The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has said Nigerian herbal medicines can attain global recognition if they undergo rigorous scientific evaluation.
Speaking on NAFDAC’s partnership with the Nigeria Natural Medicine Development Agency (NNMDA), Adeyeye emphasized the importance of clinical trials in proving the safety and effectiveness of traditional remedies.
She explained that NAFDAC operates two approval categories for herbal products: a two-year listing approval granted after successful toxicology safety tests, and a five-year full approval, which requires clinical trials to confirm efficacy.
Adeyeye noted that the high cost of clinical trials remains a major challenge for many herbal medicine practitioners. “If you have a herbal medicine and cannot scientifically prove its effectiveness and safety through data, it cannot receive full registration from NAFDAC,” she stated.
While thousands of herbal medicines have been listed by the agency, only a few have undergone clinical trials to earn full registration. Adeyeye cautioned that “natural does not always mean safe,” warning that some untested herbal products could harm vital organs like the liver and kidneys.
To address these challenges, NAFDAC is collaborating with the NNMDA to conduct clinical trials on selected listed herbal medicines. The goal, she said, is to fully register products proven effective for inclusion in a forthcoming national formulary. The agency is also seeking financial support to assist practitioners with the cost of trials.
“We are determined to support our practitioners in conducting clinical trials. Together with NNMDA, we will mobilize resources to help some herbal medicines achieve full registration after going through the due process,” Adeyeye affirmed.
Drawing from her own experience in the U.S., Adeyeye recounted leading a project that developed an anti-sickling polyherbal medicine previously listed by NAFDAC. Laboratory studies and a 2017 clinical trial—approved by Bowen University’s Ethics Committee and her U.S. university’s Institutional Review Board—confirmed its effectiveness, though more data and funding are required.
She added that NAFDAC continues to engage herbal medicine producers through stakeholder meetings and has published a simplified factory floor plan on its website to guide compliance with production standards.
“We approve herbal medicines daily, but we are moving toward a stage where only those that have undergone clinical trials and proven efficacy will be included in a national formulary,” Adeyeye said.
Through these efforts, NAFDAC aims to ensure that Nigerian herbal medicines meet international standards for safety, efficacy, and quality.
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