The National Agency for Food and Drug Administration and Control (NAFDAC) has denied the claims of efficacy of IHP Detox Tea for the cure of Covid-19 patients allegedly made by the Chief Executive Officer of Bioresources Development and Conservative Programme, Prof. Maurice Iwu.
It said the first stage of the clinical trial so far carried out on the product was not enough to confirm its efficacy until the Phase 3 Clinical Trial had been conducted with enough sample size.
It also said it discovered 17 lapses during an inspection visit to the company.
In a statement signed by NAFDAC’s Resident Media Consultant, Sayo Akintola, on Sunday, the agency frowned at 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.
It quoted the Director General of NAFDAC, Prof. Mojisola Adeyeye to have said: “Only NAFDAC has the mandate to make any pronouncement on the quality, safety, and efficacy of all regulated products that showed satisfactory scientific evidence.”
In the letter addressed to Iwu, Adeyeye said NAFDAC was the only authorised agency by law allowed to make any pronouncement on safety and efficacy of all regulated products with satisfactory scientific evidence (Clinical Trial).
She said it was worrisome that such unguided statement was made without the stated fact that no product could be approved by NAFDAC without satisfactory clinical evidence.
The NAFDAC boss however explained that three herbal formulations were approved for clinical trial studies during the COVID-19 Pandemic.
She also 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 Iwu’s company, was only a pilot study, (that is still ongoing), with a small sample size that was inadequate to make pronouncement on safety and efficacy of the product.
She 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.
Adeyeye noted with dismay that the World Health Organisation (WHO) team and other well-meaning individuals in the research space had found the claim of efficacy of the IHP Detox Tea misleading, adding that the agency was 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’s teams 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 was efficacious for the treatment of COVID-19 patients.
She however, asked 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.
The statement quoted Iwu to have admitted that NAFDAC remained the only authorised agency by law allowed to make any pronouncement on quality, safety and efficacy of all regulated products with satisfactory evidence.
Iwu was also quoted as having disowned the report describing it as, “an unsolicited and independent editorial decision of the newspaper.”
Iwu was also quoted to have said his company was not in a position to compel the newspaper to retract its story nor retract a story not published by it or at its instance.