“We Didn’t Approve Pax Herbal Product for COVID-19 Treatment,” NAFDAC

The Director General of the National Agency for Food and Drug Administration and Control, NAFDAC, Professor Mojisola Christianah Adeyeye has said that the information going round in especially the social media, that NAFDAC has approved paxherbal products specifically for treatment of COVID-19 symptoms is wrong and inaccurate. She said this yesterday 11th July, 2020, adding that until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms.

The Director General said through a press release yesterday, that NAFDAC is currently processing Twenty-One (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 the 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.

Professor Mojisola Christianah Adeyeye, Director General, NAFDAC

“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,” she explained. “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.”

She disclosed 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.”

“Paxherbal 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,” She emphasized. “Therefore the statements circulating on social media that NAFDAC has approved Paxherbal products “specifically for treating symptoms associated with Coronavirus” is WRONG and INACCURATE.”

She concluded that “until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms.”

President Muhammadu Buhari had on 3rd of November 2017 appointed Professor Mojisola Christianah Adeyeye as the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC). Professor Adeyeye earned her B.Pharm degree from University of Nigeria, Nsukka, Nigeria and MS and PhD from University of Georgia, Athens, GA, USA. Her research interests border on pre-formulation, early phase development of solid, semisolid and liquid dosage forms, and IND-based and intellectual property-driven late phase drug product development. She has mentored over 15 PhD and M.S. candidates. She has 5 patents, over 60 peer-reviewed manuscripts, book chapters and books, and more than 150 scientific presentations. She is the founder of a socially conscious start-up company – Elim Pediatric Pharmaceuticals. She used her university lab for the early phase R&D and partners with contract manufacturing organizations for the clinical and registration batches.

Pax Herbal, while announcing their listing earlier on Saturday, 11th July yesterday warned the general to not be deceived by the falsehood that their product treats COVID-19.

Pax Herbal’s announcement and disclaimer yesterday morning, 11th July, 2020

The public is hereby informed to take this clarification serious in order not to be misled by misinformation concerning the Paxherbal products.

Source: NAFDAC

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