The Food and Drugs Authority (FDA) says it has not approved the food supplement, ‘COA FS’ by the COA Herbal Centre, as a cure for the novel Coronavirus disease (COVID-19) and called on all to disregard the information.
Mr James Lartey, the Director of Communications of the FDA, in an interview with the Ghana News Agency said although the food supplement, was an immune booster, it had not been tested and approved by the Authority to cure the respiratory disease.
“FDA has not approved any product from the COA Herbal Centre to help cure COVID-19. No clinical trial has been done to prove that. I mean there is no proof at all, so that cannot be taken.”
Moreover, he said the FDA detected the presence of excessive microbial, mold and yeast contamination and Escherichia Coli (E. Coli), a pathogenic bacteria, not required for medicinal products in the product with batch numbers, “CFS00003” and “CFS00004”.
E. Coli contamination, he said, could cause health implications like diarrhea, nausea, gastroenteritis, and abdominal pain in consumers as well as hemolytic uremic syndrome, that could lead to kidney failures in children and older people.
In addition to the effects, E. Coli contamination could worsen the conditions of people with weakened immune system like persons with HIV and not give consumers the immune boosting effect they require.
He, therefore, entreated wholesalers, retailers, and consumers who had purchased COA FS supplements with the aforementioned batch numbers to return them to the retailers and wholesalers, for them to be sent to the manufacturers.
Mr Lartey said COA FS was registered with the FDA as a food supplement that supports the immune system, however, the contamination could have been caused in the process of manufacturing or by the production environment.
Explaining the mode of operation by the FDA, he said, after approving a product, the Authority allows for a product to be manufactured and distributed to the market for three years.
However, the contamination was detected during the FDA’s usual routine inspection at the factory and a market surveillance.
“So we picked samples of the product from the manufacturing centre during our routine inspection and another from the market when we conducted a market surveillance. That is how we detected the contamination,” he said.
For the FDA, he said, it was only prudent for the manufacturers to stop production and put the right mechanisms in place to ensure that there were no subsequent contaminations before reproducing.