NAFDAC Sets Conditions To Approve Herbal Products

The National Agency for Food and Drug Administration and Control has set strong conditions that herbal medicine manufacturers must meet before receiving approval.

The agency stated that no herbal products will get full regulatory approval without undergoing well-structured clinical trials to scientifically prove their safety and effectiveness.

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

In a statement released on Sunday and signed by NAFDAC’s spokesperson, 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.

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.

Adeyeye explained that the agency currently operates two levels of approval for herbal medicines.

“The first is the listing (L) approval, granted after a product has passed toxicological safety tests in our laboratory. Such products are listed for two years and carry a NAFDAC number ending with the letter ‘L’,” she said.

“The second, which is full approval, requires clinical trials to prove the product’s efficacy. Once such trials, conducted under a well-designed protocol, confirm the product’s effectiveness, it is granted full registration valid for five years.”

She identified the high cost of clinical trials as a major obstacle discouraging many practitioners from scientifically validating their products.

“If you have a herbal medicine but cannot scientifically prove its efficacy and safety, NAFDAC cannot grant it full registration,” she emphasised.

The NAFDAC boss noted that while thousands of herbal medicines have been listed, only a few have undergone clinical trials with verifiable outcomes.

“We know herbal medicines work, but we must determine scientifically the safe dosage levels. Below a certain threshold, they are safe; above it, they may damage vital organs like the liver and kidneys. The fact that a product is natural doesn’t mean it’s completely safe—that’s why regulation is crucial,” she said.

Adeyeye recalled that NAFDAC established the Herbal Medicine Products Committee shortly before the COVID-19 pandemic to foster collaboration among practitioners, researchers, and government agencies, including the Federal Ministry of Health. The committee, she said, continues to promote traditional medicine research and regulation.

She also disclosed that NAFDAC is seeking funding support to help practitioners conduct clinical trials, which are highly capital-intensive.

According to her, the ongoing partnership with the NNMDA will identify listed herbal medicines that have met preliminary regulatory standards and subject them to clinical testing.

“We need to prove beyond doubt that these medicines are effective and safe for human use. Once confirmed, they can be fully registered and possibly included in the national formulary for herbal medicines,” Adeyeye said.

She added that the agency continues to engage herbal medicine practitioners through stakeholder meetings to sensitise them on registration requirements and best practices to ensure product safety and efficacy.