The National Agency for Food and Drug Administration and Control (NAFDAC), is angry with the Chief Executive officer of Bioresources Development and Conservative Programme, Professor Maurice Iwu for claiming that the Agency had approved IHP Detox Tea for the cure of COVID-19 patients.
The Director-General of NAFDAC, Professor Mojisola Adeyeye, said in a statement that it is only NAFDAC that is mandated by law to make any pronouncement on the quality, safety, and efficacy of all regulated products that showed satisfactory scientific evidence.
Professor Mojisola said that the media reports ostensibly circulated at the instance of the promoters of IHP Detox Tea that claimed that the herbal medicine was the only product approved by the Agency for the treatment of COVID-19, was false.
In a letter to Professor Maurice Iwu, the Director-General of NAFDAC said: “it is worrisome that such an unguided statement is made without the fact that no product can be approved by NAFDAC without satisfactory clinical evidence.”
She explained that three herbal formulations were approved for clinical trial studies during the COVID-19 Pandemic.
Mojisola Adeyeye said that while two studies have commenced, including the IHP Detox Tea, the third clinical trial study is yet to start, adding that the IHP Detox Tea clinical trial study at CMU/LUTH and NAUTH, approved for Professor Iwu’s company, was only a pilot study, (that is still ongoing), with a small sample size that is inadequate to make a pronouncement on safety and efficacy of the product.
Professor Mojisola Adeyeye said that the World Health Organisation (WHO) team and other well-meaning individuals in the research space have found the claim of the efficacy of the IHP Detox Tea misleading, and that the Agency is saddled with the responsibility to provide oversight and deter such inaccurate information on regulated products in the country.
According to her, 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 seventeen (17) lapses during our inspection visit. We passed the lapses to them as compliance directive to address.”
She said that the company is yet to respond to the identified lapses by the regulatory authority before making the pronouncement that the product is efficacious for the treatment of COVID-19 patients.
She asked Professor Iwu to retract the statement on the same newspapers and any other platforms 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 of the action to avoid further regulatory sanctions.
Responding in a letter dated May 17, 2022, and addressed to the D-G NAFDAC, Professor Iwu admitted that NAFDAC is the only authorised Agency by law, allowed to make any pronouncement on the quality, safety and efficacy of all regulated products with satisfactory evidence.
