Home News General News FDA claims against COA FS not backed by facts – Manufacturers

FDA claims against COA FS not backed by facts – Manufacturers

Producers of immune booster drug COA FS, Centre of Awareness Global Peace Mission, have rejected claims by the Food and Drugs Authority (FDA) that the product is contaminated.

According to the manufacturers, a new laboratory test at the Cape Coast Teaching Hospital has proven that claims by the FDA about the drug are inaccurate.

It comes after the FDA recalled the drug from the market over claims the product has excessive contamination of yeast and mold.

In a statement, the manufacturers said: “We, therefore, find the Press Statement from the FDA that they detected a microbial contamination in COA FS as a surprise. The self-preserving nature of COA FS is the reason why we have never received any of the adverse drug reactions enumerated in the FDA Statement over the period. 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. We find it unfortunate that the FDA seeks to associate the alleged contamination in COA FS to kidney failure. 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”.

The statement added: “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 Subsequently, we ran a microbial test for the identified samples with batch numbers CFS00003 and CFS00004 on our reference samples from the microbiology laboratory of the Cape Coast Teaching Hospital. The result of the microbial test does not disclose contamination by Yeast, Mould and E-Coli as indicated in the FDA press statement.

“We are currently conducting similar tests on the above batches in other independent laboratories. We expect the results soon. The outcome will also be communicated to the general public. It therefore cannot be the case that COA FS produced by the COA Herbal Center are contaminated”.

The statement, however, noted they are willing to work with the FDA to resolve the impasse.

“We, therefore, wish to assure our distributors, agents, clients and the general public that we will not rest on our oars until all due processes are exhausted. We, therefore, wish to assure the general public that in as much as we disagree with the FDA, we are committed to working with them as the regulator to address any concerns they may have.”

Source: Ghana/Starrfm.com.gh