COA FS Challenges FDA Over Product Contamination

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The Centre of Awareness (COA) Herbal Centre, producers of COA FS immune support food supplement, says a recent microbial test conducted at the Cape Coast Teaching Hospital has revealed that none of its products is contaminated.

Reacting to the Food and Drugs Authority’s (FDA) directive for the Centre to recall its COA FS products from the market, citing contamination, the Centre said microbiology test of its products did not support contamination of any of its products.

It said the initial result of the test of the identified samples with batch numbers CFS00003 and CFS00004 “on our reference samples from the microbiology laboratory of the Cape Coast Teaching Hospital, does not disclose contamination of Yeast, Mould and E-Coli as stated in the FDA press statement.”

A statement signed by Deladem Kisseih, Public Relations Officer of the Centre, and copied to the Ghana News Agency, added that it was currently conducting similar tests on the above batches in other independent laboratories and “the outcome will also be communicated to the public.”

In the FDA’s directive directing the COA Herbal Centre to recall its product, “COA FS”, it said a contamination caused by the presence of excessive microbial, mold and yeast as well as Escherichia Coli (E. Coli), was detected when the FDA conducted a laboratory analysis on samples picked from the market and the manufacturing facility of COA Herbal Centre in Wusorkrom near Cape Coast.

However, the Centre in its response has explained 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 and 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 indicated a wide range of bioactive compounds ranging from anti-cancer, anti-bacterial, anti -fungal and anti-viral properties, it stated.

It added, “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. The Centre said since its registration by the FDA in 2016, the COA FS had passed all microbial tests and its anti-microbial activity has been “experimentally confirmed”.

“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”. It said contrary to the claims by the FDA, the evidence rather revealed that people with weakened immune systems and or kidney malfunctions, rather got better after taking COA FS.

The statement said, “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.

” It said as law abiding citizens, the Centre decided to issue a withdrawal notice of its product, in spite of its doubts of the claim, when the FDA on the 9th of April 2020 drew it attention to the supposed contamination.

That notwithstanding, the Centre assured its distributors, agents, clients and the public that it would not rest on its oars until all due processes were exhausted. “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 said.

 

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