Manufacturers Must Prove Herbal Medicines Work, Not NAFDAC, Says Adeyeye

The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has clarified that the responsibility for demonstrating the clinical effectiveness of herbal medicines lies with manufacturers, not the regulatory agency.

Speaking during an interview on Channels Television, Adeyeye explained that although NAFDAC registers herbal medicinal products, the agency's assessment focuses primarily on their quality and safety rather than conducting clinical trials to establish therapeutic efficacy.

According to her, NAFDAC performs toxicological studies and phytochemical analyses to evaluate whether herbal products meet acceptable quality standards and are safe for human use.

"We continue to register herbal medicines, but what we ensure is that they are of good quality and safe," she said.

Adeyeye noted that clinical efficacy studies –which determine whether a medicine actually works for the condition it claims to treat– are generally not conducted by NAFDAC as part of the product registration process.

Illustrating the concept, she explained that a clinical trial seeks to answer questions such as whether taking a stated dose, for example one teaspoon three times daily, will effectively treat or relieve a disease. Such studies also help establish appropriate dosing and identify potential risks associated with taking higher-than-recommended amounts.

"The clinical trial aspect is absent because it costs a lot of money, and it is not NAFDAC's responsibility," she said.

Instead, she stressed, manufacturers are expected to generate scientific evidence demonstrating that their products are both safe and effective before making therapeutic claims.

Adeyeye explained that while NAFDAC evaluates product quality and safety through laboratory testing, generating clinical evidence remains an essential responsibility of product developers.

Her remarks provide important clarification on the distinction between regulatory quality assurance and clinical efficacy evaluation, a difference that is often misunderstood by the public.

The clarification comes amid growing public interest in herbal medicines and increasing calls for stronger scientific evidence to support claims relating to their effectiveness.

Health experts have consistently emphasised that while traditional and herbal medicines may offer therapeutic benefits, claims regarding their ability to prevent, treat or cure diseases should ideally be supported by well-designed clinical studies.

Adeyeye's comments reinforce the role of manufacturers in producing robust scientific evidence while highlighting NAFDAC's mandate to ensure that regulated products placed on the Nigerian market meet established standards of quality and safety.