No Full Approval for Herbal Drugs Without Clinical Trials — NAFDAC Warns Practitioners

The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed that no herbal medicine will receive full regulatory approval without undergoing well-structured clinical trials to scientifically prove its safety and effectiveness.

In a statement released on Sunday and signed by NAFDAC’s media consultant, Sayo Akintola, the Director-General of the agency, Prof. Mojisola Adeyeye, emphasised that while Nigerian herbal medicine practitioners possess the expertise to formulate quality and effective natural remedies, scientific validation remains the key requirement for full approval.

To ensure herbal products meet international standards, NAFDAC is collaborating with the Nigeria Natural Medicine Development Agency (NNMDA) to promote evidence-based research and validation of local herbal formulations.

According to the World Health Organisation, about 80 per cent of Africa’s population depends on herbal remedies for their primary healthcare needs. NAFDAC’s new initiative seeks to bridge traditional healing practices with modern scientific standards to make Nigerian herbal medicines safe, effective, and globally acceptable.

Prof. Adeyeye explained that the agency currently operates two approval levels for herbal products: the listing approval and full registration. Products that pass toxicological safety tests receive listing approval, valid for two years, and are issued a NAFDAC number ending with the letter ‘L’. However, full registration—valid for five years—requires successful clinical trials proving the product’s efficacy under a well-designed research protocol.

She noted that the high cost of clinical trials remains a major challenge preventing many practitioners from validating their products. “If you have a herbal medicine but cannot scientifically prove its efficacy and safety, NAFDAC cannot grant it full registration,” she stated.

The NAFDAC DG revealed that while thousands of herbal medicines have been listed, only a few have undergone clinical trials with verifiable results. She cautioned that even natural products can be harmful if used improperly, stressing that determining safe dosage levels through scientific testing is essential to prevent damage to organs such as the liver and kidneys.

Adeyeye recalled that the agency established the Herbal Medicine Products Committee shortly before the COVID-19 pandemic to promote collaboration between practitioners, researchers, and government institutions, including the Federal Ministry of Health. The committee continues to drive research and regulatory development in the field of traditional medicine.

She further disclosed that NAFDAC is seeking funding support to help practitioners conduct the costly clinical trials needed for full approval. Through its ongoing partnership with the NNMDA, the agency plans to identify already listed herbal products that meet initial regulatory requirements and subject them to further clinical evaluation.

“We must scientifically confirm that these medicines are both effective and safe for human use. Once validated, they can be fully registered and possibly included in the national herbal medicine formulary,” Adeyeye said.

She added that NAFDAC will continue to engage herbal medicine practitioners through regular stakeholder meetings to guide them on regulatory processes, safety requirements, and international best practices.