The National Agency for Food and Drug Administration and Control (NAFDAC) has denounced the claims of efficacy of IHP Detox tea for the cure of COVID-19 patients, which was purportedly made by the Chief Executive Officer of Bioresources Development and Conservative Programme, Prof. Maurice Iwu.
In a statement by its Resident Media Consultant, Mr Sayo Akintola, in Abuja on Sunday, NAFDAC stated that only the Agency has the mandate to make any pronouncement on the quality, safety, and efficacy of all regulated products that showed satisfactory scientific evidence.
NAFDAC frowned at the media reports 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.
According to NAFDAC, the letter by its Director General, Prof Mojisola Adeyeye, which was addressed to Prof. Iwu, had reiterated that “NAFDAC is the only authorised Agency by law that is allowed to make any pronouncement on safety and efficacy of all regulated products with satisfactory scientific evidence (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 had commenced, including the IHP Detox Tea, the third clinical trial study was 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 pronouncement on safety and efficacy of the product.
Prof. Adeyeye insisted that only a NAFDAC approved Phase 3 Clinical Trial with enough sample size could be used to make such claims on efficacy, after regulatory approval of the study outcomes.
The DG noted with dismay that the World Health Organisation (WHO) team and other well-meaning individuals in the research space have found the claim of efficacy of the IHP Detox Tea misleading, and the Agency is saddled with the responsibility to provide oversight and deter such inaccurate information on regulated products in the country.
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 17 lapses during our inspection visit. We passed the lapses to them as 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 then 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 his response, Prof. Iwu admitted that NAFDAC is the only authorised Agency by law that is allowed to make any pronouncement on quality, safety and efficacy of all regulated products with satisfactory evidence.
Reiterating his profound gratitude to the Agency for the kind approval of the pilot study protocol during the peak of SARS-COV2 pandemic, Prof. Iwu urged the newspapers that published the report to make the necessary correction.
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’’.
He averred that the publication under reference was neither an advertisement nor authored by his organisation or its functionary or employee.
In a letter dated 17th May 2022, Prof. Iwu pointed out that from the text of the publication, it appeared 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’’, he said.