*Nigeria’s National Agency for Food and Drug Administration and Control declares the health regulatory agency has the mandate to make any pronouncement on the quality, safety and efficacy of all regulated products that show satisfactory scientific evidence in the country

Isola Moses |聽 绿帽献妻

In a swift move to protect the well-being of Nigerian consumers, the National Agency for Food and Drug Administration and Control (NAFDAC) has debunked claim of efficacy of IHP Detox Tea for the cure of COVID-19 patients.

绿帽献妻 reports the purported efficiency of the health solution was earlier made by Prof. Maurice Iwu, Chief Executive Officer (CEO) of Bioresources Development and Conservative Programme (BDCP) in a Nigerian daily.

Prof. Mojisola Adeyeye, Director General of NAFDAC, made the clarification in a statement issued by Sayo Akintola, Resident Media Consultant of the regulatory agency, in Abuja, FCT.

Prof. Adeyeye said: 鈥淥nly NAFDAC has the mandate to make any pronouncement on the quality, safety and efficacy of all regulated products that show satisfactory scientific evidence.鈥�

The health regulator decried some earlier media reports ostensibly circulated at the instance of the promoters of IHP Detox Tea, which had claimed that the herbal medicine was the only product approved by the agency for treatment of the virus.

It was stated, however, that in its letter to Prof. Iwu, the NAFDAC Director-General reminded the former that her organisation remains the only statutory body vested with powers to make such pronouncement after a clinical trial of a drug in the West African country.

Adeyeye also stated: 鈥淭herefore, 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.鈥�

She further explained that three herbal formulations were approved for clinical trials during the COVID-19 pandemic.

Adeyeye, nonetheless, noted while two studies have commenced, including the IHP Detox Tea, the third is yet to start.

The Director-General the IHP Detox Tea clinical trial at the College of Medicine, University of Lagos (CMUL)/Lagos University Teaching Hospital (LUTH) and Nnamdi Azikiwe University Teaching Hospital (NAUTH), approved for Iwu鈥檚 company, was only a pilot study (that is still ongoing), with a small sample size that 鈥渋s inadequate to make pronouncement on safety and efficacy of the product.鈥�

She, therefore, stressed that only a NAFDAC-approved Phase 3 Clinical Trial with enough sample size could be used to make such efficacy claim, after regulatory approval of the study outcomes.

In respect of circulation of misinformation regarding the alleged efficacy of IHP Detox Tea ahead of regulatory approval, Prof. Adeyeye regretted that the World Health Organisation (WHO) team and other well-meaning individuals in the research space had found the claim misleading against the background that NAFDAC is saddled with the responsibility of providing oversight while deterring such inaccurate information on regulated products in Nigeria.

According to her, preparatory to the WHO team鈥檚 visit to Nigeria for the study, NAFDAC officials on inspection of the clinical trial site of IHP Detox Tea had found some lapses in the solution.

Adeyeye as well said: 鈥淲e discovered some 17 lapses during our inspection visit.

“We passed the lapses to them as compliance directive to address, the NAFDAC boss clarified, adding that the company was yet to respond to the noticeable slips before going public with its efficacy claim.”

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