Claim
A breaking news says: “The Director of the Pax Herbal Clinic and Research Laboratories, Ewu, Edo State, Nigeria, Rev. Fr. Anslem Adodo, OSB, has reported that NAFDAC has finally approved their Herbal remedy for the Treatment of symptoms associated with COVID-19.”
The report has been widely circulated via https://fadakay.org, with the caption: “BREAKING: NAFDAC APPROVES PAX HERBAL REMEDY FOR COVID-19,” where it further states that: “In an internal memo that went viral on social media, Fr Anselm Adodo said, “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.””
The report further states: “Fada Kay got in touch with one of the Benedictine Monks, who verified the story as authentic. Recall that NAFDAC had earlier given a tacit approval for the drug to be used, even though the body was yet to make that approval official. This is why the initial packs of the herbal remedy bore the disclaimer, “these claims have not yet been verified by NAFDAC.” With that hurdle crossed, PAXHERBAL CUGZIN now has the Nafdac number A7-4358L. This is a great achievement, and it’s wonderful to see.
“Writing on their official Facebook Page, under the caption OFFICIAL ANNOUNCEMENT FROM PAXHERBAL, Fr Adodo said, “We at Pax herbals 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 CUGZIN will help to boost body immunity, as there is yet no officially 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 or images on social media about our products.””
The controversial information which has also been wildly circulated via WhatsApp, and other social media platforms states: “Cugzin: Nafdac number: A7-4358L Fr Anselm: After a series of screening spanning 8 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. PAXHERBAL CUGZIN: Nafdac number: A7-4358L.”
Pax Herbal founded by Fr Adodo Anslem in 1996, is a Nigerian alternative medicine product manufacturing company based in Esan Central Local Government area of Edo State.
NAFDAC’s reaction
However, the National Agency for Food and Drug Administration and Control (NAFDAC), has said that it has not approved any drug for treatment of COVID-19, as being circulated in certain online publications and social media.
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Specifically, it described as a untrue, the statements circulating in the social media, claiming it has approved a Pax Herbal product for the treatment of symptoms associated with the COVID-19 pandemic.
Is NAFDAC aware of Pax Herbal product, Cogzin?
With TheDailyLeaks checks, it was discovered that this is not the first time the said herbal mixture, Pax Herbal Mixture, Cugzin, would be touted as being approved by NAFDAC, as it was earlier disclaimed when the information last broke out and circulated widely.
The NAFDAC’s Director General, Prof. Mojisola Adeyeye, has again, come out to disclaim the purported approval of Pax Herbal Mixture for COVID-19 treatment, saying, her agency is currently processing 21 herbal medicinal products and has not approved any for public use.
However, Prof. Adeyeye did not deny the fact Pax Herbal Mixture has been submitted to her agency, being part of the 21 currently being processed.
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.
She said in a statement: “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 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.”
How are products listed for approval?
On the steps involved in listing products for approval, Prof. Adeyeye 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.”
Why it was said Pax Herbal Mixture has been approved for COVID-19 treatment
Zeroing in on Pax Herbal, the agency said, “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. 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 Pax Herbal 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.”
Similarly, as it concerns Pax Herbal’s claim for its Pax CVD Plus as a likely COVID-19 cure, NAFDAC had also issued a disclaimer that it had neither registered nor approved Pax CVD Plus (renamed Cogzin) or any drug whatsoever, for the treatment of COVID-19.
NAFDAC’s boss, Prof. Adeyeye, in a statement had denied every claim made in an advertorial by Pax Herbal Clinic and Research Laboratories.
She said the advertorial made a claim that “Pax Herbal had developed a herbal drug called Pax CVD Plus for the treatment of COVID-19 and was working with NAFDAC to speed up approval for its use.”
Prof. Adeyeye said: “The same advertorial claimed that I appointed experts to work with Pax Herbal on what the company has described as a special project.
“I wish to inform the public that Pax CVD Plus has not been registered or listed for treatment of COVD-19; neither have we registered nor listed any other remedy for COVID-19.
“The clinical trial has not taken place. It is, therefore, unfortunate that Pax Herbal has made claims that are not backed up by facts.
“This response is intended to correct the erroneous impression created by the advertorial.”
Herbal Clinic and Research Laboratories’ reaction
Meanwhile, the Director of Pax Herbal Clinic and Research Laboratories, Rev Fr. Anselm Adodo, had denied telling the regulatory agency that his firm had a drug or cure for COVID-19.
According to him: “What we said was that we have a herbal formulation that has the potential to treat COVID-19, just like the type Prof. Maurice Iwu came up with.
“We did not say it was a ‘drug,’ but a formulation we had worked on.
“As a regulator, it is only fair we bring it to NAFDAC’s attention for evaluation and subsequent registration if it meets the requirements,” he said.
“The ‘only mistake’ Pax Herbals made was to share the story on its Facebook wall, which subsequently went viral,” the priest said.
T him, the reactions that greeted the post must have put pressure on the agency.
“Such reactions are expected, though, because people have come to trust Pax Herbal products over the years and probably felt the formulation was a good herbal initiative both NAFDAC and NCDC could consider in the fight against the novel coronavirus.
“However, NAFDAC warned that they didn’t like being put on the spot and asked us to pull down the post and correct the impression we painted.
“We went back to Pax Herbal Facebook [page] and did what they requested.”
“NAFDAC asked us not to go further with the herbal formulation until a proper clinical trial has been concluded.
“We have so far complied with the directive, until this recent public disclaimer and media trial we are still trying to understand.
“As it stands, there is little or nothing we can do. We leave this case to the media and the Nigerian people to judge,” Fr. Adodo said.
Verdict
With the clarification made by NAFDAC’s Director General, Prof. Mojisola Adeyeye, and as attested to by Pax Herbal Mixture founder, Rev. Fr. Anslem Adodo, the information which has been widely circulated that NAFDAC has approved Pax Herbal Cugzin for treatment of COVID-19 treatment is MISLEADING and FALSE.
