NAFDAC: IHP Detox Tea Is Not COVID-19 Cure
Yesterday, the National Agency for Food and Drug Administration and Control (NAFDAC), debunked claims of the IHP Detox Tea’s efficacy as a cure for COVID-19 patients, that was purportedly made by Prof. Maurice Iwu, the Chief Executive Officer of Bioresources Development and Conservative Programme (BDCP), in a national daily.
In a media statement signed by Sayo Akintola, the agency’s Resident Media Consultant, Prof. Mojisola Adeyeye, NAFDAC’s Director General, stated that: “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 that was written to Prof. Iwu, by NAFDAC, the DG reminded him that her organisation is the only statutory body that is vested with the power to make such pronouncement after the clinical trial of a drug. She said that, “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.”
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Professor Adeyeye explained that, so far, only three herbal formulations were approved for clinical trials during the pandemic. She explained that 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 that is at the College of Medicine, University of Lagos (CMUL)/Lagos University Teaching Hospital (LUTH) and Nnamdi Azikiwe University Teaching Hospital (NAUTH), which was approved for Iwu’s company, was only a pilot study (that is still ongoing), with a rather small sample size that “is inadequate to make pronouncement on safety and efficacy of the product.”
She insists that only a NAFDAC-approved Phase 3 Clinical Trial with a large enough sample size can be used to make such efficacy claim, after the regulatory approval of the study outcomes.
Adeyeye regretted that the WHO team and other well-intentioned individuals in the research space had expressed concerns about the claim in light of the fact that her agency is responsible for providing oversight and deterring such inaccurate information regarding regulated products in the country. During an inspection of the clinical trial site for IHP Detox Tea, NAFDAC officials found some lapses in preparation for the WHO team visiting Nigeria for the study.
She clarified, saying, “We discovered some 17 lapses during our inspection visit. We passed the lapses to them as compliance directive to address”, and added that the company was yet to respond to the noticeable slips before going public with its efficacy claim.
