The National Agency for Food and Drug Administration and Control (NAFDAC) has dismissed alleged claims of efficacy of IHP Detox Tea for the cure of COVID-19 patients produced in Nigeria by the Chief Executive Officer of Bioresources Development and Conservative Programme, Prof. Maurice Iwu.
According to the Director-General of NAFDAC, Prof Mojisola Adeyeye, ‘’Only NAFDAC has the mandate to make any pronouncement on the quality, safety, and efficacy of all regulated products that showed satisfactory scientific evidence’’.
In a press statement made available to newsmen, yesterday, the agency frowned at 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.
In a letter to Iwu by the regulatory body, Adeyeyesaid that NAFDAC was 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 (clinical trial).
‘’Therefore, it is worrisome that such an unguided statement is made without the stated 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.
Adeyeye said while two studies have commenced, including the IHP Detox Tea, the third clinical trial study was yet to start.
According to her, the IHP Detox Tea clinical trial study at CMU/LUTH and NAUTH, approved for Iwu’s company, was only a pilot study (that is still ongoing), with a small sample size that was inadequate to make a 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 noted with dismay 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 the agency was 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.’’
She added that the company was yet to respond to the identified lapses by the regulatory authority before making the pronouncement that the product was efficacious for the treatment of COVID-19 patients.
She, however, asked Iwu to retract the statement on the same newspapers and any other platform used for such improper and misleading representation of the IHP Detox Tea study within 48hours 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, Iwu admitted that NAFDAC was the only authorised agency by law that was allowed to make any pronouncement on the quality, safety and efficacy of all regulated products with satisfactory evidence.