The Director-General of NAFDAC, Prof. Mojisola Adeyeye
… Says two other herbal drugs also made the Clinical trial-test list***
The National Agency for Food and Drug Administration and Control NAFDAC has denounced the claims of efficacy of IHPDetox Tea for the cure of COVID-19 patients purportedly made by the Prof. Maurice Iwu on one of the national dailies of 28th March 2022, stressing that the Tea is still undergoing Clinical Trial and is yet to receive full approval.
Maurice Iwu, the Chief Executive officer of Bioresources Development and Conservative Programme, allegedly made the statement, claiming that only his product had secured the NAFDAC endorsement, whereas, two other products, in addition to Iwu’s tea, made the blue line.
In a swift response, however, Prof. Iwu admitted that while NAFDAC is the only authorized Agency by law that is allowed to make any pronouncement on the quality, safety and efficacy of all regulated products with satisfactory evidence, he did not authorise the publication and therefore cannot compel retraction, more so, as the publication was not made, via advert placement.
He noted that being an unsolicited and independent editorial decision of the newspaper, ‘’we are not in a position to compel the newspaper to retract its story nor retract a story not published by us or at our instance’’.
The NAFDAC Boss, Prof. Mojisola Adeyeye has however frowned on the misrepresentation, only her agency is authorised to make such a declaration.
‘’Only NAFDAC has the mandate to make any pronouncement on the quality, safety, and efficacy of all regulated products that showed satisfactory scientific evidence’’, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, in a media statement signed by the Agency’s Resident Media Consultant, Sayo Akintola highlighted in Abuja on Sunday.
The Agency maintained that the media reports was ostensibly circulated at the instance of the promoters of IHP Detox Tea which claimed that the herbal medicine was the only product approved by the Agency for the treatment of COVID-19.
In a letter to the Chief Executive officer of Bioresources Development and Conservative Programme, Prof. Maurice Iwu, by the regulatory body, the Director-General of NAFDAC, Prof Mojisola Adeyeye said that NAFDAC is the only authorized Agency by law that is allowed to make any pronouncement on safety and efficacy of all regulated products with satisfactory scienti6cevidence (Clinical Trial).
‘’Therefore, it is worrisome that such unguided statement is made without the stated fact that no product can be approved by NAFDAC without satisfactory clinical evidence’’, she noted in a tone laden with grief.
The NAFDAC boss explained that three herbal formulations were approved for clinical trial studies during the COVID-19 Pandemic.
She said while two studies have commenced including the IHPDetox Tea, the third clinical trial study is yet to start. According to her, the IHP Detox Tea clinical trial study at CMU/LUTH and NAUTH, approved for Prof Iwu’s company, was only a pilot study, (that is still ongoing), with a small sample size that is inadequate to make a pronouncement on safety and efficacy of the product.
She insisted that only a NAFDAC approved Phase 3 Clinical Trial with enough sample size can be used to make such claims on efficacy, after regulatory approval of the study outcomes.
Ex-INEC boss, Prof. Maurice Iwu
Prof Mojisola Adeyeye noted with dismay that the World Health Organisation WHO team and other well-meaning individuals in the research space have found the claim of the efficacy of the IHP DetoxTea misleading, and the Agency is saddled with the responsibility to provide oversight and deter such inaccurate information on regulated products in the country.
Ex-INEC boss, Prof. Maurice Iwu
She disclosed that preparatory to the WHO team’s visit to Nigeria for the study, NAFDAC officials on inspection of the clinical trial site of IHP Detox Tea had found some lapses.
‘’We discovered some seventeen (17) lapses during our inspection visit.
We passed the lapses to them as a compliance directive to address.’’, she said, adding that the company was yet to respond to the identified lapses by the regulatory authority before making pronouncement that the product is efficacious for the treatment of COVID-19 patients.
She, however, asked Prof Iwu to retract the statement on the same newspapers and any other platform used for such improper and misleading representation of the IHP Detox Tea study within 48 hours from the receipt of the letter and inform the Agency on the action to avoid further regulatory sanctions.
In the meantime, Prof. Iwu has reiterating his profound gratitude to the Agency for the kind approval of the pilot study protocol during the peak of the SARS-COV2 pandemic, Prof Iwu urged the newspapers that published the report to make the necessary correction.
He insisted that being an unsolicited and independent editorial decision of the newspaper, ‘’we are not in a position to compel the newspaper to retract its story nor retract a story not published by us or at our instance’’.
He equally averred that the publication under reference was neither an advertisement nor authored by his organization or its functionary or employee.
It was learned that Iwu In a letter dated May 17, 2022, and addressed to the DG NAFDAC, Prof. Adeyeye, Prof Iwu pointed out that from the text of the publication, it appears to be an opinion of the journalist who wrote the story, as he admonished the newspaper to correct the said misinformation that is capable of misleading members of the public.
‘’We have, however, drawn the attention of the editor of the concerned newspaper to the observation of NAFDAC for their necessary correction’’, Iwu, according to Sayo Akintola, NAFDAC Resident Media Consultant further said.
