We did not approve Pax Herbal product as COVID-19 remedy – NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has faulted statements circulating in the social media that it has approved a Pax Herbal product for treating symptoms associated with coronavirus, stating the claim is wrong and inaccurate.

A statement signed by Mojisola Adeyeye, director-general of NAFDAC, said “until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms”.

There have been reports, quoting a memo purportedly originating from Rev. Fr. Anselm Adodo, director of the Pax Herbal Clinic and Research Laboratories, Ewu in Edo State, that NAFDAC has approved a Pax Herbal product for the treatment of symptoms associated with COVID-19.

The memo, which has gone viral on social media, quoted Adodo as saying, “After a series of screening, spanning eight weeks, NAFDAC has today approved our Paxherbal COVID-19 herbal drug, Paxherbal Cugzin, for public use.

“It is the first to be so approved and presently the only one. The drug is specifically for treating the symptoms associated with the coronavirus.”

Adodo could not be reached immediately to ascertain whether the memo actually originated from him.

But disclaiming the claim, NAFDAC explained that Pax Herbal actually 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. However, as part of the labelling of the product, and in line with global practice, a disclaimer is on the product label, which clearly states that the claims have not been evaluated by NAFDAC,” NAFDAC said.

It also stated that the agency is currently processing 21 herbal medicinal products for “Safe to use” or listing status.

“Many of the applicants claim that their products are immune boosters and anti-infectives useful for relief of symptoms that could be associated with COVID-19. However, no clinical study has been done yet on any of the products to prove their claim of efficacy,” said the NAFDAC statement.

It further clarified that 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 disclaimer that states clearly that claims have not been evaluated by NAFDAC.

“Subsequently, 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,” the statement said.

Listing of a herbal product, however, is not a requirement for the conduct of clinical trials, NAFDAC said.

It also noted that 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.