The National Agency for Food and Drug Administration and Control has disclosed that three herbal formulations have been approved for clinical trial studies for the treatment of COVID-19 during the pandemic.
The agency made the disclosure in a statement signed by its Resident Media Consultant, Sayo Akintola, in Abuja on Sunday, .
It also refuted claims of the 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, Prof Maurice Iwu, in a media report.
In the statement on Sunday, the Director General of NAFDAC, Prof Mojisola Adeyeye, said only NAFDAC could make pronouncements on the quality, safety, and efficacy of all regulated products that showed satisfactory scientific evidence.
The statement read in part, “The agency 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.
“In a letter to the Chief Executive officer of Bioresources Development and Conservative Programme, Prof Maurice Iwu, by the regulatory body, the Director General of NAFDAC, Prof Mojisola Adeyeye said 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.”
The NAFDAC boss explained that “three herbal formulations were approved for clinical trial studies during the COVID-19 pandemic.
“While two studies have commenced, including the IHP Detox Tea, the third clinical trial study is yet to start. The IHP Detox Tea clinical trial study at Lagos University Teaching Hospital and Nnamdi Azikiwe University Teaching Hospital, 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.”
She insisted that only a NAFDAC approved Phase 3 clinical trial with enough sample size can be used to make such claims on efficacy after regulatory approval of the study outcomes.
Adeyeye also noted that the 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.
In his response, 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.
He, however, urged the newspapers that published the report to make the necessary correction.
In a letter dated May 17, 2022, and addressed to the Director-General of NAFDAC, 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 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.