Our products not contaminated - COA FS responds to FDA

Producers of wonder food supplement, COA FS drug, Centre of Awareness Global Peace Mission, has hit back at the Food and Drug Authority (FDA) that its products are contaminated.

COA FS

The FDA warned consumers of COA FS products and asked them to return all purchased products to the manufacturer citing reasons that samples picked from the company and the market, indicated that it was not safe for consumption.

A statement signed by the Chief Executive Officer of the FDA, Mrs. Delese Mimi Darko, further claimed that checks revealed that the food supplement contains Escherichia coli, a type of bacteria that normally lives in the intestines.

"Testing of samples of the product in Cape Coast also revealed “excessive microbial, mold and yeast contamination," the FDA stated.

However, the company has debunked the claims made by the FDA.

In a statement, the company said the product is produced by a unique biotransformation and extraction technique at high temperature and pressure for which reason the product is as clear as water but highly aromatic.

"In spite of our doubts of the claim, subsequently, we ran a microbial test for the identified samples with batch numbers CFA00003 and CFS00004 on our reference samples from the 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.

"We are proud to say COA FS since its inception by the FDA in 2016 has passed all microbial tests. The anti-microbial activity has been experimentally confirmed," it added.

Here's the full statement below:

RE: PRODUCT RECALL – COA FS

We write in relation to the Press Statement issued by the Food and Drug Authority “FDA”, Ghana dated on the 18th April 2020, which is circulating in the media under the above subject.

We wish to state that COA FS is produced by 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 active ingredients in COA FS as revealed by independent scientific investigations using GCMS and LCMS conducted in the Kwazulu Natal University of South Africa, and recently by the Ghana Standards Authority indicates a wide range of bioactive compounds ranging from anti-cancer, anti-bacterial, anti-fungal and anti-viral properties.

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. COA FS does not contain any artificial preservatives due to the broad range of anti-microbial activities mentioned above.

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.

We, therefore, find the Press Statement from the FDA that they detected 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 problems, but the FDA has not provided any data to prove that this particular strain has been found in COA FS.

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 is contaminated.

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, 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.

It is in the spirit of growing together in a turbulent industry like ours, that we will urge all our media partners not to hesitate in asking much-needed questions to freely educate all and sundry to clear all doubts in the minds of right-thinking people. Our doors shall remain open to see all test results and relevant correspondence to ensure transparency and investor confidence.

ISSUED BY THE CENTER OF AWARENESS (COA) HERBAL CENTER, WUSORKROM, CAPE COAST

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