Follow Us on Google
From Fred Ezeh, Abuja
National Agency for Food and Drug Administration and Control (NAFDAC) has denounced claims of 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.
NAFDAC said the explanation became necessary following a newspaper publication claiming that the solution produced by Prof. Iwu’s company has been approved by NAFDAC for use against COVID-19, stating that it was a misinformation and misleading to the public.
Director General of NAFDAC, Prof. Mojisola Adeyeye, in a statement, on Sunday, confirmed that a letter has been written to Prof. Iwu, demanding that he retract the newspaper publication and set the record to avoid confusion and misleading the public.
She maintained that NAFDAC is the only authorized Agency by law 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 unguided statement was made without the stated fact that no product can be approved by NAFDAC without satisfactory clinical evidence,” she said.
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.”
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.
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.
Prof. 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 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.
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 found some lapses.
She said: ‘’We discovered 17 lapses during our inspection visit. We passed the lapses to them as compliance directive to address. The company was yet to respond to the identified lapses by the regulatory authority before making pronouncement that the product is efficacious for the treatment of COVID-19 patients.
She, however, asked Prof 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 48 hours from the receipt of the letter and inform the Agency on the action to avoid further regulatory sanctions.
She, however, confirmed that Prof. Iwu has written to the Agency pointing 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 misinformation that is 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.
Prof. Iwu admitted that NAFDAC is the only authorized Agency by law that is allowed to make any pronouncement on quality, safety and efficacy of all regulated products with satisfactory evidence.
He reiterated his profound gratitude to the Agency for the kind approval of the pilot study protocol during the peak of the COVID-19 pandemic.
