The National Agency for Food and Drug Administration Control (NAFDAC) has said that Paxherbals, which applied for Listing of Paxherbal Cugzin capsule 290mg, was approved by the agency and listed as “Safe to use”.
In a statement signed by the Director General, NAFDAC, Prof Mojisola Adeyeye, said that it is currently processing twenty one (21) herbal medicinal products, which also include Paxherbal Cugzin for “Safe to use” or Listing status.
According to her, 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.
This is coming as the Director of the Paxherbals Clinic and Research Laboratories, Ewu, Edo State, Nigeria, Rev. Fr. Anslem Adodo, OSB, allegedly reported that NAFDAC has finally approved their herbal remedy for the treatment of symptoms associated with COVID-19.
In an internal memo that went viral on social media, it was alleged that Fr Anselm Adodo said, “after a series of screening, spanning eight weeks, NAFDAC has 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.”
The DG however explained that no clinical study has been done yet on any of the products to prove theIr claim of efficacy.
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.”
Explaining further, she said: “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.”
“Paxherbals applied for Listing of Paxherbal 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.
“Therefore, the statements circulating in the social media that NAFDAC has approved Paxherbals product ‘specifically for treating symptoms associated with Coronavirus’ is WRONG and INACCURATE. Until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms,” Adeyeye reiterated.
Meanwhile, in an official statement from Paxherbals reads: “We at Paxherbals are happy to confirm that our CVD Plus, which has been renamed Cugzin, has been issued a NAFDAC number, as ‘an immune booster and anti-infective’. We are aware that there is a lot of anxiety in the land and people are hungry for any reliable immune booster as prevention. Paxherbal will help to boost body immunity, as there is yet no approved drug for the cure of COVID-19.
“We ask our followers to look out on our Facebook page for official statements and be weary of different claims or stories on social media about our product. This page remains the only authentic place for news about the activities of Paxherbals. We will continue to serve you to the best of our abilities.