The National Agency for Food and Drug Administration and Control (NAFDAC) has said that herbal medicines will not get full approval without undergoing proper clinical trials.

This was made known in a statement issued on Sunday, October 12, 2025, by the agency’s Resident Media Consultant, Sayo Akintola.

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

The Director General of NAFDAC, Prof. Mojisola Adeyeye, said Nigerian herbal medicine practitioners have the capacity to formulate safe and effective natural remedies that meet international standards.

She explained that the agency has two categories of approval for herbal medicines. 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.

Adeyeye identified the high cost of clinical trials as a major challenge facing many practitioners. She stated that products cannot be fully registered without scientific evidence of their effectiveness and safety.

“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,” she said.

The DG noted that NAFDAC has listed thousands of herbal medicines, but only a few have completed clinical trials. She added that the agency cannot grant full approval without efficacy tests.

She stressed that while herbal medicine is known to work, it is important to determine safe dosage levels and identify possible risks to organs such as the liver and kidneys. “The fact that it’s natural doesn’t mean that it’s all safe. That’s where NAFDAC regulation and control come in,” she said.

Adeyeye recalled that the agency launched the Herbal Medicine Products Committee shortly before the COVID-19 pandemic to bring together practitioners, researchers and the Ministry of Health for effective collaboration.
She said NAFDAC is seeking funding support to help practitioners carry out clinical trials, which are capital intensive. The agency is also working with the NNMDA to select some listed herbal medicines for trials that could lead to full registration and inclusion in a national herbal medicine formulary.

She added that NAFDAC has been educating practitioners on registration processes and maintaining good manufacturing practices to ensure product quality and safety.