The National Agency for Food and Drug Administration and Control (NAFDAC) yesterday warned that it had not approved IHP Detox Tea for the cure of COVID-19.
The Chief Executive Officer of Bioresources Development and Conservative Programme, Prof. Maurice Iwu, reportedly made the claim in a national daily.
The agency faulted the reports, ostensibly circulated at the instance of the promoters of the tea, who claimed that the herbal medicine was the only product approved by the agency for the treatment of COVID-19.
In a statement in Abuja by the agency’s Resident Media Consultant, Sayo Akintola, NAFDAC Director General Prof. Mojisola Adeyeye 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.
“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.”
In a letter to Prof. Iwu, the NAFDAC boss stressed that the agency is the only authority the law allows to make any pronouncement on safety and efficacy of all regulated products with satisfactory scientific evidence (clinical trial).
She explained that three herbal formulations were approved for clinical trial studies during the COVID-19 pandemic, adding that while two studies had begun, including that of the IHP Detox Tea, the third clinical trial study had not started.
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.
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’s outcomes.
The NAFDAC boss said 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, as the agency is saddled with the responsibility to provide oversight and deter such inaccurate information on regulated products in the country.
She added 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.
Adeyeye stressed that the company was yet to respond to the identified lapses by the regulatory authority before making a pronouncement that the product is efficacious for the treatment of COVID-19 patients.
The NAFDAC boss directed Prof. Iwu to retract the statement in the 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.