The National Agency for Food and Drug Administration and Control (NAFDAC) has said herbal medicines cannot receive full approval without undergoing proper clinical trials. The statement was issued on Sunday, October 12, 2025, by the agency’s Resident Media Consultant, Sayo Akintola.

NAFDAC is collaborating with the Nigeria Natural Medicine Development Agency (NNMDA) to develop scientifically proven, safe, and effective herbal medicines that meet global standards through clinical trials.

The agency’s Director General, Prof. Mojisola Adeyeye, said Nigerian herbal medicine practitioners have the capacity to formulate natural remedies that are both safe and effective.

She explained that NAFDAC has two categories of approval for herbal products: “The first is a two-year listing approval given after toxicology and safety evaluations. The second requires clinical trials to prove efficacy before a full five-year approval is granted.”

Highlighting the challenge, Adeyeye noted the high cost of clinical trials, saying, “If you have an herbal medicine that you cannot prove scientifically the extent to which it works without causing harm to the user by providing some data on the efficacy, then it cannot be fully registered by NAFDAC.”

While thousands of herbal medicines have been listed, only a few have completed clinical trials, she added.

Adeyeye stressed the importance of determining safe dosage levels and assessing possible risks to organs such as the liver and kidneys, noting, “The fact that it’s natural doesn’t mean that it’s all safe. That’s where NAFDAC regulation and control come in.”

She recalled that the agency launched the Herbal Medicine Products Committee shortly before the COVID-19 pandemic to foster collaboration among practitioners, researchers, and the Ministry of Health.

To support practitioners, NAFDAC is seeking funding to help conduct clinical trials and is working with NNMDA to select some listed herbal medicines for trials that could lead to full registration and inclusion in a national herbal medicine formulary.

Adeyeye also noted that the agency continues to educate practitioners on registration procedures and good manufacturing practices to ensure the quality and safety of herbal products.