Delese Darko, FDA Boss
THE CENTRE of Awareness (COA) Herbal Centre has denied vehemently that its antibiotic and immune-stimulating tablets, COA FS, were contaminated with E-coli (Escherichia coli), which commonly causes cancer.
According to them, the tablets are produced by what they called “a unique biotransformation and extraction technique” at high temperature and pressure, for which reason “the product is as clear as water but highly aromatic.”
The Food and Drugs Authority (FDA) is insisting that its preliminary analysis of COA FS tablets indicates that the tablets contain yeast, mould and E-coli, but the manufacturer is disputing the regulator’s claim.
A press statement by the herbal centre on Tuesday said that the active ingredients in COA FS, as revealed by independent scientific investigations using GCMS and LCMS, indicated a wide range of bioactive compounds ranging from anti-cancer, anti-bacterial, anti-fungal, and anti-viral properties.
It said the laboratory investigations were conducted in Kwazulu Natal University of South Africa, and recently by the Ghana Standards Authority.
“Other compounds with immune-stimulating activities have been found in COA FS. These compounds are mainly triterpenes and other essential oils. It is for this reason that in the manufacture of COA FS, preservatives are not added,” the statement explained.
The company added that COA FS does not contain any artificial preservatives due to the broad range of anti-microbial activities mentioned, adding, “Further, it has been subjected to annual review and certification by the FDA under prescribed regulatory standards, the last approval having been given by the FDA to cover the year 2020.” “We are proud to say that COA FS, since its registration by the FDA in 2016, has passed all microbial tests. This anti-microbial activity has been experimentally confirmed,” it added.
COA Herbal said it therefore found the press statement from the FDA that it detected a microbial contamination in COA FS as a ‘surprise,’ adding that “contrary to the claims in the press statement, the evidence rather indicates that people with weakened immune systems and or kidney malfunctions, rather got better after taking COA FS.”
It said for FDA to associate COA FS to kidney failure was unfortunate, let alone the contamination it said to be in the drug.
“A thorough search through scientific literature shows that it is a particular strain of E-coli that causes kidney problem, but the FDA has not provided any data to prove that this particular strain has been found in COA FS,” it insisted.
“We wish to inform the public that the FDA on the 9th of April 2020 drew our attention to the supposed contamination and directed us to issue a withdrawal notice, which we did as law-abiding citizens, in spite of our doubts of the claim,” the statement explained.
The centre admitted that the FDA on the 9th of April informed them about the supposed contamination and directed them to issue a withdrawal notice which they have since implemented the directive.
It said later when a microbial test was run for the identified samples with batch numbers CFS00003 and CFS00004 on its reference samples from the microbiology laboratory of the Cape Coast Teaching Hospital, the results did not disclose contamination by yeast, mould and E-coli as indicated by the FDA.
By Ernest Kofi Adu