The National Agency for Food and Drug Administration and Control (NAFDAC), yesterday, debunked claim of efficacy of IHP Detox Tea for the cure of COVID-19 patients, purportedly made by the Chief Executive Officer of Bioresources Development and Conservative Programme (BDCP), Prof. Maurice Iwu, in a national daily.
NAFDAC’s Director General, Prof. Mojisola Adeyeye, in a media statement signed by the agency’s Resident Media Consultant, Sayo Akintola, in Abuja, stated: “Only NAFDAC has the mandate to make any pronouncement on the quality, safety and efficacy of all regulated products that show satisfactory scientific evidence.”
The organisation deplored 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 treatment of the virus.
In a letter to Prof. Iwu, by the regulatory body, the NAFDAC DG reminded him that her organisation remains the only statutory body vested with powers to make such pronouncement after a clinical trial of a drug.
“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 said.
Adeyeye explained that three herbal formulations were approved for clinical trials during the pandemic.
She said while two studies have commenced, including the IHP Detox Tea, the third is yet to start.
According to her, the IHP Detox Tea clinical trial at the College of Medicine, University of Lagos (CMUL)/Lagos University Teaching Hospital (LUTH) and Nnamdi Azikiwe University Teaching Hospital (NAUTH), approved for 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.”
She insisted that only a NAFDAC-approved Phase 3 Clinical Trial with enough sample size could be used to make such efficacy claim, after regulatory approval of the study outcomes.
Adeyeye regretted that the World Health Organisation (WHO) team and other well-meaning individuals in the research space have found the claim misleading against the background that her 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, the NAFDAC boss clarified, adding that the company was yet to respond to the noticeable slips before going public with its efficacy claim.