where conventional pharmaceuticals are illegally added to herbal products to artificially enhance their perceived effects.

Furthermore, pharmacovigilance—the monitoring of adverse drug reactions—is challenging because patients often use herbal remedies alongside conventional medicines without informing their healthcare providers, making it difficult to identify herb-drug interactions. Regulators globally emphasize Good Manufacturing Practice (GMP) for these products to mitigate these risks and ensure that the contents match the label. However, enforcement remains a challenge, particularly with products sold online or through informal markets that bypass official regulatory channels.