By Biola Lawal
Abuja” (Flowerbudnews): The National Agency for Food and Drug Administration and Control ( NAFDAC), has clarified that the Agency’s label and listing approval granted for GLUCOZIL, herbal medicine for diabetes expired since November 2022.
NAFDAC Director-General, Prof. Moji Adeyeye made the clarification in a press briefing statement entitled: Re-NAFFDAC approves GLUCOZIL, AAU’s herbal medicine for diabetes made available to newsmen on Tuesday.
Flowerbudnews recall that Authorities of Ambrose Ali University, Ekpoma had on August 24, issued a public statement claiming total clearance and approval of its herbal diabetes medicine- GLUCOZIL for use by patients.
However, NAFDAC Boss, Prof Adeyeye
The Agencys (NAFDAC) 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 Agency wishes to clarify that:
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Ambrose Alli University was neither the manufacturer nor the applicant of the said product for which the Listing is no longer valid.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.
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. (Flowerbudnews)