Our product is not contaminated – COA FS … questions FDA’s motive after earlier approving drug for 2020

0

COA Herbal Centre, producer of COA FS – a dietary supplement which supports the immune system to naturally treat and prevent deadly diseases – has hit back at the Food and Drug Authority (FDA), saying their drug is not contaminated.  

According to the company, it is surprising that a product which has received certification from the FDA for the 2020 production year should all of a sudden be tagged as contaminated while it continues to produce the product under unchanged conditions.

The company said in a press statement: “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 Kwazulu Natal University of South Africa, and recently by the Ghana Standards Authority, indicate a wide range of bioactive compounds ranging from anti-cancer, anti-bacterial, anti-fungal and anti-viral properties,” the statement said.

The statement added that: “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.”

The company says it therefore finds the press statement from the FDA that they detected a microbial contamination in COA FS surprising. According to the company, “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 claims in the press statement, the evidence rather indicates that people with weakened immune systems and/or kidney malfunctions 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.”

COA Herbal Centre believes “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.”

The company said nonetheless it is “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 Centre is contaminated.”

The company has assured distributors, agents, clients and the general public that they will not rest on their oars until all due processes are exhausted.

Even though they company strongly disagrees with the FDA, it has assured the general public that it is committed to working with the FDA as the regulator to address any concern.

“It is in the spirit of growing together in a turbulent industry as ours that we 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,” the statement ended.

LEAVE A REPLY

Please enter your comment!
Please enter your name here