NAFDAC refutes approval for AAU’s herbal medicine, says license has expired
The National Agency for Food and Drug Administration and Control (NAFDAC) has refuted that it granted a license for Ambrose Alli University Ekpoma local herbal medicine.
Newsmen had earlier reported 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.
The publications had noted that Glucozil was claimed to have been scientifically tested with safety established in both humans and animals.
However, the agency clarified thus:
“The Agency 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 has expired.
“As specified in the Herbal Medicine & Related Products Labelling Regulations 2021, this listing was subject to the inclusion of the mandatory Disclaimer ‘These claims have not been evaluated by NAFDAC’ on the product label. This is the regular disclaimer that is used and required for other listed herbal products which have not undergone Clinical Trials that the Agency deemed satisfactory.
“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.
“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Ambrose Alli University was neither the manufacturer nor the applicant of the said product for which the Listing is no longer valid.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.”
The Agency however reiterated its commitment to ensuring public health and safety through stringent regulatory oversight remains steadfast.
The Agency also called the public to exercise caution when interpreting health-related claims and also to refer to NAFDAC’s official communications channels for accurate updates and information.
