The National Agency for Food and Drug Administration and Control (NAFDAC)
has distanced itself from the news making round that it approved Glucozil for the treatment and cure of Diabetes Mellitus and capable of treating Benign prostatic hyperplasia.
Director General of NAFDAC, Prof. Mojisola Adeyeye announced this on Tuesday, August 29, 2023.
Glucozil is a local Herbal Medicine produced by Ambrose Alli University Ekpoma was approved by NAFDAC for the treatment and cure of Diabetes Mellitus and capable of treating Benign prostatic hyperplasia (Prostrate enlargement) together with some anti-inflammatory properties.
According to Adeyeye, “the Agency’s attention has been drawn to a publication on August 24th, 2023, circulating in many print and online media which claims that a Listed Local Herbal Medicine Glucozil produced by Ambrose Alli University Ekpoma was approved by NAFDAC for the treatment and cure of Diabetes Mellitus and capable of treating Benign prostatic hyperplasia (Prostrate enlargement) together with some anti-inflammatory properties.
“In the said publication, Glucozil was claimed to have been scientifically tested with safety established in both humans and animals”.
The DG clarified that, NAFDAC listed Glucozil Capsule on the 10th of November 2020 for the Management OF High Blood Sugar (as captured on the approved label and Listing Certificate issued to the applicant) which was valid till 9th November 2022. Therefore the herbal medicine certificate had expired.
She informed that, as specified in the Herbal Medicine & Related Products Labelling Regulations 2021, this listing was subject to the inclusion of the mandatory Disclaimer, adding that, these claims had not been evaluated by NAFDAC on the product label.
She said that, this was the regular disclaimer that is used and required for other listed herbal products which had not undergone Clinical Trials that the Agency deemed satisfactory.
Speaking further, Adeyeye warned that,
Treatment, Curative, and Preventive Claims for Diabetes, Benign prostatic hyperplasia, and detoxification were never approved for Glucozil as claimed in the publication and hence should be disregarded by the public.
In addition, the NAFDAC Boss said, “from our records, Ambrose Alli University was neither the manufacturer nor the applicant of the said product for which the Listing is no longer valid. The University should have verified the status of the herbal medicine certificate and the approved claim.
“Manufacturing, Distribution, or Marketing of this product is not allowed until the renewal application has been submitted and approved by the Agency.
“The importance of verifying information from credible sources before disseminating cannot be overstated. Misleading reporting can misinform those seeking medical treatment thereby jeopardizing their health.
“NAFDAC’s commitment to ensuring public health and safety through stringent regulatory oversight remains steadfast. It is crucial to exercise caution when interpreting health-related claims therefore we encourage the public to refer to NAFDAC’s official communications channels for accurate updates and information”.