The Pharmacists Forum has advised manufacturers of food supplement, COA FS, to disengage from battles with the Food and Drugs Authority (FDA) over the accreditation issues bothering the product.
The Pharmacists Forum said it was prudent for the Chief Executive Officer of COA Herbal Centre, Prof. Samuel Ato Duncan, to engage in peaceful talks with the FDA in resolving matters, rather than challenge the results from the FDA.
“They [FDA] have a responsibility to monitor every product on the market. Post-marketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance,” a statement from the forum said.
The Centre for Awareness Global Peace Mission, manufacturers of the COA FS drug, has debunked assertions by the Food and Drugs Authority (FDA) that the product is unsafe for consumption.
This follows an order by the Authority to recall the food supplement from the market back to the point of sale.
According to the FDA, laboratory analysis on random COA FS products picked from the manufacturing company and the market, showed that the product has been found to contain Escherichia coli, a type of bacteria that normally lives in the intestines.
The FDA said that E Coli as it is popularly known, causes gastroenteritis, diarrhoea, abdominal pain, nausea and vomiting.
But the company in a statement rejected the FDA claims. It said tests ran by Cape Coast Teaching Hospital’s laboratories on the back of these claims, show the non-existence of the said substances in COA FS.
“We ran a microbial test for the identified samples with batch numbers CFA00003 and CFS00004 on our reference samples from microbiology laboratory of the Cape Coast Teaching Hospital. The results of the microbial tests do not disclose contamination by Yeast, Mould and E.coli as indicated in the FDA press statement,” the release read.
The communique dated April 21, 2020, also revealed that further test on the batches are being conducted in other independent laboratories, adding that, the results will be communicated to the general public when concluded.
But the Pharmacists Forum maintained the FDA had the right to pull off products from the market if it suspected any contamination.
“The FDA may even ask for everything to be pulled off the shelves even if one batch was implicated and there is evidence to show failure in the quality assurance system. This is normal practice for all regulatory organisations around the World,” the statement said.
“Post-marketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance,” the statement further said.
The Forum also condemned an action taken by COA Herbal on testing samples at different labs, against tests by the FDA.