Fred Ezeh, Abuja and Doris Obinna (Lagos)

 

The National Agency for Food and Drug Administration and Control (NAFDAC), yesterday clarified the listing status of 21 herbal medicinal products undergoing evaluation, stating they have only met the requirements for “safe to use” classification.

Director General of NAFDAC, Prof. Mojisola Adeyeye, in a statement released in Abuja noted that many of the applicants claimed that their products are immune boosters and anti-infectives which are useful for relief of symptoms that could be associated with COVID-19.

She stressed that no clinical study has been done yet on any of the products to prove their claim of efficacy, and therefore cautioned Nigerians against patronizing herbal products being promoted as efficacious against COVID-19.

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Giving further explanation, she said: “Listing status involves the review of the composition of the formulation, the labelling of the product, the process of manufacture and ‘safe to use’ testing. Once the product is able to meet all requirements, a listing status is granted with a clear disclaimer that states clearly that claims have not been evaluated by NAFDAC.

“The applicant can arrange for clinical trials that will involve use of human subjects in order to prove efficacy or claim for treatment following laid down procedures and with the approval of NAFDAC.

“However, listing of a herbal product is not a requirement for the conduct of clinical trials. Most of the applicants that submitted herbal medicines that are currently undergoing processing have been issued compliance directives to provide additional information or/and evidence of good manufacturing practice or environment fit for production of the medicines.”

Adeyeye’s statement came in reaction to claims by Pax Herbals that its product had been approved by NAFDAC as solution to COVID-19. “Pax Herbal applied for listing of Pax Herbal Cugzin capsule 290mg which was approved by NAFDAC and listed as safe to use. The applicant claimed that it is an immune booster and an anti-infective,” the DG said.

She described as “wrong and inaccurate” statements circulating on social media and gave the impression that NAFDAC had approved Paxherbal product specifically for treating symptoms associated with COVID-19, stressing that “until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms.”